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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time restricted feeding | Behavioral | We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Compare changes from baseline to the end of the 12-week intervention in systolic blood pressure. | baseline to 12 weeks |
| Diastolic Blood Pressure | Compare changes from baseline to the end of the 12-week intervention in diastolic blood pressure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly C Allison, PhD | University of Pennyslvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Six participants enrolled, and 5 completed the trial. We included 5 participants who had more than one data point to calculate weight change. | Posted | Mean | Standard Deviation | kg | baseline to 12 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients. |
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This was a small, unfunded feasibility study of this protocol. There was no control group, and no statistical tests were run to test significance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly C. Allison, PhD | Perelman School of Medicine at the University of Pennsylvania | 2158982823 | kca@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2020 | Jul 14, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2016 | Jul 15, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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Non-controlled, single arm intervention study
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| baseline to 12 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| body mass index | Mean | Standard Deviation | kg/m2 |
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| Secondary | Systolic Blood Pressure | Compare changes from baseline to the end of the 12-week intervention in systolic blood pressure. | Six participants started the intervention, and we analyzed data from 5 participant who provided blood pressure measurements before and after the intervention | Posted | Mean | Standard Deviation | mmHg | baseline to 12 weeks |
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| Secondary | Diastolic Blood Pressure | Compare changes from baseline to the end of the 12-week intervention in diastolic blood pressure. | Six participants started the intervention, and we analyzed data from 5 participant who provided blood pressure measurements before and after the intervention | Posted | Mean | Standard Deviation | mmHg | baseline to 12 weeks |
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| 6 |
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| 6 |
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