Improving Primary Care to Prevent Childhood Obesity
|ClinicalTrials.gov Identifier: NCT00377767|
Recruitment Status : Unknown
Verified September 2006 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Recruiting
First Posted : September 18, 2006
Last Update Posted : September 18, 2006
|Condition or disease||Intervention/treatment||Phase|
|Overweight in Preschool Age Children Risk of Overweight in Preschool Age Children||Behavioral: To change structure and roles of primary care teams to optimize prevention of obesity||Phase 1 Phase 2|
Overweight in the preschool age group is prevalent, increasing, and of consequence. During the last 30 years in the U.S., the prevalence of overweight among youth has dramatically increased. Overweight in young children is associated with later overweight, with childhood conditions such as hyperlipidemia, hypertension, and type II diabetes, and with higher morbidity and mortality in adulthood.
Along with the long-term risks associated with overweight in the preschool age group, there come unique opportunities to intervene and alter the subsequent course of health and disease for these individuals. These regular visits allow both detection of elevated BMI levels and opportunities for intervention.
The overall goal of this research is to assess a comprehensive, innovative, primary care practice change intervention to prevent obesity among children age 2 through 5 years at elevated risk of obesity. To achieve this goal, we will conduct a cluster-randomized controlled trial in 10 pediatric practices of Harvard Vanguard Medical Associates, a large multi-site group practice in eastern Massachusetts with a track record of research collaboration.
We will randomize five health centers to the intervention condition, and five health centers to the control (usual care) condition. The intervention will consist of state-of-the-science approaches to changing dietary, activity, and inactivity behaviors among the children.
The intervention period will be 1 year, followed by a 1 1/2 year maintenance follow-up period. Frequency of visits will be every 6 weeks for the first 6 months, and every 6 months after that. Participating families will complete a telephone-administered interview at baseline and all follow-up timepoints. There will be 3 types of measurements: 1) measurements made by the clinical staff that will also be used for outcomes in the research study (only height and weight); 2) measurements made by clinicians for feedback during counseling sessions, which will not be used for study outcomes; and 3) measurements made by the research staff for study outcomes and processes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Improving Primary Care to Prevent Childhood Obesity|
|Study Start Date :||September 2006|
|Estimated Study Completion Date :||September 2009|
- Body mass index (BMI) at 1 year.
- Television viewing behaviors at 1 year post intervention.
- Sugar-sweetened beverages intake at 1 year post intervention.
- Fast food intake at 1 year post intervention.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377767
|Contact: Katherine H Hohman, MPHfirstname.lastname@example.org|
|Contact: Sarah Price, MPHemail@example.com|
|United States, Massachusetts|
|Harvard Vanguard Medical Associates||Recruiting|
|Boston, Massachusetts, United States|
|Principal Investigator:||Matthew Gillman, MD||Department of Ambulatory Care and Prevention/Harvard Pilgrim Health Care/ Harvard Medical School|