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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01102959
Other study ID # 1182/07
Secondary ID
Status Unknown status
Phase N/A
First received April 7, 2010
Last updated April 12, 2010
Start date March 2010
Est. completion date June 2010

Study information

Verified date March 2010
Source University of Sao Paulo General Hospital
Contact Adriana S. Gandolfo, Dietitian
Phone ( 5511)30698558
Email adriana.gandolfo@icr.usp.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The hypothesis of this study focuses on obtaining accurate information on the effectiveness of photographic educational material on orientation of carbohydrate counting for adolescents with diabetes.


Description:

The adolescents with diabetes at the Pediatric Endocrinology and Diabetes outpatient clinic, will be randomly distributed between two groups: those who will receive orientation on carbohydrate counting through photographic educational material and those through a list of foods equivalent.

Research will follow 3 steps:

First, data will be collected on age, gender, BMI, HbA1C, schooling, type of educational material and parents grade level; answer sheets will be applied to evaluate previous knowledge on carbohydrate counting; orientation will be provided on counting with photo material or list.

Second, after a month of using the educational material, a quiz by phone will be conducted with the sole intent to reinforce orientation.

Third, two days later, adolescents will be directed to the experimental kitchen to see portions of real food and provide answers on amount or choice of carbohydrate.

Statistical tools will be applied to evaluate results.


Recruitment information / eligibility

Status Unknown status
Enrollment 50
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 19 Years
Eligibility Inclusion Criteria:

- Adolescents with diabetes aged 11 years to 19 years who count carbohydrates in their diet.

- Adolescents with more than 6 years of study .

- There is no restriction ethnic, social, gender, nutrition status, type of diabetes.

Exclusion Criteria:

- Adolescents with diabetes aged 11 years to 19 years who not count carbohydrate counting in your diet.

- Adolescents with less than 6 years of study.

- Adolescents who don't want to participated in this research.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Photographic Educational Material
Photographic Educational Material on Carbohydrate Counting

Locations

Country Name City State
Brazil University of São Paulo General Hospital São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number the answers correct or incorrect on carbohydrate counting in portions of real food One month after intervention the adolescents' ability in CH counting will be tested.
In an experimental kitchen, the adolescents will look at portions of real food and will provide answer sheet on carbohydrate counting.
The answer sheet have 11 questions based on the different food groups, each group will be represented by one type of food.
We will compare of photographic education material and list of foods equivalent by analysis of the answering sheets.
We will categorize the answers by correct or incorrect. The statistics analysis we will compare the average score of each group.
1 month
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