- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04006366
Time Restricted Eating Pilot - Bariatrics
July 15, 2020 updated by: Kelly Allison, University of Pennsylvania
Bariatric surgery patients have a variable course of weight loss, maintenance and regain.
Time restricted eating is an approach that may help individuals lose weight and improve metabolic functioning.
We propose a pilot 12-week trial of a 10-hour time restricted eating intervention among post-bariatric surgery patients.
The intervention would consist of weekly sessions for 4 weeks, followed by one session every two weeks through 12 weeks, with weight change as the primary outcome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We propose a pilot 12-week trial of a 10-hour time restricted eating intervention among post-bariatric surgery patients.
The intervention would consist of weekly sessions for 4 weeks, followed by one session every two weeks through 12 weeks, with weight change as the primary outcome.
We will provide behavioral weight loss education to the patients and monitor how many calories they are taking in once per week.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants will be at least two years post bariatric surgery who have completed participation in an ongoing longitudinal assessment study of bariatric patients at our medical center.
Exclusion Criteria:
- Participants who were non-compliant with the previous assessment trial, as well as those who were diagnosed with an eating disorder at their final (2 year) assessment visit. We will exclude participants at the discretion of the investigators who have unstable psychiatric issues or would be too ill to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
To test the effects of a 10-hour time restricted eating intervention before and after the 12 weeks of treatment on weight (primary), caloric and macronutrient intake, and a variety of psychosocial measures, including sleep, physical activity, blood pressure and eating behaviors (all secondary).
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We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: baseline to 12 weeks
|
Compare changes in body weight over 12 weeks in 10 bariatric patients who have undergone bariatric surgery and have completed the pilot study.
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baseline to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic Blood Pressure
Time Frame: baseline to 12 weeks
|
Compare changes from baseline to the end of the 12-week intervention in systolic blood pressure.
|
baseline to 12 weeks
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Diastolic Blood Pressure
Time Frame: baseline to 12 weeks
|
Compare changes from baseline to the end of the 12-week intervention in diastolic blood pressure.
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baseline to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kelly C Allison, PhD, University of Pennyslvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2019
Primary Completion (Actual)
November 30, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
June 26, 2019
First Submitted That Met QC Criteria
June 28, 2019
First Posted (Actual)
July 5, 2019
Study Record Updates
Last Update Posted (Actual)
July 17, 2020
Last Update Submitted That Met QC Criteria
July 15, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 833432
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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