Clinical trial NCT04942535: STEP Together: An Effectiveness-Implementation Study of Social Incentives and Physical Activity
Official title: STEP Together: A Hybrid Type 1 Effectiveness-Implementation Study of Social Incentives Strategies to Increase Physical Activity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physical Activity
Keywords: Physical Activity
Older Adults
Gamification
Social Incentives
Charity
Family
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-06-28
Enrollment: 779
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in mean daily step counts during the 12 month intervention
timeFrame: Months 1-12
Secondary outcomes:
measure: Change in mean daily step counts during the 12 month intervention and 6 month follow up
timeFrame: Months 1-18
measure: Change in mean minutes of moderate-to-vigorous physical activity (MVPA) during the 12 month intervention
timeFrame: Months 1-12
measure: Change in mean minutes of moderate-to-vigorous physical activity (MVPA) during the 12 month intervention and 6 month follow up
timeFrame: Months 1-18
measure: Difference in proportion of weeks physical activity guidelines were achieved during the 12 month intervention
timeFrame: Months 1-12
measure: Difference in proportion of weeks physical activity guidelines were achieved during the 12 month intervention and 6 month follow up
timeFrame: Months 1-18
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Karen Glanz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: