ObesityNCT02936076
Exercise as a Buffer Against Stress-induced Overeating
A study testing Exercise intervention and Delayed exercise intervention in people with Obesity, run by The Miriam Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise intervention and Delayed exercise intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2017to 21 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Inability to walk without an assisted device
- Inability to meet exercise recommendations
- Failure to adequately complete all baseline assessment measures
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center
Providence, Rhode Island, 002903
About this study
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.
- Conditions
- Obesity
- Being tested
- Exercise intervention, Delayed exercise intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionOther
Delayed exercise interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise condition | Active comparator | 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. Receives: Other: Exercise intervention |
| Delayed exercise condition | Placebo comparator | 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. Receives: Other: Delayed exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 12 weeks
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'.
Measured: 12 weeks
Secondary outcomes (2)
Change in Body Weight (% Initial Weight)
Percent weight change from baseline to 12 weeks
Measured: baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start16 Jan 2017
- Primary completion1 Nov 2018
- Study completion21 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936076
- Sponsor's protocol ID
- 592916-14
- Other IDs
- K01DK100498
- Status last verified
- Aug 2019
- First submitted
- 13 Oct 2016
- Last updated
- 29 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34261994
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as a Buffer Against Stress-induced Overeating
- ClinicalTrials.gov ID
- NCT02936076
- Acronym / sponsor ID
- 592916-14
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise condition | Active comparator | Other: Exercise interventionParticipants 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. |
| Delayed exercise condition | Placebo comparator | Other: Delayed exercise interventionParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female
- 18-60 years of age
- BMI 25 to <40 kg/m2
- Physically inactive (<60 min/week of physical activity)
- Must own a smartphone
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise intervention | Other | Exercise condition |
| Delayed exercise intervention | Other | Delayed exercise condition |
Primary outcome
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'.
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'.
2 secondary outcomes
Change in Body Weight (% Initial Weight)
Time frame: baseline and 12 weeks
Stress as Measured Via Questionnaire
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34261994Unick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention and Delayed exercise intervention in people with Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress-induced Overeating Measured Via Smartphone Surveys (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02936076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.