STEP Together: An Effectiveness-Implementation Study of Social Incentives and Physical Activity

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT04942535

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

675

Enrollment

Location

Arms

41.3

Anticipated Duration (Months)

16.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Higher levels of physical activity have been demonstrated to improve health across a wide range of contexts and reduce cognitive decline as adults become older, but more than half of all adults in the United States do not meet their physical activity goals. One type of physical activity that is broadly applicable to people of all ages is walking. This study will use a Hybrid Type 1 effectiveness-implementation design to adapt and test the effectiveness of two successful social incentive-based interventions, a gamification strategy and financial incentives donated to charity on the participants behalf, to increase physical activity among low-income, mostly minority families in community settings.

Condition or Disease	Intervention/Treatment	Phase
Physical Activity	Behavioral: Social Incentive Gamification Behavioral: Social Goals through Incentives to Charity Behavioral: Daily Performance Feedback	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

675 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

STEP Together: A Hybrid Type 1 Effectiveness-Implementation Study of Social Incentives Strategies to Increase Physical Activity

Actual Study Start Date :

Sep 21, 2021

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

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.	Behavioral: Social Incentive Gamification 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 on the prior day, the family keeps its points; if not, they lose 10 points. At the end of the week, if the family has 40 points or more, they advance one level. If they have less than 40 points, the family drops down one level. Each family team starts in the middle of 5 levels. At the end of the intervention period, families in the top 2 levels receive a small physical gift. In the 6 month follow-up period, participants receive a daily text message stating whether or not they achieved their step goal on the prior day. Behavioral: Daily Performance Feedback 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.	Behavioral: Social Goals through Incentives to Charity 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 on the prior day, the family gets credit for meeting their goal; if not, the entire family does not get credit. 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 period, participants receive a daily text message stating whether or not they achieved their step goal on the prior day. Behavioral: Daily Performance Feedback 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.
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.	Behavioral: Daily Performance Feedback 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.

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.

Behavioral: Social Incentive Gamification

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 on the prior day, the family keeps its points; if not, they lose 10 points. At the end of the week, if the family has 40 points or more, they advance one level. If they have less than 40 points, the family drops down one level. Each family team starts in the middle of 5 levels. At the end of the intervention period, families in the top 2 levels receive a small physical gift. In the 6 month follow-up period, participants receive a daily text message stating whether or not they achieved their step goal on the prior day.

Behavioral: Daily Performance Feedback

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.

Behavioral: Social Goals through Incentives to Charity

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 on the prior day, the family gets credit for meeting their goal; if not, the entire family does not get credit. 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 period, participants receive a daily text message stating whether or not they achieved their step goal on the prior day.

Behavioral: Daily Performance Feedback

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.

Behavioral: Daily Performance Feedback

Outcome Measures

Primary Outcome Measures

Change in mean daily step counts during the 12 month intervention [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.

Secondary Outcome Measures

Change in mean daily step counts during the 12 month intervention and 6 month follow up [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.
Change in mean minutes of moderate-to-vigorous physical activity (MVPA) during the 12 month intervention [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.
Change in mean minutes of moderate-to-vigorous physical activity (MVPA) during the 12 month intervention and 6 month follow up [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.
Difference in proportion of weeks physical activity guidelines were achieved during the 12 month intervention [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.
Difference in proportion of weeks physical activity guidelines were achieved during the 12 month intervention and 6 month follow up [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Able to read and speak English;
Has a smartphone;
Lives in the Philadelphia area;
Age 14 or older;
Able to provide informed consent;
Enrolled as a member of a 2 to 5 member family team with least one member 65 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.