Time-restricted Eating for Postpartum Weight Loss
NCT Number: NCT06491537
Acronym: Time4Mom
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postpartum Weight Retention|Overweight and Obesity
Interventions: BEHAVIORAL: Early Time-Restricted Eating (eTRE)|BEHAVIORAL: Control
Sponsor: University of Alabama at Birmingham
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2029-02
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States

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

Primary Outcome Measures: Participant Adherence to Intervention, Adherence to eating window based on responses to daily electronic REDCap surveys that record start and stop time of window and reasons for non-adherence. The number of completed telehealth contacts will also be collected., 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)
Secondary Outcome Measures: Study Participation Rate, Percentage of eligible subjects who agreed to participate out of those who were screened., Baseline (6-16 weeks postpartum)|Participant Retention, The proportion of enrolled participants who complete follow-up., Baseline (6-16 weeks postpartum), follow-up (18-28 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)|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)
Other Outcome Measures: 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)