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The Maternal Well-Being Study

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05484999
Acronym
MWB
Enrollment
84
Registered
2022-08-02
Start date
2022-05-16
Completion date
2025-05-30
Last updated
2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

nutrition, postpartum, perinatal mood disorders, medically-tailored meals

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.

Interventions

OTHERMeals

12 weeks of medically tailored meals

OTHERMeals + Social Support

12 weeks of medically tailored meals and12 weeks of social media based support

OTHERControl

Waitlist Control Group (no intervention for first 4 months and then receive MamaMeals between 16-20 weeks postpartum)

Sponsors

Texas Tech University Health Sciences Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
% of meals delivered to and consumed by subjects12 weeksFeasibility of meal delivery social media support delivery
perception of the nutritious home delivered meal program12 weekssubject engagement with interventions and perception of interventions

Secondary

MeasureTime frame
% of Edinburgh postnatal depression scale score >15 at 12 weeks postpartum12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026