Clinical trial NCT03850821: Social Mechanisms for Promoting Physical Activity in After School Programs for Underserved Middle School Youth
Official title: Social Mechanisms for Promoting Physical Activity in After School Programs for Underserved Middle School Youth: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Obesity Prevention
Keywords: Physical Activity
Community-based Intervention
Social Motivational Theories
Behavioral Change
Social Mechanisms
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-02-22
Enrollment: 224
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: 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).
Primary purpose: PREVENTION

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.

Detailed description: Physical inactivity has been identified as a primary contributor of childhood obesity and related diseases, with underserved youth (minority and low-income status) at greatest risk of inactivity and its health consequences. However, physical activity (PA) interventions have attained limited-to-no sustained behavior change and thus, have rarely affected targeted physiological or anthropometric health outcomes. Extensive research on participation motivation in sport and physical education shows highly engaged youth report an affiliation orientation towards PA, identifying social reasons and goals (e.g., being with, and making friends) as their primary motivations for participation, and defining PA competence as achieving these social goals. Despite substantial research noting the importance of social goals on PA-based self-determined motivation and participation, PA-based interventions have almost exclusively emphasized approaches centered on constructs related to physical ability (e.g., mastery, self-efficacy). To date, little research has focused on understanding the contributions that affiliation orientations (social goals) make toward promoting sustained youth PA. The investigators argue that adolescents' desire for social connections is a primary goal of action underpinning their PA behavior and thus, a key mechanism to target for sustained behavior change. The Active by Choice Today (ACT) program, conducted by the investigative team is one of the first after school programs (ASPs) to implement a climate-based intervention based on Self-Determination theory that showed significant improvements in PA in underserved youth. However, limited sustained effects found post-intervention, and data from interviews with ACT staff and youth which indicated the presence of several interpersonal barriers (e.g., cliques, teasing) to program effectiveness, suggests additional socially-based climate components still need to be addressed. Systematic observations of ASPs using an observational tool that the PI has developed and tested and additional interviews conducted with ASP staff and youth further suggests that targeting youth social goals (e.g., building friendships through PA) and social competencies (e.g., Friendship-building skills) may be particularly effective for increasing and sustaining the PA of underserved youth. Thus, the proposed study aims to test the feasibility of augmenting the Active by Choice Today (ACT) program through the addition of three key "PA affiliation orientation" elements shown by previous research to be particularly important to adolescents within physical domains: 1) Connecting strengthened friendships to increased PA (developing youth social skills and providing a PA environment that emphasizes friendship building as the goal of PA), 2) Improving peer connectedness and group belonging through PA participation, and 3) Improving interpersonal connections with ASP staff through PA participation. These elements have not been explored in prior research. Enhancing ACT to include these elements in the resultant ACT version 2-Connect intervention is expected to lead to sustained positive PA affect, cognitions, and behaviors in underserved youth. Comparison of ASPs receiving the "Connect" intervention (N=3 ASPs) with ASPs randomized to receive the general ASP curriculum (control condition; N=3 ASPs) will yield preliminary data on the effectiveness of social mediators for improving moderate-to-vigorous (MV)PA 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.

Specific Objectives:

Apply essential social climate elements identified from interviews and the investigators' previous research to design and test the feasibility of the 8-week "Connect" social climate intervention for increasing PA affect, cognition, and MVPA of underserved youth within ASPs.

Primary Aims (Program Development and Feasibility):

1. Through qualitative interviews with program staff and youth at 4 ASP sites serving at-risk youth: a) identify conceptual constructs most relevant for facilitating and supporting youth PA social affiliation goals; b) determine the barriers present within ASPs for meeting youth PA social goals, and; c) obtain staff/youth input on the feasibility and acceptability of initially- developed program components.
2. Explore the feasibility of the Connect program. The Connect program will be documented to be feasible in these ASP programs as shown by: 1) youth's greater perceived connectedness and affiliation goal orientation toward PA from baseline to 12- weeks 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.

Secondary Aims (Document the preliminary impact of the Connect program on PA outcomes):

1. Assess whether youth in the social climate program (vs. comparison) demonstrate greater increases in positive PA affect, cognitions, and MVPA from baseline to 2-weeks post-intervention.
2. Explore whether youth in the social climate program (vs. comparison) demonstrate healthier BMI trajectories (e.g., slight reduction) from baseline to 2-weeks post-intervention.
3. Assess whether changes in targeted social mechanisms will mediate the effects of the intervention on changes in PA affect, cognitions, and MVPA from baseline to post-intervention.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: Baseline to 8 week endpoint
Secondary outcomes:
measure: 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.
timeFrame: Baseline to 8 week endpoint
measure: 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.
timeFrame: Baseline to 2 weeks post-intervention
measure: 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.
timeFrame: Baseline to 2 weeks post-intervention
measure: 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.
timeFrame: Baseline to 2 weeks post-intervention
measure: 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.
timeFrame: Baseline to 2 weeks post-intervention
measure: Greater improvements (change) in youth PA-based peer social support among youth receiving the Connect Social Mechanisms intervention compared to youth in the Typical ASP curriculum control.
timeFrame: Baseline to 2 weeks post-intervention
measure: Greater improvements (change) in youth PA-based positive peer connections among youth receiving the Connect Social Mechanisms intervention compared to youth in the Typical ASP curriculum control.
timeFrame: Baseline to 2 weeks post-intervention
measure: 4. Document the feasibility of the Connect program through adequate dose and fidelity of program implementation as indicated by weekly process evaluation.
timeFrame: week 1 to week 8 of the intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of South Carolina
name: Nicole Zarrett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.