Small Monetary Incentives to Promote Exercise (Exercise4Good; EX4G)

September 4, 2018 updated by: Brown University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Public Health Building @ 121 South Main St

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inactive adults with an active YMCA membership
  • Currently physically able to exercise

Exclusion Criteria:

  • 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

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Incentives (Rebate)
On a weekly basis, participants receive a small monetary incentive to exercise each time they attend the YMCA.
Behavioral: Incentives (Rebate)
Experimental: 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.
Behavioral: Incentives (Donation)
Active Comparator: Control
Participants receive feedback on their exercise attendance on a weekly basis.
Behavioral: Feedback

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Exercise attendance
Time Frame: 1 year
How frequently the participant attended the YMCA during the study
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brown University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David M Williams, PhD, Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA188473-02

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.

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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