Time Restricted Eating Pilot - Bariatrics

Not Applicable

Completed

• Conditions: Time Restricted Feeding
• Interventions: Behavioral: Time restricted feeding

• Registration Number: NCT04006366
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

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 Timeline

• Study Start: 2019-06-25
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-05
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Results First Submitted: 2020-06-29
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-15
• Last Update Submitted: 2020-07-15
• Results First Posted: 2020-07-17
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Time restricted feeding	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).

Primary Outcome Measures

Name	Time	Method
Weight	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.

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	baseline to 12 weeks	Compare changes from baseline to the end of the 12-week intervention in systolic blood pressure.
Diastolic Blood Pressure	baseline to 12 weeks	Compare changes from baseline to the end of the 12-week intervention in diastolic blood pressure.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States