Time Restricted Eating Pilot - Bariatrics

NCT04006366 | Completed Results DMC

• 1 other identifier: 833432
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Time Restricted Feeding

Keywords

bariatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Systolic Blood Pressure

  baseline to 12 weeks

• Diastolic Blood Pressure

  baseline to 12 weeks

Study Arms (1)

Intervention

OTHER

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).

Behavioral: Time restricted feeding

Interventions

Time restricted feeding BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Limitations and Caveats

This was a small, unfunded feasibility study of this protocol. There was no control group, and no statistical tests were run to test significance.

Results Point of Contact

• Title: Kelly C. Allison, PhD
• Organization: Perelman School of Medicine at the University of Pennsylvania

kca@pennmedicine.upenn.edu

2158982823

Study Officials

• Kelly C Allison, PhD

  University of Pennyslvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Weight and Eating Disorders

Model Details: Non-controlled, single arm intervention study

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 5, 2019
• Study Start: June 25, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: July 17, 2020
• Results First Posted: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)