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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Primary Care to Prevent Childhood Obesity
- ClinicalTrials.gov ID
- NCT00377767
- Acronym / sponsor ID
- R01HD050966
- Keywords
- Chronic Care Model, Obesity, Overweight, Children, Body Mass Index, Primary Care
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- Sep 2006
- Study completion
- Sep 2009
- First posted
- 18 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To change structure and roles of primary care teams to optimize prevention of obesity | Behavioural | – |
Primary outcome
Body mass index (BMI) at 1 year.
3 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2006.
- Derived from this study: PubMed 24472122Wright 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.
- Derived from this study: PubMed 21997144Hohman 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.
- Derived from this study: PubMed 21464376Taveras 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.
- Derived from this study: PubMed 20847735Taveras 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.
Related trials for Overweight in Preschool Age Children
Active, not recruiting
Early-Life Strategies for Preventing Obesity in Preschool-aged Children
Childhood Obesity Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Gillman, MD principal investigator
Department of Ambulatory Care and Prevention/Harvard Pilgrim Health Care/ Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine H Hohman, MPH (617-509-9869, katherine_hohman@hphc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI) at 1 year.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00377767, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2006.