ObesityNCT03134040
Small Monetary Incentives to Promote Exercise (Exercise4Good; EX4G)
A study testing Incentives (Rebate), Incentives (Donation) and Feedback in people with Obesity and Physical Activity, run by Brown University at 1 site in United States.
Trial summary
This study is for physically inactive adults with an active membership at a Greater Providence Young Men's Christian Association (YMCA). Participants will receive weekly feedback on their attendance at the YMCA, and will be enrolled in the study for 1 year. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Activity
- What is being tested?
- Incentives (Rebate), Incentives (Donation) and Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inactive adults with an active YMCA membership
- Currently physically able to exercise
Who cannot join
- Do not plan to reside in the geographical region for the next 12 months
- Family member currently participating in the study
- Currently engaging in >150 mins of moderate/vigorous physical activity per week
- Attended the YMCA more than 4 times per month in the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health Building @ 121 South Main St
Providence, Rhode Island, 02912
About this study
Official title: Using Behavioral Economics to Promote Exercise Among Overweight Inactive Adults
This study is for physically inactive adults with an active membership at a Greater Providence Young Men's Christian Association (YMCA).
Participants will receive weekly feedback on their attendance at the YMCA, and will be enrolled in the study for 1 year.
Participants will be assigned to one of three conditions, to either receive weekly: (i) monetary incentives, (ii) donations to a charity of their choice, or (iii) feedback only.
In order to continue to receive incentives, participants must maintain an active membership at the YMCA.
Read the detailed description
The investigators propose to conduct a pilot study to test feasibility and proof-of-concept for two incentive programs to promote exercise among low-active overweight and obese adults. To address weaknesses in the literature, the programs will be (a) conducted in a community setting by the Greater Providence YMCAs and (b) financially sustainable, such that they do not require removal of the incentives after a specified period of time. In both incentive programs, participants will pay the standard monthly YMCA membership fee. In the Rebate incentive program, participants will have the opportunity to earn a small monetary incentive to exercise for each day that they attend the YMCA (verified by objective swipe-card data), with a maximum of 5 exercise sessions being incentivized per week. In the Donation incentive program, participants will have the opportunity to earn a small monetary incentive to exercise in the form of donations (using the same incentive schedule) to a registered local charity of the participant's choice. Thus, the proposed study will compare three experimental conditions: (a) Rebate incentives (n=25); (b) Donation incentives (n=25); and (c) Control (i.e., no incentives) (n=25). The Primary Aims are to test (1) feasibility of the two incentive programs, (2) feasibility of the research methods to evaluate the preliminary efficacy of the two incentive programs, and (3) proof-of-concept for the two incentive programs (relative to control), through comparison of average number of sessions/week with incentives over one year. Secondary outcomes will be self-reported minutes per week of exercise over one year. The proposed research will provide a preliminary investigation into two community-based, financially sustainable incentive programs to promote exercise for adults who are at increased risk for cancer. Positive findings from such a trial would provide a fast-track for a community-based ready-to-implement exercise promotion intervention. Additionally, such findings would have significant implications for the use of financially sustainable incentive programs for exercise through other community organizations (e.g., privately-owned health clubs), healthcare organizations, or employers (e.g., employer fitness facilities), as well as providing a model for incentive programs for other health-related behaviors (e.g., smoking cessation, weight loss).
- Conditions
- Obesity, Physical Activity
- Being tested
- Incentives (Rebate), Incentives (Donation), Feedback
- Keywords
- Incentives, Motivation
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentives (Rebate)Behavioural
Incentives (Donation)Behavioural
FeedbackBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Incentives (Rebate) | Experimental | On a weekly basis, participants receive a small monetary incentive to exercise each time they attend the YMCA. Receives: Behavioral: Incentives (Rebate) |
| Incentives (Donation) | Experimental | On a weekly basis, a small monetary incentive to exercise is provided in the form of a donation to a charity of the participant's choice for attendance at the YMCA. Receives: Behavioral: Incentives (Donation) |
| Control | Active comparator | Participants receive feedback on their exercise attendance on a weekly basis. Receives: Behavioral: Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise attendance
How frequently the participant attended the YMCA during the study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study startMay 2016
- Primary completionJun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M Williams, PhD, Principal investigator, Brown UniversityOmar Galarraga, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134040
- Sponsor's protocol ID
- CA188473-02
- Status last verified
- Sep 2018
- First submitted
- 26 Apr 2017
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with interested parties after all of the initial study analyses and outcomes have been published.
Publications
Galarraga O, Bohlen LC, Dunsiger SI, Lee HH, Emerson JA, Boyle HK, Strohacker K, Williams DM. Small sustainable monetary donation-based incentives to promote physical activity: A randomized controlled trial. Health Psychol. 2020 Apr;39(4):265-268. doi: 10.1037/hea0000818. Epub 2019 Nov 21.
PubMed 31750676
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Behavioral Economics to Promote Exercise Among Overweight Inactive Adults
- ClinicalTrials.gov ID
- NCT03134040
- Acronym / sponsor ID
- CA188473-02
- Conditions
- Obesity, Physical Activity
- Keywords
- Incentives, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for physically inactive adults with an active membership at a Greater Providence Young Men's Christian Association (YMCA).
Participants will receive weekly feedback on their attendance at the YMCA, and will be enrolled in the study for 1 year.
Participants will be assigned to one of three conditions, to either receive weekly: (i) monetary incentives, (ii) donations to a charity of their choice, or (iii) feedback only.
In order to continue to receive incentives, participants must maintain an active membership at the YMCA.
Detailed description
The investigators propose to conduct a pilot study to test feasibility and proof-of-concept for two incentive programs to promote exercise among low-active overweight and obese adults. To address weaknesses in the literature, the programs will be (a) conducted in a community setting by the Greater Providence YMCAs and (b) financially sustainable, such that they do not require removal of the incentives after a specified period of time. In both incentive programs, participants will pay the standard monthly YMCA membership fee. In the Rebate incentive program, participants will have the opportunity to earn a small monetary incentive to exercise for each day that they attend the YMCA (verified by objective swipe-card data), with a maximum of 5 exercise sessions being incentivized per week. In the Donation incentive program, participants will have the opportunity to earn a small monetary incentive to exercise in the form of donations (using the same incentive schedule) to a registered local charity of the participant's choice. Thus, the proposed study will compare three experimental conditions: (a) Rebate incentives (n=25); (b) Donation incentives (n=25); and (c) Control (i.e., no incentives) (n=25). The Primary Aims are to test (1) feasibility of the two incentive programs, (2) feasibility of the research methods to evaluate the preliminary efficacy of the two incentive programs, and (3) proof-of-concept for the two incentive programs (relative to control), through comparison of average number of sessions/week with incentives over one year. Secondary outcomes will be self-reported minutes per week of exercise over one year. The proposed research will provide a preliminary investigation into two community-based, financially sustainable incentive programs to promote exercise for adults who are at increased risk for cancer. Positive findings from such a trial would provide a fast-track for a community-based ready-to-implement exercise promotion intervention. Additionally, such findings would have significant implications for the use of financially sustainable incentive programs for exercise through other community organizations (e.g., privately-owned health clubs), healthcare organizations, or employers (e.g., employer fitness facilities), as well as providing a model for incentive programs for other health-related behaviors (e.g., smoking cessation, weight loss).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Incentives (Rebate) | Experimental | Behavioral: Incentives (Rebate)On a weekly basis, participants receive a small monetary incentive to exercise each time they attend the YMCA. |
| Incentives (Donation) | Experimental | Behavioral: Incentives (Donation)On a weekly basis, a small monetary incentive to exercise is provided in the form of a donation to a charity of the participant's choice for attendance at the YMCA. |
| Control | Active comparator | Behavioral: FeedbackParticipants receive feedback on their exercise attendance on a weekly basis. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inactive adults with an active YMCA membership
- Currently physically able to exercise
Key exclusion criteria (4 listed)
- Do not plan to reside in the geographical region for the next 12 months
- Family member currently participating in the study
- Currently engaging in >150 mins of moderate/vigorous physical activity per week
- Attended the YMCA more than 4 times per month in the last 6 months
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 |
|---|---|---|
| Incentives (Rebate) | Behavioural | Incentives (Rebate) |
| Incentives (Donation) | Behavioural | Incentives (Donation) |
| Feedback | Behavioural | Control |
Primary outcome
Exercise attendance
Time frame: 1 year
How frequently the participant attended the YMCA during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Derived from this study: PubMed 31750676Galarraga O, Bohlen LC, Dunsiger SI, Lee HH, Emerson JA, Boyle HK, Strohacker K, Williams DM. Small sustainable monetary donation-based incentives to promote physical activity: A randomized controlled trial. Health Psychol. 2020 Apr;39(4):265-268. doi: 10.1037/hea0000818. Epub 2019 Nov 21.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with interested parties after all of the initial study analyses and outcomes have been published.
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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.
David M Williams, PhD principal investigator
Brown University
Omar Galarraga, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentives (Rebate), Incentives (Donation) and Feedback in people with Obesity and Physical Activity, run by Brown University 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 2 inclusion and 4 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 6 Sep 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exercise attendance (time frame: 1 year). 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 NCT03134040, 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 6 Sep 2018.