NCT05484999

The Maternal Well-Being Study

The Maternal Well-Being Study: A Feasibility and Acceptability Trial of Postpartum Support Interventions

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Texas Tech University Health Sciences Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This project aims to understand the local feasibility and acceptability of MamaMeals (a home-delivered nutritious, postpartum meal delivery program) and MamaMatters (a moderated social media-based peer support group) among peripartum women who are eligible for federal supplemental nutrition assistance programs such as The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) or Supplemental Nutrition Assistance Program (SNAP). The investigators will conduct a prospective randomized controlled trial (RCT) of these two interventions among postpartum individuals. Analyses will be performed to determine the relative risk of postpartum depressive or anxiety symptoms (primary outcome) and overall well-being and maternal/infant health (secondary/exploratory outcomes) between groups. Findings from this pilot intervention study will inform a future, large RCT exploring the effectiveness of MamaMeals and/or MamaMatters on reducing postpartum mental health symptoms and cardiovascular morbidity among individuals with food insecurity during and after pregnancy.

Detailed description

1. To assess the local feasibility and acceptability of MamaMeals (home-delivered, nutritious meals) during the 4th trimester for mothers with peripartum food insecurity. 2. To explore perceptions about receiving a medically-tailored meal delivery intervention during the 4th trimester (MamaMeals) among a diverse sample of peripartum individuals with food insecurity (FI). 3. To assess through a randomized trial the potential efficacy of the MamaMeals (nutritious, home-delivered meals) and MamaMatters (ehealth postpartum support) interventions on peripartum mood disorders (primary outcome), postpartum cardiometabolic risk\* (exploratory outcome), maternal wellbeing (exploratory outcome), and infant health (exploratory outcome) during the first 12 months following delivery. Hypothesis: Individuals who receive the MamaMeals + MamaMatters interventions will have lower Edinburgh Postpartum Depression Scale (EPDS) scores throughout the first 12 weeks postpartum compared to groups receiving only one intervention or the control group.

Conditions

• Postpartum Depression
• Postpartum Anxiety
• Weight Retention, Postpartum
• Nutritional and Metabolic Diseases

Interventions

Type	Name	Description
OTHER	Meals	12 weeks of medically tailored meals
OTHER	Meals + Social Support	12 weeks of medically tailored meals and12 weeks of social media based support
OTHER	Control	Waitlist Control Group (no intervention for first 4 months and then receive MamaMeals between 16-20 weeks postpartum)

Timeline

• Start date: 2022-05-16
• Primary completion: 2024-07-30
• Completion: 2025-05-30
• First posted: 2022-08-02
• Last updated: 2024-08-29

Locations

1 site across 1 country: United States