FOR HEALTH: A Family-oriented Healthy Eating, Activity and Lifestyle Intervention for Obese Preschool Children and Their Families.
This study is currently recruiting participants.
Verified April 2013 by Lawson Health Research Institute
Sponsor:
Lawson Health Research Institute
Information provided by (Responsible Party):
Dirk Bock, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01698606
First received: October 1, 2012
Last updated: April 17, 2013
Last verified: April 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 1, 2012 | ||||||||
| Last Updated Date | April 17, 2013 | ||||||||
| Start Date ICMJE | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
BMI z-score [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ] Change in BMI z-score |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01698606 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 |
Change in parental BMI (kg/m2) [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ] Assessment of change in BMI of the caregiver primary attending the intervention with the child. |
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| Original Other Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | FOR HEALTH: A Family-oriented Healthy Eating, Activity and Lifestyle Intervention for Obese Preschool Children and Their Families. | ||||||||
| Official Title ICMJE | FOR HEALTH: A Family-ORiented Healthy Eating, Activity and Lifestyle Training With Hands-on Experience - a Pilot Trial. | ||||||||
| Brief Summary | The aim of this study is to investigate whether a community-based 6-month intervention for obese preschool children 2-5 years of age and their families, referred by their family physician, will be successful in preventing further increase in the participants' degree of obesity. Participating children will be randomized to either receive a multidisciplinary lifestyle intervention during the first 6 months, treatment arm, or 6 months later, control or wait list arm. Within each arm participants will further be randomized to either a standard intervention group, or to an extended intervention group, which will receive an additional free 6-month YMCA membership. |
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| Detailed Description | Not Provided | ||||||||
| 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 | Childhood Obesity | ||||||||
| Intervention ICMJE | Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling
Parent/caregiver education with skill training and practical activities revolving around healthy dietary choices, establishing an active versus a sedentary lifestyle, and behavioral aspects, while children will be engaged in active play. |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 32 | ||||||||
| Estimated Completion Date | December 2014 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 2 Years to 5 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01698606 | ||||||||
| Other Study ID Numbers ICMJE | 103011 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dirk Bock, Lawson Health Research Institute | ||||||||
| Study Sponsor ICMJE | Lawson Health Research Institute | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Lawson Health Research Institute | ||||||||
| Verification Date | April 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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