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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: Early Time-Restricted Eating (eTRE)
    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.
    Other names:
    • Intermittent Fasting
    • Timed Eating
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.
  • Behavioral: Control
    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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Camille S Worthington, PhD
205-975-7274
cschneid@uab.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Camille S Worthington, PhD
205.975.7274
cschneid@uab.edu

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.