NCT03873051

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

March 5, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

March 2, 2019

Last Update Submit

May 8, 2023

Conditions

Keywords

Community-based interventionMotivation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in moderate to vigorous physical activity

    Baseline to 2 months

Other Outcomes (2)

  • Change in Self-Efficacy for physical activity

    Baseline to 2 months

  • Change in Self-Concept for PA

    Baseline to 2 months

Study Arms (2)

Challenge-Focused Program

EXPERIMENTAL

This group will receive the challenge-focused group program

Behavioral: Challenge-Focused Program

Rewards-Focused Program

EXPERIMENTAL

This group will receive the rewards-focused group program

Behavioral: Rewards-Focused Program

Interventions

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.

Challenge-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.

Rewards-Focused Program

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having a condition that would limit participation in PA (assessed with the Physical Activity Readiness Questionnaire)
  • Uncontrolled blood pressure (\> 180/120 mm Hg).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29201, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The randomized pilot study compares the effects of receiving a matched (Autonomous \& Challenge-Focused; Controlled \& Rewards-Focused) versus an non-matched (Autonomous \& Rewards-Focused; Controlled \& Challenge -Focused) group-based PA intervention program over an 8-week time period. Randomization to the Rewards- or Challenge-focused intervention is stratified by degree of autonomous motivation (low, medium, high). A total of 150 African American women will be randomly assigned to either receive the Rewards- or the Challenge-focused intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

March 2, 2019

First Posted

March 13, 2019

Study Start

March 5, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The data will become available after the primary and secondary outcome papers have been published (starting 6 months after publication).
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.

Locations