Trial Outcomes & Findings for Exercise as a Buffer Against Stress-induced Overeating (NCT NCT02936076)

NCT ID: NCT02936076

Last Updated: 2021-03-29

Results Overview

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'.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-03-29

Participant Flow

Participant milestones

Participant milestones
Measure
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
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
Overall Study
STARTED
25
24
Overall Study
COMPLETED
19
20
Overall Study
NOT COMPLETED
6
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exercise as a Buffer Against Stress-induced Overeating

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Exercise Condition
n=25 Participants
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
Delayed Exercise Condition
n=24 Participants
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
Total
n=49 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
25 Participants
n=99 Participants
24 Participants
n=107 Participants
49 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Continuous
39.9 years
STANDARD_DEVIATION 11.7 • n=99 Participants
41.0 years
STANDARD_DEVIATION 10.0 • n=107 Participants
40.4 years
STANDARD_DEVIATION 10.8 • n=206 Participants
Sex: Female, Male
Female
25 Participants
n=99 Participants
24 Participants
n=107 Participants
49 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=99 Participants
2 Participants
n=107 Participants
5 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
22 Participants
n=99 Participants
22 Participants
n=107 Participants
44 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
4 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
White
21 Participants
n=99 Participants
16 Participants
n=107 Participants
37 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=99 Participants
3 Participants
n=107 Participants
6 Participants
n=206 Participants
Region of Enrollment
United States
25 participants
n=99 Participants
24 participants
n=107 Participants
49 participants
n=206 Participants

PRIMARY outcome

Timeframe: 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'.

Outcome measures

Outcome measures
Measure
Exercise Condition
n=19 Participants
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
Delayed Exercise Condition
n=20 Participants
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
Stress-induced Overeating Measured Via Smartphone Surveys
0.74 episodes
Standard Deviation 1.56
0.55 episodes
Standard Deviation 1.0

PRIMARY outcome

Timeframe: 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'.

Outcome measures

Outcome measures
Measure
Exercise Condition
n=19 Participants
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
Delayed Exercise Condition
n=20 Participants
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
Percentage of Overeating Episodes Characterized as 'Overeating'
21.98 % of eating episodes
Standard Deviation 3.32
26.62 % of eating episodes
Standard Deviation 3.58

SECONDARY outcome

Timeframe: baseline and 12 weeks

Percent weight change from baseline to 12 weeks

Outcome measures

Outcome measures
Measure
Exercise Condition
n=19 Participants
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
Delayed Exercise Condition
n=20 Participants
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
Change in Body Weight (% Initial Weight)
-1.1 percent change
Standard Deviation 3.5
0.4 percent change
Standard Deviation 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Exercise Condition
n=19 Participants
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
Delayed Exercise Condition
n=20 Participants
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
Stress as Measured Via Questionnaire
22.7 units on a scale
Standard Error 0.8
21.5 units on a scale
Standard Error 0.8

Adverse Events

Exercise Condition

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Delayed Exercise Condition

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jessica Unick

The Miriam Hospital

Phone: 401-793-8966

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place