Exercise as a Buffer Against Stress-induced Overeating

NCT ID: NCT02936076

Last Updated: 2021-03-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-16

Study Completion Date

2019-05-21

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Exercise intervention

Intervention Type OTHER

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.

Group Type PLACEBO_COMPARATOR

Delayed exercise intervention

Intervention Type OTHER

Interventions

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Exercise intervention

Intervention Type OTHER

Delayed exercise intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34261994 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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K01DK100498

Identifier Type: NIH

Identifier Source: secondary_id

View Link

592916-14

Identifier Type: -

Identifier Source: org_study_id

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