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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00974116 |
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Date of registration:
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07/09/2009 |
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Primary sponsor: |
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Public title:
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Trial of the MEND Childhood Obesity Treatment Program
MEND |
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Scientific title:
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MEND Childhood Obesity Treatment Programme: An RCT to Improve Body Composition and Cardiovascular Health in Overweight and Obese Children. |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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300 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00974116 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Sally Barber, PhD |
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Address:
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Telephone:
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Email:
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s.barber@ich.ucl.ac.uk |
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Affiliation:
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Name:
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Prof Atul Singhal |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Child Health |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children enrolled in the MEND Programme who are yet to be given a start date for the programme.
- Aged between 7-13 years old.
- Overweight or obese as defined by a BMI which falls above the 91st centile on the boys/girls BMI chart UK cross-sectional reference data:1997/1).
- Clinically well with no known chronic illness.
Exclusion Criteria:
- Age less than 7 years or older than 13.
- Known chronic illness.
Age minimum:
7 Years
Age maximum:
13 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Behavioral: Control Group
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Behavioral: MEND Childhood Obesity Program
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Primary Outcome(s)
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Body Mass Index z-score
[Time Frame: 6 months]
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Secondary Outcome(s)
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Body fat, waist circumference, blood pressure, arterial stiffness, heart rate control, fitness, physical activity and sedentary behaviour status, self esteem and health related quality of life.
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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