An interventional study of Exercise intervention and Delayed exercise intervention in Obesity, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-29.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Treatment
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.
94 studies on the registry are indexed under Hyperphagia; 25 are open to participants now.
This study's enrollment of 49 is close to the median of 50 across 81 interventional studies indexed under Hyperphagia.
Browse Hyperphagia studies →The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Exercise intervention
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.
Other: Delayed exercise intervention
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'.
Time frame: 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'.
Time frame: 12 weeks
Change in Body Weight (% Initial Weight)
Percent weight change from baseline to 12 weeks
Time frame: baseline and 12 weeks
Stress as Measured Via Questionnaire
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.
Time frame: Baseline and 12 weeks
| Milestone | Exercise Condition | Delayed Exercise Condition |
|---|---|---|
| Started | 25 | 24 |
| Completed | 19 | 20 |
| Not completed | 6 | 4 |
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'.
| episodes | Exercise Condition | Delayed Exercise Condition |
|---|---|---|
| Stress-induced Overeating Measured Via Smartphone Surveys | 0.74 ± 1.56 | 0.55 ± 1.0 |
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'.
| % of eating episodes | Exercise Condition | Delayed Exercise Condition |
|---|---|---|
| Percentage of Overeating Episodes Characterized as 'Overeating' | 21.98 ± 3.32 | 26.62 ± 3.58 |
Percent weight change from baseline to 12 weeks
| percent change | Exercise Condition | Delayed Exercise Condition |
|---|---|---|
| Change in Body Weight (% Initial Weight) | -1.1 ± 3.5 | 0.4 ± 2.0 |
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.
| units on a scale | Exercise Condition | Delayed Exercise Condition |
|---|---|---|
| Stress as Measured Via Questionnaire | 22.7 ± 0.8 | 21.5 ± 0.8 |
Collected over 12 weeks post randomization. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exercise Condition | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Delayed Exercise Condition | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Categorical(Participants) | Exercise Condition | Delayed Exercise Condition | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 24 | 49 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Exercise Condition | Delayed Exercise Condition | Total |
|---|---|---|---|
| Mean | 39.9 ± 11.7 | 41.0 ± 10.0 | 40.4 ± 10.8 |
| Sex: Female, Male(Participants) | Exercise Condition | Delayed Exercise Condition | Total |
|---|---|---|---|
| Female | 25 | 24 | 49 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Exercise Condition | Delayed Exercise Condition | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 22 | 22 | 44 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Exercise Condition | Delayed Exercise Condition | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 4 | 4 |
| White | 21 | 16 | 37 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 3 | 3 | 6 |
| Region of Enrollment(participants) | Exercise Condition | Delayed Exercise Condition | Total |
|---|---|---|---|
| United States | 25 | 24 | 49 |
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