Fotonovela for Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00472095
Recruitment Status : Unknown
Verified January 2014 by University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : May 11, 2007
Last Update Posted : January 23, 2014
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Procedure: fotonovela Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Utility of a Diabetes Themed Fotonovela to Encourage Glycemic Control: a Culturally Appropriate Tool for Education in Latinos
Study Start Date : June 2007
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: diabetes fotonovela
spanish language comic book describing diabetes care and consequences
Procedure: fotonovela
Placebo Comparator: placebo fotonovela

Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 1 year ]
    blood test

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A1c> 7.0

Exclusion Criteria:

  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00472095

Contact: Roger B Mortimer, MD 559-459-6450

United States, California
Adventist Health Selma Recruiting
Fresno, California, United States
Contact: Roger Mortimer, MD         
Clinica Sierra Vista Recruiting
Fresno, California, United States
Contact: Roger Mortimer, MD         
Deran Colegian Ambulatory Care Center Recruiting
Fresno, California, United States
Contact: Roger Mortimer, MD         
Principal Investigator: Roger Mortimer, MD         
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Roger B Mortimimer, MD UCSF-Fresno Medical Education Program, Department of Family Medicine

Responsible Party: University of California, San Francisco Identifier: NCT00472095     History of Changes
Other Study ID Numbers: UMC 2007-34
First Posted: May 11, 2007    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014

Keywords provided by University of California, San Francisco:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases