Parent Supported Weight Reduction in Down Syndrome

Completed · Not applicable

Conditions studied: Down Syndrome

In brief

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 behavioral lifestyle change strategies are added.

Key facts

Study ID

NCT01256112

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

21

Starts

2006-09-01

Expected to finish

2010-03-01

Last updated by the study team

2017-10-18

Who can join

Age: 13 and older, up to 26. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Eunice Kennedy Shriver Center at UMASS Medical School — Waltham, Massachusetts, United States

Full record on ClinicalTrials.gov

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