Publications by authors named "Megan A Lewis"

94 Publications

Examining Information Needs of Heart Failure Patients and Family Companions using a Pre-Visit Question Prompt List and Audiotaped Data: Findings from a Pilot Study.

J Card Fail 2021 Nov 21. Epub 2021 Nov 21.

University of North Carolina, Chapel Hill, USA; Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, USA. Electronic address:

Background: Question prompt lists (QPLs) are an effective tool for improving communication during medical visits. However, no studies have attempted to correlate intentions related to question asking and actual questions asked during visits. Moreover, few studies have used QPLs with patients with Heart Failure (HF) or family companions who accompany them to visits. We examined the usage of a pre-visit QPL for patients with HF and their family companions intended to enhance engagement in HF care. The aim of this research was to assess which questions from the QPL patients and companions selected most frequently to ask and compare this to which questions were actually asked during the medical visit.

Methods: This is a secondary analysis of question prompt list and audiotaped visit data from a pilot study which enrolled and consented HF patients, family companions, and heart failure clinicians. A single group of 30 HF patients and 23 family companions received the QPL to complete in the waiting room immediately before their cardiology visit. To meet our aims, we calculated frequencies for each question selected and asked from the QPL, using data derived from completed prompt lists and audiotaped medical visits. A follow-up survey was administered 2 days after the appointment to assess differences in how participants filled out and used the prompt list.

Results: Patients and companions primarily selected and asked questions from the QPL regarding management and treatment of the disease, general questions about HF, and questions about prognosis. Participants rarely asked questions about support for family and friends or healthcare team roles and responsibilities. Patients and companions did not ask many of the questions they reported wanting to ask.

Conclusion: Prompt lists may empower patients and companions to communicate with their clinician by identifying important questions to help overcome patients' and companions' knowledge gaps. More research is needed to understand the true impact of prompt lists on patient-family-clinician communication and subsequent HF outcomes, and how best to implement them in clinical workflows to increase their potential utility.
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http://dx.doi.org/10.1016/j.cardfail.2021.11.012DOI Listing
November 2021

Problem-solving therapy-induced amygdala engagement mediates lifestyle behavior change in obesity with comorbid depression: a randomized proof-of-mechanism trial.

Am J Clin Nutr 2021 Sep 2. Epub 2021 Sep 2.

Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.

Background: Depression hinders obesity treatment; elucidating mechanisms may enable treatment enhancements.

Objectives: The aim was to investigate whether changes in neural targets in the negative affect circuit following psychotherapy mediate subsequent changes in weight and behaviors.

Methods: Adults (n = 108) with obesity and depression were randomly assigned to usual care or an intervention that delivered problem-solving therapy (PST) for depression over 2 mo. fMRI for brain imaging was performed at baseline and 2 mo. BMI, physical activity, and diet were measured at baseline and 12 mo. Mediation analysis assessed between-group differences in neural target changes using t test and correlations between neural target changes and outcome changes (simple and interaction effect) using ordinary least-squares regression.

Results: Compared with usual care, PST led to reductions in left amygdala activation (-0.75; 95% CI: -1.49, -0.01) and global scores of the negative affect circuit (-0.43; -0.81, -0.06), engaged by threat stimuli. Increases in amygdala activation and global circuit scores at 2 mo correlated with decreases in physical activity outcomes at 12 mo in the usual-care group; these relations were altered by PST. In relation to change in leisure-time physical activity, standardized β-coefficients were -0.67 in usual care and -0.01 in the intervention (between-group difference: 0.66; 0.02, 1.30) for change in left amygdala activation and -2.02 in usual care and -0.11 in the intervention (difference: 1.92; 0.64, 3.20) for change in global circuit scores. In relation to change in total energy expenditure, standardized β-coefficients were -0.65 in usual care and 0.08 in the intervention (difference: 0.73; 0.29, 1.16) for change in left amygdala activation and -1.65 in usual care and 0.08 in the intervention (difference: 1.74; 0.85, 2.63) for change in global circuit scores. Results were null for BMI and diet.

Conclusions: Short-term changes in the negative affect circuit engaged by threat stimuli following PST for depression mediated longer-term changes in physical activity. This trial was registered at www.clinicaltrials.gov as NCT02246413 (https://clinicaltrials.gov/ct2/show/NCT02246413).
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http://dx.doi.org/10.1093/ajcn/nqab280DOI Listing
September 2021

Seeking a pot of gold with integrated behavior therapy and research to improve health equity: insights from the RAINBOW trial for obesity and depression.

Transl Behav Med 2021 09;11(9):1691-1698

Department of Medicine and Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.

More than one third of adults in the United States (U.S.) live with multiple chronic conditions that affect their physical and mental health, functional outcomes, independence, and mortality. The COVID-19 pandemic has exposed not only an increased risk for infection, morbidity, and mortality among those with chronic conditions but long-standing health inequities by age, race, sex, and other social determinants. Obesity plus depression represent one such prevalent comorbidity for which few effective integrated interventions exist, prompting concern about the potential for secondary physical and mental health pandemics post COVID-19. Translational behavioral medicine research can play an important role in studying integrated collaborative healthcare approaches and advancing scientific understanding on how to engage and more effectively treat diverse populations with physical and mental health comorbidities. The RAINBOW (Research Aimed at Improving Both Mood and Weight) clinical trial experience offers a wealth of insights into the potential of collaborative care interventions to advance behavior therapy research and practice. Primary care patients with co-occurring obesity and depression were assigned to either Integrated Coaching for Mood and Weight (I-CARE), which blended Group Lifestyle Balance (GLB) for weight management and the Program to Encourage Active Rewarding Lives (PEARLS) for depression, or usual care, to examine clinical, cost-effectiveness, and implementation outcomes. This commentary highlights the empirical findings of eight RAINBOW research papers and discusses implications for future studies, including their relevance in the U.S. COVID-19 context. Organized by key principles of translational behavioral medicine research, the commentary aims to examine and embrace the heterogeneity of baseline and intervention response differences among those living with multiple chronic conditions. We conclude that to prevent health and healthcare disparities from widening further, tailored engagement, dissemination, and implementation strategies and flexible delivery formats are essential to improve treatment access and outcomes among underrepresented populations.
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http://dx.doi.org/10.1093/tbm/ibab069DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8344914PMC
September 2021

Early changes in neural circuit function engaged by negative emotion and modified by behavioural intervention are associated with depression and problem-solving outcomes: A report from the ENGAGE randomized controlled trial.

