- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01102959
The Effectiveness of Photographic Educational Material on Carbohydrate Counting for Adolescents With Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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São Paulo, Brazil, 05403000
- Recruiting
- University of Sao Paulo General Hospital
-
Contact:
- Alexandre A. Ferraro, PHD
- Phone Number: ( 5511) 30698672
- Email: ferraro@usp.br
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Principal Investigator:
- Adriana S. Gandolfo, Dietitian
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Photographic Material
Photographic Educational Material on Carbohydrate Counting
|
Photographic Educational Material on Carbohydrate Counting
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number the answers correct or incorrect on carbohydrate counting in portions of real food
Time Frame: 1 month
|
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
|
Collaborators and Investigators
Investigators
- Study Chair: Alexandre A. Ferraro, Phd, University of Sao Paulo General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1182/07
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