Trials / Recruiting
RecruitingNCT06491537
Time-restricted Eating for Postpartum Weight Loss
Use of Early Time-restricted Eating to Promote Weight Loss and Improve Cardiometabolic Health in Postpartum Women
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is being done to assess the feasibility and acceptability of a time-restricted eating intervention among postpartum women with overweight/obesity.
Detailed description
Existing postpartum weight retention (PPWR) interventions have had limited success. Timing-based interventions, such as early time-restricted eating (eTRE), show significant improvements in cardiometabolic endpoints in non-postpartum cohorts. The purpose of the Time4Mom study is to conduct a pilot randomized trial of a postpartum-adapted eTRE intervention to test feasibility and acceptability of the eTRE intervention and trial protocol. We will also compare changes in clinical outcomes of interest and patient-reported outcomes between eTRE (intervention) and control groups. This 2-arm trial will randomize 60 postpartum women to either Control or eTRE for 12 weeks (n=30/group).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Early Time-Restricted Eating (eTRE) | 12 weeks of eTRE intervention. Study staff will provide 7 support sessions with brief behavioral support, including evidence based strategies of problem-solving, action planning, and motivational interviewing. |
| BEHAVIORAL | Control | The control group will be instructed to maintain their average eating window for the 12-week period. Study staff will contact participants 7 times to encourage maintenance. |
Timeline
- Start date
- 2025-05-22
- Primary completion
- 2029-01-01
- Completion
- 2029-02-01
- First posted
- 2024-07-09
- Last updated
- 2025-06-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06491537. Inclusion in this directory is not an endorsement.