Overweight in Preschool Age ChildrenPhase 1/2NCT00377767
Improving Primary Care to Prevent Childhood Obesity
A Phase 1/2 study testing To change structure and roles of primary care teams to optimize prevention of obesity in people with Overweight in Preschool Age Children and Risk of Overweight in Preschool Age Children, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Overweight in Preschool Age Children, Risk of Overweight in Preschool Age Children
- What is being tested?
- To change structure and roles of primary care teams to optimize prevention of obesity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2009
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Harvard Vanguard Medical Associates
Boston, Massachusetts
About this study
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.
Read the 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.
- Being tested
- To change structure and roles of primary care teams to optimize prevention of obesity
- Keywords
- Chronic Care Model, Obesity, Overweight, Children, Body Mass Index, Primary Care
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To change structure and roles of primary care teams to optimize prevention of obesityBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI) at 1 year.
Secondary outcomes (3)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startSep 2006
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Overweight in Preschool Age ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Harvard School of Public Health (HSPH)
- Investigators
- Matthew Gillman, MD, Principal investigator, Department of Ambulatory Care and Prevention/Harvard Pilgrim Health Care/ Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377767
- Sponsor's protocol ID
- R01HD050966
- Status last verified
- Sep 2006
- First submitted
- 15 Sep 2006
- Last updated
- 18 Sep 2006
- Results posted
- No
Publications
Wright DR, Taveras EM, Gillman MW, Horan CM, Hohman KH, Gortmaker SL, Prosser LA. The cost of a primary care-based childhood obesity prevention intervention. BMC Health Serv Res. 2014 Jan 29;14:44. doi: 10.1186/1472-6963-14-44.
PubMed 24472122Hohman KH, Price SN, Sonneville K, Rifas-Shiman SL, Gortmaker SL, Gillman MW, Taveras EM. Can the Internet be used to reach parents for family-based childhood obesity interventions? Clin Pediatr (Phila). 2012 Apr;51(4):314-20. doi: 10.1177/0009922811423310. Epub 2011 Oct 12.
PubMed 21997144Taveras EM, Gortmaker SL, Hohman KH, Horan CM, Kleinman KP, Mitchell K, Price S, Prosser LA, Rifas-Shiman SL, Gillman MW. Randomized controlled trial to improve primary care to prevent and manage childhood obesity: the High Five for Kids study. Arch Pediatr Adolesc Med. 2011 Aug;165(8):714-22. doi: 10.1001/archpediatrics.2011.44. Epub 2011 Apr 4.
PubMed 21464376Taveras EM, Hohman KH, Price SN, Rifas-Shiman SL, Mitchell K, Gortmaker SL, Gillman MW. Correlates of participation in a pediatric primary care-based obesity prevention intervention. Obesity (Silver Spring). 2011 Feb;19(2):449-52. doi: 10.1038/oby.2010.207. Epub 2010 Sep 16.
PubMed 20847735