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Behavioral Intervention

Time-Restricted Eating for Postpartum Weight Loss (Time4Mom Trial)

N/A
Waitlist Available
Led By Camille Worthington, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Be older than 18 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if postpartum women who are overweight or obese can successfully follow a time-restricted eating plan and if they find it manageable."

Who is the study for?
This trial is for postpartum women who are dealing with overweight or obesity. It's designed to see if eating during a specific time frame each day can help with weight loss after having a baby.
What is being tested?
The study is testing an Early Time-Restricted Eating (eTRE) method against a control group to evaluate its effectiveness in helping postpartum women lose weight.
What are the potential side effects?
Since this trial involves dietary changes, side effects may include hunger outside of the eating window, potential mood changes, and variations in energy levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a major health condition like kidney disease, cancer, or diabetes.
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I am not currently being treated for a severe psychiatric disorder.
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I have been diagnosed with anorexia or bulimia.
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I am taking medication that could majorly affect my weight.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (6-16 weeks postpartum), follow-up (18-28 weeks postpartum) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participant Adherence to Intervention
eTRE Intervention Satisfaction
Secondary study objectives
Change in Visceral Fat
Oral Glucose Tolerance Test (OGTT)
Participant Retention
+1 more
Other study objectives
Energy Intake

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: eTRE InterventionExperimental Treatment1 Intervention
A 10-hour eating/14-hour fasting time-restricted eating (eTRE) intervention with tapered remote behavioral support sessions delivered by a trained interventionist.
Group II: ControlActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,651 Previous Clinical Trials
2,443,651 Total Patients Enrolled
1 Trials studying Postpartum Weight Retention
11 Patients Enrolled for Postpartum Weight Retention
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,065 Previous Clinical Trials
2,746,882 Total Patients Enrolled
Camille Worthington, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
35 Total Patients Enrolled
~40 spots leftby Jan 2029