The Maternal Well-Being Study

Not Applicable

Active, not recruiting

• Conditions: Postpartum Depression; Postpartum Anxiety; Weight Retention, Postpartum; Nutritional and Metabolic Diseases
• Interventions: Other: Meals; Other: Control; Other: Meals + Social Support

• Registration Number: NCT05484999
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief 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.

Study Timeline

• Study Start: 2022-05-16
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-02
• Primary Completion: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• screen positive for food insecurity or qualify for any of the following governmental assistance programs Medicaid, WIC, SNAP, TANF,
• speak English,
• are between 20-40 completed weeks of pregnancy,
• are ages 18 years or older.

Exclusion Criteria

• type 1 diabetes
• dietary contraindications (e.g., severe food allergy, or inflammatory bowel disease, celiac disease, chronic renal disease, bariatric surgery, short bowel syndrome)
• an active eating disorder (self-reported)
• hospitalization in the past 12 months for a mental health concern
• a history of postpartum psychosis
• Individuals with a history of being banned from any social media site will also be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual interventions	Meals	Receive both interventions: MamaMeals and MamaMatters Interventions
Dual interventions	Meals + Social Support	Receive both interventions: MamaMeals and MamaMatters Interventions
Meals intervention only	Meals	MamaMeals
Control	Control	Wait-list control (received MamaMeals between 16-20 weeks postpartum) (after primary data collection time point)

Primary Outcome Measures

Name	Time	Method
% of meals delivered to and consumed by subjects	12 weeks	Feasibility of meal delivery social media support delivery
perception of the nutritious home delivered meal program	12 weeks	subject engagement with interventions and perception of interventions

Secondary Outcome Measures

Name	Time	Method
% of Edinburgh postnatal depression scale score >15 at 12 weeks postpartum	12 weeks

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Amarillo, Texas, United States