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Active, Not Recruiting

NCT Number: NCT05484999

The Maternal Well-Being Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Postpartum Depression Body Weight Body Weight Changes Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Gestational Weight Gain Mental Disorders Mood Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Postpartum Anxiety Pregnancy Complications Puerperal Disorders Signs and Symptoms Urogenital Diseases Weight Gain Weight Retention, Postpartum

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University Health Sciences Center

Amarillo, Texas, 79106, United States

About this study

  • To assess the local feasibility and acceptability of MamaMeals (home-delivered, nutritious meals) during the 4th trimester for mothers with peripartum food insecurity.
  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meals

Other

12 weeks of medically tailored meals

Other names: MamaMeals

Meals + Social Support

Other

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

Other names: MamaMeals + MamaMatters

Control

Other

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

Primary outcomes

  1. % of meals delivered to and consumed by subjects

    Time frame: 12 weeks

    Feasibility of meal delivery social media support delivery

  2. perception of the nutritious home delivered meal program

    Time frame: 12 weeks

    subject engagement with interventions and perception of interventions

Secondary outcomes

  1. % of Edinburgh postnatal depression scale score >15 at 12 weeks postpartum

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

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

Acronym: MWB

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 2, 2022
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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