Time-restricted Eating for Postpartum Weight Loss

Not Applicable

Recruiting

• Conditions: Postpartum Weight Retention; Overweight and Obesity

• Registration Number: NCT06491537
• Lead Sponsor: University of Alabama at Birmingham

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.

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).

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Study Start: 2025-05-22
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-12
• Primary Completion: 2029-01-01
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Study Participation Rate	Baseline (6-16 weeks postpartum)	Percentage of eligible subjects who agreed to participate out of those who were screened.
Oral Glucose Tolerance Test (OGTT)	Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)	Indices of glucose tolerance and insulin action will be assessed via a 2-hr OGTT. Participants will consume a 75-g glucose load within 5 minutes, which will be timed to begin at each participant's habitual breakfast time. Fasting blood samples will be collected at 15-, 30-, 60-, 90-, and 120-minutes relative to glucose consumption.
Energy Intake	Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)	Dietary intake will be collected at each assessment by 3 self-administered 24-hr recalls on 3 non-consecutive days (2 weekdays, 1 weekend day) using the Automatic Self-Administered 24-hour Dietary Assessment Tool (ASA24), an online platform developed and hosted by the National Cancer Institute. Total energy intake and kcals from each macronutrient will be derived from 24-hr recalls.
Participant Retention	Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)	The proportion of enrolled participants who complete follow-up.
Change in Visceral Fat	Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)	Bioelectrical impedance analysis (BIA) (seca® mBCA 514) will be used to assess visceral adipose tissue.
Participant Adherence to Intervention	Collected daily from intervention start (6-16 weeks postpartum) to follow-up (18-28 weeks postpartum)	Adherence to eating window based on responses to daily electronic REDCap surveys that record start and stop time of the eating window.
eTRE Intervention Satisfaction	Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)	Participant satisfaction with the eating schedule will be assessed using a 5-point Likert scale. Long-term eating schedule preferences will be assessed by asking intervention participants at follow-up whether they plan to: (a) continue following the assigned eTRE schedule; (b) follow a modified eTRE schedule \[and specifying what modifications they plan to make\]; or (c) stop eTRE and return to prior meal timing habits.; Qualitative data on eTRE intervention satisfaction will be collected at follow-up. These one-on-one interviews will be conducted in-person or remotely via videoconferencing. Topics explored will include participants' typical day during the intervention, experiences with eTRE, adherence barriers/facilitators, intervention satisfaction, and suggested improvements.
Change in Body Weight	Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)	Body weight measured at baseline and follow-up will be used to calculate weight change.
Change in Subjective Appetite	Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)	Subjective ratings of appetite (hunger and satiety) over the past week will be collected at baseline and follow-up using visual analogue scales scored from 0 (less hunger/less satiety) to 100 (more feelings of hunger/more feelings of satiety) based on the response along a 100-mm line.
Self-Reported Fatigue	Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)	Fatigue will be assessed using the NIH's validated 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 8a to assess fatigue over the past 7 days. The PROMIS Fatigue SF 8a is scored on a T-score metric with a mean of 50 and standard deviation of 10. The T-score metric is referenced to the US general population with respect to race/ethnicity, age, education, and sex (e.g., T-score of 40 would be one SD below the US general population). A higher PROMIS T-score represents more of the concept being measured (higher score indicates more fatigue).

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States