Childhood Obesity Prevention
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | February 14, 2012 | ||||||||||||||||
| Last Updated Date | January 11, 2013 | ||||||||||||||||
| Start Date ICMJE | March 2012 | ||||||||||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01539070 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Feasibility of the intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ] Feasibility will be evaluated through:
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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 | Childhood Obesity Prevention | ||||||||||||||||
| Official Title ICMJE | Design and Feasibility of a Clinical-based Intervention to Prevent Obesity in Preschool Children | ||||||||||||||||
| Brief Summary | The purpose of this study is to develop, implement and evaluate an intervention focused to change feeding practices and patterns of physical activity of preschool children through providing motivational counseling to the mother. The aim is to prevent obesity in children aged 2 to 4 years 11 months with risk of overweight or with overweight. |
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| Detailed Description | Obesity has a multi-causal origin in which participate, in a similar way, the individual behavior and family and community contexts and the social environment. Participation of primary care services is key to solve the problem. These services have the possibility to detect timely children with high body mass index, and to promote behavior to improve feeding practices and physical activity in both, the child and his family. The study is divided in two stages:
The evaluation of the study comprise feasibility and acceptability of the intervention and its effect in the behavior of the mothers in terms of changing feeding practices and practicing physical exercise. |
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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 | Childhood Obesity | ||||||||||||||||
| Intervention ICMJE | Behavioral: Eating and physical activity counseling
The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions. There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity. Other Name: Nutritional intervention |
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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 | Active, not recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||||||||||
| Estimated Completion Date | June 2013 | ||||||||||||||||
| 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 | 24 Months to 59 Months | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Mexico | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01539070 | ||||||||||||||||
| Other Study ID Numbers ICMJE | 2009-785-120, HIM/2010/025, 1R03TW008708 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Gloria Oliva Martinez Andrade, Coordinación de Investigación en Salud, Mexico | ||||||||||||||||
| Study Sponsor ICMJE | Coordinación de Investigación en Salud, Mexico | ||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Coordinación de Investigación en Salud, Mexico | ||||||||||||||||
| Verification Date | January 2013 | ||||||||||||||||
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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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