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The Effectiveness of Photographic Educational Material on Carbohydrate Counting for Adolescents With Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01102959
First received: April 7, 2010
Last updated: April 12, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
 Device: Photographic Educational Material

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Photographic Educational Material on Carbohydrate Counting for Adolescents With Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Number the answers correct or incorrect on carbohydrate counting in portions of real food [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 50
Study Start Date: March 2010
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Photographic Material
Photographic Educational Material on Carbohydrate Counting
 Device: Photographic Educational Material
Photographic Educational Material on Carbohydrate Counting
Other Names:
  • Photo
  • Education
  • Nutrition

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.

  Eligibility

Ages Eligible for Study:   11 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102959

Contacts
Contact: Adriana S. Gandolfo, Dietitian ( 5511)30698558 adriana.gandolfo@icr.usp.br

Locations
Brazil
University of São Paulo General Hospital Recruiting
São Paulo, Brazil, 05403000
Contact: Alexandre A. Ferraro, PHD     ( 5511) 30698672     ferraro@usp.br    
Principal Investigator: Adriana S. Gandolfo, Dietitian            
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Study Chair: Alexandre A. Ferraro, Phd University of São Paulo General Hospital
  More Information

No publications provided

Responsible Party: Sandra Josefina Ferraz Ellero Grisi, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01102959     History of Changes
Other Study ID Numbers: 1182/07
Study First Received: April 7, 2010
Last Updated: April 12, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
EDUCATION
DIABETES MELLITUS
ADOLESCENT
DIABETIC DIET

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013