Prader Willi SyndromeAPAHNCT02058342
Family-based Intervention for Youth With Prader-Willi Syndrome: The Active Play at Home Study
A study testing Active Play at Home in people with Prader Willi Syndrome and Childhood Obesity, run by California State University, Fullerton at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Prader Willi Syndrome, Childhood Obesity
- What is being tested?
- Active Play at Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Obese children without Prader-Willi Syndrome currently on lipid-lowering medication, diabetes medications, or blood pressure medications.
- Being pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
California State University Fullerton
Fullerton, California, 92831
Daniela A Rubin, Ph.D., 657-278-4704 ext. 4704, drubin@fullerton.edu
Diobel L Castner, M.S., 657-278-8737 ext. 8737, dcastner@fullerton.edu
- Recruiting
University of Florida Gainesville
Gainesville, Florida, 32610
Marilyn C Dumont-Driscoll, Ph.D. M.D., 352-334-1340, dumonmd@peds.ufl.edu
Marilyn C Dumont-Driscoll, Ph.D., M.D.
About this study
Official title: Family-based Exercise Intervention for Children and Adolescents With Prader-Willi Syndrome
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.
Read the 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.
- Conditions
- Prader Willi Syndrome, Childhood Obesity
- Being tested
- Active Play at Home
- Keywords
- Prader Willi syndrome, Obesity, Childhood, Family, Interactive games, Playground games, Exercise routine
- Medical subject headings
- Prader-Willi Syndrome, Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Play at HomeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 24 weeks
Secondary outcomes (5)
Body composition
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.
Measured: Baseline to 24 weeks
Motor proficiency
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.
Measured: Baseline to 24 weeks
Sensory reception and motor integration
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).
Measured: Baseline to 24 weeks
Physical activity self-efficacy
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.
Measured: Baseline to 24 weeks
Quality of life
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)
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startMay 2011
- Primary completionJun 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prader Willi SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California State University, Fullerton
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida
- Responsible party
- Sponsor
- Investigators
- Daniela A Rubin, Ph.D., Principal investigator, California State University Fullerton, Department of Kinesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058342
- Sponsor's protocol ID
- HSR-13-0142.54155
- Other IDs
- W81XWH-09-1-0682
- Acronym
- APAH
- Status last verified
- Feb 2014
- First submitted
- 6 Feb 2014
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30833118Rubin 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.
PubMed 30407275Rubin 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.
PubMed 30346530Rubin 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.
PubMed 24529259
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-based Exercise Intervention for Children and Adolescents With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT02058342
- Acronym / sponsor ID
- APAH / HSR-13-0142.54155
- Conditions
- Prader Willi Syndrome, Childhood Obesity
- Keywords
- Prader Willi syndrome, Obesity, Childhood, Family, Interactive games, Playground games, Exercise routine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- California State University, FullertonUniversity, hospital or other
- Collaborators
- University of Florida
- Study start
- May 2011
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Play at Home Intervention | Experimental | Behavioral: Active Play at HomeParticipant 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 |
| 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. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Obese children without Prader-Willi Syndrome currently on lipid-lowering medication, diabetes medications, or blood pressure medications.
- Being pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Play at HomeThe 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. | Behavioural | Active Play at Home Intervention |
Primary outcome
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.
5 secondary outcomes
Body composition
Time frame: Baseline to 24 weeks
Motor proficiency
Time frame: Baseline to 24 weeks
Sensory reception and motor integration
Time frame: Baseline to 24 weeks
Physical activity self-efficacy
Time frame: Baseline to 24 weeks
Quality of life
Time frame: Baseline to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Derived from this study: PubMed 30833118Rubin 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.
- Derived from this study: PubMed 30407275Rubin 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.
- Derived from this study: PubMed 30346530Rubin 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.
- Derived from this study: PubMed 24529259Rubin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela A Rubin, Ph.D. principal investigator
California State University Fullerton, Department of Kinesiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Play at Home in people with Prader Willi Syndrome and Childhood Obesity, run by California State University, Fullerton at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela A Rubin, Ph.D. (657-278-4704 ext. 4704, drubin@fullerton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02058342, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2014.