NCT03732144

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 3, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4.4 years

First QC Date

October 6, 2018

Last Update Submit

May 8, 2023

Conditions

Keywords

Physical ActivityCommunity-based InterventionSocial Motivational TheoriesBehavioral ChangeAgents of ChangeSocial Mechanisms

Outcome Measures

Primary Outcomes (1)

  • 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.

    Objective assessments of PA will be obtained on both staff and youth with omni- directional accelerometers. Data will be recorded in 30-s epochs to best capture short bouts of vigorous activity and raw activity data will be converted into time spent in light PA (1.6-2.9 metabolic equivalents (METS); count cut points=100 and 1500 for youth and 110-1534 for adults) and moderate-to-vigorous (MV)PA (3-8.9 METS; counts ≥ 1500 for youth and ≥ 1535 for adults) based on activity count thresholds for youth (identified by Puyau et al.) and adults (identified by Wilson, Co-I and Troiano et al) respectively. Youth and staff will wear the belts for one full week at baseline, the 8 wk intervention midpoint, 16 week endpoint, and 6 mo follow-up.

    baseline to 6mo follow-up

Secondary Outcomes (11)

  • 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

    baseline to 6mo follow-up

  • 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.

    baseline to 6mo follow-up

  • 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.

    baseline to 6mo follow-up

  • 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.

    baseline to 6mo follow-up

  • 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.

    baseline to 6mo follow-up

  • +6 more secondary outcomes

Study Arms (2)

Connect Staff-based PA intervention

EXPERIMENTAL

Sites receiving the Connect physical activity intervention will involve three related components - a staff health promotion initiative that helps staff pursue personally-tailored health goals and involves weekly 'check-ins', a tailored social PA curriculum to implement within the program's enrichment hour at least 3 times per week, and a comprehensive staff training program that provides strategies and tools for improving social connections within the program and guided support for implementing the social PA curriculum.

Behavioral: Connect Staff-based PA intervention

Connect Health Curriculum Control

OTHER

Sites receiving the general health curriculum control will also involve three related components- a comprehensive health program curriculum that includes activities that are interactive and fun and where students will learn about a variety of health behaviors (nutrition, stress reduction, etc.) and life skills through group activities, a staff training program that provides strategies and tools for implementing program curriculum, and on-going support from the Connect staff.

Other: Connect Health Curriculum Control

Interventions

After school program sites receiving the Connect intervention will receive a 16 week program that includes three related components - a staff health promotion initiative that helps staff pursue personally-tailored health goals and involves weekly 'check-ins', a tailored social PA curriculum to implement within the program's enrichment hour at least 3 times per week, and a comprehensive staff training program that provides strategies and tools for improving social connections within the program and guided support for implementing the social PA curriculum. 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 PA-related social mechanisms, youth PA, and staff PA.

Also known as: Connect through PLAY
Connect Staff-based PA intervention

After school program sites receiving the general ASP health curriculum control will address the prevention of several negative health behaviors (e.g., substance use, stress, etc) and also involve three related components- a comprehensive health program curriculum that includes activities that are interactive and fun and where students will learn about a variety of health behaviors (nutrition, stress reduction, etc.) and life skills through group activities, a staff training program that provides strategies and tools for implementing program curriculum, and on-going support from the Connect staff. This arm will serve as the comparison group to the Connect Staff-based PA intervention

Also known as: Connect through PLAY
Connect Health Curriculum Control

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

RECRUITING

Related Publications (3)

  • Deng A, Zarrett N. Examining variations in perceived barriers and self-efficacy for physical activity among adults in underserved communities. J Behav Med. 2026 Jan 19. doi: 10.1007/s10865-025-00627-1. Online ahead of print.

  • Deng A, Zarrett N, Sweeney AM. The mediating effects of motivation on the relations between occupational stress and physical activity among underresourced afterschool program staff. BMC Public Health. 2024 Jan 30;24(1):327. doi: 10.1186/s12889-024-17800-x.

  • Deng A, Zarrett N, Moon J, Sweeney AM. Changing trajectory of daily physical activity levels among at-risk adolescents: influences of motivational mechanisms. BMC Public Health. 2023 Oct 25;23(1):2089. doi: 10.1186/s12889-023-16949-1.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Nicole Zarrett, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Zarrett, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

October 6, 2018

First Posted

November 6, 2018

Study Start

January 3, 2019

Primary Completion

May 31, 2023

Study Completion

May 31, 2024

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations