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Improving Primary Care to Prevent Childhood Obesity

Improving Primary Care to Prevent Childhood Obesity

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00377767
Enrollment
500
Registered
2006-09-18
Start date
2006-09-30
Completion date
2009-09-30
Last updated
2006-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight in Preschool Age Children, Risk of Overweight in Preschool Age Children

Keywords

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

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.

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.

Interventions

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

Sponsors

Harvard School of Public Health (HSPH)
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
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

Design outcomes

Primary

MeasureTime frame
Body mass index (BMI) at 1 year.

Secondary

MeasureTime frame
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.

Countries

United States

Contacts

Primary ContactKatherine H Hohman, MPH
katherine_hohman@hphc.org617-509-9869
Backup ContactSarah Price, MPH
sarah_price@hphc.org617-509-9873

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026