CClinicalTrials.gg
Active, not recruitingNCT05484999MWBUpdated Aug 29, 2024

The Maternal Well-Being Study

An interventional study of Meals and Meals + Social Support in Postpartum Depression, Postpartum Anxiety and Weight Retention, Postpartum, sponsored by Texas Tech University Health Sciences Center. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-29.

Sponsored by Texas Tech University Health Sciences Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

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

Keywords

  • nutrition
  • postpartum
  • perinatal mood disorders
  • medically-tailored meals
03

In context

Depression, Postpartum

528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.

This study's planned enrollment of 84 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Texas Tech University Health Sciences Center is the lead sponsor of 97 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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 20-40 completed weeks of pregnancy,
  • are ages 18 years or older.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    Dual interventions

    Receive both interventions: MamaMeals and MamaMatters Interventions

    Other: Meals · Other: Meals + Social Support

  • Active comparator
    Meals intervention only

    MamaMeals

    Other: Meals

  • Sham comparator
    Control

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

    Other: Control

Interventions

  • OtherMeals

    12 weeks of medically tailored meals

    Also known as: MamaMeals

  • OtherMeals + Social Support

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

    Also known as: MamaMeals + MamaMatters

  • OtherControl

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

06

What researchers measure

Primary outcomes

  1. % of meals delivered to and consumed by subjects

    Feasibility of meal delivery social media support delivery

    Time frame: 12 weeks

  2. perception of the nutritious home delivered meal program

    subject engagement with interventions and perception of interventions

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: 12 weeks

07

Study locations

1 site
  • Texas Tech University Health Sciences Center
    Amarillo, Texas 79106, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05484999
Lead sponsor
Texas Tech University Health Sciences Center
Responsible party
Sponsor
First posted
Aug 2, 2022
Start date
May 16, 2022
Primary completion
Jul 30, 2024
Completion
May 30, 2025 (estimated)
Last update
Aug 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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