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Completed

NCT Number: NCT04006366

Time Restricted Eating Pilot - Bariatrics

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.

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Key information

Conditions

Time Restricted Feeding Behavior Fasting Feeding Behavior Intermittent Fasting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time restricted feeding

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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