Family-based Intervention for Youth With Prader-Willi Syndrome: The Active Play at Home Study

Status unconfirmed · Not applicable

Conditions studied: Prader Willi Syndrome, Childhood Obesity

In brief

Compared to other children, those with disability have additional challenges to being physically active. Prader-Willi Syndrome (PWS) is a genetic form of childhood obesity that is characterized by hypotonia, growth hormone deficiency, behavioral, and cognitive disability. In children, the low prevalence of PWS (1 in 10,000 to 15,000 live births) makes group-based physical activity (PA) interventions impossible. In contrast, the home environment presents a natural venue to establish a PA routine for this population. The present high prevalence of non-syndromal childhood obesity (one in four) and high physical inactivity rates, make alternative approaches to increasing PA in this population an area of high interest. Therefore, we have developed a 24-week home-based physical activity that could be suitable for children and adolescents ages 8-15 with PWS as well as obese children without PWS ages 8-11 years. It is hypothesized that: 1) an age-appropriate 24-week home-based PA intervention will increase PA levels in youth with PWS and without the syndrome but with obesity; 2) motor proficiency, central sensory reception and integration, and body composition will significantly improve in youth with and without PWS following completion of the home-based PA intervention and 3) physical activity self-efficacy and quality of life will increase significantly in youth with and without PWS who complete the home-based PA intervention. The study participants are 115 youth ages 8-15 y (45 with PWS and 70 without PWS but categorized as obese). The study utilizes a parallel design with the wait-listed control group receiving the intervention after serving as control. Participants are expected to complete the PA curriculum 4 days a week for six months including playground games 2 days a week and interactive console games 2 days a week. Parents are trained at baseline and then provided with a PA curriculum (Active Play at Home) and equipment to guide their implementation of the program at home. Measurements of children and parent dyads are assessed at baseline and at the end (week 24) of the intervention or control periods. Outcome measures include PA, body composition, motor proficiency, central sensory reception and integration (subsample of children only), quality of life and physical activity self-efficacy. PA intervention compliance is monitored using mail-in daily self-report checklists.

Key facts

Study ID
NCT02058342
Run by
California State University, Fullerton
People needed
115
Starts
2011-05-01
Expected to finish
2015-10-01
Last updated by the study team
2014-02-10

Who can join

Age: 8 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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