- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03873051
Developing Real Incentives and Volition for Exercise (DRIVE)
May 8, 2023 updated by: Allison M. Sweeney, University of South Carolina
Developing Real Incentives and Volition for Exercise Project
The overall goal of the Developing Real Incentives and Volition for Exercise (DRIVE) Project is to evaluate whether matching an intervention to individual differences in motivation (high autonomous vs high controlled) is a feasible strategy for engaging African American women in greater total physical activity (PA).
The DRIVE Project will develop and evaluate two novel interventions: 1) a challenge-focused program that targets greater PA enjoyment, PA valuation, and relatedness through team-based activities, behavioral skills, and a positive social climate; and 2) a rewards-focused program that targets greater PA competency and relatedness through financial incentives, behavioral skills, and structured social support.
To this end, the investigators will be implementing a randomized pilot study at a community center.
It is hypothesized that participants who receive an intervention that is matched to their motivation for PA initiation (High Autonomous & Challenge-Focused; High Controlled & Rewards-Focused) will demonstrate greater improvements from baseline to post- in total physical activity than those who receive an unmatched intervention (High Autonomous & Rewards-Focused; High Controlled & Challenge-Focused).
The DRIVE project will provide proof-of-concept for the feasibility and usefulness of developing motivationally-targeted intervention programs for engaging African American women in greater PA.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Although engaging in regular physical activity (PA) plays a critical role in reducing one's risk for numerous health problems, 4 out of 5 U.S. adults fail to meet national PA guidelines, with underserved groups (low income and racial/ethnic minority groups) having the highest rates of physical inactivity.
Developing innovative strategies to motivate underserved groups to initiate PA has become an increasing national priority, but many implementation challenges remain, as evidenced by relatively low levels of program engagement among underserved groups.
Increasingly, researchers have begun to show that rather than using a "one-size-fits all" intervention approach, developing interventions that target specific individual differences in cultural or social-cognitive factors is a highly effective approach for increasing engagement among underserved groups.
Broadening this approach in a novel domain, the proposed research tests whether developing interventions that target differences in autonomous (internally-driven) vs. controlled (externally-driven) motivation is a feasible and useful approach for engaging African American women in PA initiation.
The proposed study is a randomized pilot study comparing two intervention programs: a Challenge-focused program targeted toward high autonomous motivation and a Rewards-focused program targeted toward high controlled motivation.
The Challenge-focused program targets greater PA enjoyment, PA valuation, and relatedness, and the Rewards-focused program targets greater PA competence and structured social support for PA.
It is hypothesized that baseline motivation (measured with the Behavioral Regulation in Exercise questionnaire) will moderate treatment effects.
Specifically, participants with relatively higher autonomous motivation will demonstrate greater improvements from baseline to post- in total physical activity when they receive the "matched" intervention (Challenge-Focused program) relative to the non-matched intervention (Rewards-Focused Program).
Additionally, participants with relatively higher controlled motivation will demonstrate greater improvements from baseline to post- in total physical activity when they receive the "matched" intervention (Rewards-Focused program) relative to the non-matched intervention (Challenge-Focused Program).
The results of this study will provide support of the feasibility and proof-of-concept for conducting a large scale randomized controlled trial.
Study Type
Interventional
Enrollment (Actual)
68
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 Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29201
- University of South Carolina
-
-
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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Self-identify as African American
- Female
- At least 21 years old
- Engage in < 150 min. of moderate to vigorous physical activity per week for the last 3 months
Exclusion Criteria:
- Having a condition that would limit participation in PA (assessed with the Physical Activity Readiness Questionnaire)
- Uncontrolled blood pressure (> 180/120 mm Hg).
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 |
Intervention / Treatment |
---|---|
Experimental: Challenge-Focused Program
This group will receive the challenge-focused group program
|
Participants receiving the Challenge-Focused intervention will complete an 8-week group program.
Group sessions meet once per week for 90 minutes and include three components - discussion-based health promotion initiative, team-based physical activity games/activities, and team-based goal-setting and behavioral skills training.
Among participants with high autonomous motivation, those receiving the Challenge-focused intervention are expected to show greater improvement from baseline to post- in total PA than those receiving the Rewards-Focused intervention.
|
Experimental: Rewards-Focused Program
This group will receive the rewards-focused group program
|
Participants receiving the Rewards-Focused intervention will complete an 8-week group program.
Group sessions meet once per week for 90 minutes and include three components - discussion-based health promotion initiative, group-based walking program, and individual-based goal-setting and behavioral skills training with partner-based contracts and financial incentives.
Among participants with high controlled motivation, those receiving the Rewards-focused intervention are expected to show greater improvement from baseline to post- in total PA than those receiving the Challenge-Focused intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total physical activity
Time Frame: Baseline to 2 months
|
Average minutes of total physical activity (PA) per day; Objective assessments of total PA will be obtained with omni- directional accelerometers.
Participants will wear the monitor affixed by an elastic belt over the right hip for 7 consecutive days during baseline and post-intervention (2 months).
Consistent with previous studies, a valid day will consist of 10 hours of wear time, and 60 consecutive zeros will indicate non-wear with the allowance of up to 2 minutes under the count threshold for sedentary activity.
Data reduction will use previously established accelerometer cut-points (Light PA: 100-1534, MVPA > = 1535), which will be summed to calculate total PA.
|
Baseline to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in moderate to vigorous physical activity
Time Frame: Baseline to 2 months
|
Average minutes of moderate to vigorous physical activity (MVPA) per day; Objective assessments of MVPA will be obtained with omni-directional accelerometers.
Participants will wear the monitor affixed by an elastic belt over the right hip for 7 consecutive days during baseline and post-intervention (2 months).
Consistent with previous studies, a valid day will consist of 10 hours of wear time, and 60 consecutive zeros will indicate non-wear with the allowance of up to 2 minutes under the count threshold for sedentary activity.
Data reduction will use previously established accelerometer cut-points, such that MVPA > = 1535.
|
Baseline to 2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-Efficacy for physical activity
Time Frame: Baseline to 2 months
|
The Self-Efficacy for Exercise Questionnaire (10 items; 5 point scale; 1-not at all confident; 5=extremely confident) will be used to evaluate self-efficacy for PA at baseline and 2 months (adapted from Sallis et al, 1988).
|
Baseline to 2 months
|
Change in Self-Concept for PA
Time Frame: Baseline to 2 months
|
The Self Concept and Motivation to Exercise Scale (10 items; 1-strongly disagree, 6-strongly agree) will be used to evaluate self-concept for PA at baseline and 2 months (Wilson et al., 2002)
|
Baseline to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 5, 2019
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
March 2, 2019
First Submitted That Met QC Criteria
March 11, 2019
First Posted (Actual)
March 13, 2019
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00085166
- F32HL138928-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
There is a plan to make the data (psychosocial, physical activity, data dictionaries) available through a private study registration on the Open Science Framework.
Study protocols, measures, and materials will also be made available on the the Open Science Framework.
The PI will review requests for accessing the private study registration.
IPD Sharing Time Frame
The data will become available after the primary and secondary outcome papers have been published (starting 6 months after publication).
IPD Sharing Access Criteria
Requests will be reviewed by the PI, Allison Sweeney (sweeneam@mailbox.sc.edu).
Requests must include information about the reason for wanting to access the data/materials and planned analyses.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- 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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