Time Restricted Feeding
Conditions
Keywords
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.
Interventions
BEHAVIORALTime restricted feeding
We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-controlled, single arm intervention study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 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
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | baseline to 12 weeks | Compare changes from baseline to the end of the 12-week intervention in systolic blood pressure. |
| Diastolic Blood Pressure | baseline to 12 weeks | Compare changes from baseline to the end of the 12-week intervention in diastolic blood pressure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 48.7 years STANDARD_DEVIATION 5.2 |
| body mass index | 40.8 kg/m2 STANDARD_DEVIATION 4.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: baseline to 12 weeks
Population: Six participants enrolled, and 5 completed the trial. We included 5 participants who had more than one data point to calculate weight change.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Weight | -.07 kg | Standard Deviation 1.53 |
Secondary
Diastolic Blood Pressure
Compare changes from baseline to the end of the 12-week intervention in diastolic blood pressure.
Time frame: baseline to 12 weeks
Population: Six participants started the intervention, and we analyzed data from 5 participant who provided blood pressure measurements before and after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Diastolic Blood Pressure | -1.8 mmHg | Standard Deviation 6.34 |
Secondary
Systolic Blood Pressure
Compare changes from baseline to the end of the 12-week intervention in systolic blood pressure.
Time frame: baseline to 12 weeks
Population: Six participants started the intervention, and we analyzed data from 5 participant who provided blood pressure measurements before and after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Systolic Blood Pressure | 5.4 mmHg | Standard Deviation 14.75 |