NOURISH: Nourishing Our Understanding of Role Modeling to Improve Support and Health
| Tracking Information | |||||
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| First Received Date ICMJE | February 22, 2008 | ||||
| Last Updated Date | May 24, 2011 | ||||
| Start Date ICMJE | April 2008 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Child BMI [ Time Frame: Baseline, Posttest (6 or 12 weeks), 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Child BMI [ Time Frame: Baseline, Posttest (12 weeks), 6 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00628030 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | NOURISH: Nourishing Our Understanding of Role Modeling to Improve Support and Health | ||||
| Official Title ICMJE | Parent Skills Training to Enhance Weight Loss in Overweight Children | ||||
| Brief Summary | The percentage of overweight children between the ages of 6 and 11 has nearly tripled in the last three decades, and rates are even higher among African Americans.Overweight children are at-risk for numerous health problems, thus effective treatments are urgently needed. This study will evaluate an innovative intervention for ethnically diverse parents (NOURISH), which focuses on helping parents role model and teach their children healthy behaviors. |
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| Detailed Description | Pediatric overweight is a national public health concern. The percentage of overweight children in the U.S. between the ages of 6 and 11 has nearly tripled in the last 3 decades. African American children are particularly at risk. Pediatric overweight is associated with numerous physical and psychological health problems. Moreover, overweight children are at significant risk for obesity in adulthood. Thus, a focus on pediatric overweight is an important step in the prevention of adult obesity. Despite the urgent need for pediatric overweight interventions, outcomes of some of the most rigorous treatments are, at best, mixed. Although research has found that including parents in interventions for pediatric overweight has positive effects on outcomes, parental involvement is usually limited. Moreover, relatively few studies have included sufficient numbers of lower-SES, African American participants, a group at increased risk for pediatric overweight and associated complications. This study will evaluate the efficacy of an intensive intervention targeting ethnically diverse parents of overweight, children ages 6-11 (NOURISH—Nourishing Our Understanding of Role Modeling to Improve Support and Health). |
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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: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: NOURISH
1 of 2 groups:One has 12 (or 6) weekly face-to-face sessions and the other has a face-to-face and information provided on a regular basis via mail. Both groups will be followed up for 6 months. |
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| Study Arm (s) |
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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 | Completed | ||||
| Enrollment ICMJE | 183 | ||||
| Completion Date | July 2010 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
All parents meeting study criteria will be offered participation in the randomized trial comparing NOURISH with a control group. |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00628030 | ||||
| Other Study ID Numbers ICMJE | PT101376, 1r03hd056050-01a1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Suzanne E. Mazzeo, Ph.D., Associate Professor, Virginia Commonwealth University | ||||
| Study Sponsor ICMJE | Virginia Commonwealth University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Virginia Commonwealth University | ||||
| Verification Date | May 2011 | ||||
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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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