Obesity
Conditions
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.
Interventions
OTHERExercise intervention
OTHERDelayed exercise intervention
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress-induced Overeating Measured Via Smartphone Surveys | 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'. |
| Percentage of Overeating Episodes Characterized as 'Overeating' | 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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (% Initial Weight) | baseline and 12 weeks | Percent weight change from baseline to 12 weeks |
| Stress as Measured Via Questionnaire | Baseline and 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Exercise intervention | 25 |
| 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.
Delayed exercise intervention | 24 |
| Total | 49 |
Baseline characteristics
| Characteristic | Exercise Condition | Delayed Exercise Condition | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 24 Participants | 49 Participants |
| Age, Continuous | 39.9 years STANDARD_DEVIATION 11.7 | 41.0 years STANDARD_DEVIATION 10 | 40.4 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 22 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 21 Participants | 16 Participants | 37 Participants |
| Region of Enrollment United States | 25 participants | 24 participants | 49 participants |
| Sex: Female, Male Female | 25 Participants | 24 Participants | 49 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Condition | Percentage of Overeating Episodes Characterized as 'Overeating' | 21.98 % of eating episodes | Standard Deviation 3.32 |
| Delayed Exercise Condition | Percentage of Overeating Episodes Characterized as 'Overeating' | 26.62 % of eating episodes | Standard Deviation 3.58 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Condition | Stress-induced Overeating Measured Via Smartphone Surveys | 0.74 episodes | Standard Deviation 1.56 |
| Delayed Exercise Condition | Stress-induced Overeating Measured Via Smartphone Surveys | 0.55 episodes | Standard Deviation 1 |
Secondary
Change in Body Weight (% Initial Weight)
Percent weight change from baseline to 12 weeks
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Condition | Change in Body Weight (% Initial Weight) | -1.1 percent change | Standard Deviation 3.5 |
| Delayed Exercise Condition | Change in Body Weight (% Initial Weight) | 0.4 percent change | Standard Deviation 2 |
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exercise Condition | Stress as Measured Via Questionnaire | 22.7 units on a scale | Standard Error 0.8 |
| Delayed Exercise Condition | Stress as Measured Via Questionnaire | 21.5 units on a scale | Standard Error 0.8 |