- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01256112
Parent Supported Weight Reduction in Down Syndrome
October 16, 2017 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 risk for Type-2 diabetes, orthopedic problems, sleep apnea, elevated cardiovascular risk and menstrual irregularities.
Research indicating a high prevalence of overweight, obesity, low fitness levels and other health problems among adults with DS suggest the need for more attention to health promotion among adolescents with DS, which has been limited to date.
Educational interventions in nutrition and physical activity have not been tested through randomized clinical trial with families of adolescents with DS; nor have behavioral "lifestyle change" interventions based on Social Cognitive Theory.
Among typical populations, the addition of training in behavior and lifestyle change to education-alone interventions increasingly is being seen as critical in helping to promote long-term weight loss and weight maintenance.
The hypothesis of this study is that a parent supported weight reduction (PSWR) intervention that combines behavioral strategies with nutrition and activity education (NAE) will be more effective in reducing overweight in adolescents with DS than a program that provides NAE alone or a Wait-List (WL) control.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Waltham, Massachusetts, United States, 02452
- Eunice Kennedy Shriver Center at UMASS Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
Other Names:
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Active Comparator: Nutrition/Activity Education
Parents and participants receive a standard nutrition and physical activity education (NAE) program.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Richard K Fleming, PhD, University of Massachusetts Medical School, Eunice Kennedy Shriver Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
December 6, 2010
First Submitted That Met QC Criteria
December 6, 2010
First Posted (Estimate)
December 8, 2010
Study Record Updates
Last Update Posted (Actual)
October 18, 2017
Last Update Submitted That Met QC Criteria
October 16, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 R03 DK070627 (completed)
- R03DK070627 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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