Vida Sana y Completa: A randomized controlled trial to examine the effectiveness of diabetes prevention with and without medically supportive groceries among Latina women.

Latina women have a high prevalence of obesity and obesity-related chronic diseases, such as diabetes. Approximately half of Latinas with obesity will also experience food insecurity, or a lack of access to enough food for an active and healthy life. Food insecurity is a barrier for effective prevention and management of obesity-related chronic diseases. The goal of this type 1 hybrid comparative effectiveness trial is to compare a culturally-tailored diabetes prevention intervention with and without medically supportive groceries. Adult Latina women (n = 412) with obesity (Body Mass Index (BMI) of >30 kg/m2) and food insecurity will be 1:1 randomized to the Vida Sana intervention (control), or to Vida Sana y Completa (intervention plus integrated treatment for food insecurity). Vida Sana is an evidence-based culturally tailored, 12-month diabetes prevention intervention that targets at least 5% weight loss and at least 150 min/week of moderate-to-vigorous physical activity. Participants enrolled in Vida Sana y Completa will also receive 12 weekly deliveries of medically supportive groceries. Those in Vida Sana alone will receive information on local food resources. Participants will be assessed at baseline and every 6 months for 24 months. The primary outcome is weight loss at 12 months. Secondary outcomes include weight loss maintenance, diet quality, and quality of life. Barriers and facilitators of implementation will be assessed using mixed methods according to the Consolidated Framework for Implementation Research. This study will provide critical evidence for addressing the combination of obesity and food insecurity in primary care for diabetes prevention. Trial Registration: NCT052111.

Similarities and differences in factors associated with high and low sedentary behavior after stroke: a mixed methods study.

PURPOSE: To identify similarities and differences in factors affecting activity engagement between adults with stroke who are more and less sedentary. MATERIALS AND METHODS: Data were pooled from two studies of adults with stroke (N = 36). Sedentary time was measured activPAL micro3. Participants completed activPAL interviews, which were analyzed using framework analysis. Participants were stratified into more and less sedentary groups based on activPAL data. Between-group similarities and differences were identified. RESULTS: Adults with stroke (mean [SD] age = 65.8 [13.6] years, stroke chronicity = 40.5 [SD = 38.3] months, 36.1% female) were more sedentary (785.5 [64.7] sedentary minutes/day) and less sedentary (583.6 [87.4] sedentary minutes/day). Those who were more sedentary: engaged in basic activities of daily living, avoided activities, received assistance from other people, and did not use strategies to overcome barriers. Those who were less sedentary: engaged in instrumental and community activities, embraced new strategies, did activities with other people, and used strategies to overcome environmental barriers. CONCLUSIONS: Factors affecting activity engagement differed between people who are more and less sedentary. Interventions that aim to reduce post-stroke sedentary behavior should consider the: (1) types of activities, (2) role of other people, and (2) application of strategies to overcome activity and environment-related barriers.

People with lower levels of post-stroke sedentary behavior engaged in instrumental and community activities, relative to those with higher levels who primarily engaged in basic activities of daily living.Applying models of social support that emphasize doing with rather than doing for may be important for facilitating non-sedentary lifestyles.Facilitating the use of strategies to overcome environmental barriers to activities may be an important aspect of facilitating non-sedentary lifestyles.

Cost Analysis of the Positive Health Check Intervention to Suppress HIV Viral Load and Retain Patients in HIV Clinical Care.

CONTEXT: Digital video-based behavioral interventions are effective tools for improving HIV care and treatment outcomes. OBJECTIVE: To assess the costs of the Positive Health Check (PHC) intervention delivered in HIV primary care settings. DESIGN, SETTING, AND INTERVENTION: The PHC study was a randomized trial evaluating the effectiveness of a highly tailored, interactive video-counseling intervention delivered in 4 HIV care clinics in the United States in improving viral suppression and retention in care. Eligible patients were randomized to either the PHC intervention or the control arm. Control arm participants received standard of care (SOC), and intervention arm participants received SOC plus PHC. The intervention was delivered on computer tablets in the clinic waiting rooms. The PHC intervention improved viral suppression among male participants. A microcosting approach was used to assess the program costs, including labor hours, materials and supplies, equipment, and office overhead. PARTICIPANTS: Persons with HIV infection, receiving care in participating clinics. MAIN OUTCOME MEASURES: The primary outcome was the number of patients virally suppressed, defined as having fewer than 200 copies/mL by the end of their 12-month follow-up. RESULTS: A total of 397 (range across sites [range], 95-102) participants were enrolled in the PHC intervention arm, of whom 368 participants (range, 82-98) had viral load data at baseline and were included in the viral load analyses. Of those, 210 (range, 41-63) patients were virally suppressed at the end of their 12-month follow-up visit. The overall annual program cost was $402 274 (range, $65 581-$124 629). We estimated the average program cost per patient at $1013 (range, $649-$1259) and the cost per patient virally suppressed at $1916 (range, $1041-$3040). Recruitment and outreach costs accounted for 30% of PHC program costs. CONCLUSIONS: The costs of this interactive video-counseling intervention are comparable with other retention in care or reengagement interventions.

Making the Case for Joint Decision-Making in Future Multipurpose Prevention Technology (MPT) Choice: Qualitative Findings on MPT Attribute Preferences from the CUPID Study (MTN-045).

INTRODUCTION: Young women in sub-Saharan Africa account for two-thirds of all new HIV infections and face high rates of unintended pregnancy. Multipurpose prevention technologies (MPTs) are promising products under development that are designed to simultaneously prevent HIV and unintended pregnancy. Since MPTs will be used in the context of sexual relationships, ensuring acceptability and use requires understanding the role of male partners in MPT use decision-making. METHODS: This paper draws on qualitative data from 39 couples enrolled in the Microbicide Trials Network (MTN) 045 study, conducted in 2019-2020. Partners completed a discrete choice experiment (DCE), first separately and then jointly, to measure preferences for future MPT attributes and then completed a qualitative interview. We also draw on quantitative data from interviewer observation about who dominated the decision-making process during the joint DCE. Content analysis was used to examine (1) how couples made decisions on existing non-MPT HIV and pregnancy prevention products; (2) how couples made decisions on future ideal-MPT product during the DCE; and (3) how these decision-making processes varied by decision-making dominance (10 male, 10 female and 19 equal) and interview type (19 joint and 20 separate). RESULTS: Existing non-MPT product decisions focused on trust between partners and product attributes, while future ideal-MPT product decisions exclusively focused on product attributes. Across existing and future products, preferences for product attributes varied by gender. Male partners were most concerned with limiting side effects impacting sexual pleasure, female partners were most concerned with limiting side effects causing physical symptoms and both were concerned with the return to fertility. Across all dominance and interview types, couples reported making decisions together and female partners were often able to negotiate with male partners for their preferred product or set of product attributes. CONCLUSIONS: Research activities in this study provided an opportunity for couples to openly present their product attribute preferences to their partner, learn about their partner's attribute preferences, negotiate for their ideal set of attributes and ultimately choose attributes that benefited the couple without disempowering the female partner. Future research should focus on the utility of couple-based decision-making aids or similar tools for facilitating joint MPT decision-making.

A Method to Deliver Automated and Tailored Intervention Content: 24-month Clinical Trial.

