NCT01102959

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 13, 2010

Status Verified

March 1, 2010

Enrollment Period

3 months

First QC Date

April 7, 2010

Last Update Submit

April 12, 2010

Conditions

Keywords

EDUCATIONDIABETES MELLITUSADOLESCENTDIABETIC DIET

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Photographic Material

EXPERIMENTAL

Photographic Educational Material on Carbohydrate Counting

Device: Photographic Educational Material

Interventions

Photographic Educational Material on Carbohydrate Counting

Also known as: Photo, Education, Nutrition
Photographic Material

Eligibility Criteria

Age11 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo General Hospital

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alexandre A. Ferraro, Phd

    University of São Paulo General Hospital

    STUDY CHAIR

Central Study Contacts

Adriana S. Gandolfo, Dietitian

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 13, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 13, 2010

Record last verified: 2010-03

Locations