Clinical trial NCT03732144: Connect Through PLAY: A Staff-based Physical Activity Intervention for Middle School Youth
Official title: Connect Through PLAY: A Staff-based Physical Activity Intervention for Middle School Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Obesity Prevention
Keywords: Physical Activity
Community-based Intervention
Social Motivational Theories
Behavioral Change
Agents of Change
Social Mechanisms
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-11-06
Enrollment: 1350
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The prospective randomized controlled trial is a nested cohort design that compares two levels of the intervention, a staff-based social development PA program to a generalized ASP health curriculum control, over a 10-month (40 week) time period (16-week intervention, 6 month followup). A total of 30 ASPs serving underserved middle school (\~40 youth and \~5 staff per school; N=1200 youth, 150 staff) will be randomly assigned to either receive the Connect intervention or serve as the standard ASP Health curriculum control. The project will be implemented over a 5-year period with a new cohort of 6 ASPs added each year (a total of 5 cohorts, with 6 ASPs in each cohort).
Primary purpose: PREVENTION

Brief summary: The overall goal of the Connect Through Positive Leisure Activities for Youth (PLAY) Project is to improve staff capacity for implementing effective physical activity (PA) programming within middle school after school programs serving high-risk youth. All components of the 'Connect' intervention (health promotion initiative, comprehensive training, and tailored physical activity curriculum) aim to support staff cohesion, motivation and efficacy in facilitating a PA context that supports youth social goals and meaningful connections. To this end, the investigators will be implementing a 5-year randomized controlled trial with 30 ASPs. Compared to control programs, after school programs receiving the 'Connect' program are expected to show greater improvements from baseline to post- and 6 mo follow-up in social mechanisms, youth PA, and staff PA. The Connect through PLAY project will provide important insights into what supports are needed (and efficacious) for after school program staff to create a positive social climate to promote increases in youth motivation and participation in physical activity.

Detailed description: Although after school programs (ASPs) have been recognized as a critical context for promoting youth physical activity (PA), with broad reach to underserved communities, research by the Principal Investigator and others have indicated that ASPs continue to struggle to meet policy guidelines for daily youth PA. Moreover, despite continued increases in obesity rates among U.S. adolescents, there have been few ASP interventions focused on underserved adolescents, and limited-to-no impact on adolescents' sustained behavior change. Previous ASP studies by the PI demonstrate that social mechanisms overlooked in previous interventions (e.g., developing friendship and connection to peers and staff through PA; group belonging, including positive peer PA norms and tangible support) are key predictors of youth PA. The research team recently completed a feasibility trial (NIH R21 HD077357) within 6 ASPs (3 intervention vs. 3 standard- health curriculum controls) for underserved middle school youth that was the first intervention to date to address these youth PA social goals/mechanisms. Findings showed positive effects for changing staff behaviors, improving youth PA social supports and connections with peers and staff, and increasing youth PA. The proposed study will expand on the previous ASP feasibility trial with a novel translational approach that works with pre-existing ASPs and targets staff as instrumental for sustainable changes in social mechanisms within the ASP setting for increasing the daily PA of underserved adolescents. The proposed project will be a prospective, randomized controlled trial comparing a staff-based social development PA program to a standard ASP health curriculum control. The proposed efficacy trial will enhance the influence of pre-existing ASP staff as key change agents and address social developmental needs of adolescents overlooked in previous interventions through employing a novel theoretical framework that expands on social developmental theory and the social mechanisms highlighted by Self-Determination Theory, Achievement Goal Theory, and Social Cognitive Theory. The intervention will target the three key social mechanisms of "PA social affiliation goals" for increased and sustained PA of staff and underserved middle school youth (i.e., Friendships/connections through PA; Group Belonging, and; Staff Connection). All components of the intervention (health promotion initiative, comprehensive training, and tailored social PA curriculum) aim to improve staff capacity for facilitating a PA context that supports these social goals/mechanisms (connections, group belonging) and increases the influence of ASP staff as positive PA role models and agents of change.

