Clinical trial

Time-restricted Eating for Postpartum Weight Loss

Recruiting now · Not applicable · 1 countries · Registry ID NCT06491537

Recruiting nowNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersNot accepted

ConditionPostpartum Weight Retention, Overweight and Obesity

Full registry criteria

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

Treatments and study arms

Early Time-Restricted Eating (eTRE)

Behavioral

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

Behavioral

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 outcomes

Study Participation RateBaseline (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 IntakeBaseline (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 RetentionBaseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)

The proportion of enrolled participants who complete follow-up.

Change in Visceral FatBaseline (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 InterventionCollected 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 SatisfactionBaseline (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 WeightBaseline (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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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

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Camille S Worthington, PhDContact

Email · Call 205-975-7274