- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936076
Exercise as a Buffer Against Stress-induced Overeating
March 26, 2021 updated by: The Miriam Hospital
The purpose of this study is to examine the psychological benefits of chronic exercise as well as the effects of exercise training on eating behaviors and stress-induced overeating in overweight and obese women.
Participants will be randomized to an 12-week exercise condition or a delayed exercise condition.
Assessments will occur at baseline, 6 weeks, and 12 weeks and will include answering surveys in real-time using smartphones, several assessments of eating behaviors and dietary intake, and questionnaire measures of factors which could mediate the relationship between exercise and eating.
Participants will be compensated for completing assessments and for adherence to the exercise protocol.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Rhode Island
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Providence, Rhode Island, United States, 002903
- Weight Control and Diabetes Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- 18-60 years of age
- BMI 25 to <40 kg/m2
- Physically inactive (<60 min/week of physical activity)
- Must own a smartphone
- Must be willing to receive and respond to text message prompts for 14 days at baseline, 6 and 12 weeks
Exclusion Criteria:
- Shift workers
- Individuals who do not endorse stress-eating
- Recent weight loss or current enrollment in a weight loss program
- Women who are pregnant or plan on becoming pregnant in the next 6 months
- Any medical condition that would limit participation in physical activity
- Diabetes
- Inability to walk without an assisted device
- Inability to meet exercise recommendations
- Failure to adequately complete all baseline assessment measures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exercise condition
Participants randomized to the exercise condition will participate in a 12-week exercise training program.
The exercise intervention will consist of both supervised and unsupervised exercise sessions and progress to 200 minutes/week of moderate-intensity exercise.
Exercise bouts will be spread across 4-6 days and be at least 20 minutes in duration.
During supervised visits, heart rate will be monitored by a member of the research staff to ensure that exercise is within the prescribed intensity range and ratings of perceived exertion and feeling state will be assessed periodically.
Unsupervised exercise will be verified using objective physical activity monitors.
|
|
Placebo Comparator: Delayed exercise condition
Participants randomized to the delayed exercise condition will be asked not to change their exercise or eating habits over the 12-week period and will complete the same assessment measures as the exercise condition.
However, following the completion of the 12-week period, participants will be given two options: 1) receive a one-on-one session with an exercise physiologist at our center and receive a written exercise program, and at this time point all study obligations will be completed, or 2) complete the identical exercise protocol as the 'exercise' condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress-induced Overeating Measured Via Smartphone Surveys
Time Frame: 12 weeks
|
Participants completed EMA surveys (5x/day for 14 days).
At each prompt they were asked if an eating episode occurred.
If they indicated 'yes', they were asked to check all that apply: a) I ate past the point of feeling full, b) I ate more than usual, c) I had unplanned eating (i.e., consumed food when I don't usually eat and was not making up for a missed meal, or d) None of the above.
If the participant responded with a, b, or c, it was classified as an 'overeating episode'.
Further, at each prompt, participants were asked to the respond to the following: 'Right now I feel stressed' (1=not at all, 7=very much so).
If the stress score was >=5 at the prompt just prior to an overeating episode, then it was considered a 'stress-induced overeating episode'.
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12 weeks
|
Percentage of Overeating Episodes Characterized as 'Overeating'
Time Frame: 12 weeks
|
If an eating episode occurred, participants were asked to check all that apply: a) I ate past the point of feeling full, b) I ate more than usual, c) I had unplanned eating (i.e., consumed food when I don't usually eat and was not making up for a missed meal, or d) None of the above.
If response was a, b, or c, it was classified as an 'overeating episode'.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Weight (% Initial Weight)
Time Frame: baseline and 12 weeks
|
Percent weight change from baseline to 12 weeks
|
baseline and 12 weeks
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Stress as Measured Via Questionnaire
Time Frame: Baseline and 12 weeks
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The 10-item Perceived Stress Scale (Cohen 1988) was used to assess changes in stress by treatment arm from baseline to 12 weeks.
Scores on this measure range from 0-40 with a higher score indicating greater perceived stress.
Presented values are 12 week scores adjusted for baseline values.
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Baseline and 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 16, 2017
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
May 21, 2019
Study Registration Dates
First Submitted
October 13, 2016
First Submitted That Met QC Criteria
October 14, 2016
First Posted (Estimate)
October 18, 2016
Study Record Updates
Last Update Posted (Actual)
March 29, 2021
Last Update Submitted That Met QC Criteria
March 26, 2021
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 592916-14
- K01DK100498 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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