NCT02936076

Exercise as a Buffer Against Stress-induced Overeating

Completed NA Results posted Last updated 29 March 2021

What this trial tests

NA trial testing Exercise intervention in Obesity in 49 participants. Completed in 21 May 2019.

Timeline

16 January 2017

Primary endpoint
1 November 2018

21 May 2019

Quick facts

Lead sponsor	The Miriam Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	49
Start date	16 January 2017
Primary completion	1 November 2018
Estimated completion	21 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Exercise intervention
• Delayed exercise intervention

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

The Miriam Hospital

Who can join

Adults 18 to 60, female only, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Stress-induced Overeating Measured Via Smartphone Surveys Primary · 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 a

Group	Value	95% CI
Exercise Condition	0.74	± 1.56
Delayed Exercise Condition	0.55	± 1.0

Percentage of Overeating Episodes Characterized as 'Overeating' Primary · 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'.

Group	Value	95% CI
Exercise Condition	21.98	± 3.32
Delayed Exercise Condition	26.62	± 3.58

Change in Body Weight (% Initial Weight) Secondary · baseline and 12 weeks

Percent weight change from baseline to 12 weeks

Group	Value	95% CI
Exercise Condition	-1.1	± 3.5
Delayed Exercise Condition	0.4	± 2.0

Stress as Measured Via Questionnaire Secondary · 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.

Group	Value	95% CI
Exercise Condition	22.7	± 0.8
Delayed Exercise Condition	21.5	± 0.8

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomized Trial Examining the Effect of a 12-wk Exercise Program on Hedonic Eating.
   Unick JL, Dunsiger SI, Leblond T, Hahn K, et al · · 2021 · cited 3× · PMID 34261994 · DOI 10.1249/mss.0000000000002619