An interventional study of Parent Supported Behavioral Intervention and Nutrition/Activity Education (NAE) in Down Syndrome, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 13 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-18.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Not applicable, Interventional, and Treatment
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.
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.
432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's enrollment of 21 is below the median of 36 across 283 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
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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)
Parents and participants receive a standard nutrition and physical activity education (NAE) program.
Behavioral: Nutrition/Activity Education (NAE)
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
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)