- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04942535
STEP Together: An Effectiveness-Implementation Study of Social Incentives and Physical Activity
STEP Together: A Hybrid Type 1 Effectiveness-Implementation Study of Social Incentives Strategies to Increase Physical Activity
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to read and speak English;
- Has a smartphone or tablet;
- Lives in the Philadelphia area;
- Age 14 or older;
- Able to provide informed consent;
- Enrolled as a member of a 2 to 10 member family team with least one member 60 years or older.
Exclusion Criteria:
- Already participating in another physical activity study;
- An 18-month physical activity program is infeasible (e.g., metastatic cancer, unable to ambulate or provide informed consent) or unsafe (currently pregnant or told by a physician not to exercise);
- Do not have sufficient eyesight or dexterity to operate device;
- Average step count greater than 7,500 steps/day during the run-in period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Social Incentive Gamification
Each participant is enrolled as part of a family team. Each participant wears a Fitbit every day and strives to achieve their daily step goal. Participants in this arm receive the Social Incentive Gamification intervention during the 12 month intervention and Daily Performance Feedback during the 6 month follow up. |
Participants enroll as a family team. They are asked to use a Fitbit activity tracker daily. Each participant sets a daily step goal based on their baseline step count. Each participant signs a pre-commitment contract. Participants are entered into a game with their family members. Each family receives 70 points weekly. Each day, a family member is selected at random to represent the family. If that person's step goal was achieved, the family keeps its points; if not, they lose 10 points. The participant is notified the following day if they were the family rep. At the end of the week, if the family has 40 points or more, they advance 1 level. If they have less than 40 points, the family drops down 1 level. Each family team starts in the middle of 5 levels. At the end of the intervention, families in the top 2 levels receive a small gift. In the 6 month follow-up, participants receive a daily text message stating whether or not they achieved their step goal on the prior day. Participants enroll as a family team. They are asked to use a Fitbit activity tracker daily. Each participant sets a daily step goal based on their baseline step count. Participants receive a daily text message stating whether or not they achieved their step goal on the prior day. |
Experimental: Social Goals through Incentives to Charity
Each participant is enrolled as part of a family team. Each participant wears a Fitbit every day and strives to achieve their daily step goal. Participants in this arm receive the Social Goals through Incentives to Charity intervention during the 12 month intervention and Daily Performance Feedback during the 6 month follow up. |
Participants enroll as a family team. They are asked to use a Fitbit activity tracker daily. Each participant sets a daily step goal based on their baseline step count. Participants receive a daily text message stating whether or not they achieved their step goal on the prior day. Participants enroll as a family team. They are asked to use a Fitbit activity tracker daily. Each participant sets a daily step goal based on their baseline step count. Families select a charity at the beginning of the intervention. They are informed that $20 is available each week to be donated to a charity of their choice. Each day, a family member is selected at random to represent the family. If that person's step goal was achieved, the family gets credit for meeting their goal; if not, the entire family does not get credit. The participant is notified the following day if they were the family rep. If the family achieves their goal on at least 4 of 7 days in a week, $20 is donated to charity. In the 6 month follow-up, participants receive a daily text message stating whether or not they achieved their step goal on the prior day. |
Active Comparator: Control
Each participant is enrolled as part of a family team. Each participant wears a Fitbit every day and strives to achieve their daily step goal. Participants in this arm receive Daily Performance Feedback during the 12 month intervention and 6 month follow up. |
Participants enroll as a family team. They are asked to use a Fitbit activity tracker daily. Each participant sets a daily step goal based on their baseline step count. Participants receive a daily text message stating whether or not they achieved their step goal on the prior day. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean daily step counts during the 12 month intervention
Time Frame: Months 1-12
|
Change in mean daily steps from baseline to the end of the 12 month intervention period.
Steps will be measured using the Fitbit Inspire 2 wearable device.
|
Months 1-12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean daily step counts during the 12 month intervention and 6 month follow up
Time Frame: Months 1-18
|
Change in mean daily steps from baseline to the end of the 12 month intervention and 6 month follow up.
Steps will be measured using the Fitbit Inspire 2 wearable device.
|
Months 1-18
|
Change in mean minutes of moderate-to-vigorous physical activity (MVPA) during the 12 month intervention
Time Frame: Months 1-12
|
Change in mean daily minutes of MVPA from baseline to the end of the 12 month intervention period.
Minutes of MVPA will be measured using the Fitbit Inspire 2 wearable device.
|
Months 1-12
|
Change in mean minutes of moderate-to-vigorous physical activity (MVPA) during the 12 month intervention and 6 month follow up
Time Frame: Months 1-18
|
Change in mean daily minutes of MVPA from baseline to the end of the 12 month intervention and 6 month follow up.
Minutes of MVPA will be measured using the Fitbit Inspire 2 wearable device.
|
Months 1-18
|
Difference in proportion of weeks physical activity guidelines were achieved during the 12 month intervention
Time Frame: Months 1-12
|
Difference between study arms in the proportion of weeks that physical activity guidelines (150 minutes per week of MVPA) were achieved.
Minutes of MVPA will be measured using the Fitbit Inspire 2 wearable device.
|
Months 1-12
|
Difference in proportion of weeks physical activity guidelines were achieved during the 12 month intervention and 6 month follow up
Time Frame: Months 1-18
|
Difference between study arms in the proportion of weeks that physical activity guidelines (150 minutes per week of MVPA) were achieved.
Minutes of MVPA will be measured using the Fitbit Inspire 2 wearable device.
|
Months 1-18
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Karen Glanz, PhD, MPH, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 02022
- 842677 (Other Identifier: IRB Number)
- 1R01HL152430 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Physical Activity
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
University of Colorado, DenverCompletedPhysical Activity | Physical ImpairmentUnited States
-
PXL University CollegeHasselt UniversityNot yet recruitingPhysical Activity - Digital Phenotyping - Activity Tracking
-
University of ExtremaduraThe Spanish Ministry of Science, Innovation and UniversitiesRecruitingPhysical Activity | Cognition | Physical Fitness | AdolescentsSpain
-
AdventHealth Translational Research InstituteWake Forest UniversityRecruiting
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruitingPhysical ActivityUnited States
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruiting
Clinical Trials on Social Incentive Gamification
-
University of PennsylvaniaCompleted
-
VA Office of Research and DevelopmentCompletedPhysical ActivityUnited States
-
University of PennsylvaniaDeloitteCompletedObesityUnited States
-
University of PennsylvaniaCompleted
-
University of PennsylvaniaNational Institute on Aging (NIA)Enrolling by invitationHeart Failure | Hypertension | Diabetes | Mobility Limitation | Ambulatory DifficultyUnited States
-
University of PennsylvaniaCompleted
-
Carnegie Mellon UniversityUniversity of VirginiaCompletedSocial Isolation | Activity, MotorUnited States
-
Abramson Cancer Center at Penn MedicineAmerican Heart Association; City of Hope National Medical CenterActive, not recruitingCardiovascular Diseases | Breast Cancer | Prostate Cancer | Physical InactivityUnited States
-
University of PennsylvaniaCompletedPneumonia | Diabetes | Chronic Obstructive Pulmonary Disease | Congestive Heart FailureUnited States
-
University of PennsylvaniaCompletedStroke | Ischemic Attack, TransientUnited States