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

California State University, Fullerton

Status: Unknown

Conditions: Childhood Obesity; Prader Willi Syndrome

Treatments: Behavioral: Active Play at Home

Study type: Interventional

Funder types: Other

Identifiers

NCT02058342

HSR-13-0142.54155

W81XWH-09-1-0682 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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. Specifically, approaches that involve the family have been identified as possible areas where further research is needed. 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. Tips related to scheduling and coping with barriers to daily program implementation are also included. Throughout, parents are contacted by phone once a week (weeks 1-4) and then every other week to provide support in between visits. Measurements of children and parent dyads are assessed at baseline, at 12-weeks of receiving the intervention and at the end (week 24) of the intervention or control periods. PA intervention compliance is monitored using mail-in daily self-report checklists.

Enrollment: 115 estimated patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having Prader-Willi Syndrome and being between ages 8-15 years. PWS status will be documented by appropriate molecular and cytogenetic testing (i.e., chromosomes, florescence in situ hybridization [FISH] 15, DNA methylation, DNA polymorphism studies)
• Being obese and between ages 8-11 years. Obesity is defined as having a body fat percentage greater than the 95th percentile (McCarthy, H. D., Cole, T. J., Fry, T., Jebb, S. A., & Prentice, A. M. (2006). Body fat reference curves for children. International Journal of Obesity (Lond), 30(4), 598-602).

Exclusion criteria

• Obese children without Prader-Willi Syndrome currently on lipid-lowering medication, diabetes medications, or blood pressure medications.
• Being pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Active Play at Home Intervention

Experimental group

Description:

Participant parents in the intervention arm will receive: 1) Active Play at Home curriculum and equipment, 2) Training session on Active Play at Home curriculum, 3) counseling on physical activity scheduling, identification of barriers, motivational strategies, 4) phone calls to check on compliance and issues with doing the program at home

Treatment:

Behavioral: Active Play at Home

Wait-listed control

No Intervention group

Description:

Participants will attend the baseline visit to do baseline measurements but will not receive any materials related to the Active Play at Home curriculum and will also not be contacted by phone during the control 24 weeks. After they serve as control group, they will be provided with the opportunity to receive the intervention.