EBioMedicine 2021 May 17;67:103387. Epub 2021 May 17.

Stanford University, Stanford, CA, United States; Sierra-Pacific Mental Illness Research, Education, and Clinical Center (MIRECC) Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, United States. Electronic address:

Background: Depression exerts a staggering toll that is worsened with co-occurring chronic conditions such as obesity. It is imperative to develop more effective interventions for depression and to identify objective and biological plausible neural mechanisms to understand intervention outcomes. The current study uses functional neuroimaging to determine whether a behavioural intervention changes the negative affect circuit and whether these changes relate to subsequent improvements in both symptom and problem-solving outcomes in depressed patients with co-occurring obesity.

Methods: This study ('ENGAGE') was a pre-planned element of the randomized controlled trial, 'RAINBOW' (ClinicalTrials.gov NCT02246413). 108 depressed patients with obesity were randomized to receive an integrated collaborative care intervention (I-CARE) or usual care. Participants underwent functional neuroimaging using an established facial emotion task at baseline and two months (coinciding with the first two months of intervention focused on problem-solving therapy ('PST')). Amygdala, insula and anterior cingulate cortex activation was extracted using pre-planned definitions and standardized methods. The primary health and behavioural outcomes were depression symptom severity and problem-solving ability respectively, assessed at baseline, the main 6-month outcome point and at 12-month follow up. Mediation analyses used an intent-to-treat approach.

Findings: PST, relative to usual care, reduced amygdala activation engaged by threat stimuli at two months. This reduction mediated subsequent improvements in depression severity in an intervention-dependent manner. PST did not change insula activation at two months but did temper the strength of the relationship between insula activation and improvements in problem-solving ability.

Interpretation: The negative affect circuit may be an important neural target and potential mediator of PST in patients with comorbid obesity.

Funding: US National Institutes of Health/National Heart Lung and Blood Institute R01 HL119453 and UH2/UH3 HL132368.
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http://dx.doi.org/10.1016/j.ebiom.2021.103387DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141669PMC
May 2021

Challenges of and Solutions for Developing Tailored Video Interventions That Integrate Multiple Digital Assets to Promote Engagement and Improve Health Outcomes: Tutorial.

JMIR Mhealth Uhealth 2021 03 23;9(3):e21128. Epub 2021 Mar 23.

Translational Health Sciences Division, Research Triangle International, Seattle, WA, United States.

Background: Video is a versatile and popular medium for digital health interventions. As mobile device and app technology advances, it is likely that video-based interventions will become increasingly common. Although clinic waiting rooms are complex and busy environments, they offer the opportunity to facilitate engagement with video-based digital interventions as patients wait to see their providers. However, to increase efficiency in public health, leverage the scalability and low cost of implementing digital interventions, and keep up with rapidly advancing technology and user needs, more design and development guidance is needed for video-based tailored interventions.

Objective: We provide a tutorial for digital intervention researchers and developers to efficiently design and develop video-based tailored digital health interventions. We describe the challenges and solutions encountered with Positive Health Check (PHC), a hybrid app used to deliver a brief, interactive, individually tailored video-based HIV behavioral counseling intervention. PHC uses video clips and multimedia digital assets to deliver intervention content, including interactive tailored messages and graphics, a repurposed animated video, and patient and provider handouts generated in real time by PHC.

Methods: We chronicle multiple challenges and solutions for the following: (1) using video as a medium to enhance user engagement, (2) navigating the complexity of linking a database of video clips with other digital assets, and (3) identifying the main steps involved in building an app that will seamlessly deliver to users individually tailored messages, graphics, and handouts.

Results: We leveraged video to enhance user engagement by featuring "video doctors," full-screen video, storyboards, and streamlined scripts. We developed an approach to link the database of video clips with other digital assets through script coding and flow diagrams of algorithms to deliver a tailored user experience. We identified the steps to app development by using keyframes to design the integration of video and digital assets, using agile development methods to gather iterative feedback from multidisciplinary teams, and creating an intelligent data-driven back-end solution to tailor message delivery to individual users.

Conclusions: Video-based digital health interventions will continue to play an important role in the future of HIV prevention and treatment, as well as other clinical health practices. However, facilitating the adoption of an HIV video intervention in HIV clinical settings is a work in progress. Our experience in designing and developing PHC presented unique challenges due to the extensive use of a large database of videos tailored individually to each user. Although PHC focuses on promoting the health and well-being of persons with HIV, the challenges and solutions presented in this tutorial are transferable to the design and development of video-based digital health interventions focused on other areas of health.
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http://dx.doi.org/10.2196/21128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8294466PMC
March 2021

Using RE-AIM to examine the potential public health impact of an integrated collaborative care intervention for weight and depression management in primary care: Results from the RAINBOW trial.

PLoS One 2021 11;16(3):e0248339. Epub 2021 Mar 11.

Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, IL, United States of America.

Background: An integrated collaborative care intervention was used to treat primary care patients with comorbid obesity and depression in a randomized clinical trial. To increase wider uptake and dissemination, information is needed on translational potential.

Methods: The trial collected longitudinal, qualitative data at baseline, 6 months (end of intensive treatment), 12 months (end of maintenance treatment), and 24 months (end of follow-up). Semi-structured interviews (n = 142) were conducted with 54 out of 409 randomly selected trial participants and 37 other stakeholders, such as recruitment staff, intervention staff, and clinicians. Using a Framework Analysis approach, we examined themes across time and stakeholder groups according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework.

Results: At baseline, participants and other stakeholders reported being skeptical of the collaborative care approach related to some RE-AIM dimensions. However, over time they indicated greater confidence regarding the potential for future public health impact. They also provided information on barriers and actionable information to enhance program reach, effectiveness, adoption, implementation, and maintenance.

