Status:
COMPLETED
Parent Supported Weight Reduction in Down Syndrome
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
University of Massachusetts, Worcester
Conditions:
Down Syndrome
Eligibility:
All Genders
13-26 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether a nutrition and physical activity education program for families of overweight or obese adolescents with Down syndrome is more effective when behavior...
Detailed Description
Children with intellectual disabilities, including Down syndrome (DS), are as likely to be overweight than their typically developing peers. The consequences of childhood obesity include increased ris...
Eligibility Criteria
Inclusion
- Age 13-26 with Down syndrome
- Living at home in single- or two-parent family, w/no plans to leave home in next year
- Achieves IQ score 45 or above on the Kaufman Brief Intelligence Test (K-BIT)
- Academic ability and necessary behavioral/social control to participate in a group classroom-based educational program
- Clinically overweight, as indicated by a BMI at or above 85th percentile for age and gender
- Signed approval to participate, which includes a completed recent thyroid screen, provided by participant's Primary Physician (and participant's cardiologist is he/she has a history of a heart condition), and participant's neurologist if he/she has a history of seizures)
Exclusion
- Untreated thyroid disorder
- Type I or II Diabetes
- Cardiac problem, treated or untreated, for whom the participant's treating cardiologist indicates restrictions in physical activity
- Epilepsy/seizure disorder in which participant is not stable on medications
- Orthopedic injuries or deformities
- Chronic GI illness (except constipation) including inflammatory bowel diseases and celiac disease
- Prader Willi syndrome
- Unwillingness to wear accelerometer at screening or enrollment
- Non-ambulatory, i.e., uses wheelchair or other assistive devices for moving about and walking
- Chronic/severe foot infection (as screened by physical therapist, but in coordination with physician)
- Severe balance problems (as screened by physical therapist)
- Resting heart rate less than 50 beats per minute (bpm), or greater to or equal to 100 bpm (observed in physical therapy screening)
- History of major medical illness (i.e., cancer, leukemia)
- History of profound behavioral problems, i.e., self injury, injury to others, property destruction, etc.
- Other diagnosed disorders, including autism spectrum disorders, bipolar disorder (within the last year), eating disorder (within the last year), major depression (within the last year), psychosis \& schizophrenia
- Other exclusion conditions left to the discretion of the study team
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01256112
Start Date
September 1 2006
End Date
March 1 2010
Last Update
October 18 2017
Active Locations (1)
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1
Eunice Kennedy Shriver Center at UMASS Medical School
Waltham, Massachusetts, United States, 02452