Clinical trial NCT06491537: Time-restricted Eating for Postpartum Weight Loss
Official title: Use of Early Time-restricted Eating to Promote Weight Loss and Improve Cardiometabolic Health in Postpartum Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Weight Retention
Overweight and Obesity
Keywords: postpartum
weight management
time-restricted eating
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-07-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Study Participation Rate
timeFrame: Baseline (6-16 weeks postpartum)
measure: Oral Glucose Tolerance Test (OGTT)
timeFrame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
measure: Energy Intake
timeFrame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
measure: Participant Retention
timeFrame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
measure: Change in Visceral Fat
timeFrame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
measure: Participant Adherence to Intervention
timeFrame: Collected daily from intervention start (6-16 weeks postpartum) to follow-up (18-28 weeks postpartum)
measure: eTRE Intervention Satisfaction
timeFrame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
measure: Change in Body Weight
timeFrame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
measure: Change in Subjective Appetite
timeFrame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
measure: Self-Reported Fatigue
timeFrame: Baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Camille Worthington, PhD
role: PRINCIPAL_INVESTIGATOR
References: