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ISRCTN
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ISRCTN49438757
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of a reduced carbohydrate diet versus a low fat diet for the treatment of childhood obesity: The Eat Smart Study
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Scientific title
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A controlled trial of a reduced carbohydrate diet versus a low fat diet on weight, body composition and metabolic profile in obese adolescents
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Acronym
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Eat Smart
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Serial number at source
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2008000262
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Study hypothesis
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There will be no differences between a reduced carbohydrate diet and a low carbohydrate diet in markers of body composition after 6 months.
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Ethics approval
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1. Royal Children's hospital Human Ethics Committee. Date of approval: 08/01/2007 (ref: 2006/096)
2. University of Queensland Ethics Committee. Date of approval: 25/10/2006 (ref: 2006000667)
3. Mater Hospital Ethics Committee. Date of approval: 01/08/2007 (ref: 1140C)
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Study design
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Randomised controlled trial.
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Countries of recruitment
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Australia
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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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1. Age 11- 17 years, both males and females
2. Body mass index >90th percentile for age
3. Parents/guardians are able to give informed written consent and child to give assent
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Participants - exclusion criteria
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The following will be assessed at baseline, 12 weeks (all three arms) and 24 weeks (only in active diet arms):
1. Obesity with known medical cause
2. Taking stimulants, psychotropic medication, steroids or insulin senstisers
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Anticipated start date
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02/02/2008
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Anticipated end date
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02/02/2011
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet.
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Target number of participants
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135
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Interventions
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1. Low fat diet (25% fat, 55% carbohydrate, 20% protein) for 24 weeks
2. Reduced carbohydrate diet (35% carbohydrate, 35% fat, 30% protein) for 24 weeks
3. Wait list control group. Those families allocated to the wait list control group will receive the full dietary program of their choice at the end of the control period (i.e. 12 weeks)
Both dietary programmes are structured with a lunch box and a standardised plate template system for dinner for portion size control. These are used across both intervention arms to ensure fidelity of intervention and increase compliance with dietary advice. Compliance is measured by diet diaries and activity diaries. Subjects are monitored weekly by phone and have 5 face to face sessions with study dietitian to assist with dietary adherence.
Duration of interventions: 24 weeks
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Primary outcome measure(s)
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1. Change in body mass index standard deviation score (BMI Z score), assessed at baseline, 12 weeks (all three arms) and 24 weeks (only in active diet arms).
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Secondary outcome measure(s)
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The following will be assessed at baseline, 12 weeks (all three arms) and 24 weeks (only in active diet arms):
1. Change in percentage body fat
2. Cardiometabolic markers of disease risk, including insulin level
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Sources of funding
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1. National Heart Foundation (ref: G 07B 3130) (Australia)
2. Royal Children's Hospital Foundation, Near Miss Fund (Australia)
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Trial website
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http://www.som.uq.edu.au/research/cnrc/eatsmart.asp
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Publications
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Contact name
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Dr
Helen
Truby
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Address
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The Children's Nutrition Research Centre
Royal Children's hospital
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City/town
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Herston
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Zip/Postcode
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4029
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Country
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Australia
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Tel
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+617 3636 9271
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Fax
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+617 3346 4684
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Email
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h.truby@uq.edu.au
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Sponsor
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National Heart Foundation (Australia)
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Address
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411 King Street
Melbourne 3003
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City/town
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Melbourne
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Zip/Postcode
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3003
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Country
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Australia
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Email
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research@heartfoundation.com.au
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Sponsor website:
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http://www.heartfoundation.org.au
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Date applied
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25/03/2008
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Last edited
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20/05/2008
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Date ISRCTN assigned
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16/05/2008
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