Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-05-22
2029-02-01
Brief Summary
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Detailed Description
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This 2-arm trial will randomize 60 postpartum women to either Control or eTRE for 12 weeks (n=30/group).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Experienced a healthy singleton pregnancy
* 6-16 weeks postpartum at enrollment
* Body mass index ≥25 at enrollment
* Willing to consent
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Camille S Worthington, PhD
Primary Investigator
Principal Investigators
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Camille Worthington, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-300012535
Identifier Type: -
Identifier Source: org_study_id
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