Family-based Intervention for Youth With Prader-Willi Syndrome: The Active Play at Home Study (APAH)
|ClinicalTrials.gov Identifier: NCT02058342|
Recruitment Status : Unknown
Verified February 2014 by California State University, Fullerton.
Recruitment status was: Recruiting
First Posted : February 10, 2014
Last Update Posted : February 10, 2014
|Condition or disease||Intervention/treatment|
|Prader Willi Syndrome Childhood Obesity||Behavioral: Active Play at Home|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Family-based Exercise Intervention for Children and Adolescents With Prader-Willi Syndrome|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||October 2015|
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.
- Physical Activity [ Time Frame: Baseline to 24 weeks ]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.
- Body composition [ Time Frame: Baseline to 24 weeks ]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 ]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 ]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 ]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 ]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)
- Anthropometrics [ Time Frame: Baseline to 24 weeks ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058342
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058342
|Contact: Daniela A Rubin, Ph.D.||657-278-4704 ext email@example.com|
|United States, California|
|California State University Fullerton||Recruiting|
|Fullerton, California, United States, 92831|
|Contact: Daniela A Rubin, Ph.D. 657-278-4704 ext 4704 firstname.lastname@example.org|
|Contact: Diobel L Castner, M.S. 657-278-8737 ext 8737 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Marilyn C Dumont-Driscoll, Ph.D., M.D.|
|Sub-Investigator: Daniel Driscoll, Ph.D. M.D.|
|Principal Investigator:||Daniela A Rubin, Ph.D.||California State University Fullerton, Department of Kinesiology|