Epidemiology of Body Mass Index Rebound
| Tracking Information | |||||
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| First Received Date ICMJE | September 28, 2000 | ||||
| Last Updated Date | January 18, 2008 | ||||
| Start Date ICMJE | August 2000 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00006307 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Epidemiology of Body Mass Index Rebound | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | To investigate the relationship between obesity, body mass index (BMI) rebound, body composition changes, associated factors (e.g., diet, physical activity), and cardiovascular risk factor status in a longitudinal study of young children, age three at the beginning of the study. |
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| Detailed Description | BACKGROUND: Obesity is the most prevalent nutritional problem in the United States. It appears that both the prevalence and severity of obesity have been increasing in recent years. Obesity often begins in childhood and has a number of severe sequelae, including non insulin dependent diabetes mellitus and cardiovascular disease. Unfortunately, obesity is very resistant to treatment. This places a premium on prevention. However, the identification of clinically useful predictors of obesity which are present prior to the onset of excess weight gain has been problematic. Recently, it has been shown that the timing of body mass index (BMI) rebound may be a predictor of future obesity. BMI increases during the first year of life. It then declines until it reaches a minimum value during childhood and subsequently increases into adolescence and adulthood. The nadir of BMI is called BMI rebound. Studies have shown that BMI rebound at a young age is associated with increased risk of obesity later in life. Currently, very little is known about the epidemiology of BMI rebound. DESIGN NARRATIVE: The investigation is a cohort study designed to follow 320 children from age three to age seven years. The study design will be a longitudinal one in which the children will be followed for a period of four years during which repeat measurements of body composition, diet, and physical activity will be made every four months. Parental height and weight data will be collected, in addition to family health history, parental smoking and alcohol intake. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Burdette HL, Whitaker RC, Daniels SR. Parental report of outdoor playtime as a measure of physical activity in preschool-aged children. Arch Pediatr Adolesc Med. 2004 Apr;158(4):353-7. | ||||
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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 | Not Provided | ||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Both | ||||
| Ages | 3 Years to 7 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00006307 | ||||
| Other Study ID Numbers ICMJE | 915 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | January 2008 | ||||
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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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