Exercise as a Buffer Against Stress-induced Overeating
2 other identifiers
interventional
49
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jan 2017
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2016
CompletedFirst Posted
Study publicly available on registry
October 18, 2016
CompletedStudy Start
First participant enrolled
January 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2019
CompletedResults Posted
Study results publicly available
October 23, 2019
CompletedMarch 29, 2021
August 1, 2019
1.8 years
October 13, 2016
October 3, 2019
March 26, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Stress-induced Overeating Measured Via Smartphone Surveys
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'.
12 weeks
Percentage of Overeating Episodes Characterized as 'Overeating'
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 Outcomes (2)
Change in Body Weight (% Initial Weight)
baseline and 12 weeks
Stress as Measured Via Questionnaire
Baseline and 12 weeks
Study Arms (2)
Exercise condition
ACTIVE COMPARATORParticipants 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.
Delayed exercise condition
PLACEBO COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Female
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weight Control and Diabetes Research Center
Providence, Rhode Island, 002903, United States
Related Publications (1)
Unick JL, Dunsiger SI, Leblond T, Hahn K, Thomas JG, Abrantes AM, Stroud LR, Wing RR. Randomized Trial Examining the Effect of a 12-wk Exercise Program on Hedonic Eating. Med Sci Sports Exerc. 2021 Aug 1;53(8):1638-1647. doi: 10.1249/MSS.0000000000002619.
PMID: 34261994DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jessica Unick
- Organization
- The Miriam Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2016
First Posted
October 18, 2016
Study Start
January 16, 2017
Primary Completion
November 1, 2018
Study Completion
May 21, 2019
Last Updated
March 29, 2021
Results First Posted
October 23, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share