Time-restricted Eating for Postpartum Weight Loss
Time4Mom
Use of Early Time-restricted Eating to Promote Weight Loss and Improve Cardiometabolic Health in Postpartum Women
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2024
CompletedFirst Posted
Study publicly available on registry
July 9, 2024
CompletedStudy Start
First participant enrolled
May 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
June 12, 2025
June 1, 2025
3.6 years
July 1, 2024
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Study Participation Rate
Percentage of eligible subjects who agreed to participate out of those who were screened.
Baseline (6-16 weeks postpartum)
Oral Glucose Tolerance Test (OGTT)
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.
Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Energy Intake
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.
Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Participant Retention
The proportion of enrolled participants who complete follow-up.
Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Change in Visceral Fat
Bioelectrical impedance analysis (BIA) (seca® mBCA 514) will be used to assess visceral adipose tissue.
Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Participant Adherence to Intervention
Adherence to eating window based on responses to daily electronic REDCap surveys that record start and stop time of the eating window.
Collected daily from intervention start (6-16 weeks postpartum) to follow-up (18-28 weeks postpartum)
eTRE Intervention Satisfaction
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.
Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Change in Body Weight
Body weight measured at baseline and follow-up will be used to calculate weight change.
Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Change in Subjective Appetite
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.
Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Self-Reported Fatigue
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).
Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Study Arms (2)
eTRE Intervention
EXPERIMENTALA 9-hour eating/15-hour fasting time-restricted eating (eTRE) intervention with tapered remote behavioral support sessions delivered by a trained interventionist.
Control
ACTIVE COMPARATORControl 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
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.
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.
Eligibility Criteria
You may qualify if:
- years of age or older
- Experienced a healthy singleton pregnancy
- weeks postpartum at enrollment
- Body mass index ≥25 at enrollment
- Willing to consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camille Worthington, PhD
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
July 1, 2024
First Posted
July 9, 2024
Study Start
May 22, 2025
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
February 1, 2029
Last Updated
June 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be made available at the time of associated publication or by the end of the clinical trial.
- Access Criteria
- To request access to the data, the user must submit a valid scientific question, include a statistical analysis plan, and complete all required fields on the Vivli data request form. Vivli will review the data request for completeness. Anyone who has submitted an approved data request and signed a DUA on Vivli will be given access to the data without cost for a set period
The following data produced during the project will be preserved and shared: Aggregate data on recruitment rates and reasons for refusal, retention rates, adherence rates, and treatment satisfaction will be shared publicly. Individual participant data (IPD) for the following measures will be restricted with a data use agreement: anthropometrics (weight, height, waist circumference); body composition; the following serum levels at each timepoint from the oral glucose tolerance test: insulin, glucose, and c-peptide; dietary data; survey responses/total scores; demographics; and pregnancy-related medical history. All aggregate datasets that can be shared publicly will be deposited in the Open Science Framework (OSF) generalist repository. De-identified IPD will be shared via controlled access in the Vivli repository.