Postpartum DepressionMWBNCT05484999
The Maternal Well-Being Study
A study testing Meals and Meals + Social Support in people with Postpartum Depression and Postpartum Anxiety, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Postpartum Anxiety, Weight Retention, Postpartum
- What is being tested?
- Meals and Meals + Social Support
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Amarillo, Texas, 79106
About this study
Official title: The Maternal Well-Being Study: A Feasibility and Acceptability Trial of Postpartum Support Interventions
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
- 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.
- Conditions
- Postpartum Depression, Postpartum Anxiety, Weight Retention, Postpartum, Nutritional and Metabolic Diseases
- Being tested
- Meals, Meals + Social Support, Control
- Keywords
- nutrition, postpartum, perinatal mood disorders, medically-tailored meals
- Medical subject headings
- Depression, Postpartum, Gestational Weight Gain, Nutritional and Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MealsOther
Also called MamaMeals
12 weeks of medically tailored meals
Meals + Social SupportOther
Also called MamaMeals + MamaMatters
12 weeks of medically tailored meals and12 weeks of social media based support
ControlOther
Waitlist Control Group (no intervention for first 4 months and then receive MamaMeals between 16-20 weeks postpartum)
| Study group | Role | What they receive |
|---|---|---|
| Dual interventions | Experimental | Receive both interventions: MamaMeals and MamaMatters Interventions Receives: Other: Meals; Other: Meals + Social Support |
| Meals intervention only | Active comparator | MamaMeals Receives: Other: Meals |
| Control | Sham comparator | Wait-list control (received MamaMeals between 16-20 weeks postpartum) (after primary data collection time point) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of meals delivered to and consumed by subjects
Feasibility of meal delivery social media support delivery
Measured: 12 weeks
perception of the nutritious home delivered meal program
subject engagement with interventions and perception of interventions
Measured: 12 weeks
Secondary outcomes (1)
% of Edinburgh postnatal depression scale score >15 at 12 weeks postpartum
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start16 May 2022
- Primary completion30 Jul 2024
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484999
- Sponsor's protocol ID
- A22-4290
- Acronym
- MWB
- Status last verified
- Aug 2024
- First submitted
- 16 Jun 2022
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Maternal Well-Being Study: A Feasibility and Acceptability Trial of Postpartum Support Interventions
- ClinicalTrials.gov ID
- NCT05484999
- Acronym / sponsor ID
- MWB / A22-4290
- Conditions
- Postpartum Depression, Postpartum Anxiety, Weight Retention, Postpartum, Nutritional and Metabolic Diseases
- Keywords
- nutrition, postpartum, perinatal mood disorders, medically-tailored meals
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dual interventions | Experimental | Other: Meals, Other: Meals + Social SupportReceive both interventions: MamaMeals and MamaMatters Interventions |
| Meals intervention only | Active comparator | Other: MealsMamaMeals |
| Control | Sham comparator | Other: ControlWait-list control (received MamaMeals between 16-20 weeks postpartum) (after primary data collection time point) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MealsAlso: MamaMeals12 weeks of medically tailored meals | Other | Dual interventions, Meals intervention only |
| Meals + Social SupportAlso: MamaMeals + MamaMatters12 weeks of medically tailored meals and12 weeks of social media based support | Other | Dual interventions |
| ControlWaitlist Control Group (no intervention for first 4 months and then receive MamaMeals between 16-20 weeks postpartum) | Other | Control |
Primary outcome
% of meals delivered to and consumed by subjects
Time frame: 12 weeks
Feasibility of meal delivery social media support delivery
perception of the nutritious home delivered meal program
Time frame: 12 weeks
subject engagement with interventions and perception of interventions
1 secondary outcome
% of Edinburgh postnatal depression scale score >15 at 12 weeks postpartum
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meals and Meals + Social Support in people with Postpartum Depression and Postpartum Anxiety, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of meals delivered to and consumed by subjects (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.