BACKGROUND: The use of digital technologies and software allows for new opportunities to communicate and engage with research participants over time. When software is coupled with automation, we can engage with research participants in a reliable and affordable manner. Research Electronic Data Capture (REDCap), a browser-based software, has the capability to send automated text messages. This feature can be used to automate delivery of tailored intervention content to research participants in interventions, offering the potential to reduce costs and improve accessibility and scalability. OBJECTIVE: This study aimed to describe the development and use of 2 REDCap databases to deliver automated intervention content and communication to index participants and their partners (dyads) in a 2-arm, 24-month weight management trial, Partner2Lose. METHODS: Partner2Lose randomized individuals with overweight or obesity and cohabitating with a partner to a weight management intervention alone or with their partner. Two databases were developed to correspond to 2 study phases: one for weight loss initiation and one for weight loss maintenance and reminders. The weight loss initiation database was programmed to send participants (in both arms) and their partners (partner-assisted arm) tailored text messages during months 1-6 of the intervention to reinforce class content and support goal achievement. The weight maintenance and reminder database was programmed to send maintenance-related text messages to each participant (both arms) and their partners (partner-assisted arm) during months 7-18. It was also programmed to send text messages to all participants and partners over the course of the 24-month trial to remind them of group classes, dietary recall and physical activity tracking for assessments, and measurement visits. All text messages were delivered via Twilio and were unidirectional. RESULTS: Five cohorts, comprising 231 couples, were consented and randomized in the Partner2Lose trial. The databases will send 53,518 automated, tailored text messages during the trial, significantly reducing the need for staff to send and manage intervention content over 24 months. The cost of text messaging will be approximately US $450. Thus far, there is a 0.004% known error rate in text message delivery. CONCLUSIONS: Our trial automated the delivery of tailored intervention content and communication using REDCap. The approach described provides a framework that can be used in future behavioral health interventions to create an accessible, reliable, and affordable method for intervention delivery and engagement that requires minimal trial-specific resources and personnel time. TRIAL REGISTRATION: ClinicalTrials.gov NCT03801174; https://clinicaltrials.gov/ct2/show/NCT03801174?term=NCT03801174.

Effectiveness of an Interactive, Highly Tailored "Video Doctor" Intervention to Suppress Viral Load and Retain Patients With HIV in Clinical Care: A Randomized Clinical Trial.

BACKGROUND: To determine whether Positive Health Check, a highly tailored video doctor intervention, can improve viral suppression and retention in care. SETTING: Four clinics that deliver HIV primary care. METHODS: A hybrid type 1 effectiveness-implementation randomized trial design was used to test study hypotheses. Participants (N = 799) who were not virally suppressed, were new to care, or had fallen out of care were randomly assigned to receive Positive Health Check or the standard of care alone. The primary endpoint was viral load suppression, and the secondary endpoint was retention in care, both assessed at 12 months, using an intention-to-treat approach. A priori subgroup analyses based on sex assigned at birth and race were examined as well. RESULTS: There were no statistically significant differences between Positive Health Check (N = 397) and standard of care (N = 402) for either endpoint. However, statistically significant group differences were identified from a priori subgroup analyses. Male participants receiving Positive Health Check were more likely to achieve suppression at 12 months than male participants receiving standard of care adjusted risk ratio [aRR] [95% confidence interval (CI)] = 1.14 (1.00 to 1.29), P = 0.046}. For retention in care, there was a statistically significant lower risk for a 6-month visit gap in the Positive Health Check arm for the youngest participants, 18-29 years old [aRR (95% CI) = 0.55 (0.33 to 0.92), P = 0.024] and the oldest participants, 60-81 years old [aRR (95% CI) = 0.49 (0.30 to 0.81), P = 0.006]. CONCLUSIONS: Positive Health Check may help male participants with HIV achieve viral suppression, and younger and older patients consistently attend HIV care. REGISTRY NAME: Positive Health Check Evaluation Trial. Trial ID: 1U18PS004967-01. URL: https://clinicaltrials.gov/ct2/show/NCT03292913.

HOMBRE: A Trial Comparing 2 Weight Loss Approaches for Latino Men.

