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Main
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Note: This record shows only 22 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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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12608000025336 |
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Date of registration:
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17/01/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ready to eat cereal and weight loss in overweight children
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Scientific title:
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Effect of ready to eat cereal intake in weight reduction, body composition and blood lipids profile in overweight Mexican children |
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Date of first enrolment:
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01/11/2002 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12608000025336.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Mexico
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Contacts
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Name:
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María del Carmen Caamaño
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Address:
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Av. Ciencias S/N
Juriquilla, Queretaro, Qro 76230.
Mexico |
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Telephone:
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52 (442) 1921200 Ext. 5351 |
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Email:
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mccaamano@hotmail.com |
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Affiliation:
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Name:
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Olga Patricia García
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Address:
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Av. Ciencias S/N
Juriquilla, Queretaro, Qro 76230.
Mexico |
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Telephone:
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52 (442) 1921200 Ext. 5351 |
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Email:
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opgarciao@yahoo.com.mx |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: BMI percentile >85%
Enrolled one of the randomly selected primary schools
Signed informed consent
Exclusion criteria: BMI percent < 85%
Severe illness
Age minimum:
6 Years
Age maximum:
12 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Diet and Nutrition - Obesity
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Overweight;Lipids;Body composition;
Overweight
Lipids
Body composition
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Intervention(s)
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Children consumed for 12 weeks one of the following treatments: One serving (33g) of ready to eat cereal (RTEC) at breakfast; two servings of RTEC, one at breakfast and another serving at dinner; one serving RTEC and mothers received a nutrition education guidance which consisted of delivering orally and written general recommendations for a healthy eating during 12 sessions.
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Primary Outcome(s)
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Weight Body Mass Index. Weight and height we meassured with an electronic scale (SECA, Erecta 844, Hamburg, Germany) and a portable stadimeter (SECA, Bodymeter 208, Germany) by personnel standardized following standard procedures recommended by the World Health Organization.[Baseline, week 4, 8 and 12]
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Secondary Outcome(s)
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Body fat. A body composition analysis was carried out by bioelectrical impedance using a conductance measurement apparatus (BIA 101, RJL Systems, Clinton TWP, MI).[Baseline and week 12]
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Blood lipids. A fasting blood sample was drawn from every child at basal and after 12 weeks of treatment. Blood samples were centrifuged at 1800-2000 rpm during 15 minutes and plasma was stored at -20oC until analysis. Biochemical analysis in plasma samples included triglycerides, total cholesterol and HDL cholesterol and were done using a commercial kit (Sera?Pak Kit Bayer Diagnostics, France).[Baseline and week 12]
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Source(s) of Monetary Support
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Universidad Autonoma de Queretaro
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Ethics review
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Status: Approved
Approval date:
Contact:
Internal Committee of Human Research of the University of Queretaro
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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