Janelle W. Coughlin

Purpose:Behavioral weight loss (BWL) interventions consisting of remote coaching and self-monitoring have limited effectiveness in breast cancer survivors. We conducted a single-arm phase II study evaluating the addition of Contrave for <5% weight loss (%WL) after 2 months of BWL. Patients and Methods:Women with prior stage 0 to III breast cancer and a body mass index ≥27 kg/m2 were eligible and initiated BWL. We collected weight, patient-reported outcomes, and labs at baseline, 2 months, and 6 months. At 2 months, participants with ≥5% WL (FAST-BWL) continued BWL, whereas those with <5% WL (SLOW-BWL) received BWL + Contrave. The primary endpoint was the proportion of SLOW-BWL with ≥5% WL at 6 months, with 30 participants providing 80% power with 5% type I error. Paired t tests, Kruskal–Wallis tests, and mixed-effects models were utilized. Results:Of 55 participants, 2 withdrew prior to 2 months. At 2 months, 15 (28.3%) were FAST-BWL with mean% WL [standard deviation (SD)] of 7.2% (1.5) and 38 (71.7%) were SLOW-BWL with mean% WL (SD) of 1.2% (2.2). Mean% WL between 2 and 6 months was similar in SLOW-BWL (3.8% ± 3.6) and FAST-BWL (3.6% ± 2.6). At 6 months, mean% WL (SD) was 5.1% (2.9) for SLOW-BWL and 10.8% (3.5) for FAST-BWL; 13 of 15 (86.7%) FAST-BWL and 16 of 38 (42%) SLOW-BWL had ≥5% WL. Physical function and pain improved with ≥5% WL (P = 0.03 and P = 0.02, respectively). SLOW-BWL had improved HbA1c (P = 0.003) and triglycerides (P = 0.04). Gastrointestinal symptoms were reported in 74% of SLOW-BWL. Of 6 withdrawals on Contrave, 1 was due to adverse events. Conclusions:Adding Contrave for breast cancer survivors with minimal initial benefit from BWL results in clinically meaningful WL (≥5%) in 42% following 6 months of treatment, which also improves selective cardiometabolic risk factors.

Includes 5 tables and 3 figures

Purpose: Behavioral weight loss (BWL) interventions consisting of remote coaching and self-monitoring have limited effectiveness in breast cancer survivors. We conducted a single-arm phase II study evaluating the addition of Contrave for <5% weight loss (%WL) after 2 months of BWL. Patients and Methods: Women with prior stage 0 to III breast cancer and a body mass index ≥27 kg/m2 were eligible and initiated BWL. We collected weight, patient-reported outcomes, and labs at baseline, 2 months, and 6 months. At 2 months, participants with ≥5% WL (FAST-BWL) continued BWL, whereas those with <5% WL (SLOW-BWL) received BWL + Contrave. The primary endpoint was the proportion of SLOW-BWL with ≥5% WL at 6 months, with 30 participants providing 80% power with 5% type I error. Paired t tests, Kruskal–Wallis tests, and mixed-effects models were utilized. Results: Of 55 participants, 2 withdrew prior to 2 months. At 2 months, 15 (28.3%) were FAST-BWL with mean% WL [standard deviation (SD)] of 7.2% (1.5) and 38 (71.7%) were SLOW-BWL with mean% WL (SD) of 1.2% (2.2). Mean% WL between 2 and 6 months was similar in SLOW-BWL (3.8% ± 3.6) and FAST-BWL (3.6% ± 2.6). At 6 months, mean% WL (SD) was 5.1% (2.9) for SLOW-BWL and 10.8% (3.5) for FAST-BWL; 13 of 15 (86.7%) FAST-BWL and 16 of 38 (42%) SLOW-BWL had ≥5% WL. Physical function and pain improved with ≥5% WL (P = 0.03 and P = 0.02, respectively). SLOW-BWL had improved HbA1c (P = 0.003) and triglycerides (P = 0.04). Gastrointestinal symptoms were reported in 74% of SLOW-BWL. Of 6 withdrawals on Contrave, 1 was due to adverse events. Conclusions: Adding Contrave for breast cancer survivors with minimal initial benefit from BWL results in clinically meaningful WL (≥5%) in 42% following 6 months of treatment, which also improves selective cardiometabolic risk factors.