INTRODUCTION: Latino men have been drastically under-represented in research to identify effective behavioral weight-loss interventions. This trial compared 2 interventions for weight loss: (1) a culturally adapted intervention (HOMBRE) and (2) a minimal-intensity intervention. STUDY DESIGN: Randomized controlled trial. SETTING/PARTICIPANTS: Latino men with a BMI ≥27 kg/m2 and 1 or more cardiometabolic risk factors (N=424) were recruited (February 15, 2017‒October 2, 2018) from 14 medical centers and randomized to receive 1 of the 2 interventions. INTERVENTION: HOMBRE provided men a choice among 3 options: coach-facilitated group sessions using online video conferencing, coach-facilitated group sessions in person, and prerecorded videos of group sessions available online. MAIN OUTCOME MEASURES: The primary outcome was the proportion of participants sustaining clinically significant (≥5% of baseline) weight loss at 18 months. Secondary outcomes included weight loss trajectory over time, 3% and 10% weight loss, cardiometabolic risk factors, health behaviors, and psychosocial well-being at baseline and 18 months. Data were analyzed from October 6, 2020 to January 15, 2022. RESULTS: Participants were predominantly middle aged (47.0 [SD=11.9] years), were married (74.3%), were with at least some college experience (79.7%), and had middle to upper incomes (72.4% with annual family incomes >$75,000). Their average BMI was 33.1 kg/m2 (SD=5.1). The proportion achieving clinically significant weight loss at 18 months was 27.4% in the HOMBRE intervention and 20.6% in the minimal-intensity intervention (mean difference=7.2%, 95% CI= -1.8, 17.0; p=0.13). Mean difference between the HOMBRE vs the minimal-intensity group was ‒1.25 kg at 6 months (95% CI= -2.28, -0.21; p=0.02) and ‒1.11 kg at 12 months (95% CI= -2.11, -0.10; p=0.03) using weight measurement data abstracted from the Electronic Health Record and by self report. There were no significant differences in secondary outcomes. CONCLUSIONS: Among Latino men with overweight and obesity, HOMBRE was not more effective for clinically significant weight loss than a minimal-intensity intervention at 18 months.

A Longitudinal Mixed-Methods Examination of Positive Health Check: Implementation Results From a Type 1 Effectiveness-Implementation Hybrid Trial.

BACKGROUND: Positive Health Check is an evidence-based video doctor intervention developed for improving the medication adherence, retention in care, and viral load suppression of people with HIV receiving clinical care. SETTING: Four HIV primary care clinics within the United States. METHODS: As part of a type 1 hybrid trial, a mixed-methods approach was used to longitudinally assess the following 3 key implementation constructs over a 23-month period: innovation-values fit (ie, the extent to which staff perceive innovation use will foster the fulfillment of their values), organizational readiness for change (ie, the extent to which organizational members are psychologically and behaviorally prepared to implement organizational change), and implementation climate (ie, the extent to which implementation is expected, supported, and rewarded). Quantitative mixed-effects regression analyses were conducted to assess changes over time in these constructs. Qualitative analyses were integrated to help provide validation and understanding. RESULTS: Innovation-values fit and organizational readiness for change were found to be high and relatively stable. However, significant curvilinear change over time was found for implementation climate. Based on the qualitative data, implementation climate declined toward the end of implementation because of decreased engagement from clinic champions and differences in priorities between research and clinic staff. CONCLUSIONS: The Positive Health Check intervention was found to fit within HIV primary care service settings, but there were some logistical challenges that needed to be addressed. Additionally, even within the context of an effectiveness trial, significant and nonlinear change in implementation climate should be expected over time.

Preferences for Technology-Mediated Behavioral Lifestyle Interventions With Different Levels of Coach and Peer Support Among Latino Men: Comparative Study Within One Arm of a Randomized Controlled Trial.

