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

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

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

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.
68

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
    • 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

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

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

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: Challenge-Focused Program
This group will receive the challenge-focused group program
Behavioral: Challenge-Focused 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
Behavioral: Rewards-Focused 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

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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

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.
March 5, 2019

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, 2020

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, 2020

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).
March 2, 2019

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.
March 11, 2019

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.
March 13, 2019

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.
May 9, 2023

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.
May 8, 2023

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.
May 1, 2023

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.
  • 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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