Time Restricted Eating Pilot - Bariatrics

NCT ID: NCT04006366

Last Updated: 2020-07-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-25

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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Time Restricted Feeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Non-controlled, single arm intervention study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

Time restricted feeding

Intervention Type BEHAVIORAL

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

Interventions

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Time restricted feeding

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Kelly Allison

Director, Center for Weight and Eating Disorders

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kelly C Allison, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennyslvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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833432

Identifier Type: -

Identifier Source: org_study_id

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