Background: Maternal obesity is associated with significant racial disparities. People who identify as non-Hispanic Black and Latinx are at the highest risk related adverse short- and long-term health outcomes (eg, hypertension in pregnancy and postpartum weight retention). Remote lifestyle interventions delivered during and after pregnancy hold promise for supporting healthy weight outcomes; however, few are tested in groups of people who self-identify as non-Hispanic Black and Latinx or address the neighborhood-level and psychosocial factors driving maternal health disparities. Implementing remote lifestyle interventions within community-based programs that serve birthing people may optimize trust and engagement, promote scalability and sustainability, and have the broadest public health impact. Objective: The goal of this trial is to test the effectiveness of a culturally adapted remote lifestyle intervention (Healthy for Two–Home Visiting) implemented within home visiting compared to usual home visiting services on postpartum weight retention among pregnant or postpartum individuals, in particular those who identify as non-Hispanic Black and Latinx. Facilitators and barriers to implementation of the intervention within home visiting will be examined. Methods: We describe the rationale and protocol for this hybrid type I effectiveness-implementation randomized controlled trial. In this paper, we highlight the community-engaged approach and trial design features that enable the implementation of the intervention within home visiting and demonstrate its applicability to the target population. Participants will be 360 pregnant individuals with overweight or obesity enrolled between 20 and 33 weeks of gestation and randomized 1:1 to Healthy for Two–Home Visiting or usual home visiting services. The primary outcome is weight retention at 6 months post partum, calculated as 6-month postpartum weight minus earliest pregnancy weight (≤18 wk of gestation). The measures of implementation include intervention feasibility, acceptability, reach, adoption, and fidelity. Throughout the paper, we highlight the community input used to improve intervention effectiveness and study implementation and as a strategy to promote maternal health equity. Results: This study was funded in June 2021, and recruitment began in April 2023. As of November 2024, we enrolled 90 participants. Data collection to assess the intervention’s effectiveness is expected to end in June 2026. Implementation evaluation is expected to conclude in December 2026. Conclusions: This hybrid type I effectiveness-implementation randomized controlled trial integrates a culturally adapted remote lifestyle intervention into early home visiting services to examine its effectiveness on postpartum weight retention compared to usual home visiting. We anticipate that the study results will enable an understanding of the drivers of successful implementation within a community-based setting to maximize the future sustainability and dissemination of a strategy for reducing long-term obesity and other maternal health disparities. Trial Registration: Clinicaltrials.gov NCT05619705; https://clinicaltrials.gov/study/NCT05619705 International Registered Report Identifier (IRRID): DERR1-10.2196/62847

Purpose of Review To highlight recent research on antidepressant use and weight change and explore best clinical practices for reducing weight gain and obesity risk in individuals with depression. Recent Findings Research on antidepressant use and weight gain suggests that genetic and biological factors including metabolizer phenotypes and inflammation can help to predict an individual’s threshold for weight change among specific agents. For individuals with increased susceptibility to metabolic complications, medications including bupropion, fluoxetine, and newer agents (e.g., gepirone) have shown to be efficacious in improving depressive symptoms while concurrently reducing metabolic risks. Additional areas of focus following antidepressant related weight gain include switching to a weight neutral drug alternative, integrated behavioral interventions, and/or pharmacotherapy including GLP-1 receptor agonists (e.g., metformin, liraglutide). Summary Individuals experiencing depression are at heightened risk of metabolic disorders and weight gain, which may be further exacerbated by antidepressant treatment. The increased support of weight neutral antidepressant agents in addition to innovative lifestyle interventions, breakthroughs in drug mechanisms, anti-obesity medications and overall familiarity with the side effects of each antidepressant class will help clinicians make appropriate decisions when treating patients with depression.

BACKGROUND Maternal obesity is associated with significant racial disparities. People who identify as non-Hispanic Black and Latinx are at the highest risk related adverse short- and long-term health outcomes (eg, hypertension in pregnancy and postpartum weight retention). Remote lifestyle interventions delivered during and after pregnancy hold promise for supporting healthy weight outcomes; however, few are tested in groups of people who self-identify as non-Hispanic Black and Latinx or address the neighborhood-level and psychosocial factors driving maternal health disparities. Implementing remote lifestyle interventions within community-based programs that serve birthing people may optimize trust and engagement, promote scalability and sustainability, and have the broadest public health impact. OBJECTIVE The goal of this trial is to test the effectiveness of a culturally adapted remote lifestyle intervention (Healthy for Two–Home Visiting) implemented within home visiting compared to usual home visiting services on postpartum weight retention among pregnant or postpartum individuals, in particular those who identify as non-Hispanic Black and Latinx. Facilitators and barriers to implementation of the intervention within home visiting will be examined. METHODS We describe the rationale and protocol for this hybrid type I effectiveness-implementation randomized controlled trial. In this paper, we highlight the community-engaged approach and trial design features that enable the implementation of the intervention within home visiting and demonstrate its applicability to the target population. Participants will be 360 pregnant individuals with overweight or obesity enrolled between 20 and 33 weeks of gestation and randomized 1:1 to Healthy for Two–Home Visiting or usual home visiting services. The primary outcome is weight retention at 6 months post partum, calculated as 6-month postpartum weight minus earliest pregnancy weight (≤18 wk of gestation). The measures of implementation include intervention feasibility, acceptability, reach, adoption, and fidelity. Throughout the paper, we highlight the community input used to improve intervention effectiveness and study implementation and as a strategy to promote maternal health equity. RESULTS This study was funded in June 2021, and recruitment began in April 2023. As of November 2024, we enrolled 90 participants. Data collection to assess the intervention’s effectiveness is expected to end in June 2026. Implementation evaluation is expected to conclude in December 2026. CONCLUSIONS This hybrid type I effectiveness-implementation randomized controlled trial integrates a culturally adapted remote lifestyle intervention into early home visiting services to examine its effectiveness on postpartum weight retention compared to usual home visiting. We anticipate that the study results will enable an understanding of the drivers of successful implementation within a community-based setting to maximize the future sustainability and dissemination of a strategy for reducing long-term obesity and other maternal health disparities. CLINICALTRIAL Clinicaltrials.gov NCT05619705; https://clinicaltrials.gov/study/NCT05619705 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/62847