Conclusions: RE-AIM provided a useful framework for understanding how to increase the impact of a collaborative and integrative approach for treating comorbid obesity and depression. It also demonstrates the utility of using the framework as a planning tool early in the evidence-generation pipeline.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0248339PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7951877PMC
October 2021

Sex Moderates Treatment Effects of Integrated Collaborative Care for Comorbid Obesity and Depression: The RAINBOW RCT.

Ann Behav Med 2021 Nov;55(12):1157-1167

Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, IL, USA.

Background: Sex influences health and related behaviors due to biological and psychosocial/socioeconomic factors. Assessing sex-specific responses to integrated treatment for comorbid obesity and depression could inform intervention targeting.

Purpose: To test (a) whether sex moderates the effects of integrated collaborative care on weight and depression outcomes through 24 months and (b) whether treatment response at 6 months predicts 12 and 24 month outcomes by sex.

Methods: Secondary data analyses on weight and depression severity (SCL-20) measured over 24 months among 409 adults with obesity and depression in the Research Aimed at Improving Both Mood and Weight trial.

Results: Men achieved significantly greater weight reductions in intervention versus usual care than women, whereas women achieved significantly greater percentage reductions in SCL-20 than men at both 12 and 24 months. In logistic models, at 80% specificity for correctly identifying participants not achieving clinically significant long-term outcomes, women who lost <3.0% weight and men who lost <4.1% weight at 6 months had ≥84% probability of not meeting 5% weight loss at 24 months. Similarly, at 80% specificity, women who reduced SCL-20 by <39.5% and men who reduced by <53.0% at 6 months had ≥82% probability of not meeting 50% decrease in SCL-20 at 24 months.

Conclusions: Sex modified the integrated treatment effects for obesity and depression. Sex-specific responses at 6 months predicted clinically significant weight loss and depression outcomes through 24 months. Based on early responses, interventions may need to be tailored to address sex-specific barriers and facilitators to achieving healthy weight and depression outcomes at later time points.

Clinical Trial Registration: NCT02246413 (https://clinicaltrials.gov/ct2/show/NCT02246413).
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http://dx.doi.org/10.1093/abm/kaaa125DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8601047PMC
November 2021

Outreach to new mothers through direct mail and email: recruitment in the Early Check research study.

Clin Transl Sci 2021 05 13;14(3):880-889. Epub 2021 Feb 13.

RTI International, Research Triangle Park, North Carolina, USA.

Meeting recruitment targets for clinical trials and health research studies is a notable challenge. Unsuccessful efforts to recruit participants from traditionally underserved populations can limit who benefits from scientific discovery, thus perpetuating inequities in health outcomes and access to care. In this study, we evaluated direct mail and email outreach campaigns designed to recruit women who gave birth in North Carolina for a statewide research study offering expanded newborn screening for a panel of rare health conditions. Of the 54,887 women who gave birth in North Carolina from September 28, 2018, through March 19, 2019, and were eligible to be included on the study's contact lists, we had access to a mailing address for 97.9% and an email address for 6.3%. Rural women were less likely to have sufficient contact information available, but this amounted to less than a one percentage point difference by urbanicity. Native American women were less likely to have an email address on record; however, we did not find a similar disparity when recruitment using direct-mail letters and postcards was concerned. Although we sent letters and emails in roughly equal proportion by urbanicity and race/ethnicity, we found significant differences in enrollment across demographic subgroups. Controlling for race/ethnicity and urbanicity, we found that direct-mail letters and emails were effective recruitment methods. The enrollment rate among women who were sent a recruitment letter was 4.1%, and this rate increased to 5.0% among women who were also sent an email invitation. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? Under-representation by traditionally underserved populations in clinical trials and health research is a challenge that may in part reflect inequitable opportunities to participate. WHAT QUESTION DID THIS STUDY ADDRESS? Are direct-mail and email outreach strategies effective for reaching and recruiting women from traditionally underserved and rural populations to participate in large-scale, population-based research? WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? Despite sending recruitment letters and email invitations in roughly equal proportion by urbanicity and race/ethnicity, women living in rural areas were less likely to enroll (2.8%) than women from urban areas (4.2%). Additionally, enrollment rates decreased as the probability that women were members of a racial or ethnic minority group increased. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? Results from this study might encourage researchers to take a holistic and participant-centered view of barriers to study enrollment that may disproportionately affect underserved communities, including differences in willingness to participate, trust, and access to resources needed for uptake.
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http://dx.doi.org/10.1111/cts.12950DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8212727PMC
May 2021

Effect of a Culturally Adapted Behavioral Intervention for Latino Adults on Weight Loss Over 2 Years: A Randomized Clinical Trial.

JAMA Netw Open 2020 12 1;3(12):e2027744. Epub 2020 Dec 1.

Vitoux Program on Aging and Prevention, Department of Medicine, University of Illinois at Chicago, Chicago.

Importance: Identifying effective weight loss interventions for Latino adults at risk of diabetes is of critical public health importance.

Objective: To determine whether a culturally adapted behavioral intervention for Latino adults was more effective than usual care for weight loss over 24 months.

Design, Setting, And Participants: In this randomized clinical trial, Latino adults with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 24 or greater and a high risk for type 2 diabetes were recruited in primary care practices in the San Francisco, California, area, randomized to receive the Vida Sana intervention or usual care, and followed up for 24 months. The study was conducted from November 2015 to May 2019, and data were analyzed from July 2019 to Septmeber 2020.

Interventions: The treatment group received Vida Sana, a culturally adapted lifestyle intervention that included a family-based orientation session and 22 group sessions over 12 months. Participants were encouraged to use a wearable activity tracker and mobile applications to track their physical activity and dietary intake. Participants received monthly email messages for an additional 12 months. The control group received usual care.

Main Outcomes And Measures: The primary outcome was weight loss at 24 months. Secondary outcomes included weight loss at 12 months and achieving at least 5% weight loss at 12 and 24 months. Associations of baseline characteristics and intervention adherence with weight loss outcomes were also examined.

