Recruiting

Time-Restricted Eating

Sponsor:

University of Alabama at Birmingham

Code:

NCT06491537

Conditions

Postpartum Weight Retention

Overweight and Obesity

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early Time-Restricted Eating (eTRE)

Control

Study Details

Brief summary:

This study is being done to assess the feasibility and acceptability of a time-restricted eating intervention among postpartum women with overweight/obesity.

Conditions

Postpartum Weight Retention

Overweight and Obesity

Study ID

NCT06491537

Start date

May 22, 2025

Status verified date

Jun, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: eTRE Intervention

A 9-hour eating/15-hour fasting time-restricted eating (eTRE) intervention with tapered remote behavioral support sessions delivered by a trained interventionist.

active comparator: Control

Control condition in which participants are instructed to maintain their baseline eating window with tapered remote behavioral support check-ins delivered by a trained interventionist to encourage maintenance of the baseline eating window.

Interventions

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.

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.

Primary outcome measure

  • Study Participation Rate [ Time Frame: Baseline (6-16 weeks postpartum) ]
  • Oral Glucose Tolerance Test (OGTT) [ Time Frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum) ]
  • Energy Intake [ Time Frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum) ]
  • Participant Retention [ Time Frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum) ]
  • Change in Visceral Fat [ Time Frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum) ]
  • Participant Adherence to Intervention [ Time Frame: Collected daily from intervention start (6-16 weeks postpartum) to follow-up (18-28 weeks postpartum) ]
  • eTRE Intervention Satisfaction [ Time Frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum) ]
  • Change in Body Weight [ Time Frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum) ]
  • Change in Subjective Appetite [ Time Frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum) ]
  • Self-Reported Fatigue [ Time Frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum) ]

Central Contacts and Locations

Central contacts

Camille S Worthington, PhD

205.975.7274cschneid@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Camille S Worthington, PhD

205-975-7274cschneid@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • postpartum
  • weight management
  • time-restricted eating

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-29.