Exercise as a Buffer Against Stress-induced Overeating

Obesity Clinical Trial

Official title:

Exercise as a Buffer Against Stress-induced Overeating

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936076
• Other study ID #: 592916-14
• Secondary ID: K01DK100498
• Status: Completed
• Phase: N/A
• Start date: January 16, 2017
• Est. completion date: May 21, 2019

Study information

• Verified date: August 2019
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 21, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperphagia
• Obesity

Intervention

Other:
• Exercise intervention

• Delayed exercise intervention

Locations

Country	Name	City	State
United States	Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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'.	12 weeks
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'.	12 weeks
Secondary	Change in Body Weight (% Initial Weight)	Percent weight change from baseline to 12 weeks	baseline and 12 weeks
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.	Baseline and 12 weeks