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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by California State University, Fullerton
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
California State University, Fullerton
ClinicalTrials.gov Identifier:
NCT02058342
First received: February 6, 2014
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Prader Willi Syndrome
Childhood Obesity
Behavioral: Active Play at Home

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family-based Exercise Intervention for Children and Adolescents With Prader-Willi Syndrome

Resource links provided by NLM:


Further study details as provided by California State University, Fullerton:

Primary Outcome Measures:
  • Physical Activity [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Body composition [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    Percentage of body fat will be measured using dual x-ray absorptiometry (DXA) model Lunar Prodigy Advance Plus (GE Healthcare, Milwaukee, WI). For female participants who have had their first menses, a urine pregnancy test will be completed before conducting the DXA scan. A pregnancy test is required by law because the x-rays might be harmful to the fetuses. If the participant is pregnant, she will be excluded from the study as a major study outcome is body composition and the participant will experience changes in body composition because of pregnancy, thus invalidating the study findings.

  • Motor proficiency [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    The Bruininks-Oseretsky Test of Motor Proficiency (BOTMP™-2) is used to evaluate overall motor proficiency. The BOTMP™-2 test measures fine manual control (fine motor precision and fine motor integration), manual coordination (manual dexterity and upper limb coordination), body coordination (bilateral coordination and balance), and strength and agility (running speed and agility and strength). This test also provides an overall motor proficiency score, as well as separate scores for the different domains of motor proficiency (Bruininks, R., Bruininks-Oseretsky test of motor proficiency: examiner's manual. 1978, MN: American Guidance Service). It is expected that significant improvements are demonstrated following completion of the PA intervention in the areas of upper limb coordination, bilateral coordination, balance, running speed, and agility and strength.

  • Sensory reception and motor integration [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    Sensory reception and motor integration will be measured using The Sensory Organization Test. The SOT is designed to identify impairments in one or more of the three sensory systems (i.e., vision, somatosensory, vestibular) that contribute to standing balance. This test has been previously used with pediatric populations, with and without disabilities such as cerebral palsy. The test is comprised of six test conditions. This test will be administered only in a subsample of participants (30 with PWS and 55 with non-syndromal obesity).

  • Physical activity self-efficacy [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    Self-efficacy for physical activity will be measured with an eight item questionnaire rated on a five point scale ranging from disagree a lot to agree a lot . This questionnaire was originally developed for use with children in fifth grade, but also validated with children in eighth grade. This questionnaire had a test-retest reliability of r= 0.84 over a period of two weeks. Additionally, the questionnaire had an internal consistency score of 0.88. Dishman, R.K., et al. Factorial invariance and latent mean structure of questionnaires measuring social-cognitive determinants of physical activity among black and white adolescent girls. Prev Med, 2002. 34(1): p. 100-8.

  • Quality of life [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    will be measured using Pediatric Quality of Life Inventory (PedsQL™) to assess multidimensional constructs covering physical, emotional, mental, social, and behavioral components of well-being and function in youth (Varni, J.W., et al., The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr, 2003. 3(6): p. 329-41)


Other Outcome Measures:
  • Anthropometrics [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    Stature, measured to the nearest 0.1 cm using a wall-mounted stadiometer. Body mass, obtained to the nearest 0.1 kg following Third U.S. National Health and Nutrition Examination Survey procedures. BMI will be computed by dividing body mass (kg) by stature (m2).

  • Dietary intake [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    To help interpret whether changes in body composition can be solely attributed to the PA intervention, dietary intake will also be assessed at the same time points as the other variables of interest. The participating parent or legal guardian will maintain a food record of the child's diet during two days of the week and one day on the weekend. In this record the parent will include quantity of food and fluids consumed, the preparation method, and the brand of the product. Before the baseline measurement, parents will attend a training session with a registered dietitian to learn how to estimate portion sizes and keep a food record. The information collected through the food records will be entered into The Food Processor, ESHA Research, Salem, OR, USA program and analyzed for macronutrient percent intake and total calories.

  • Parent confidence [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    Parent's Confidence: will be measured by the Proxy Self-efficacy questionnaire (Shields CA, & Brawley LR. (2006) Preferring proxy-agency: Impact on self-efficacy for exercise. Journal of Health Psychology,11, 904-914) to assess parents' confidence and self-efficacy in scheduling and managing their child's physical activity behaviors and adherence to the physical activity program.

  • Parent influence [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    Parent Influence: will be measured by the Parental Influence Question is Parental Social Control (Wilson, K.S., Spink, K.S., & Priebe, C.S. (2010). Parental social control in reaction to a hypothetical lapse in their child's activity: The role of parental activity and importance. Psychology of Sport and Exercise, 11, 231-237) to assess how the specific tactics parents choose to motivate their child influences the child's physical activity levels.


Estimated Enrollment: 115
Study Start Date: May 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Play at Home Intervention
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
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.
No Intervention: Wait-listed control
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058342

Contacts
Contact: Daniela A Rubin, Ph.D. 657-278-4704 ext 4704 drubin@fullerton.edu

Locations
United States, California
California State University Fullerton Recruiting
Fullerton, California, United States, 92831
Contact: Daniela A Rubin, Ph.D.    657-278-4704 ext 4704    drubin@fullerton.edu   
Contact: Diobel L Castner, M.S.    657-278-8737 ext 8737    dcastner@fullerton.edu   
Principal Investigator: Daniela A Rubin, Ph.D.         
Sub-Investigator: Kathleen S Wilson, Ph.D.         
Sub-Investigator: Debra J Rose, Ph.D.         
Sub-Investigator: Leonard Wiersma, Ph.D.         
United States, Florida
University of Florida Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: Marilyn C Dumont-Driscoll, Ph.D. M.D.    352-334-1340    dumonmd@peds.ufl.edu   
Principal Investigator: Marilyn C Dumont-Driscoll, Ph.D., M.D.         
Sub-Investigator: Daniel Driscoll, Ph.D. M.D.         
Sponsors and Collaborators
California State University, Fullerton
University of Florida
Investigators
Principal Investigator: Daniela A Rubin, Ph.D. California State University Fullerton, Department of Kinesiology
  More Information

No publications provided by California State University, Fullerton

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: California State University, Fullerton
ClinicalTrials.gov Identifier: NCT02058342     History of Changes
Other Study ID Numbers: HSR-13-0142.54155, W81XWH-09-1-0682
Study First Received: February 6, 2014
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by California State University, Fullerton:
Prader Willi syndrome
Obesity
Childhood
Family
Interactive games
Playground games
Exercise routine

Additional relevant MeSH terms:
Prader-Willi Syndrome
Obesity
Syndrome
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014