Developing Real Incentives and Volition for Exercise

Physical Activity Clinical Trial

— DRIVE  

Official title:

Developing Real Incentives and Volition for Exercise Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873051
• Other study ID #: Pro00085166
• Secondary ID: F32HL138928-01A1
• Status: Completed
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: May 2023
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Self-Efficacy for physical activity	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
Other	Change in Self-Concept for PA	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
Primary	Change in total physical activity	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	Change in moderate to vigorous physical activity	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