Parent Supported Weight Reduction in Down Syndrome

NCT01256112 | Completed

• 2 other identifiers: 1 R03 DK070627 (completed)R03DK070627
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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 behavioral lifestyle change strategies are added.

Conditions

Down Syndrome

Keywords

obesity; behavioral intervention; family based; weight loss

Study Arms (2)

NAE + Behavioral Intervention

EXPERIMENTAL

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; Behavioral: Nutrition/Activity Education (NAE)

Nutrition/Activity Education

ACTIVE COMPARATOR

Parents and participants receive a standard nutrition and physical activity education (NAE) program.

Behavioral: Nutrition/Activity Education (NAE)

Interventions

Parent Supported Behavioral Intervention BEHAVIORAL

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.

Also known as: lifestyle modification, behavior modification, behavior therapy

NAE + Behavioral Intervention

Nutrition/Activity Education (NAE) BEHAVIORAL

NAE + Behavioral Intervention; Nutrition/Activity Education

Eligibility Criteria

• Age: 13 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• University of Massachusetts, Worcester: collaborator

Study Sites (1)

Eunice Kennedy Shriver Center at UMASS Medical School

Waltham, Massachusetts, 02452, United States

Location

Related Publications (1)

• 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.

  PMID: 23968742 RESULT

Related Links

• Web site for organization in which research was conducted

MeSH Terms

Conditions

Down Syndrome; Obesity; Weight Loss

Interventions

Behavior Therapy; Nutritional Status

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Richard K Fleming, PhD

  University of Massachusetts Medical School, Eunice Kennedy Shriver Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 8, 2010
• Study Start: September 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

US (1)