Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000025336
Ethics application status
Approved
Date submitted
9/01/2008
Date registered
17/01/2008
Date last updated
17/01/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ready to eat cereal and weight loss in overweight children
Scientific title
Effect of ready to eat cereal intake in weight reduction, body composition and blood lipids profile in overweight Mexican children
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 2679 0
Lipids 2680 0
Body composition 2681 0
Condition category
Condition code
Diet and Nutrition 2803 2803 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2422 0
Treatment: Other
Intervention code [2] 2423 0
Lifestyle
Comparator / control treatment
No treatment or intervention
Control group
Active

Outcomes
Primary outcome [1] 3691 0
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.
Timepoint [1] 3691 0
Baseline, week 4, 8 and 12
Secondary outcome [1] 6228 0
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).
Timepoint [1] 6228 0
Baseline and week 12
Secondary outcome [2] 6229 0
Body fat. A body composition analysis was carried out by bioelectrical impedance using a conductance measurement apparatus (BIA 101, RJL Systems, Clinton TWP, MI).
Timepoint [2] 6229 0
Baseline and week 12

Eligibility
Key inclusion criteria
BMI percentile >85%
Enrolled one of the randomly selected primary schools
Signed informed consent
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
BMI percent < 85%
Severe illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children were first measured and weighted, those with BMI >85% and assesed by a physician as healthy, were cited few days later to let them know the treatment they were allocated to which was determined by another person in the central office.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Several randomizations were performed to each of the different groups stratified by gender, age, height and BMI percentile. This was achieved with a computer program developed by one of us.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 724 0
Mexico
State/province [1] 724 0
Queretaro

Funding & Sponsors
Funding source category [1] 2939 0
University
Name [1] 2939 0
Universidad Autonoma de Queretaro
Country [1] 2939 0
Mexico
Primary sponsor type
University
Name
Universidad Autonoma de Queretaro
Address
Av. Ciencias S/N
Juriquilla, Queretaro, Qro. 76230
Country
Mexico
Secondary sponsor category [1] 2653 0
Commercial sector/Industry
Name [1] 2653 0
Kellogg Company
Address [1] 2653 0
Km. 1 Carretera al campo Militar, Quer?taro, Qro.
Country [1] 2653 0
Mexico

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4884 0
Internal Committee of Human Research of the University of Queretaro
Ethics committee address [1] 4884 0
Av. Ciencias S/N
Juriquilla, Queretaro, Qro 76230.
Ethics committee country [1] 4884 0
Mexico
Date submitted for ethics approval [1] 4884 0
Approval date [1] 4884 0
01/11/2002
Ethics approval number [1] 4884 0
(No HREC number was given at that time)

Summary
Brief summary
The study objective was to determine if the increase of ready to eat cereal intake alone or with a nutrition education program is an effective strategy to reduce excess body weight and blood lipids in overweight and obese children.
Trial website
Trial related presentations / publications
Jorge Luis Rosado, María del Rocío Arellano, Karina Montemayor, Olga Patricia García, and María del Carmen Caamaño. An increase in dietary carbohydrates as an approach to weight reduction in children is effective only when accompanied with nutrition education. FASEB J. 2007 21:359.6.
Public notes

Contacts
Principal investigator
Name 28279 0
Address 28279 0
Country 28279 0
Phone 28279 0
Fax 28279 0
Email 28279 0
Contact person for public queries
Name 11436 0
María del Carmen Caamaño
Address 11436 0
Av. Ciencias S/N
Juriquilla, Queretaro, Qro 76230.
Country 11436 0
Mexico
Phone 11436 0
52 (442) 1921200 Ext. 5351
Fax 11436 0
Email 11436 0
[email protected]
Contact person for scientific queries
Name 2364 0
Olga Patricia García
Address 2364 0
Av. Ciencias S/N
Juriquilla, Queretaro, Qro 76230.
Country 2364 0
Mexico
Phone 2364 0
52 (442) 1921200 Ext. 5351
Fax 2364 0
Email 2364 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIAn increase of cereal intake as an approach to weight reduction in children is effective only when accompanied by nutrition education: a randomized controlled trial2008https://doi.org/10.1186/1475-2891-7-28
N.B. These documents automatically identified may not have been verified by the study sponsor.