NCT01823367

Encourage Healthy Families

Primary Prevention of Diabetes in Children and Mothers at Increased Risk: Encourage Healthy Families.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized intervention that will test two different approaches reflecting diverse levels of both intensity and cost, to achieving risk reduction of T2D. This will help address a critical question in the translation of primary prevention research into the public health: how much intensity (and thus cost) is required to achieve an effective outcome? In addition, the proposed study will address a critical need in diabetes prevention that has not received sufficient scholarly attention: the prevention of T2D in children. No studies of diabetes prevention similar in scope to the DPP have been performed in school-aged children; however, reducing childhood obesity is widely accepted as the primary pathway to decreasing the growing prevalence of T2D in the pediatric population.

Detailed description

The proposed interventions will target mothers with a history of Gestational Diabetes (GDM), who gave birth to babies 9 pounds or greater, or who have prediabetes who are thus at very high risk for developing diabetes, and by virtue of their GDM/prediabetes, their children are also at high risk. Because of the genetic components involved, all children born by a woman afflicted with gestational diabetes mellitus or prediabetes have elevated risk of developing Type 2 Diabetes. This first intervention builds upon the evidence-based curriculum used in the DPP and incorporates into the curriculum detailed education regarding ways to help their children adopt healthier lifestyle behaviors. It will be delivered in groups of mothers only at community sites using trained laypeople. The second intervention will use the same parent curriculum, but adds a group program for children that teach them (directly) strategies for eating better and increasing physical activity. This program will be delivered to both mothers and children in separate groups. The group sessions will take place at the same time and in the same location by a trained facilitator.

Conditions

• Gestational Diabetes Mellitus
• Pre-diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Diabetes Prevention Program (DPP)	Diabetes Prevention Program (DPP): This is an evidence-based curriculum that has shown that it is possible to prevent or delay Type 2 Diabetes (T2D) in individuals if they keep a healthy weight, eat a nutritious diet, and stay physically active.

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-04-27
• Completion: 2016-04-27
• First posted: 2013-04-04
• Last updated: 2017-08-25

Locations

1 site across 1 country: United States