Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALEarly 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.
BEHAVIORALControlThe 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.