Imogen Bylinsky

Background/Objectives: Several randomized controlled trials have found that dietary interventions promoting self-guided shifts away from ultra-processed foods (UPFs) and toward minimally processed, nutrient-dense foods may alleviate depressive symptoms. However, translating these interventions into scalable and sustainable real-world approaches remains a key challenge. Adopting a minimally processed dietary pattern requires sustained effort (e.g., meal planning, shopping, and preparation) within environments where UPFs are pervasive and convenient. These demands may be especially burdensome for individuals experiencing depressive symptoms. Consequently, interventions that rely heavily on individual effort may be difficult to maintain. Commercial meal delivery services may offer a structural solution by reducing logistical and cognitive barriers to dietary change, yet little is known about how individuals with depressive symptoms experience this approach. Methods: In a parent study, we conducted a randomized pilot study of a meal delivery service designed to provide minimally processed meals to adults with moderate to moderately severe depressive symptoms; here we report qualitative findings from post-intervention interviews with participants assigned to the meal delivery condition (n = 20). Results: Participants appreciated reductions in preparatory effort and mental load, which supported adherence. Dietary changes were also linked to improved mood through increased energy, mood stability, and more positive self-evaluation. However, social settings were a near-universal barrier, and acceptability depended on palatability, compatibility with personal preferences, and perceived autonomy. Several participants also described a temporal adjustment process (early cravings/withdrawal followed by adaptation). Conclusions: Overall, these findings suggest participant-informed priorities for future testing and refinement of scalable meal delivery interventions for depression, including personalization and choice, quality control, and support for social and withdrawal-related challenges.

Background: In the United States, mental health complications and cardiovascular events are the 2 leading causes of death for birthing parents in the year following delivery. Most of these deaths are preventable, with Black and Latinx individuals experiencing higher rates of these postpartum complications. Current postpartum care has not reduced these disparities. Objective: This randomized controlled trial aims to train nonmedical professionals in a novel intervention to prevent postpartum depressive symptoms and improve cardiovascular health following childbirth in a low-income New York City (NYC) birthing population. Methods: We aim to recruit 600 birthing individuals over 3 sites across NYC. After screening and consent, participants will be randomized to the Living Healthy for Moms intervention (doula-delivered cognitive behavioral therapy and cardiovascular behavioral health intervention) or attention control (a variation of standard postpartum doula care). Daily telephone contacts for the first 7 days immediately after hospital discharge are followed by 12 doula-led video sessions conducted over 6 months. The primary outcomes are postpartum depressive symptoms and cardiovascular health, with secondary outcomes of psychosocial status, health behaviors, health care use, and patient satisfaction. All outcomes are measured via REDCap (Research Electronic Data Capture; Vanderbilt University) surveys administered at baseline, 2 weeks, 6 weeks, 3 months, and 6 months post discharge. Physiological measurements of glycated hemoglobin (hemoglobin A1c), lipids, and blood pressure will be collected at baseline, 3 months, and 6 months. Doulas, hospital staff, and birthing individuals will be recruited to evaluate the implementation of the intervention following the conclusion of recruitment at each site. A mixed methods triangulated approach will be used, including electronic health record data extraction, web-based surveys, key informant interviews, and focus groups. Results: Recruitment and data collection began at the first site in Brooklyn on January 23, 2025. Data collection for participants from each of the 3 recruitment sites will be concluded by November 30, 2027, February 29, 2028, and August 31, 2029, respectively, for Brooklyn, Queens, and upper Manhattan. Thus, all data for the total expected 600 participants will be collected by the end of the grant year 6, August 31, 2029. Trial results will not be analyzed until grant year 7, beginning September 1, 2029. Data will be analyzed on an intention-to-treat basis by study team members blinded to participant conditions. Conclusions: This hybrid type 1 effectiveness-implementation randomized controlled trial will test a novel nonspecialist intervention to prevent mental health and cardiovascular health complications of childbirth, culturally adapted to our local population in NYC. We expect that our findings will contribute to knowledge on the effectiveness and implementation of nonspecialist postpartum interventions in low-resourced settings and the expansion of doula care in the post partum. Trial Registration: ClinicalTrials.gov NCT06666400; https://clinicaltrials.gov/study/NCT06666400 International Registered Report Identifier (IRRID): DERR1-10.2196/76871

BACKGROUND In the United States, mental health complications and cardiovascular events are the 2 leading causes of death for birthing parents in the year following delivery. Most of these deaths are preventable, with Black and Latinx individuals experiencing higher rates of these postpartum complications. Current postpartum care has not reduced these disparities. OBJECTIVE This randomized controlled trial aims to train nonmedical professionals in a novel intervention to prevent postpartum depressive symptoms and improve cardiovascular health following childbirth in a low-income New York City (NYC) birthing population. METHODS We aim to recruit 600 birthing individuals over 3 sites across NYC. After screening and consent, participants will be randomized to the Living Healthy for Moms intervention (doula-delivered cognitive behavioral therapy and cardiovascular behavioral health intervention) or attention control (a variation of standard postpartum doula care). Daily telephone contacts for the first 7 days immediately after hospital discharge are followed by 12 doula-led video sessions conducted over 6 months. The primary outcomes are postpartum depressive symptoms and cardiovascular health, with secondary outcomes of psychosocial status, health behaviors, health care use, and patient satisfaction. All outcomes are measured via REDCap (Research Electronic Data Capture; Vanderbilt University) surveys administered at baseline, 2 weeks, 6 weeks, 3 months, and 6 months post discharge. Physiological measurements of glycated hemoglobin (hemoglobin A1c), lipids, and blood pressure will be collected at baseline, 3 months, and 6 months. Doulas, hospital staff, and birthing individuals will be recruited to evaluate the implementation of the intervention following the conclusion of recruitment at each site. A mixed methods triangulated approach will be used, including electronic health record data extraction, web-based surveys, key informant interviews, and focus groups. RESULTS Recruitment and data collection began at the first site in Brooklyn on January 23, 2025. Data collection for participants from each of the 3 recruitment sites will be concluded by November 30, 2027, February 29, 2028, and August 31, 2029, respectively, for Brooklyn, Queens, and upper Manhattan. Thus, all data for the total expected 600 participants will be collected by the end of the grant year 6, August 31, 2029. Trial results will not be analyzed until grant year 7, beginning September 1, 2029. Data will be analyzed on an intention-to-treat basis by study team members blinded to participant conditions. CONCLUSIONS This hybrid type 1 effectiveness-implementation randomized controlled trial will test a novel nonspecialist intervention to prevent mental health and cardiovascular health complications of childbirth, culturally adapted to our local population in NYC. We expect that our findings will contribute to knowledge on the effectiveness and implementation of nonspecialist postpartum interventions in low-resourced settings and the expansion of doula care in the post partum. CLINICALTRIAL ClinicalTrials.gov NCT06666400; https://clinicaltrials.gov/study/NCT06666400 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/76871