MWB: The Maternal Well-Being Study

Sponsor

Texas Tech University Health Sciences Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05484999

Collaborator

(none)

Enrollment

Location

Arms

24.5

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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 2x2 factorial RCT exploring the ability of MamaMeals and/or MamaMatters to reduce postpartum mental health symptoms and cardiovascular morbidity among individuals with food insecurity during and after pregnancy.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Depression Postpartum Anxiety Weight Retention, Postpartum Nutritional and Metabolic Diseases	Other: Meals Other: Social Support Other: Control	N/A

Detailed Description

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 2x2 randomized trial the potential efficacy of the MamaMeals (nutritious, home-delivered meals) and MamaMatters (moderated social mediabased peer 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

2x2 factorial randomized controlled trial will be conducted2x2 factorial randomized controlled trial will be conducted

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 16, 2022

Anticipated Primary Completion Date :

May 30, 2023

Anticipated Study Completion Date :

May 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dual interventions Receive both interventions: MamaMeals and MamaMatters Interventions	Other: Meals 12 weeks of medically tailored meals Other Names: MamaMeals Other: Social Support 12 weeks of social media based support Other Names: MamaMatters
Active Comparator: Mental health intervention only MamaMatters + Standard Nutritional Information	Other: Social Support 12 weeks of social media based support Other Names: MamaMatters Other: Control Standard educational materials/Facebook group
Active Comparator: Meals intervention only MamaMeals + Control Facebook Group	Other: Meals 12 weeks of medically tailored meals Other Names: MamaMeals Other: Control Standard educational materials/Facebook group
Sham Comparator: Control Control Facebook Group + Standard Nutritional Information	Other: Control Standard educational materials/Facebook group

Outcome Measures

Primary Outcome Measures

% of meals delivered to and consumed by subjects [12 months]
Feasibility of meal delivery social media support delivery
perception of the nutritious home delivered meal program [12 months]
subject engagement with interventions and perception of interventions

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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 28-36 completed weeks of pregnancy,
are ages 18 years or older.

Exclusion Criteria:

a pregnancy complicated by known major fetal anomalies
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
current mental health concern for which they are not receiving treatment
Individuals with a history of being banned from any social media site will also be excluded.