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Improving Primary Care to Prevent Childhood Obesity

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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
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
To determine the extent to which a clinical intervention based on the Chronic Care Model (CCM), compared with the usual care control condition, results in a smaller age-associated increase in body mass index (BMI) over a 1 year intervention (primary outcome) and a 1 1/2-year follow-up period.

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

Detailed Description:

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Improving Primary Care to Prevent Childhood Obesity
Study Start Date : September 2006
Estimated Study Completion Date : September 2009



Primary Outcome Measures :
  1. Body mass index (BMI) at 1 year.

Secondary Outcome Measures :
  1. Television viewing behaviors at 1 year post intervention.
  2. Sugar-sweetened beverages intake at 1 year post intervention.
  3. Fast food intake at 1 year post intervention.


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 2.0 through 5.9 years receiving primary care in a multi-site group practice
  • BMI > 95th percentile for age and sex, or 85th - 95th percentile if at least one parent is overweight

Exclusion Criteria:

  • Child currently enrolled in a formal weight management program
  • Child is in foster care
  • Chronic conditions that may limit our ability to measure height and weight or that may interfere with their growth, physical activity, or dietary recommendations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377767


Contacts
Contact: Katherine H Hohman, MPH 617-509-9869 katherine_hohman@hphc.org
Contact: Sarah Price, MPH 617-509-9873 sarah_price@hphc.org

Locations
United States, Massachusetts
Harvard Vanguard Medical Associates Recruiting
Boston, Massachusetts, United States
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Harvard School of Public Health
Investigators
Principal Investigator: Matthew Gillman, MD Department of Ambulatory Care and Prevention/Harvard Pilgrim Health Care/ Harvard Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00377767     History of Changes
Other Study ID Numbers: R01HD050966 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: September 18, 2006
Last Verified: September 2006

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Chronic Care Model
Obesity
Overweight
Children
Body Mass Index
Primary Care

Additional relevant MeSH terms:
Obesity
Overweight
Pediatric Obesity
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms