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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03574519
Other study ID # 1601004185-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date January 30, 2018

Study information

Verified date June 2018
Source Drexel University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the main effects of daily vs. weekly feedback and contingent vs. non-contingent incentives for increasing walking behavior among overweight and obese adults.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date January 30, 2018
Est. primary completion date January 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Behavioral:
Non-contingent incentives
Incentives are provided for participation
Contingent incentives
Incentives are provided for attaining daily goals
Weekly feedback
Text message feedback is delivered weekly summarizing the past week's progress
Daily feedback
Text message feedback is delivered daily summarizing the current day's progress

Locations

Country Name City State
United States Drexel University Philadelphia Pennsylvania

Sponsors (4)

Lead Sponsor Collaborator
Drexel University American College of Sports Medicine, Psi Chi, Qualtrics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Step counts Average daily step counts Change from baseline to end of 6-week intervention
Secondary Step counts Average daily step counts Change from end of intervention to end of 2-week follow-up
Secondary Step counts Daily change during 6-week intervention
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