Early time-restricted eating to support postpartum weight loss
Use of Early Time-restricted Eating to Promote Weight Loss and Improve Cardiometabolic Health in Postpartum Women
This program will test whether an early time-restricted eating schedule helps postpartum women with overweight or obesity lose weight and is acceptable for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06491537 on ClinicalTrials.gov |
What this trial studies
This pilot randomized two-arm trial will enroll 60 postpartum women (6–16 weeks after a healthy singleton birth) with BMI ≥25 and randomize them 1:1 to a 12-week early time-restricted eating (eTRE) intervention or a control group. The eTRE approach is adapted for postpartum life and limits daily eating to an earlier daily window, while the control arm receives usual care. Primary aims are to measure feasibility and acceptability of the intervention and trial procedures, with secondary comparisons of clinical outcomes (weight and cardiometabolic markers) and patient-reported outcomes. Participants with major medical conditions, diagnosed eating disorders, recent extensive fasting, or other exclusion criteria will be excluded from enrollment.
Who should consider this trial
Good fit: Ideal candidates are postpartum women 6–16 weeks after a healthy singleton birth with BMI ≥25 who can consent, communicate in English, and do not meet any exclusion criteria.
Not a fit: Patients with major medical conditions such as diabetes or renal disease, diagnosed eating disorders, current use of weight-altering medications, frequent overnight shift work, regular long fasting habits, or current participation in another dietary/weight program are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this could offer a simple timing-based approach to help postpartum women with overweight or obesity lose weight and improve cardiometabolic health.
How similar studies have performed: Early time-restricted eating has shown cardiometabolic benefits in non-postpartum adult studies, but applying eTRE specifically in postpartum women is relatively novel and not well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Experienced a healthy singleton pregnancy * 6-16 weeks postpartum at enrollment * Body mass index ≥25 at enrollment * Willing to consent Exclusion Criteria: * 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 * Performing overnight shiftwork \>1x/week * Regularly fasting ≥14 hr/day or completing twelve or more 24-hr fasts within the past year * Unable to understand and communicate in English
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Camille Worthington, PhD — University of Alabama at Birmingham
- Study coordinator: Camille S Worthington, PhD
- Email: cschneid@uab.edu
- Phone: 205.975.7274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.