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OpenTrials
Completed

NCT Number: NCT02936076

Exercise as a Buffer Against Stress-induced Overeating

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Weight Control and Diabetes Research Center

Providence, Rhode Island, 002903, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise intervention

Other

Delayed exercise intervention

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 18, 2016
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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