Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Obesity

In brief

The number of youth with Type 2 diabetes (T2D) is rising in the population, which is a concerning public health trend. There has been little research testing ways to prevent the development of this disease in children who are at increased risk to develop T2D. This study tests a family treatment program that treats 4-8 year old children who are at risk for T2D because they are overweight and have a family history of the disease. Sixty at risk children and their parents were assigned to one of 2 treatment conditions. Half of the families (randomly determined) received an intensive family treatment program that trains parents in how to increase healthier foods choices and physical activity for themselves and their children using "behavior modification" strategies. Children receiving this treatment were allowed to taste new fruits and vegetables used a pedometer to record how far they walked every day, and were given a "tool box" of toys and interactive games which promoted physical activity. The other half of the families only received instruction about healthier choices, but received no behavioral modification strategies or physical activity promotion tools. Improvements in children's body weight, blood measures, and behavior patterns were measured after treatment ended (6 months) and then again after 12 months. The results may lead to a better understanding of how family members can positively influence young children's behaviors to help prevent T2D. The objective of proposed study was to test a family-based intervention designed to reduce excess body weight, improve metabolic and cardiovascular profile, and improve diet and physical activity levels in 4 - 8 year old youth who are "at risk" for T2D. This intervention was tested in a 2-arm randomized controlled clinical trial. Primary Hypotheses: 1. Compared to children receiving NPA, children receiving LMDP will show greater reductions in excess body weight, greater improvements in metabolic and cardiovascular measures, improved diet, increased physical activity, and reduced television viewing. 2. Greater reductions in child excess body weight will be associated with greater improvements in metabolic and cardiovascular measures. Secondary Hypotheses: 1. Compared to parents receiving the NPA intervention, parents receiving the LMDP intervention will show greater reductions in BMI. 2. Greater improvements in parent BMI will be associated with greater improvements in child body composition, metabolic and cardiovascular measures, and behavioral outcomes. 3. Compared to families receiving the NPA intervention, families receiving the LMDP intervention will show an increase in the number of fruits and vegetables and lower energy density foods stored at home.

Key facts

Study ID
NCT01610219
Run by
University of Pennsylvania
People needed
52
Starts
2008-08-01
Expected to finish
2011-01-01
Last updated by the study team
2012-06-01

Who can join

Age: 4 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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