Time-restricted Eating for Postpartum Weight Loss (Time4Mom)

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Overweight and Obesity; Postpartum Weight Retention

Treatments: Behavioral: Control; Behavioral: Early Time-Restricted Eating (eTRE)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06491537

IRB-300012535

K23HD108345 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

eTRE Intervention

Experimental group

Description:

A 9-hour eating/15-hour fasting time-restricted eating (eTRE) intervention with tapered remote behavioral support sessions delivered by a trained interventionist.

Treatment:

Behavioral: Early Time-Restricted Eating (eTRE)

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control