Results: Among 191 participants (mean [SD] age, 50.2 [12.2] years; 118 [61.8%] women; 107 participants [57.2%] of Mexican origin; mean [SD] baseline BMI, 32.4 [5.7]) randomized, 92 participants were randomized to the intervention and 99 participants were randomized to usual care. Of these, 185 participants (96.9%) completed 24-month follow-up. Mean (SD) weight loss did not differ significantly by group at 24 months (intervention: -1.1 [5.7] kg; control: -1.1 [7.1] kg; P = .93). However, mean (SD) weight loss was significantly greater in the intervention group (-2.6 [6.0] kg) than the control group (-0.3 [4.2] kg) at 12 months (mean difference, -2.1 [95% CI, -3.6 to -0.7] kg; P = .005). Intervention participants were more likely to achieve at least 5% weight loss than control participants at 12 months (22 participants [25.9%] vs 9 participants [9.2%]; P = .003), and participants who achieved at least 5% weight loss attended more intervention sessions than those who did not (mean [SD], 16.6 [7.6] sessions vs 12.4 [7.5] sessions; P = .03).

Conclusions And Relevance: These findings suggest that among Latino adults with high diabetes risk, a culturally adapted behavioral lifestyle intervention was effective for weight loss over 12 months but not 24 months.

Trial Registration: ClinicalTrials.gov Identifier: NCT02459691.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.27744DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7749441PMC
December 2020

Genomic Sequencing for Newborn Screening: Results of the NC NEXUS Project.

Am J Hum Genet 2020 10 26;107(4):596-611. Epub 2020 Aug 26.

Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA. Electronic address:

Newborn screening (NBS) was established as a public health program in the 1960s and is crucial for facilitating detection of certain medical conditions in which early intervention can prevent serious, life-threatening health problems. Genomic sequencing can potentially expand the screening for rare hereditary disorders, but many questions surround its possible use for this purpose. We examined the use of exome sequencing (ES) for NBS in the North Carolina Newborn Exome Sequencing for Universal Screening (NC NEXUS) project, comparing the yield from ES used in a screening versus a diagnostic context. We enrolled healthy newborns and children with metabolic diseases or hearing loss (106 participants total). ES confirmed the participant's underlying diagnosis in 15 out of 17 (88%) children with metabolic disorders and in 5 out of 28 (∼18%) children with hearing loss. We discovered actionable findings in four participants that would not have been detected by standard NBS. A subset of parents was eligible to receive additional information for their child about childhood-onset conditions with low or no clinical actionability, clinically actionable adult-onset conditions, and carrier status for autosomal-recessive conditions. We found pathogenic variants associated with hereditary breast and/or ovarian cancer in two children, a likely pathogenic variant in the gene associated with Lowe syndrome in one child, and an average of 1.8 reportable variants per child for carrier results. These results highlight the benefits and limitations of using genomic sequencing for NBS and the challenges of using such technology in future precision medicine approaches.
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http://dx.doi.org/10.1016/j.ajhg.2020.08.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7536575PMC
October 2020

Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss.

Contemp Clin Trials 2020 09 1;96:106092. Epub 2020 Aug 1.

Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Box 90399, Durham, NC 27708, USA.

Background: Behavioral interventions produce clinically significant weight reduction, with many participants regaining weight subsequently. Most interventions focus on an individual, but dietary and physical activity behaviors occur with, or are influenced by, domestic partners. According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change. We utilized interdependence theory to develop a partner-assisted intervention to increase long-term weight loss.

Methods: Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity are randomized to participate in a standard weight management program alone or with their partner. The weight management program involves biweekly, in-person, group sessions focusing on weight loss for six months, followed by three group sessions and nine telephone calls focusing on weight loss maintenance for twelve months. In the partner-assisted arm, partners participate in half of the group sessions and telephone calls. Couples receive training in principles of cognitive behavioral therapy for couples, including sharing thoughts and feelings and joint problem solving, to increase communal coping. The primary outcome is participant weight loss at 24 months, with caloric intake and moderate-intensity physical activity as secondary outcomes. Partner weight and caloric intake will also be analyzed. Mediation analyses will examine the role of interdependence variables and social support.

Discussion: This trial will provide knowledge about effective ways to promote long-term weight loss and the role of interdependence constructs in weight loss. Clinical trials identifier: NCT03801174.
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http://dx.doi.org/10.1016/j.cct.2020.106092DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395658PMC
September 2020

Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care.

Contemp Clin Trials 2020 09 29;96:106097. Epub 2020 Jul 29.

Rutgers New Jersey Medical School, Newark, NJ, United States of America.

For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people with HIV in health care. Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only. The primary aim is to determine the effectiveness of the intervention. A second aim is to understand the implementation potential of the intervention in clinic workflows, and a third aim is to assess the costs of intervention implementation. The trial findings will have important real-world applicability for understanding how digital interventions that take the form of video doctors can be used to decrease viral load and to support retention in care among diverse patients attending HIV primary care clinics.
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http://dx.doi.org/10.1016/j.cct.2020.106097DOI Listing
September 2020

Identifying Implementation Strategies That Address Barriers and Facilitate Implementation of Digital Interventions in HIV Primary Care Settings: Results from the Pilot Implementation of Positive Health Check.

AIDS Behav 2021 Jan;25(1):154-166

RTI International, 119 S. Main St., Suite 220, Seattle, WA, 98104, USA.

We used the 1-month pilot implementation of Positive Health Check, a brief web-based video counseling intervention that supports patients with HIV attending HIV primary care clinics, to exemplify how studying implementation strategies earlier in the evidence-generation process can improve implementation outcomes in later pragmatic trials. We identified how implementation strategies were operationalized and the barriers and facilitators these strategies addressed using multiple data sources, including adapted implementation procedures and weekly structured interviews conducted with 9 key stakeholders in 4 HIV primary care clinics. Nineteen of 73 discrete implementation strategies for clinical innovations were used in the pilot implementation of Positive Health Check. Clinic staff reported 17 barriers and facilitators related to the clinic environment, patient population, intervention characteristics, and training and technical assistance. Identifying the link between strategies, barriers, and facilitators helped plan for a subsequent larger multisite pragmatic trial.
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http://dx.doi.org/10.1007/s10461-020-02944-9DOI Listing
January 2021

Parental Views on Newborn Next Generation Sequencing: Implications for Decision Support.

