The Maternal Well-Being Study (MWB)

Texas Tech University Health Sciences Center

Status: Active, not recruiting

Conditions: Weight Retention, Postpartum; Postpartum Anxiety; Postpartum Depression; Nutritional and Metabolic Diseases

Treatments: Other: Meals; Other: Meals + Social Support; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05484999

A22-4290

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 3 patient groups

Dual interventions

Experimental group

Description:

Receive both interventions: MamaMeals and MamaMatters Interventions

Treatment:

Other: Meals + Social Support

Other: Meals

Meals intervention only

Active Comparator group

Description:

MamaMeals

Treatment:

Other: Meals

Control

Sham Comparator group

Description:

Wait-list control (received MamaMeals between 16-20 weeks postpartum) (after primary data collection time point)

Treatment:

Other: Control