NCT Number: NCT00472095
Fotonovela for Type 2 Diabetes Mellitus
Diabetes with poor sugar control can lead to blindness, heart attacks, and amputations. Latinos are more at risk for diabetes. A fotonovela is a type of comic book commonly read by Latinos that might be a way to teach them about the risk of high sugars. The researchers will give patients either a fotonovela about diabetes or one with nothing to do with diabetes. Then they will compare how well sugars were controlled afterward in each group. This way they can see if these fotonovelas were useful.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Adventist Health Selma, Fresno, California, United States
About this study
Elevated glucose in diabetics is a risk for amputation, renal failure, coronary artery disease, neuropathy, and blindness. Controlling glucose better as measured by hemoglobin A1c (A1c) reduces risk for these complications. Information itself is often not enough to change behaviors that increase risk for these complications. Latinos in America are particularly at risk for diabetes (DM) and its complications. A fotonovela is a booklet telling a story using photos with superimposed speech bubbles much like an American style comic book. These are commonly read by Latinos. A fotonovela that tells a story about diabetes complications in a culturally appropriate context that emphasized impact on family might help motivate Hispanic patients to control their sugar better. We propose a single-blinded, randomized, controlled trial of a DM themed fotonovela against a non-DM themed fotonovela to assess its effect on glycemia as measured by A1c. After a primary care provider has seen a Latino type 2 diabetic patient, the investigator will consent them then give them an envelope with the DM themed fotonovela or another that is indistinguishable in the sealed envelope. The primary outcome is hemoglobin A1c one month or more after randomization. Secondary outcomes will A1c in the 1-5 month and 6-12 month time period looking for durability of effect. A sample size of 260 allows for a 30% fallout and gives an 80% power to detect a 0.5% change in A1c with a 1.2% standard deviation on that change with a two-tailed alpha of 0.05.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- A1c> 7.0
Exclusion criteria
- Pregnant
Treatment and study plan
Placebo Fotonovela
OtherPrimary outcomes
-
Hemoglobin A1c
Time frame: 1 year
blood test
Sponsors and collaborators
Lead sponsor
University of California, San Francisco
Other
Registry information
Official study title
Utility of a Diabetes Themed Fotonovela to Encourage Glycemic Control: a Culturally Appropriate Tool for Education in Latinos
Important dates
- Study start
- 2007
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- May 11, 2007
- Registry last updated
- Aug 25, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Combined Active Treatment in Type 2 Diabetes With NASH
NCT04639414
Diabetes Mellitus, Diabetes Mellitus, Type 2
Graz, Austria
View Trial DetailsTogether Overcoming Diabetes
NCT04734015
Diabetes Mellitus, Diabetes Mellitus, Type 2
Duluth, Minnesota, United States
View Trial DetailsPromote Health With Digital Tools Among Adults With Type 2 Diabetes/Prediabetes and/or Hypertension
NCT05648383
Body Weight, Cardiovascular Diseases
Tirana, Rruga E Dibrës, Albania
View Trial DetailsRemote Pharmacy Services Plus Continuous Glucose Monitoring in an Underserved Population
NCT07587151
Diabetes Mellitus, Diabetes Mellitus, Type 2
Rockford, Illinois, United States
View Trial Details