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The Maternal Well-Being Study (MWB)

Primary Purpose

Postpartum Depression, Postpartum Anxiety, Weight Retention, Postpartum

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meals
Meals + Social Support
Control
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression focused on measuring nutrition, postpartum, perinatal mood disorders, medically-tailored meals

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Dual interventions

Meals intervention only

Control

Arm Description

Receive both interventions: MamaMeals and MamaMatters Interventions

MamaMeals

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 16, 2022
Last Updated
September 20, 2023
Sponsor
Texas Tech University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT05484999
Brief Title
The Maternal Well-Being Study
Acronym
MWB
Official Title
The Maternal Well-Being Study: A Feasibility and Acceptability Trial of Postpartum Support Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Postpartum Anxiety, Weight Retention, Postpartum, Nutritional and Metabolic Diseases
Keywords
nutrition, postpartum, perinatal mood disorders, medically-tailored meals

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual interventions
Arm Type
Experimental
Arm Description
Receive both interventions: MamaMeals and MamaMatters Interventions
Arm Title
Meals intervention only
Arm Type
Active Comparator
Arm Description
MamaMeals
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Wait-list control (received MamaMeals between 16-20 weeks postpartum) (after primary data collection time point)
Intervention Type
Other
Intervention Name(s)
Meals
Other Intervention Name(s)
MamaMeals
Intervention Description
12 weeks of medically tailored meals
Intervention Type
Other
Intervention Name(s)
Meals + Social Support
Other Intervention Name(s)
MamaMeals + MamaMatters
Intervention Description
12 weeks of medically tailored meals and12 weeks of social media based support
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Waitlist Control Group (no intervention for first 4 months and then receive MamaMeals between 16-20 weeks postpartum)
Primary Outcome Measure Information:
Title
% of meals delivered to and consumed by subjects
Description
Feasibility of meal delivery social media support delivery
Time Frame
12 weeks
Title
perception of the nutritious home delivered meal program
Description
subject engagement with interventions and perception of interventions
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
% of Edinburgh postnatal depression scale score >15 at 12 weeks postpartum
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Texas Tech University Health Sciences Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Maternal Well-Being Study

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