Matern Child Health J 2020 Jul;24(7):856-864

Center for Communication Science, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA.

Objective: This study aimed to understand parental decisions, perspectives, values, and beliefs on next generation sequencing in the newborn period (NGS-NBS) to inform the development of a decision aid to support parental decision making in the North Carolina Newborn Exome Sequencing for Universal Screening study.

Methods: We conducted dyadic interviews with 66 current or expectant parents (33 couples) to understand overall decisions about NGS-NBS and reasons for and against learning NGS-NBS results differing by age of onset and medical actionability. Audio recordings were transcribed, coded, and analyzed using qualitative framework analyses.

Results: Favorable views of NGS-NBS included benefits of early intervention, preparedness, child autonomy, and altruism. Unfavorable views were the potential negative effects from early intervention, psychosocial harm, and religious beliefs. Parents universally reported quality of life as important.

Conclusion: Interviews elucidated what is important in deciding to have NGS-NBS. Understanding parental perspectives, values, and beliefs and integrating evidence-based findings into a parent-centric decision aid provides value and support in making decisions related to NGS-NBS, where there is no clear course of action.
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http://dx.doi.org/10.1007/s10995-020-02953-zDOI Listing
July 2020

First-Year Economic and Quality of Life Effects of the RAINBOW Intervention to Treat Comorbid Obesity and Depression.

Obesity (Silver Spring) 2020 06 22;28(6):1031-1039. Epub 2020 Apr 22.

Division of Academic Internal Medicine and Geriatrics, Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA.

Objective: Obesity and depression are prevalent and often co-occurring conditions in the United States. The Research Aimed at Improving Both Mood and Weight (RAINBOW) randomized trial demonstrated the effectiveness of an integrated intervention for adults with both conditions. Characterizing the intervention's economic effects is important for broader dissemination and implementation.

Methods: This study evaluated the cost (2018 US dollars) and health-related quality of life (HRQoL) impacts during RAINBOW's first year, comparing intervention (n = 204) and usual-care groups (n = 205). Outcomes included intervention delivery costs, differential changes in antidepressant medication spending compared with the pretrial year, differential changes in medical services spending compared with the pretrial year, and HRQoL changes from baseline using Euroqol-5D US utility weights.

Results: RAINBOW's 1-year delivery cost per person was $2,251. Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027). Annual antidepressant medication spending had a larger, nonsignificant increase ($89 [95% CI: -$20 to $197]; P = 0.109). Annual spending on medical care services had a smaller, nonsignificant decrease (-$54 [95% CI: -$832 to $941]; P = 0.905). HRQoL had a nonsignificant increase (0.011 [95% CI: -0.025 to 0.047]; P = 0.546).

Conclusions: The RAINBOW intervention's economic value will depend on how its 1-year improvements in obesity and depression translate into long-term reduced morbidity, delayed mortality, or averted costs.
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http://dx.doi.org/10.1002/oby.22805DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7245568PMC
June 2020

Variability in engagement and progress in efficacious integrated collaborative care for primary care patients with obesity and depression: Within-treatment analysis in the RAINBOW trial.

PLoS One 2020 21;15(4):e0231743. Epub 2020 Apr 21.

Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois, United States of America.

Introduction: The RAINBOW randomized clinical trial validated the efficacy of an integrated collaborative care intervention for obesity and depression in primary care, although the effect was modest. To inform intervention optimization, this study investigated within-treatment variability in participant engagement and progress.

Methods: Data were collected in 2014-2017 and analyzed post hoc in 2018. Cluster analysis evaluated patterns of change in weekly self-monitored weight from week 6 up to week 52 and depression scores on the Patient Health Questionnaire-9 (PHQ-9) from up to 15 individual sessions during the 12-month intervention. Chi-square tests and ANOVA compared weight loss and depression outcomes objectively measured by blinded assessors to validate differences among categories of treatment engagement and progress defined based on cluster analysis results.

Results: Among 204 intervention participants (50.9 [SD, 12.2] years, 71% female, 72% non-Hispanic White, BMI 36.7 [6.9], PHQ-9 14.1 [3.2]), 31% (n = 63) had poor engagement, on average completing self-monitored weight in <3 of 46 weeks and <5 of 15 sessions. Among them, 50 (79%) discontinued the intervention by session 6 (week 8). Engaged participants (n = 141; 69%) self-monitored weight for 11-22 weeks, attended almost all 15 sessions, but showed variable treatment progress based on patterns of change in self-monitored weight and PHQ-9 scores over 12 months. Three patterns of weight change (%) represented minimal weight loss (n = 50, linear β1 = -0.06, quadratic β2 = 0.001), moderate weight loss (n = 61, β1 = -0.28, β2 = 0.002), and substantial weight loss (n = 12, β1 = -0.53, β2 = 0.005). Three patterns of change in PHQ-9 scores represented moderate depression without treatment progress (n = 40, intercept β0 = 11.05, β1 = -0.11, β2 = 0.002), moderate depression with treatment progress (n = 20, β0 = 12.90, β1 = -0.42, β2 = 0.006), and milder depression with treatment progress (n = 81, β0 = 7.41, β1 = -0.23, β2 = 0.003). The patterns diverged within 6-8 weeks and persisted throughout the intervention. Objectively measured weight loss and depression outcomes were significantly worse among participants with poor engagement or poor progress on either weight or PHQ-9 than those showing progress on both.

Conclusions: Participants demonstrating poor engagement or poor progress could be identified early during the intervention and were more likely to fail treatment at the end of the intervention. This insight could inform individualized and timely optimization to enhance treatment efficacy.

Trial Registration: ClinicalTrials.gov# NCT02246413.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0231743PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7173791PMC
July 2020

Understanding mechanisms of integrated behavioral therapy for co-occurring obesity and depression in primary care: a mediation analysis in the RAINBOW trial.

Transl Behav Med 2021 03;11(2):382-392

Department of Medicine, College of Medicine, University of Illinois at Chicago, Chicago, IL.

