Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2006-09-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NAE + Behavioral Intervention
Parents of participants receive training in behavioral support at home, in addition to a standard nutrition and physical activity education (NAE) program.
Parent Supported Behavioral Intervention
Parents of participants receive training in behavioral support at home in order to facilitate lifestyle change associated with dietary choices and physical activity designed to produce gradual weight loss.
Nutrition/Activity Education (NAE)
Nutrition/Activity Education
Parents and participants receive a standard nutrition and physical activity education (NAE) program.
Nutrition/Activity Education (NAE)
Interventions
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Parent Supported Behavioral Intervention
Parents of participants receive training in behavioral support at home in order to facilitate lifestyle change associated with dietary choices and physical activity designed to produce gradual weight loss.
Nutrition/Activity Education (NAE)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
13 Years
26 Years
ALL
Yes
Sponsors
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University of Massachusetts, Worcester
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Richard K Fleming, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts Medical School, Eunice Kennedy Shriver Center
Locations
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Eunice Kennedy Shriver Center at UMASS Medical School
Waltham, Massachusetts, United States
Countries
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References
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Curtin C, Bandini LG, Must A, Gleason J, Lividini K, Phillips S, Eliasziw M, Maslin M, Fleming RK. Parent support improves weight loss in adolescents and young adults with Down syndrome. J Pediatr. 2013 Nov;163(5):1402-8.e1. doi: 10.1016/j.jpeds.2013.06.081. Epub 2013 Aug 20.
Related Links
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Web site for organization in which research was conducted
Other Identifiers
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1 R03 DK070627 (completed)
Identifier Type: -
Identifier Source: org_study_id