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The Maternal Well-Being Study

NCT05484999 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-08-29

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • Texas Tech University Health Sciences Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2024-07-30
Completion
2025-05-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05484999 on ClinicalTrials.gov