Prevention of Overweight in Infancy (POInz)
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| First Received Date ICMJE | May 3, 2009 | ||||||||
| Last Updated Date | August 2, 2011 | ||||||||
| Start Date ICMJE | May 2009 | ||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Anthropometric measures - weight velocity 0 - 12 months, 12 - 24 months and 24 to 36 months as well as BMI z score and abdominal circumference at 24 and 36 months. [ Time Frame: 1, 2 and 3 years ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00892983 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 | Prevention of Overweight in Infancy | ||||||||
| Official Title ICMJE | Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial | ||||||||
| Brief Summary | Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. This rapid early weight gain occurs most often at weaning when eating patterns emerge. Infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in New Zealand. This would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications. |
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| Detailed Description | We plan on undertaking a 4-arm randomised controlled trial to test the following hypotheses:
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Taylor BJ, Heath AL, Galland BC, Gray AR, Lawrence JA, Sayers RM, Dale K, Coppell KJ, Taylor RW. Prevention of Overweight in Infancy (POI.nz) study: a randomised controlled trial of sleep, food and activity interventions for preventing overweight from birth. BMC Public Health. 2011 Dec 19;11:942. | ||||||||
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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 | 800 | ||||||||
| Estimated Completion Date | April 2017 | ||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 15 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | New Zealand | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00892983 | ||||||||
| Other Study ID Numbers ICMJE | 105891.01.P.NH, HRC 08/374 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Professor Barry J Taylor, University of Otago | ||||||||
| Study Sponsor ICMJE | University of Otago | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Otago | ||||||||
| 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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