BACKGROUND: Although Latino men have the highest prevalence (45%) of obesity among all men in the United States, traditional weight loss interventions have not effectively engaged this hard-to-reach and diverse group. Offering choices among technology-mediated weight loss interventions may offer advantages. OBJECTIVE: The aim of this study is to examine Latino men's preferences among 3 weight loss intervention options. We also examined whether attendance in group sessions (videoconference and in person) and weight loss differed according to intervention choice. METHODS: Latino men (n=200; mean age 47.3, SD 11.8 years) participated in a comparative effectiveness trial based on primary care and were randomized to receive the 1-year HOMBRE (Hombres con Opciones para Mejorar su Bienestar para Reducir Enfermedades Crónicas; English translation: Men With Options to Improve Their Well-being and Reduce Chronic Disease) intervention. HOMBRE is a weight loss intervention that offers 3 delivery options. During an orientation session, a trained bilingual coach helped men select 1 of the 3 intervention options that differed in coach, peer support, and available language. We used canonical discriminant analysis to assess multivariate associations of demographic, clinical, employment, cultural, and technology use and access factors with men's intervention choices. We used generalized linear models to estimate weight loss at 6, 12, and 18 months for men in each intervention option. RESULTS: Among Latino men, 28% (56/200) chose videoconference groups, 31% (62/200) chose web-based videos, and 41% (82/200) chose in-person groups. The canonical discriminant analysis identified 1 orthogonal dimension that distinguished between men who chose an in-person group and men who chose web-based videos. Men who were older, spoke Spanish, and did not use a computer frequently had a higher probability of choosing in-person groups versus web-based videos. For men who selected a group delivery option, 86.9% (107/123) attended ≥25% of the sessions, 83.7% (103/123) attended ≥50% of the sessions, and 73.2% (90/123) attended ≥75% of the sessions, with no differences by type of group (videoconference or in person). Men who chose videoconference and in-person group sessions lost significantly more weight at 6 months (both P<.001) and 18 months (P=.02 and P=.04, respectively) than those who chose web-based videos. Men who chose in-person group sessions also lost significantly more weight at 12 months (P=.008) than those who chose web-based videos. CONCLUSIONS: There were significant differences according to demographic, employment, cultural, and technology use factors between men who chose 1 of the 3 intervention options. Men who chose one of the group-based options (videoconference or in person) lost significantly more weight than those who chose web-based videos. Providing options that accommodate the diversity of Latino men's preferences is important for increasing engagement in behavioral interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03092960; https://clinicaltrials.gov/ct2/show/NCT03092960.

Engagement marketing for social good: Application to the All of Us Research Program.

Engagement marketing, when applied to increasing the social good, involves making a deliberate effort to engage communities with an organization's brand that might not have otherwise happened organically. Organizations that typically focus on increasing the social good include non-profits, community organizations, public health departments, and federal, state, and local agencies. Engagement marketing builds relationships, gives a voice to, and fosters collaboration with community members to transform their insights into impactful experiences that motivate and empower them to act to increase the social good. These actions may include making an informed decision, changing a health or prosocial behavior, or joining an effort that promotes or increases social good. In this paper, we translate the commercial engagement marketing approach, typically used, and studied widely to increase profits, to one that uses engagement marketing to increase prosocial outcomes. We propose a new definition of engagement marketing applied to the social good, a multi-level conceptual framework that integrates individual, social, community and macro-level processes and outcomes, and illustrates an example applying this translated model to co-create digital engagement experiences using a human centered design approach for the All of Us Research Program. This model can also guide research and practice related to DNA-based population screening.

Examining Information Needs of Heart Failure Patients and Family Companions Using a Previsit Question Prompt List and Audiotaped Data: Findings From a Pilot Study.

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 use of a previsit 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 item with which questions were actually asked during the medical visit. METHODS AND RESULTS: This secondary analysis of QOLs and audiotaped visit data from a pilot study enrolled and consented patients with HF, family companions, and HF clinicians. A single group of 30 patients with HF and 23 family companions received the QPL to complete in the waiting room immediately before their cardiology visit. To meet our aims, we calculated the 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. Patients and companions primarily selected and asked questions from the QPL regarding the 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 health care team roles and responsibilities. Patients and companions did not ask many of the questions they reported wanting to ask. CONCLUSIONS: 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 usefulness.

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

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 ß-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 ß-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).

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

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.

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.

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.

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

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.

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.

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.

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

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).

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

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.

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

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.