The Maternal Well-Being Study

NCT05484999 | Active Not Recruiting

• 1 other identifier: A22-4290
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• % of meals delivered to and consumed by subjects

  Feasibility of meal delivery social media support delivery

  12 weeks

• perception of the nutritious home delivered meal program

  subject engagement with interventions and perception of interventions

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (3)

Dual interventions

EXPERIMENTAL

Receive both interventions: MamaMeals and MamaMatters Interventions

Other: Meals; Other: Meals + Social Support

Meals intervention only

ACTIVE COMPARATOR

MamaMeals

Other: Meals

Control

SHAM COMPARATOR

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

Other: Control

Interventions

Meals OTHER

12 weeks of medically tailored meals

Also known as: MamaMeals

Dual interventions; Meals intervention only

Meals + Social Support OTHER

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

Also known as: MamaMeals + MamaMatters

Dual interventions

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Amarillo, Texas, 79106, United States

Location

MeSH Terms

Conditions

Depression, Postpartum; Gestational Weight Gain; Nutritional and Metabolic Diseases

Interventions

Meals

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: August 2, 2022
• Study Start: May 16, 2022
• Primary Completion: July 30, 2024
• Study Completion: May 30, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

US (1)