Postpartum Weight RetentionNCT05579990
Feasibility of Meal Delivery Postpartum
A study testing Meal Delivery in people with Postpartum Weight Retention and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study is being done to assess the feasibility and acceptability of a meal delivery intervention among low-income postpartum women with obesity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Weight Retention, Obesity
- What is being tested?
- Meal Delivery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2023to 11 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medicaid eligible and/or have a household income at or below 185 percent of the federal poverty line
- 18 years of age or older
- Initiated prenatal care at a University of Alabama at Birmingham prenatal clinic
- Experienced a healthy singleton pregnancy
- 5-45 weeks postpartum at enrollment
- Body mass index >= 30 at enrollment
- Residing within the meal company's delivery radius
- Willing to consent
Who cannot join
- Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 2 diabetes)
- Current treatment for severe psychiatric disorder (such as schizophrenia)
- Self-reported diagnosis of anorexia or bulimia
- Current use of medication expected to significantly impact body weight
- Current substance abuse
- Participation in another dietary and/or weight management intervention postpartum
- Unable to understand and communicate in English
- Unwilling or unable to consume study meals
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Feasibility of a Meal Delivery Intervention for Postpartum Weight Management
This study is being done to assess the feasibility and acceptability of a meal delivery intervention among low-income postpartum women with obesity.
Read the detailed description
This is a single-group pilot study in which subjects will receive 10 home-delivered meals per week for 8 weeks.
- Conditions
- Postpartum Weight Retention, Obesity
- Being tested
- Meal Delivery
- Keywords
- Postpartum, Weight management, Meal delivery
- Medical subject headings
- Gestational Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal DeliveryBehavioural
10 home-delivered meals per week provided by a local meal delivery company supplemented by remote weekly behavioral support with study staff.
| Study group | Role | What they receive |
|---|---|---|
| Meal Delivery | Experimental | Meal delivery intervention program designed to help low income postpartum women lose weight through weekly meal delivery and behavioral strategies. Receives: Behavioral: Meal Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Proportion of Received Study Meals Consumed
Proportion of received weekly study meals participants reported consuming each week collected via weekly electronic surveys in which participants will self-report the number of study meals a) they consumed, b) other household members consumed, or c) that were uneaten.
Measured: Collected weekly from intervention start (6-45 weeks postpartum) to follow-up (14-53 weeks postpartum)
Secondary outcomes (3)
Study Participation Rate
Total number of eligible subjects who agreed to participate out of those who were screened.
Measured: baseline (5-45 weeks postpartum)
Participant Retention
The number of enrolled participants who completed some or all follow-up assessment visit measurements.
Measured: baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)
Change in Participant Satisfaction With Diet
To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire (DSAT-28) will be used in which participants respond to 28 statements using a 5-point Likert scale. Responses to all 28-items are averaged to produce a total diet satisfaction score (designed to reflect satisfaction as it relates to following a weight-management diet) ranging from 1-5. Subscale scores for Cost Factor (reflects financial cost of the diet) and Planning \& Preparation Factor (reflects amount of time and effort spent in planning and preparing) will also be calculated and range from 1-5. For the overall diet satisfaction score and subscale scores, higher scores represent greater satisfaction. Changes in overall diet satisfaction, as well as changes in subscale scores for Cost Factor and Planning \& Preparation Factor will be examined from baseline to follow-up.
Measured: baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start27 Sep 2023
- Primary completion29 Jul 2024
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postpartum Weight RetentionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Camille S Worthington, PhD, University of Alabama at Birmingham
- Investigators
- Camille S Worthington, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579990
- Sponsor's protocol ID
- IRB-300010155
- Other IDs
- U54MD000502
- Status last verified
- Sep 2025
- First submitted
- 11 Oct 2022
- Last updated
- 23 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in a publication will be made available upon request beginning 9 months and ending 36 months following article publication. The research team will keep a record of all individuals and/or research teams who request and receive a copy of the project data. Interested investigators will be asked to submit a document indicating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Meal Delivery Intervention for Postpartum Weight Management
- ClinicalTrials.gov ID
- NCT05579990
- Acronym / sponsor ID
- IRB-300010155
- Conditions
- Postpartum Weight Retention, Obesity
- Keywords
- Postpartum, Weight management, Meal delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Posted 5 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to assess the feasibility and acceptability of a meal delivery intervention among low-income postpartum women with obesity.
Detailed description
This is a single-group pilot study in which subjects will receive 10 home-delivered meals per week for 8 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meal Delivery | Experimental | Behavioral: Meal DeliveryMeal delivery intervention program designed to help low income postpartum women lose weight through weekly meal delivery and behavioral strategies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Medicaid eligible and/or have a household income at or below 185 percent of the federal poverty line
- 18 years of age or older
- Initiated prenatal care at a University of Alabama at Birmingham prenatal clinic
- Experienced a healthy singleton pregnancy
- 5-45 weeks postpartum at enrollment
Key exclusion criteria (8 listed)
- Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 2 diabetes)
- Current treatment for severe psychiatric disorder (such as schizophrenia)
- Self-reported diagnosis of anorexia or bulimia
- Current use of medication expected to significantly impact body weight
- Current substance abuse
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 |
|---|---|---|
| Meal Delivery10 home-delivered meals per week provided by a local meal delivery company supplemented by remote weekly behavioral support with study staff. | Behavioural | Meal Delivery |
Primary outcome
Self-Reported Proportion of Received Study Meals Consumed
Time frame: Collected weekly from intervention start (6-45 weeks postpartum) to follow-up (14-53 weeks postpartum)
Proportion of received weekly study meals participants reported consuming each week collected via weekly electronic surveys in which participants will self-report the number of study meals a) they consumed, b) other household members consumed, or c) that were uneaten.
3 secondary outcomes
Study Participation Rate
Time frame: baseline (5-45 weeks postpartum)
Participant Retention
Time frame: baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)
Change in Participant Satisfaction With Diet
Time frame: baseline (5-45 weeks postpartum), follow-up (14-53 weeks postpartum)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in a publication will be made available upon request beginning 9 months and ending 36 months following article publication. The research team will keep a record of all individuals and/or research teams who request and receive a copy of the project data. Interested investigators will be asked to submit a document indicating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed.
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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.
Camille S Worthington, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal Delivery in people with Postpartum Weight Retention and Obesity, run by University of Alabama at Birmingham 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 23 Sep 2025. 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. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-Reported Proportion of Received Study Meals Consumed (time frame: Collected weekly from intervention start (6-45 weeks postpartum) to follow-up (14-53 weeks postpartum)). 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 23 Sep 2025.