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

NCT02058342 | Unknown

• 2 other identifiers: HSR-13-0142.54155W81XWH-09-1-0682
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prader Willi Syndrome; Childhood Obesity

Keywords

Prader Willi syndrome; Obesity; Childhood; Family; Interactive games; Playground games; Exercise routine

Outcome Measures

Primary Outcomes (1)

• Physical Activity

  PA level: This outcome will be measured using accelerometers which provide detailed information on the temporal patterns (duration, frequency, and intensity) of PA. Data are stored as acceleration counts and data can be downloaded to a personal computer. Youth will use the 4MB GT3X (Actigraph, Pensacola, FL) triaxial activity monitor at the hip for eight consecutive days. Participants should wear the monitor all day while they are awake and remove the monitor when they shower, bathe, swim, or do something that may get the monitor completely wet. The youth and parents will be asked to fill out a log of all the physical activities they engage in during the days they wear the accelerometer. The child will wear the accelerometer for eight days to capture two typical weekend days. Physical activity will be defined as minutes per day of Moderate to Vigorous Physical Activity. Accelerometry cut-points published by Evenson et al. will be used to determine MVPA.

  Baseline to 24 weeks

Secondary Outcomes (5)

• Body composition

  Baseline to 24 weeks

• Motor proficiency

  Baseline to 24 weeks

• Sensory reception and motor integration

  Baseline to 24 weeks

• Physical activity self-efficacy

  Baseline to 24 weeks

• Quality of life

  Baseline to 24 weeks

Other Outcomes (4)

• Anthropometrics

  Baseline to 24 weeks

• Dietary intake

  Baseline to 24 weeks

• Parent confidence

  Baseline to 24 weeks

Study Arms (2)

Active Play at Home Intervention

EXPERIMENTAL

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

Behavioral: Active Play at Home

Wait-listed control

NO INTERVENTION

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.

Interventions

Active Play at Home BEHAVIORAL

The Active Play at Home (APAH) curriculum includes age-appropriate goal-oriented physical activities that combine playground and video games using the Nintendo Wii™ with exercises targeting: muscular strength and endurance, aerobic endurance, flexibility, balance, agility, and motor coordination. APAH was designed for children ages 8-11 without disability and ages 8-15 years with PWS. The playground games and interactive console-based games are to be performed twice weekly each. The activity is progressed from 25 to 45 minutes of moderate to vigorous physical activity throughout the 24 weeks period. Parents and children are trained to use the curriculum hands-on at baseline.

Active Play at Home Intervention

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• California State University, Fullerton: lead
• University of Florida: collaborator

Study Sites (2)

California State University Fullerton

Fullerton, California, 92831, United States

RECRUITING

University of Florida Gainesville

Gainesville, Florida, 32610, United States

RECRUITING

Related Publications (4)

• Rubin DA, Wilson KS, Castner DM, Dumont-Driscoll MC. Changes in Health-Related Outcomes in Youth With Obesity in Response to a Home-Based Parent-Led Physical Activity Program. J Adolesc Health. 2019 Sep;65(3):323-330. doi: 10.1016/j.jadohealth.2018.11.014. Epub 2019 Mar 2.

  PMID: 30833118 DERIVED

• Rubin DA, Wilson KS, Dumont-Driscoll M, Rose DJ. Effectiveness of a Parent-led Physical Activity Intervention in Youth with Obesity. Med Sci Sports Exerc. 2019 Apr;51(4):805-813. doi: 10.1249/MSS.0000000000001835.

  PMID: 30407275 DERIVED

• Rubin DA, Wilson KS, Honea KE, Castner DM, McGarrah JG, Rose DJ, Dumont-Driscoll M. An evaluation of the implementation of a parent-led, games-based physical activity intervention: the Active Play at Home quasi-randomized trial. Health Educ Res. 2019 Feb 1;34(1):98-112. doi: 10.1093/her/cyy035.

  PMID: 30346530 DERIVED

• Rubin DA, Wilson KS, Wiersma LD, Weiss JW, Rose DJ. Rationale and design of active play @ home: a parent-led physical activity program for children with and without disability. BMC Pediatr. 2014 Feb 14;14:41. doi: 10.1186/1471-2431-14-41.

  PMID: 24529259 DERIVED

MeSH Terms

Conditions

Prader-Willi Syndrome; Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniela A Rubin, Ph.D.

  California State University Fullerton, Department of Kinesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela A Rubin, Ph.D.

CONTACT

657-278-4704; drubin@fullerton.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 10, 2014
• Study Start: May 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 10, 2014

Record last verified: 2014-02

Locations

US (2)