361 Background: Cancer treatments often result in unfavorable early and late side effects that impact quality of life. Many forms of cancer, including some types of breast cancer, are also associated with obesity, which may be mediated by lifestyle behaviors. Providing comprehensive cancer treatment and prevention requires assessment and management of both behavioral and psychosocial domains. We initiated a quality improvement project to determine the feasibility of collecting patient-reported outcomes electronically and to identify behavioral and psychosocial needs and interests of women with early stage breast cancer (ESBC) receiving treatment at Johns Hopkins. Methods: We reviewed the outpatient schedules of 2 medical oncologists at different Johns Hopkins sites and identified 169 patients with ESBC who completed a lumpectomy or mastectomy. Using the electronic medical records (EMR) patient portal and/or email, we sent messages to women approximately 3 days prior to an oncology visit with a survey link to a behavioral battery. The battery included assessment of behavioral/psychosocial domains including: nutrition/eating behaviors, weight, pain, substance use, sleep, mental health, sexual health). Women were also asked if they desired additional information on specific behaviors. Results: A total of 100 women responded to the survey (59% response rate). Mean Age = 58.35 years (SD 11.54, range 33-78); 12% Asian, 18% Black, 68% White; 80% married; Mean BMI = 27.8 kg/m2 (SD 6.56). Main results are shown in the table. Behaviors most frequently identified as concerns that patients wanted additional resources for included nutrition (14%) and sleep (11%). Conclusions: Use of the patient portal to gauge patient concerns is feasible, and may help identify the most pressing issues of patients prior to scheduled visits. Our results will be used to develop an EMR-based dashboard and strategies for early interventions to improve wellness and survival outcomes in patients with ESBC.

Background: To address the obesity epidemic, there is a need for novel paradigms, including those that address the timing of eating and sleep in relation to circadian rhythms. Electronic health records (EHRs) are an efficient way to identify potentially eligible participants for health research studies. Mobile health (mHealth) apps offer available and convenient data collection of health behaviors, such as timing of eating and sleep. Objective: The aim of this descriptive analysis was to report on recruitment, retention, and app use from a 6-month cohort study using a mobile app called Daily24. Methods: Using an EHR query, adult patients from three health care systems in the PaTH clinical research network were identified as potentially eligible, invited electronically to participate, and instructed to download and use the Daily24 mobile app, which focuses on eating and sleep timing. Online surveys were completed at baseline and 4 months. We described app use and identified predictors of app use, defined as 1 or more days of use, versus nonuse and usage categories (ie, immediate, consistent, and sustained) using multivariate regression analyses. Results: Of 70,661 patients who were sent research invitations, 1021 (1.44%) completed electronic consent forms and online baseline surveys; 4 withdrew, leaving a total of 1017 participants in the analytic sample. A total of 53.79% (n=547) of the participants were app users and, of those, 75.3% (n=412), 50.1% (n=274), and 25.4% (n=139) were immediate, consistent, and sustained users, respectively. Median app use was 28 (IQR 7-75) days over 6 months. Younger age, White race, higher educational level, higher income, having no children younger than 18 years, and having used 1 to 5 health apps significantly predicted app use (vs nonuse) in adjusted models. Older age and lower BMI predicted early, consistent, and sustained use. About half (532/1017, 52.31%) of the participants completed the 4-month online surveys. A total of 33.5% (183/547), 29.3% (157/536), and 27.1% (143/527) of app users were still using the app for at least 2 days per month during months 4, 5, and 6 of the study, respectively. Conclusions: EHR recruitment offers an efficient (ie, high reach, low touch, and minimal participant burden) approach to recruiting participants from health care settings into mHealth research. Efforts to recruit and retain less engaged subgroups are needed to collect more generalizable data. Additionally, future app iterations should include more evidence-based features to increase participant use.