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
| Type | Name | Description |
|---|---|---|
| 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. |
| BEHAVIORAL | Nutrition/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.