The Maternal Well-Being Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Other: Meals
* Other: Meals + Social Support
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual interventions<br>Receive both interventions: MamaMeals and MamaMatters Interventions | Other: Meals<br>* 12 weeks of medically tailored meals<br>* Other names: MamaMeals;Other: Meals + Social Support<br>* 12 weeks of medically tailored meals and12 weeks of social media based support<br>* Other names: MamaMeals + MamaMatters;|
| Active Comparator: Meals intervention only<br>MamaMeals | Other: Meals<br>* 12 weeks of medically tailored meals<br>* Other names: MamaMeals;|
| Sham Comparator: Control<br>Wait-list control (received MamaMeals between 16-20 weeks postpartum) (after primary data collection time point) | Other: Control<br>* Waitlist Control Group (no intervention for first 4 months and then receive MamaMeals between 16-20 weeks postpartum)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of Edinburgh postnatal depression scale score >15 at 12 weeks postpartum |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, postpartum, perinatal mood disorders, medically-tailored meals