Compared to control ASPs, ASPs receiving the 'Connect' program are expected to show greater improvements from baseline to post- and 6 mo follow-up in social mechanisms, youth PA, and staff PA. The results of this proposed project will demonstrate the efficacy of the intervention, and will assist in developing a model of training, motivating, and empowering ASP staff to address social mechanisms that promote youth PA for conducting a large scale effectiveness trial.

Eligibility criteria: Inclusion Criteria for Adolescents:

* Must be currently enrolled in the after school program
* Have parental consent to participate
* Agree to study participation (assent)
* Be available for baseline and post-intervention measurement.

Inclusion for Adults (Program Staff):

* Must be part of the after school staff
* No medical condition or disorder that would limit participation
* Available and able to participate in the data collection and the intervention phase (trainings, health initiative, etc) for the study period.

Exclusion Criteria for Adolescents and Adults (Program Staff)

* Have a medical condition that would interfere with the prescribed physical activity intervention plan
* Have a developmental delay or are in treatment for a psychiatric disorder such that the intervention materials will not be appropriate.

Primary outcomes:
measure: Greater increases (change) in physical activity (i.e., light, moderate, vigorous PA; using 7-day omni-directional accelerometers) of youth and staff receiving the Connect Staff-based PA intervention compared to General Health Curriculum control.
timeFrame: baseline to 6mo follow-up
Secondary outcomes:
measure: Greater improvements (change) in the Connect Staff-based PA intervention ASPs compared to General Health Curriculum control in targeted social mechanisms within the ASP for promoting physical activity using a social climate observation tool
timeFrame: baseline to 6mo follow-up
measure: Greater improvements (change) in targeted youth PA-based social motivational outcomes of youth receiving the Connect Staff-based PA intervention compared to General Health Curriculum control.
timeFrame: baseline to 6mo follow-up
measure: Greater improvements (change) in targeted youth PA-based cognitive motivational outcomes of youth receiving the Connect Staff-based PA intervention compared to General Health Curriculum control.
timeFrame: baseline to 6mo follow-up
measure: Greater improvements (change) in targeted youth PA-based affective motivational outcomes of youth receiving the Connect Staff-based PA intervention compared to General Health Curriculum control.
timeFrame: baseline to 6mo follow-up
measure: Greater improvements (change) in youth-staff PA-based social connections for promoting physical activity among youth receiving the Connect Staff-based PA intervention compared to youth in the General Health Curriculum control.
timeFrame: baseline to 6mo follow-up
measure: Greater improvements (change) in youth PA-based peer social support among youth receiving the Connect Staff-based PA intervention compared to youth in the General Health Curriculum control.
timeFrame: baseline to 6mo follow-up
measure: Greater improvements (change) in youth PA-based positive peer connections among youth receiving the Connect Staff-based PA intervention compared to youth in the General Health Curriculum control.
timeFrame: baseline to 6mo follow-up
measure: Document the Fidelity of the Connect program through changes in Staff's collective capacity to lead youth in PA activities within ASPs receiving the Connect Staff-based PA intervention.
timeFrame: baseline to 6 mo follow-up
measure: Greater improvements (change) in targeted staff PA motivational outcomes of staff receiving the Connect Staff-based PA intervention compared to General Health Curriculum control.
timeFrame: baseline to 6 mo follow-up
measure: Greater improvements (change) in targeted staff PA self-concept and efficacy to overcome barriers of staff receiving the Connect Staff-based PA intervention compared to General Health Curriculum control.
timeFrame: baseline to 6 mo follow-up
measure: Greater improvements (change) in staff PA-based social support among staff receiving the Connect Staff-based PA intervention compared to General Health Curriculum control.
timeFrame: baseline to 6 mo follow-up
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Nicole Zarrett, PhD
role: PRINCIPAL_INVESTIGATOR
References: