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ISRCTN
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ISRCTN30238779
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ClinicalTrials.gov identifier
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Public title
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Improving health outcomes in obese children: a randomised controlled trial of the MEND programme
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Scientific title
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Acronym
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MEND (Mind, Exercise, Nutrition and Diet)
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Serial number at source
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N&AHP/02/RDA/033
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Study hypothesis
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Current hypothesis as of 28/06/2007:
We propose a randomised controlled trial in obese 8 - 12 year old children to test the hypothesis that an intensive family-based programme of nutrition education, exercise and behavioural modification, followed by free access to leisure facilities will improve body composition, cardiovascular fitness and self-esteem in obese school-aged children compared to a waiting list control group. The trial will be conservatively powered, with outcomes relevant to public health and the NHS Plan and could provide the first proven childhood obesity intervention programme in the UK.
Previous hypothesis:
We propose a randomised controlled trial in obese 8 - 11 year old children to test the hypothesis that an intensive family-based programme of nutrition education, exercise and behavioural modification, followed by free access to leisure facilities will improve body composition, cardiovascular fitness and self-esteem in obese school-aged children compared to a waiting list control group. The trial will be conservatively powered, with outcomes relevant to public health and the NHS Plan and could provide the first proven childhood obesity intervention programme in the UK.
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Lay summary
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Ethics approval
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MREC approval gained.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Childhood Obesity
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Participants - inclusion criteria
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Current inclusion criteria as of 28/06/2007:
Obese 8 - 12 year old children and their families.
Previous inclusion criteria:
Obese 8 - 11 year old children and their families.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/04/2005
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Anticipated end date
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13/01/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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100
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Interventions
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Please note that this trial has concluded; the official end date of this trial was 13th January 2007. The previous end date for this trial was 30/04/2008.
Interventions:
Childhood obesity treatment programme combining nutrition education, behavioural modification and physical activity.
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Primary outcome measure(s)
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Waist circumference
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Secondary outcome measure(s)
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Body composition, weight, height, Body Mass Index (BMI), self- esteem, family functioning, child mental health, cardiovascular fitness and dietary intake and composition.
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Sources of funding
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1. Department of Health (UK) (ref: N&AHP/02/RDA/033)
2. Sainsbury's Supermarkets Ltd (UK)
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Trial website
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http://www.mendprogramme.org/the_research/
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20107463
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Contact name
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Mr
Paul
Sacher
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Address
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MRC Childhood Nutrition Research Centre
Institute of Child Health
30 Guilford Street
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City/town
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London
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Zip/Postcode
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WC1N 1EH
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Country
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United Kingdom
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Tel
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+44 (0)20 7905 2258
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Fax
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+44 (0)20 7831 9903
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Email
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p.sacher@ich.ucl.ac.uk
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Sponsor
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UK Department of Health
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Address
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Blenheim House
Duncombe Street
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City/town
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Leeds
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Zip/Postcode
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LS1 4PL
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Country
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United Kingdom
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Tel
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+44 (0)113 254 3837
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Fax
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+44 (0)113 254 3844
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Email
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barbara.sutherland@doh.gsi.gov.uk
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Date applied
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13/09/2004
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Last edited
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21/04/2010
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Date ISRCTN assigned
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06/10/2004
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