- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03574519
Project Step II: The Effects of Incentives and Feedback on Promoting Walking Within Overweight and Obese Adults
Study Overview
Status
Detailed Description
Approximately 68% of adults are overweight or obese, which is associated with increased risk for health conditions, including cardiovascular disease, type 2 diabetes, and cancer. These individuals are more often sedentary than the general population, which compounds the risk for these same conditions. While the benefits of engaging in physical activity are well-established, few individuals are able to successfully increase activity to recommended levels. Existing intervention programs, often derived from theories such as social cognitive theory or related theories, have had limited success. Behavioral economics offers a promising alternative, suggesting that engagement in any behavior is based on the maximizing utility and happiness (i.e., weighing the cost and benefit of the behavior). Interventions based on this theory aim to increase the immediate benefit of engaging in physical activity, often using a financial incentive.
This study will last for 8 weeks. All participants will have the use of a FitBit for ongoing self-monitoring and a personalized step-count goal designed to help increase daily steps. Participants will receive feedback on reaching their goals either daily or weekly.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Drexel University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 25 kg/m2 ≤ BMI ≤ 45 kg/m2
- Age 18-70
- Currently inactive (engages in less than 6,000 steps/day on at least 4 of 7 days per week OR engaged in less than 10,000 steps /day on at least 5/7 days per week, confirmed by FitBit at baseline)
- Able to engage in moderate amount of walking
- Able to receive email/text messages from study staff
Exclusion Criteria:
- Psychiatric conditions that would make it difficult to comply
- Medical conditions that would make it difficult to comply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Non-contingent incentives and weekly feedback
Participants will receive payment for participating in the study (regardless of goal attainment) and will receive weekly updates about their performance.
|
Incentives are provided for participation
Text message feedback is delivered weekly summarizing the past week's progress
|
Experimental: Non-contingent incentives and daily feedback
Participants will receive payment for participating in the study (regardless of goal attainment) and will receive daily updates about their performance.
|
Incentives are provided for participation
Text message feedback is delivered daily summarizing the current day's progress
|
Experimental: Contingent incentives and weekly feedback
Participants will receive payment for meeting their daily goals and will receive weekly updates about their performance.
|
Text message feedback is delivered weekly summarizing the past week's progress
Incentives are provided for attaining daily goals
|
Experimental: Contingent incentives and daily feedback
Participants will receive payment for meeting their daily goals and will receive daily updates about their performance.
|
Text message feedback is delivered daily summarizing the current day's progress
Incentives are provided for attaining daily goals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Step counts
Time Frame: Change from baseline to end of 6-week intervention
|
Average daily step counts
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Change from baseline to end of 6-week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Step counts
Time Frame: Change from end of intervention to end of 2-week follow-up
|
Average daily step counts
|
Change from end of intervention to end of 2-week follow-up
|
Step counts
Time Frame: Daily change during 6-week intervention
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Daily change during 6-week intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1601004185-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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