Clinical trial NCT05484999: The Maternal Well-Being Study
Official title: The Maternal Well-Being Study: A Feasibility and Acceptability Trial of Postpartum Support Interventions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postpartum Depression
Postpartum Anxiety
Weight Retention, Postpartum
Nutritional and Metabolic Diseases
Keywords: nutrition
postpartum
perinatal mood disorders
medically-tailored meals
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: % of meals delivered to and consumed by subjects
timeFrame: 12 weeks
measure: perception of the nutritious home delivered meal program
timeFrame: 12 weeks
Secondary outcomes:
measure: % of Edinburgh postnatal depression scale score >15 at 12 weeks postpartum
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Amarillo
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
References: