- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05704712
Exercise Incentives for YMCA Based Exercise
June 26, 2024 updated by: David M. Williams, Brown University
Empirical Testing of a Widely Available Insurance-based Monetary Incentive Program for Exercise: A Randomized Trial
The investigators will conduct a randomized controlled trial to test financial incentive programs (versus control) to promote physical activity among 330 adults who have a YMCA membership.
Participants will have the opportunity to earn up to $100 or $200 (depending on the condition they are assigned to) for attending at least 50 sessions at the YMCA over 6 months.
Participants will have two 6-month windows during which they will have the opportunity to earn the incentive.
In addition to the incentives, participants will complete research assessments every 3 months.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
330
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lauren C Bohlen, Ph.D.
- Phone Number: 401-863-6559
- Email: exercise4good@brown.edu
Study Contact Backup
- Name: Viveka Ayala-Heredia
- Phone Number: 401-206-5403
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Recruiting
- Brown University
-
Contact:
- Lauren Connell Bohlen, PhD
- Phone Number: 401-863-6559
- Email: lauren_bohlen@brown.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
A current member, or willing to become a current member of one of the following branches of the YMCA:
- Bayside Family YMCA (Barrington, RI)
- Cranston YMCA (Cranston, RI)
- East Side/Mt. Hope YMCA (Providence, RI)
- Kent County YMCA (Warwick, RI)
- Newman YMCA (Seekonk, MA)
- South County YMCA (South Kingston, RI)
- Age 18 years or older
- Physically capable of engaging in exercise
Exclusion Criteria:
- Not a current member, and unwilling to become a member of one of the above listed YMCA branches.
- Under age 18.
- Physically incapable of exercise
- Doctor has recommended that you should not exercise because of a current health condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Message 1 - $100
Participants are offered an incentive of $100 to complete 50 exercise sessions at the YMCA within 6 months (Description of incentive 1)
|
Monetary incentives, provided in the form of pre-loaded Visa debit cards are provided to encourage exercise.
|
|
Experimental: Message 2 - $100
Participants are offered an incentive of $100 to complete 50 exercise sessions at the YMCA within 6 months (Description of incentive 2).
|
Monetary incentives, provided in the form of pre-loaded Visa debit cards are provided to encourage exercise.
|
|
Experimental: Message 1 - $200
Participants are offered an incentive of $200 to complete 50 exercise sessions at the YMCA within 6 months (Description of incentive 1).
|
Monetary incentives, provided in the form of pre-loaded Visa debit cards are provided to encourage exercise.
|
|
Experimental: Message 2 - $200
Participants are offered an incentive of $200 to complete 50 exercise sessions at the YMCA within 6 months (Description of incentive 2).
|
Monetary incentives, provided in the form of pre-loaded Visa debit cards are provided to encourage exercise.
|
|
No Intervention: Control
Participants complete all assessments, and are eligible to receive compensation for participating in the research components of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Number of YMCA visits
Time Frame: Baseline, 6 months, 12 months, 24 months
|
Number of sessions (max 1 per day) a person signs into the YMCA
|
Baseline, 6 months, 12 months, 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Accelerometry
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Minutes of physical activity weighted by intensity, expressed in metabolic equivalent (MET) minutes per week as determined by accelerometers (Actigraph [model wGT3x-BT]) worn during one-week periods.
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Self-report physical activity (Godin)
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Self-reported minutes of leisure time physical activity (inside and outside the YMCA) per week weighted by intensity
|
Measured at baseline, and months 3, 6, 9, and 12.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Self-Reported Habit of Physical Activity Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures a person's habits regarding exercise, with a minimum value of 1 and a maximum value of 7, higher scores indicate a stronger habit.
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Anticipated Regret Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures a person's anticipated feelings of remorse if they do not do exercise, or achieve the incentives, on a scale from 1-11, with higher scores indicating more anticipated regret.
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Opportunity Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures a person's opportunity to do regular aerobic physical activity, with scores ranging from 1-7, and higher scores indicating more opportunity for physical activity.
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Capability Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures a person's physical and psychological capability to do regular aerobic physical activity with scores ranging from 1-7, and higher scores indicating more capability for physical activity.
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Exercise Facility Use Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures access and membership to fitness facilities.
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Physical Activity Hedonic/Reflective Motivation
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures the extent to which a person's motivation for physical activity is rooted in reflective and/or hedonic processes.
There are two subscales.
The hedonic subscale ranges from 0-10, with higher scores indicating more hedonic motivation for physical activity.
The reflective subscale ranges from 0-10 with higher scores indicating more reflective motivation for physical activity.
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Subjective Social Status
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures a person's perception of their subjective social status
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Reward Responsiveness
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures the extent to which a person is responsive to external rewards
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Consideration of Future Consequences
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures the extent to which a person considers the future (delayed) consequences of their actions
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Delay Discounting
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures the extent to which a person discounts future rewards and prioritizes immediate rewards
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Loss Aversion
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures the extent to which a person chooses actions in an attempt to avoid experiencing losses
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Overall Health (SF-12 Survey)
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures a person's perception of their overall health and quality of life, scores range from 1-5 with higher scores indicating poorer health outcomes.
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Quality of Life and Health Status (EQ-5D-5L)
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
The EQ-5D-5L comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding, taking only a few minutes to complete.
The questionnaire provides a simple descriptive profile of a respondent's health state.
The EQ VAS provides an alternative way to elicit an individual's rating of their own overall current health.
When the descriptive system profile is linked to a 'value set', a single summary index value for health status is derived that can be used in economic evaluations of health-care interventions.
A value set provides values (weights) for each health state description according to the preferences of the general population of a country/region.
Value sets for the EQ-5D-5L and 3L versions are available in a large and growing number of countries.
|
Measured at baseline, and months 3, 6, 9, and 12.
|
|
Change in Absenteeism and Presenteeism
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
|
Measures the amount of time a person worked and was expected to work in the past 7-28 days; and their perceived job performance when at work
|
Measured at baseline, and months 3, 6, 9, and 12.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David M Williams, Ph.D., Brown University School of Public Health
- Principal Investigator: Omar Galarraga, Ph.D., Brown University School of Public Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 16, 2023
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
June 30, 2027
Study Registration Dates
First Submitted
January 9, 2023
First Submitted That Met QC Criteria
January 27, 2023
First Posted (Actual)
January 30, 2023
Study Record Updates
Last Update Posted (Actual)
June 27, 2024
Last Update Submitted That Met QC Criteria
June 26, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01CA262894 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data will be shared with interested parties after all of the initial study analyses and outcomes have been published.
IPD Sharing Time Frame
Data will be available 1 year after study completion.
IPD Sharing Access Criteria
All data access requests will be reviewed by a panel prior to acceptance
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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