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
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.