An interventional study of Early Time-Restricted Eating (eTRE) and Control in Postpartum Weight Retention and Overweight and Obesity, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
This study is being done to assess the feasibility and acceptability of a time-restricted eating intervention among postpartum women with overweight/obesity.
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).
134 studies on the registry are indexed under Gestational Weight Gain; 24 are open to participants now.
This study's planned enrollment of 60 is below the median of 104 across 108 interventional studies indexed under Gestational Weight Gain.
Browse Gestational Weight Gain studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 9-hour eating/15-hour fasting time-restricted eating (eTRE) intervention with tapered remote behavioral support sessions delivered by a trained interventionist.
Behavioral: Early Time-Restricted Eating (eTRE)
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.
Behavioral: Control
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.
Also known as: Intermittent Fasting, Timed Eating
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.
Study Participation Rate
Percentage of eligible subjects who agreed to participate out of those who were screened.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Participant Retention
The proportion of enrolled participants who complete follow-up.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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
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University of Alabama at Birmingham →