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Parent Supported Weight Reduction in Down Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01256112
First Posted: December 8, 2010
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
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.

Condition Intervention
Down Syndrome Behavioral: Parent Supported Behavioral Intervention Behavioral: Nutrition/Activity Education (NAE)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parent Supported Weight Reduction in Down Syndrome

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Enrollment: 21
Study Start Date: September 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: 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.
Other Names:
  • lifestyle modification
  • behavior modification
  • behavior therapy
Behavioral: Nutrition/Activity Education (NAE)
Active Comparator: Nutrition/Activity Education
Parents and participants receive a standard nutrition and physical activity education (NAE) program.
Behavioral: Nutrition/Activity Education (NAE)

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256112


Locations
United States, Massachusetts
Eunice Kennedy Shriver Center at UMASS Medical School
Waltham, Massachusetts, United States, 02452
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Massachusetts, Worcester
Investigators
Principal Investigator: Richard K Fleming, PhD University of Massachusetts Medical School, Eunice Kennedy Shriver Center
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01256112     History of Changes
Other Study ID Numbers: 1 R03 DK070627 (completed)
R03DK070627 ( U.S. NIH Grant/Contract )
First Submitted: December 6, 2010
First Posted: December 8, 2010
Last Update Posted: October 18, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
obesity
behavioral intervention
family based
weight loss

Additional relevant MeSH terms:
Syndrome
Down Syndrome
Weight Loss
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Body Weight Changes
Body Weight
Signs and Symptoms