NCT03850821

Brief Summary

The primary goal of the Connect feasibility trial was to develop and test the feasibility of a physical activity (PA) social-climate-based intervention within pre-existing after school programs (ASPs) that targets youth social goals (e.g., building friendships through PA) and social competencies (e.g., friendship-building skills) to increase the positive PA affect, cognitions, and moderate-to-vigorous (MV) PA of underserved (i.e., low income, minority status) middle school youth. The 8-week intervention was designed to improve several key social mechanisms within ASPs 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) that are key predictors of youth PA and included: 1) "Get to know you" sessions aimed at providing youth guided social opportunities to foster friendship-building skills, and to promote acceptance, cooperation, contribution, and friendship affiliation, and; 2) a novel socially-oriented physical activity curriculum tailored to meet the social goals and needs of program staff and participating youth. Comparison of ASPs receiving the 8-week "Connect" intervention (N=3 ASPs) with ASPs randomized to receive the general ASP curriculum (wait-list control condition; N=3 ASPs) will yield preliminary data on the effectiveness of social mediators for improving moderate-to-vigorous physical activity (MVPA) and preventing obesity among at-risk youth that can inform future intervention design and youth programming policy. Results of this proposed project will provide the basis for conducting a large scale efficacy trial. First, it is hypothesized that the Connect program will be documented to be feasible as shown by: 1) youth's greater perceived connectedness and PA affiliation goal orientation from baseline to post-intervention; 2). changes in targeted social climate components from baseline to post-intervention as measured by systematic observations, and; 3) adequate dose and fidelity of program implementation as indicated by weekly process evaluations. Second, it is hypothesized that youth in the social climate program (vs. comparison) demonstrate greater increases in positive PA affect, cognitions, and MVPA from baseline to post-intervention.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

2.5 years

First QC Date

December 5, 2018

Last Update Submit

February 19, 2019

Conditions

Keywords

Physical ActivityCommunity-based InterventionSocial Motivational TheoriesBehavioral ChangeSocial Mechanisms

Outcome Measures

Primary Outcomes (1)

  • Greater increases (change) in MVPA (using 7-day omni-directional accelerometers) of youth receiving the Connect Social Mechanisms intervention compared to the typical ASP curriculum control.

    Objective assessments of PA will be obtained on 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 moderate-to-vigorous (MV)PA (3-8.9 METS; counts ≥ 1500 for youth) based on activity count thresholds for youth identified by Puyau and colleagues. Youth and staff will wear the belts for one full week at baseline, and again at the 8 wk intervention endpoint.

    Baseline to 8 week endpoint

Secondary Outcomes (8)

  • Greater improvements (change) in the Social Mechanisms intervention ASPs compared to control ASPs in targeted social mechanisms within the ASP for promoting physical activity using a social climate observation tool.

    Baseline to 8 week endpoint

  • Greater improvements (change) in targeted youth PA-based social motivational outcomes of youth receiving the Connect Social Mechanisms intervention compared to the Typical ASP control.

    Baseline to 2 weeks post-intervention

  • Greater improvements (change) in targeted youth PA-based cognitive motivational outcomes of youth receiving the Connect Staff-based PA intervention compared to the Typical ASP curriculum control.

    Baseline to 2 weeks post-intervention

  • Greater improvements (change) in targeted youth PA-based social motivational outcomes of youth receiving the Connect Social Mechanisms intervention compared to the Typical ASP curriculum control.

    Baseline to 2 weeks post-intervention

  • Greater improvements (change) in youth-staff PA-based social connections for promoting physical activity among youth receiving the Connect Social Mechanisms intervention compared to the Typical ASP curriculum control.

    Baseline to 2 weeks post-intervention

  • +3 more secondary outcomes

Study Arms (2)

Connect Social Mechanisms Intervention

EXPERIMENTAL

The primary components of the intervention included: "Get-to-know-you" sessions aimed specifically at providing youth guided social opportunities to foster friendships, group belonging, and social skills, and novel socially-oriented 'PA sessions' infused within the daily time slot that ASPs' allocated towards recreation. Drawing from theoretical models of motivation, and the investigators' previous ASP studies, key essential elements were identified for facilitating improvements in targeted PA social mechanisms (i.e., friendships, group belonging, and staff connection) and included: 1) social-emotional goal-oriented support, 2) collaborative/cooperative play centered on friendship and informal fun; 3) equal treatment/access, and; 4) inclusive and engaging.

Behavioral: Connect Social Mechanisms Intervention

Typical ASP curriculum wait-list control

NO INTERVENTION

No intervention was implemented within the active wait-list control condition, which served as the typical ASP curriculum control/comparison. After completion of the 8-week intervention (12 weeks including baseline and post-intervention data collection), the control condition received the social mechanisms curriculum as a token of appreciation for participating in measurement.

Interventions

The "Get-to-Know-You" small group sessions (30 minutes) were designed to increase friendship building skills and involved interactive student-led discussions and activities designed to foster the assets needed to build and support friendships, group cohesion, and staff connections through PA. The PA component of the program (60 minutes) was designed to promote a positive PA social experience and meet youth social affiliation goals. Available games to choose from were novel, inclusive, emphasized teamwork, and centered on social goals. Three different PA stations were offered each program day in which youth rotated. One day each week was designated as a "choice day", whereby youth activity preference ratings were used to determine which activities were offered that day.

Connect Social Mechanisms Intervention

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

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/measures will not be appropriate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Zarrett N, Wilson DK, Sweeney A, Bell B, Fairchild AJ, Pinto BM, Miller C, Thames T. An overview of the Connect through PLAY trial to increase physical activity in underserved adolescents. Contemp Clin Trials. 2022 Mar;114:106677. doi: 10.1016/j.cct.2022.106677. Epub 2022 Jan 17.

  • Zarrett N, Law LH, Wilson DK, Abraczinskas M, Taylor S, Cook BS, Roberts A. Connect through PLAY: a randomized-controlled trial in afterschool programs to increase adolescents' physical activity. J Behav Med. 2021 Jun;44(3):379-391. doi: 10.1007/s10865-021-00206-0. Epub 2021 Mar 7.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Nicole Zarrett, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized study design will be implemented in which 6 ASPs are randomly assigned to either the Connect Social Mechanisms intervention condition or the active-wait list control condition (8-week intervention, with a 2 week post-intervention data collection).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

December 5, 2018

First Posted

February 22, 2019

Study Start

September 18, 2014

Primary Completion

March 3, 2017

Study Completion

March 3, 2017

Last Updated

February 22, 2019

Record last verified: 2019-02