Exercise as a Buffer Against Stress-induced Overeating

• ClinicalTrials.gov Identifier: NCT02936076
• Recruitment Status: Completed
• First Posted: October 18, 2016
• Results First Posted: October 23, 2019
• Last Update Posted: March 29, 2021
• Sponsor: The Miriam Hospital
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): The Miriam Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Other: Exercise intervention; Other: Delayed exercise intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exercise as a Buffer Against Stress-induced Overeating
• Actual Study Start Date: January 16, 2017
• Actual Primary Completion Date: November 1, 2018
• Actual Study Completion Date: May 21, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Other: Exercise intervention
Placebo Comparator: 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.	Other: Delayed exercise intervention

Outcome Measures

Primary Outcome Measures :

1. Stress-induced Overeating Measured Via Smartphone Surveys [ Time Frame: 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'.
2. Percentage of Overeating Episodes Characterized as 'Overeating' [ Time Frame: 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 Outcome Measures :

1. Change in Body Weight (% Initial Weight) [ Time Frame: baseline and 12 weeks ]
   Percent weight change from baseline to 12 weeks
2. Stress as Measured Via Questionnaire [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Rhode Island

Weight Control and Diabetes Research Center

Providence, Rhode Island, United States, 002903

Sponsors and Collaborators

The Miriam Hospital

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  Study Documents (Full-Text)

Documents provided by The Miriam Hospital:

Study Protocol  [PDF] October 11, 2017

Statistical Analysis Plan  [PDF] September 11, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: The Miriam Hospital
• ClinicalTrials.gov Identifier: NCT02936076
• Other Study ID Numbers: 592916-14; K01DK100498 ( U.S. NIH Grant/Contract )
• First Posted: October 18, 2016
• Results First Posted: October 23, 2019
• Last Update Posted: March 29, 2021
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Hyperphagia; Signs and Symptoms, Digestive