Physical Activity Clinical Trial
Official title:
Social Mechanisms for Promoting Physical Activity in After School Programs for Underserved Middle School Youth: A Feasibility Trial
Verified date | February 2019 |
Source | University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 224 |
Est. completion date | March 3, 2017 |
Est. primary completion date | March 3, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 16 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of South Carolina | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Systematic observations will be conducted using the System for Observing Children's Activity and Relationships during Play (SOCARP) which includes a social climate supplement (MCOT-PA) developed by the PI. Key social mechanisms observed include youth peer interactions and social behaviors (e.g., prosocial interactions like praising peers, antisocial interactions like teasing/bullying), staff behaviors and interactions with youth (e.g., providing praise; engaging in PA with youth), and the nature of program activities for supporting connection and belongingness (e.g., inclusive). Consistent with other PA interventions, teams of two coders will make continuous observations of daily activities throughout 5 days at each ASP at baseline, 4wk midpoint, 8wk endpoint. | Baseline to 8 week endpoint | |
Secondary | 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. | Changes in social, cognitive, and affective components of youth PA motivations will be assessed. Improvements in PA social motivations will be measured using The Social Motivational Orientations Scale for Sport (SMOSS) which assesses youth's social affiliation orientation toward PA (7 items; 5pt scale: 1=strongly disagree, 5=strongly agree; M=2.44; SD=1.04; reliability coefficients range from .77 to .87), with higher mean scores on the affiliation sub scale indicating greater affiliation goals for PA participation. | Baseline to 2 weeks post-intervention | |
Secondary | 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. | Changes in social, cognitive, and affective components of youth PA motivations will be assessed. Youth cognitive components of PA motivation will be assessed using the Treatment Self-Regulation Questionnaire (15 items; 7pt scale: 1=not at all true for me [not autonomously regulated], 7=very true for me; reliability coefficient= .73) autonomous motivation/regulation for exercise, with higher mean scores across scale items indicating greater autonomous regulation. | Baseline to 2 weeks post-intervention | |
Secondary | 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. | Changes in social, cognitive, and affective components of youth PA motivations will be assessed. The Affective component of motivation will be assessed using The Intrinsic Interest and Regulatory Motives Scale (reliability coefficients from .83 to .94; 5-pt scale: 1=very false [does not enjoy], 5= very true; M=3.7, SD=1.0) with higher mean scores across scale items indicating youth greater intrinsic enjoyment and degree of affective engagement in exercise. | Baseline to 2 weeks post-intervention | |
Secondary | 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. | Changes in youth PA-based social connections will be measured at three levels: youth-staff connections, peer social connections, and peer support for PA. The Perceived teacher support scale (reliability coefficient =.84; 5-pt scale: 1=completely false [not supportive relationship], 5=completely true [very supportive relationship]; M=3.22; SD=1.05) will be used to evaluate improvements in staff-youth connections, with higher mean scores across the scale items indicating higher quality staff-youth connections. | Baseline to 2 weeks post-intervention | |
Secondary | 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. | The Social Support and Exercise Survey (reliability coefficients= .80-.87; short form, 4 items; 5pt scale: 1=never [receive support], 5=very often [receive support]) will be used to measure increases in youth PA-based peer social support, with higher mean scores indicating greater peer support for PA. | Baseline to 2 weeks post-intervention | |
Secondary | 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. | The Peer Motivational Climate in Youth Sport Questionnaire (reliability coefficients=.69-.82; 5-pt scale: 1-completely false, 5=completely true; M=3.18, SD=1.32) will be used to measure youth perceptions peer connections within the program, with higher mean scores across scale items indicating greater positive peer connections. | Baseline to 2 weeks post-intervention | |
Secondary | 4. Document the feasibility of the Connect program through adequate dose and fidelity of program implementation as indicated by weekly process evaluation. | A process evaluation observational tool developed and tested by the PI that monitors dose and fidelity will be conducted within both the intervention and control conditions once a week by an independent process evaluator for the duration of the program. Through observation and use of a quantitative checklist and rating system, the process evaluator will assess whether there are any changes in the structure, delivery, or climate of the control condition, and whether the social climate of intervention ASPs achieve the program's essential elements. | week 1 to week 8 of the intervention |
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