Time Restricted Eating Pilot - Bariatrics

Time Restricted Feeding Clinical Trial

Official title:

Time Restricted Eating Pilot - Bariatrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04006366
• Other study ID #: 833432
• Status: Completed
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: July 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Time Restricted Feeding

Intervention

Behavioral:
• Time restricted feeding
We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Compare changes in body weight over 12 weeks in 10 bariatric patients who have undergone bariatric surgery and have completed the pilot study.	baseline to 12 weeks
Secondary	Systolic Blood Pressure	Compare changes from baseline to the end of the 12-week intervention in systolic blood pressure.	baseline to 12 weeks
Secondary	Diastolic Blood Pressure	Compare changes from baseline to the end of the 12-week intervention in diastolic blood pressure.	baseline to 12 weeks