Clinical Trials Directory

Trials / Completed

CompletedNCT01256112

Parent Supported Weight Reduction in Down Syndrome

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Sex
All
Age
13 Years – 26 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALParent Supported Behavioral InterventionParents 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.
BEHAVIORALNutrition/Activity Education (NAE)

Timeline

Start date
2006-09-01
Primary completion
2010-03-01
Completion
2010-03-01
First posted
2010-12-08
Last updated
2017-10-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01256112. Inclusion in this directory is not an endorsement.