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出境医 / 临床实验 / Time Restricted Eating Pilot - Bariatrics

Time Restricted Eating Pilot - Bariatrics

Study Description
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.

Condition or disease Intervention/treatment Phase
Time Restricted Feeding Behavioral: Time restricted feeding Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Non-controlled, single arm intervention study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Time Restricted Eating Pilot - Bariatrics
Actual Study Start Date : June 25, 2019
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : November 30, 2019
Arms and Interventions
Arm Intervention/treatment
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).
 Behavioral: Time restricted feeding
We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Kelly C Allison, PhD University of Pennyslvania
Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE July 5, 2019
Results First Submitted Date  ICMJE June 29, 2020
Results First Posted Date  ICMJE July 17, 2020
Last Update Posted Date July 17, 2020
Actual Study Start Date  ICMJE June 25, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2020) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019) 		Weight [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Calorie intake [ Time Frame: 12 weeks ]
    Compare changes before and after the 12-week intervention in caloric intake (ASA-24).
  • Macronutrient intake [ Time Frame: 12 weeks ]
    Compare changes before and after the 12-week intervention in macronutrient intake (ASA-24).
  • Physical activity [ Time Frame: 12 weeks ]
    Compare changes before and after the 12-week intervention in physical activity (Paffenbarger).
  • Sleep [ Time Frame: 12 weeks ]
    Compare changes before and after the 12-week intervention in sleep quantity and quality (PSQI).
  • Eating patterns [ Time Frame: 12 weeks ]
    Compare changes before and after the 12-week intervention in eating patterns (Eating Inventory).
  • Blood pressure [ Time Frame: 12 weeks ]
    Compare changes before and after the 12-week intervention in blood pressure.
  • Psychosocial factors [ Time Frame: 12 weeks ]
    Compare changes before and after the 12-week intervention in depressed mood (BDI-II).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Time Restricted Eating Pilot - Bariatrics
Official Title  ICMJE Time Restricted Eating Pilot - Bariatrics
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Non-controlled, single arm intervention study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Time Restricted Feeding
Intervention  ICMJE Behavioral: Time restricted feeding
We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.
Study Arms  ICMJE 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).
Intervention: Behavioral: Time restricted feeding
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2020) 		6
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2019) 		10
Actual Study Completion Date  ICMJE November 30, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04006366
Other Study ID Numbers  ICMJE 833432
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kelly Allison, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kelly C Allison, PhD University of Pennyslvania
PRS Account University of Pennsylvania
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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