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Improving Primary Care to Prevent Childhood Obesity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
Harvard School of Public Health
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier:
First received: September 15, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Improving Primary Care to Prevent Childhood Obesity

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 500
Study Start Date: September 2006
Estimated Study Completion Date: September 2009
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.


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00377767

Contact: Katherine H Hohman, MPH 617-509-9869
Contact: Sarah Price, MPH 617-509-9873

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
Principal Investigator: Matthew Gillman, MD Department of Ambulatory Care and Prevention/Harvard Pilgrim Health Care/ Harvard Medical School
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00377767     History of Changes
Other Study ID Numbers: R01HD050966 ( US NIH Grant/Contract Award Number )
Study First Received: September 15, 2006
Last Updated: September 15, 2006

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

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on May 25, 2017