Healthy Homes/Healthy Kids_5-9 (HHHK_5-9)
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 9, 2010 | ||||||||
| Last Updated Date | November 19, 2012 | ||||||||
| Start Date ICMJE | March 2010 | ||||||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
BMI percentile change [ Time Frame: 24 months ] [ Designated as safety issue: No ] Children at risk for obesity (defined as having a BMI%ile between the 75th and 85th%ile) whose parent participates in the Healthy Eating/Physical Activity Intervention will have a significantly lower BMI percentile at 12 and 24 month-follow up when compared to children whose parents participated in the Safety/Injury Prevention Intervention. |
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| Original Primary Outcome Measures ICMJE |
BMI percentile change [ Time Frame: 24 months ] [ Designated as safety issue: No ] Children at risk for obesity (defined as having a BMI%ile between the 75th and 85th%ile) whose parent participates in theHealthy Eathing/Physical Activity Intervention will have a significantly lower BMI percentile at 12 and 24 month-follow up when compared to children whose parents participated in the Safety/Injury Prevention Intervention. |
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| Change History | Complete list of historical versions of study NCT01084590 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Healthy Homes/Healthy Kids_5-9 | ||||||||
| Official Title ICMJE | Healthy Homes/Healthy Kids: Pediatric Primary Care-based Obesity Prevention | ||||||||
| Brief Summary | The pediatric primary care setting is a relatively untapped resource for addressing obesity prevention. The main goal of this study is to evaluate the efficacy of a relatively low cost pediatric primary-care based obesity prevention intervention. The intervention will consist of brief pediatrician counseling as well as phone coaching for parents with overweight children who are between the ages of five and nine. We propose to enroll and randomize 425 parent-child dyads with children who have a measured body mass index (BMI) the 75th and 95th percentile. They will be randomized one of into two groups, the (a) Healthy Eating/Physical Activity Intervention, or the (b) General Healthy/Safety/Injury Prevention Contact Control Intervention. Both groups will receive brief pediatrician counseling regarding their child's current BMI percentile status and recommendations for home environmental changes to achieve a healthy weight gain trajectory and to improve home safety and reduce injury risk. This will be paired with a 12 month home-based program delivered via phone by health behavior specialists to help parents make environmental changes specific to their group assignment. |
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| Detailed Description | The goal of this study is to evaluate the efficacy of a relatively low cost pediatric primary-care based intervention that integrates brief pediatric counseling and a home-based phone program to prevent unhealthy weight gain in overweight children ages five-nine. Parent-child dyads will be recruited for the Healthy Homes/Healthy Kids Study via a multi-step process including use of electronic medical record data to identify children, pediatrician approval, and outreach via letters and phone calls. Four hundred and twenty five parent-child dyads from pediatric primary care will be recruited to participate and be randomized to one of two interventions: Healthy Eating/Physical Activity Home-based Intervention: This intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies. Safety/Injury Prevention Home-based Contact Control Intervention: This intervention arm will include the same brief counseling from the pediatrician paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 425 | ||||||||
| Estimated Completion Date | March 2014 | ||||||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 5 Years to 9 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01084590 | ||||||||
| Other Study ID Numbers ICMJE | A08-132, 1R01DK084475 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | HealthPartners Institute for Education and Research | ||||||||
| Study Sponsor ICMJE | HealthPartners Institute for Education and Research | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | HealthPartners Institute for Education and Research | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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