Time-restricted Eating for Postpartum Weight Loss

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06491537
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
May 22, 2025
Status verified
Jun 2025
Primary completion
Jan 1, 2029
Completion
Feb 1, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: eTRE Intervention
    A 9-hour eating/15-hour fasting time-restricted eating (eTRE) intervention with tapered remote behavioral support sessions delivered by a trained interventionist.
  • Active Comparator: Control
    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.

Primary Outcome Measure

Study Participation Rate [ Time Frame: Baseline (6-16 weeks postpartum) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Camille S Worthington, PhD
205-975-7274

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