Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Code:

NCT00377767

Conditions

Overweight in Preschool Age Children

Risk of Overweight in Preschool Age Children

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

Interventions

To change structure and roles of primary care teams to optimize prevention of obesity

Study Details

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.

Conditions

Overweight in Preschool Age Children

Risk of Overweight in Preschool Age Children

Study ID

NCT00377767

Start date

Sep, 2006

Status verified date

Sep, 2006

Completion date

Sep, 2009

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Interventions

To change structure and roles of primary care teams to optimize prevention of obesity

Primary outcome measure

  • Body mass index (BMI) at 1 year. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Katherine H Hohman, MPH

617-509-9869katherine_hohman@hphc.org

Sarah Price, MPH

617-509-9873sarah_price@hphc.org

Locations

Harvard Vanguard Medical Associates

Recruiting

Boston, Massachusetts, United States

More Information

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Last update posted

Sep 18, 2006

Last verified

Sep, 2006

Keywords

  • Chronic Care Model
  • Obesity
  • Overweight
  • Children
  • Body Mass Index
  • Primary Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2006-09-18.