The RAINBOW trial demonstrated that an integrated collaborative care intervention was effective for improving weight and depression. This study examined mediation of the treatment effect by a priori specified lifestyle behaviors and cognitive functioning. Participants were randomized to a 12-month integrated intervention (n = 204) or usual care (n = 205). Body mass index (BMI) and 20-item Depression Symptom Check List (SCL-20) were co-primary outcomes (Y). To examine mediation, we assessed (a) the effect of the integrated intervention (X) on lifestyle behaviors (diet and physical activity) and cognitive functioning (problem-solving; M, X→M path a) and (b) the association of these behaviors with BMI and SCL-20 (M→Y path b). Mediation existed if paths a and b were significant or if path a and the product of coefficients test (paths a and b) were significant. Compared with usual care, the intervention led to significant improvements in leisure time physical activity (201.3 MET minutes/week [SD, 1,457.6]) and total calorie intake (337.4 kcal/day [818.3]) at 6 months but not 12 months (path a). These improvements were not significantly associated with improvements in BMI or SCL-20 (path b). However, avoidant problem-solving style score and increased fruit and vegetable intake significantly correlated with improvements in BMI at 6 and 12 months, respectively. Also, increased fruit and vegetable intake, higher dietary quality, and better problem-solving abilities significantly correlated with improvements in SCL-20 at 6 and 12 months. These findings did not support the hypothesized mediation, but suggest lifestyle behaviors and cognitive functioning to target in future intervention optimization.
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http://dx.doi.org/10.1093/tbm/ibaa024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7963297PMC
March 2021

Using 360-Degree Video as a Research Stimulus in Digital Health Studies: Lessons Learned.

JMIR Serious Games 2020 Jan 6;8(1):e15422. Epub 2020 Jan 6.

Center for Communication Science, RTI International, Research Triangle Park, NC, United States.

Due to the accessibility of omnidirectional cameras to record 360-degree videos and the technology to view the videos via mobile phones and other devices, 360-degree videos are being used more frequently to place people in different contexts and convey health-related information. Increasingly, 360-degree videos are being employed in health marketing because they have the potential to enhance health-related attitudes and behaviors. As a case study on how this technology may be used for health-related information and its effect on health care providers, we created a 360-degree video that portrays the experience of a migraine sufferer to be used as a stimulus in an online study. We describe the challenges and lessons learned in designing and implementing a 360-degree video as part of an online experiment focused on inducing empathy among clinicians for understanding patient experience. Given the rapid change in digital technology, future research can use this knowledge to design and implement 360-degree video studies more effectively.
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http://dx.doi.org/10.2196/15422DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6971508PMC
January 2020

Values clarification and parental decision making about newborn genomic sequencing.

Health Psychol 2020 Apr 30;39(4):335-344. Epub 2019 Dec 30.

Center for Communication Science.

Objective: Using an online decision aid developed to support parental decision making about newborn genomic sequencing, we tested whether adding a values clarification exercise to educational content would improve decision making outcomes and influence intention to pursue genomic sequencing. We also examined whether the effect of values clarification varied depending on one's health literacy level.

Method: In an online experiment, women and men aged 18 to 44 who were either pregnant or had a pregnant partner, were currently trying to get pregnant, or were preparing for a pregnancy within the next 2 years were randomly assigned to complete either a decision aid with educational information about newborn genomic sequencing or a decision aid with the same educational information and a values clarification exercise.

Results: Of the 1,000 participants who completed the decision aid, those who completed the values clarification exercise reported less decision regret, (1, 995) = 6.19, = .01, and were clearer about their personal values, (1, 995) = 6.39, = .01. Moderation analyses revealed that the benefit of values clarification on decisional conflict was particularly evident among participants with lower health literacy, = -3.94, = 1.67, = -2.36, = .018. There was not a significant moderation effect of health literacy and decision aid condition on decision regret.

Conclusions: Adding a values clarification exercise to decision aids for parents making decisions about genomic sequencing may improve the decision-making experience and provide some benefit to individuals with lower health literacy. (PsycINFO Database Record (c) 2020 APA, all rights reserved).
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http://dx.doi.org/10.1037/hea0000829DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7078054PMC
April 2020

Dynamic Consent: An Evaluation and Reporting Framework.

J Empir Res Hum Res Ethics 2020 07 15;15(3):175-186. Epub 2019 Nov 15.

Melbourne Law School, The University of Melbourne, Carlton, Victoria, Australia.

Dynamic consent (DC) is an approach to consent that enables people, through an interactive digital interface, to make granular decisions about their ongoing participation. This approach has been explored within biomedical research, in fields such as biobanking and genomics, where ongoing contact is required with participants. It is posited that DC can enhance decisional autonomy and improve researcher-participant communication. Currently, there is a lack of evidence about the measurable effects of DC-based tools. This article outlines a framework for DC evaluation and reporting. The article draws upon the evidence for enhanced modes of informed consent for research as the basis for a logic model. It outlines how future evaluations of DC should be designed to maximize their quality, replicability, and relevance based on this framework. Finally, the article considers best-practice for reporting studies that assess DC, to enable future research and implementation to build upon the emerging evidence base.
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http://dx.doi.org/10.1177/1556264619887073DOI Listing
July 2020

Assessing multiple features of partner support for smoking cessation in dual-smoker couples.

J Health Psychol 2021 09 23;26(10):1561-1574. Epub 2019 Oct 23.

Duke University School of Nursing, USA.

The purpose of this study was to evaluate a new scale to measure multiple aspects of partner support for quitting smoking relevant to dual-smoker couples, called the Partner Support for Quitting Scale. The best model fit ( = 238 individuals in 119 couples) considers the frequency of, confidence in, and perceived usefulness of partner support behaviors. Path analysis revealed that the Partner Support for Quitting Scale factors were uniquely predicted by relationship commitment and nicotine dependence and, in turn, predicted self-efficacy for smoking cessation and desire to quit. Preliminary support was found for the Partner Support for Quitting Scales' value as an assessment tool for measuring partner support for smoking cessation among dual-smoker couples.
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http://dx.doi.org/10.1177/1359105319883924DOI Listing
September 2021

Early Check: translational science at the intersection of public health and newborn screening.

BMC Pediatr 2019 07 17;19(1):238. Epub 2019 Jul 17.

North Carolina State Laboratory of Public Health, Raleigh, NC, USA.

Background: Newborn screening (NBS) occupies a unique space at the intersection of translational science and public health. As the only truly population-based public health program in the United States, NBS offers the promise of making the successes of translational medicine available to every infant with a rare disorder that is difficult to diagnose clinically, but for which strong evidence indicates that presymptomatic treatment will substantially improve outcomes. Realistic NBS policy requires data, but rare disorders face a special challenge: Screening cannot be done without supportive data, but adequate data cannot be collected in the absence of large-scale screening. The magnitude and scale of research to provide this expanse of data require working with public health programs, but most do not have the resources or mandate to conduct research.

Methods: To address this gap, we have established Early Check, a research program in partnership with a state NBS program. Early Check provides the infrastructure needed to identify conditions for which there have been significant advances in treatment potential, but require a large-scale, population-based study to test benefits and risks, demonstrate feasibility, and inform NBS policy.

Discussion: Our goal is to prove the benefits of a program that can, when compared with current models, accelerate understanding of diseases and treatments, reduce the time needed to consider inclusion of appropriate conditions in the standard NBS panel, and accelerate future research on new NBS conditions, including clinical trials for investigational interventions.

Trial Registration: Clinicaltrials.gov registration # NCT03655223 . Registered on August 31, 2018.
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http://dx.doi.org/10.1186/s12887-019-1606-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6636013PMC
July 2019

Do Couple-Focused Cessation Messages Increase Motivation to Quit Among Dual-Smoker Couples?

J Smok Cessat 2019 Jun 28;14(2):95-103. Epub 2018 Jun 28.

School of Nursing, Duke University, Durham, North Carolina.

Introduction: Dual-smoker couples are a highly prevalent group who report low motivation to quit smoking.

Aims: This study tested the effect of a messaging intervention (couples- vs. individual-focused smoking outcomes) on motivation to quit among dual-smoker couples and examined the moderating effect of perceived support.

Methods: A total of 202 individuals in 101 dual-smoker couples were randomized by dyad using a 2 (frame: gain/loss) by 2 (outcome focus: individual/couple) factorial design. Participants reviewed scenarios of either positive or negative outcomes of quitting versus not quitting as they applied to either the individual or the couple. Participants then reported their own motivation to quit and motivation for their partner to quit. The main outcome was motivation to quit smoking.

Results: No main effects of framing or message focus emerged. Significant interactions between message focus and negative support predicted motivation for self and partner to quit. Individuals who reported lower negative support reported greater motivation for self to quit and less motivation for partner to quit after reviewing couple- (vs. individual-) focused messages.

Conclusions: Individuals in dual-smoker couples typically report low motivation to quit smoking. Couple-focused messages may increase motivation to quit among individuals who are not receiving negative support from their partners.
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http://dx.doi.org/10.1017/jsc.2018.19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6561728PMC
June 2019

Advancing science and practice using immersive virtual reality: what behavioral medicine has to offer.

Transl Behav Med 2019 11;9(6):1040-1046

Patient & Family Engagement Research Program, Center for Communication Science, RTI International, Research Triangle Park, NC, USA.

Interest in immersive virtual reality (VR) technologies is burgeoning as the hardware becomes less costly and more accessible to users, including researchers and practitioners. This commentary outlines the field of immersive VR and highlights applications of its use relevant to translational behavioral medicine. We describe the challenges facing VR applications for health and medicine, and how the core strengths of behavioral medicine can advance theory, research, and practice using VR. By highlighting potential uses of immersive VR alongside the challenges facing the field, we hope to inspire researchers to apply robust theories, methods, and frameworks to generate stronger evidence about the feasibility, acceptability, efficacy, and effectiveness of using this technology in translational behavioral medicine.
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http://dx.doi.org/10.1093/tbm/ibz068DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7184907PMC
November 2019

Expert and lay perspectives on burden, risk, tolerability, and acceptability of clinical interventions for genetic disorders.

Genet Med 2019 11 26;21(11):2561-2568. Epub 2019 Apr 26.

Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA.

Purpose: The Clinical Genome Resource (ClinGen) Actionability Working Group (AWG) developed a semiquantitative scoring metric to rate clinical actionability of genetic disorders and associated genes in four domains: (1) severity of the outcome, (2) likelihood of the outcome, (3) effectiveness of the intervention to prevent/minimize the outcome, and (4) nature of the intervention with respect to burden, risk, tolerability, and acceptability to the patient. This study aimed to assess whether nature of the intervention scores assigned by AWG experts reflected lay perceptions of intervention burden, risk, tolerability, and acceptability given the subjectivity of this domain.

Methods: In July 2017, a general population sample of 1344 adults completed the study. Each participant was asked to read 1 of 24 plain language medical intervention synopses and answer questions related to its burden, risk, tolerability, and acceptability. We conducted three multilevel mixed model analyses predicting the perceived burden, perceived risk, and perceived overall nature of the intervention.

Results: As AWG nature of the intervention scores increased, lay perceptions of intervention burden and risk decreased, and perceptions of tolerability and acceptability increased.

Conclusion: The findings show alignment between the ClinGen actionability scoring metric and lay perceptions of the nature of the intervention.
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http://dx.doi.org/10.1038/s41436-019-0524-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6815237PMC
November 2019

Implementing Web-Based Interventions in HIV Primary Care Clinics: Pilot Implementation Evaluation of Positive Health Check.

JMIR Form Res 2019 Apr 18;3(2):e10688. Epub 2019 Apr 18.

Center for Communication Science, RTI International, Durham, NC, United States.

Background: Web-based interventions can help people living with HIV achieve better clinical outcomes and behaviors, but integrating them into clinical practice remains challenging. There is a gap in understanding the feasibility of implementing these interventions in HIV clinic settings from the clinicians' perspective.

Objective: The goal of the research was to determine whether Positive Health Check (PHC)-a Web-based, tailored video counseling tool focused on increasing patient adherence and retention in care and reducing HIV risk among HIV-positive patients-was acceptable, appropriate, and feasible for HIV primary care clinic staff to implement in clinic workflows.

Methods: A multiple-case study design was used to evaluate the pilot implementation. Four primary care clinics located in the southeastern United States implemented PHC over a 1-month period. Nine clinic staff across the clinics participated in structured interviews before, during, and after the implementation. In total, 54 interviews were conducted. We used a framework analysis approach to code the data and identify themes related to implementation outcomes, including acceptability, appropriateness, and feasibility. We also analyzed patient intervention use metrics (n=104) to quantify patient intervention completion rates (n=68).

Results: Overall, clinicians viewed PHC as acceptable and appropriate. Themes that emerged related to these implementation outcomes include the ability for PHC to increase provider-patient communication and its ability to engage patients due to the tailored and interactive design. While generally feasible to implement, challenges to the clinic workflow and physical environment were areas that clinics needed to manage to make PHC work in their clinics.

Conclusions: Findings from this pilot implementation suggest that clinical staff viewed PHC as acceptable and appropriate, especially as more patients used the intervention over the pilot period. Feasibility of implementation was challenging in some cases, and lessons learned from this pilot implementation can provide information for larger scale tests of the intervention that include assessment of both implementation outcomes and clinical outcomes.
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http://dx.doi.org/10.2196/10688DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6495292PMC
April 2019

Effect of Integrated Behavioral Weight Loss Treatment and Problem-Solving Therapy on Body Mass Index and Depressive Symptoms Among Patients With Obesity and Depression: The RAINBOW Randomized Clinical Trial.

JAMA 2019 03;321(9):869-879

Department of Biomedical Data Science, Stanford University, Stanford, California.

Importance: Coexisting obesity and depression exacerbate morbidity and disability, but effective treatments remain elusive.

Objective: To test the hypothesis that an integrated collaborative care intervention would significantly improve both obesity and depression at 12 months compared with usual care.

Design, Setting, And Participants: The Research Aimed at Improving Both Mood and Weight (RAINBOW) randomized clinical trial enrolled 409 adults with body mass indices (BMIs) of 30 or greater (≥27 for Asian adults) and 9-item Patient Health Questionnaire (PHQ-9) scores of 10 or greater. Primary care patients at a health system in Northern California were recruited from September 30, 2014, to January 12, 2017; the date of final 12-month follow-up was January 17, 2018.

Interventions: All participants randomly assigned to the intervention (n = 204) or the usual care control group (n = 205) received medical care from their personal physicians as usual, received information on routine services for obesity and depression at their clinic, and received wireless physical activity trackers. Intervention participants also received a 12-month intervention that integrated a Diabetes Prevention Program-based behavioral weight loss treatment with problem-solving therapy for depression and, if indicated, antidepressant medications.

Main Outcomes And Measures: The co-primary outcome measures were BMI and 20-item Depression Symptom Checklist (SCL-20) scores (range, 0 [best] to 4 [worst]) at 12 months.

Results: Among 409 participants randomized (mean age of 51.0 years [SD, 12.1 years]; 70% were women; mean BMI of 36.7 [SD, 6.4]; mean PHQ-9 score of 13.8 [SD, 3.1]; and mean SCL-20 score of 1.5 [SD, 0.5]), 344 (84.1%) completed 12-month follow-up. At 12 months, mean BMI declined from 36.7 (SD, 6.9) to 35.9 (SD, 7.1) among intervention participants compared with a change in mean BMI from 36.6 (SD, 5.8) to 36.6 (SD, 6.0) among usual care participants (between-group mean difference, -0.7 [95% CI, -1.1 to -0.2]; P = .01). Mean SCL-20 score declined from 1.5 (SD, 0.5) to 1.1 (SD, 1.0) at 12 months among intervention participants compared with a change in mean SCL-20 score from 1.5 (SD, 0.6) to 1.4 (SD, 1.3) among usual care participants (between-group mean difference, -0.2 [95% CI, -0.4 to 0]; P = .01). There were 47 adverse events or serious adverse events that involved musculoskeletal injuries (27 in the intervention group and 20 in the usual care group).

Conclusions And Relevance: Among adults with obesity and depression, a collaborative care intervention integrating behavioral weight loss treatment, problem-solving therapy, and as-needed antidepressant medications significantly improved weight loss and depressive symptoms at 12 months compared with usual care; however, the effect sizes were modest and of uncertain clinical importance.

Trial Registration: ClinicalTrials.gov Identifier: NCT02246413.
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http://dx.doi.org/10.1001/jama.2019.0557DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439596PMC
March 2019

A behavior-theoretic evaluation of values clarification on parental beliefs and intentions toward genomic sequencing for newborns.

Soc Sci Med 2021 02 9;271:112037. Epub 2018 Nov 9.

RTI International, Research Triangle Park, NC, United States.

Decision aids commonly include values clarification exercises to help people consider which aspects of a choice matter most to them, and to help them make decisions that are congruent with their personal values and preferences. Using a randomized online experiment, we examined the influence of values clarification on parental beliefs and intentions about having genomic sequencing for newborns. We recruited 1186 women and men ages 18-44 who were pregnant or whose partner was pregnant or planning to become pregnant in the next two years. Participants (N = 1000) completed one of two versions of an online decision aid developed as part of a larger project examining the technical, clinical, and social aspects of using exome sequencing to screen newborns for rare genetic conditions. The education-only version provided information about using genomic sequencing to screen newborns for medically treatable conditions. The education-plus-values-clarification version included the same information, along with a values clarification exercise in which participants classified as important or unimportant five reasons in support of having and five reasons against having their newborn undergo genomic sequencing. We conducted partial correlations, regression analysis, and MANCOVAs with sex, health literacy, and experience with genetic testing as covariates. Participants who completed the decision aid with the values clarification exercise agreed less strongly with four of the five statements against sequencing compared to participants who viewed the education-only decision aid. The groups did not differ on agreement with reasons in support of sequencing. Agreement with four of five reasons against genomic sequencing was negatively associated with intentions to have their newborn sequenced, whereas agreement with all five reasons in support of sequencing were positively associated with intentions.
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http://dx.doi.org/10.1016/j.socscimed.2018.11.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6509013PMC
February 2021
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