The Maternal Well-Being Study

Postpartum Depression Clinical Trial

— MWB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05484999
• Other study ID #: A22-4290
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression, Postpartum
• Gestational Weight Gain
• Metabolic Diseases
• Nutritional and Metabolic Diseases
• Postpartum Anxiety
• Postpartum Depression

Intervention

Other:
• Meals
12 weeks of medically tailored meals
• Meals + Social Support
12 weeks of medically tailored meals and12 weeks of social media based support
• Control
Waitlist Control Group (no intervention for first 4 months and then receive MamaMeals between 16-20 weeks postpartum)

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Amarillo	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of meals delivered to and consumed by subjects	Feasibility of meal delivery social media support delivery	12 weeks
Primary	perception of the nutritious home delivered meal program	subject engagement with interventions and perception of interventions	12 weeks
Secondary	% of Edinburgh postnatal depression scale score >15 at 12 weeks postpartum		12 weeks