Diabetes MellitusNCT01102959
The Effectiveness of Photographic Educational Material on Carbohydrate Counting for Adolescents With Diabetes
A study testing Photographic Educational Material in people with Diabetes Mellitus, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 11 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Photographic Educational Material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo General Hospital
São Paulo, São Paulo, 05403000
Alexandre A. Ferraro, PHD, ( 5511) 30698672, ferraro@usp.br
Adriana S. Gandolfo, Dietitian
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Photographic Educational Material
- Keywords
- EDUCATION, DIABETES MELLITUS, ADOLESCENT, DIABETIC DIET
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photographic Educational MaterialDevice
Also called Photo, Education, Nutrition
Photographic Educational Material on Carbohydrate Counting
| Study group | Role | What they receive |
|---|---|---|
| Photographic Material | Experimental | Photographic Educational Material on Carbohydrate Counting Receives: Device: Photographic Educational Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Alexandre A. Ferraro, Phd, Study chair, University of São Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102959
- Sponsor's protocol ID
- 1182/07
- Status last verified
- Mar 2010
- First submitted
- 7 Apr 2010
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Photographic Educational Material on Carbohydrate Counting for Adolescents With Diabetes
- ClinicalTrials.gov ID
- NCT01102959
- Acronym / sponsor ID
- 1182/07
- Conditions
- Diabetes Mellitus
- Keywords
- EDUCATION, DIABETES MELLITUS, ADOLESCENT, DIABETIC DIET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photographic Material | Experimental | Device: Photographic Educational MaterialPhotographic Educational Material on Carbohydrate Counting |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photographic Educational MaterialAlso: Photo, Education, NutritionPhotographic Educational Material on Carbohydrate Counting | Device | Photographic Material |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre A. Ferraro, Phd study chair
University of São Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photographic Educational Material in people with Diabetes Mellitus, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriana S. Gandolfo, Dietitian (( 5511)30698558, adriana.gandolfo@icr.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number the answers correct or incorrect on carbohydrate counting in portions of real food (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2010.