Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Risk Communication Within Mexican-American Families

This study has been completed.
Information provided by:
National Institutes of Health Clinical Center (CC) Identifier:
First received: May 3, 2007
Last updated: September 6, 2014
Last verified: August 2014

May 3, 2007
September 6, 2014
April 2007
December 2010   (final data collection date for primary outcome measure)
Family Communication about Risk
Same as current
Complete list of historical versions of study NCT00469339 on Archive Site
Illness representations, Cooperative strategies to screen and adopt healthy behaviors
Same as current
Not Provided
Not Provided
Risk Communication Within Mexican-American Families
The Role of Family History and Culture in Communal Coping Within Mexican-American Families

This study will examine what methods work best for encouraging Mexican-American family members to talk about their risk for diabetes, heart disease, breast cancer and colon cancer. Within the Mexican-American community, the family culture provides an important setting in which individuals interpret and share their health information and formulate strategies to engage in health-promoting behaviors. The information from the study will be used to design risk communication approaches for Mexican-American households.

Members of households with at least three adults 18 to 70 years of age who are part of the existing Mexican-American households recruited by the University of Texas M.D. Anderson Cancer Center may be eligible for this study.

Participants are interviewed about their medical history, family history of disease, health behaviors, beliefs about disease and disease risk, experiences living in the United States, and relationships with family members and close friends. They are then provided information about their family risk for diabetes, heart disease, breast cancer and colon cancer, based on the information they provided in the interview. Two additional interviews are conducted over the telephone that include questions about how the participants communicate with family members about their risk and health behaviors.

The current project aims to understand the mechanisms underlying communications about familial risk for common, complex diseases and the development of strategies by Mexican American families to address this risk. For the Mexican American community, the family culture provides an important setting within which individuals will interpret their health information, share health information, and formulate strategies to engage in health promoting behaviors. This family culture can be defined by the family social structure, the degree of acculturation represented by household members, as well as socio-economic factors. Participants for the current project will be recruited from an ongoing population-based cohort of Mexican American households initiated by the Department of Epidemiology at the University of Texas MD Anderson Cancer Center (UTMDACC). At least three adults, two of which are biological relatives, living within the same residence from 160 multigenerational Mexican American households will participate in this study. Medical risk information (feedback) will be provided to participants based upon family history information that they provide about four complex diseases: diabetes, heart disease, breast cancer and colon cancer. The feedback will be randomized in two ways varying who within the family is provided the feedback (Receiver of the Feedback) and what information is provided (Content of Feedback). The data will allow us to examine whether the family-centered feedback approach (where all participating family members receive feedback), rather than the individual-focused feedback approach (where only one participating family member receives feedback), encourages communications regarding disease risk among family members. The medical risk feedback will also be randomized as to whether they receive disease risk information only (predisposing risk feedback) or disease risk information coupled with personalized recommendations for behavior change to reduce risks (predisposing plus enabling feedback). These data will allow us to examine the impact of the content of risk feedback based on the CDC s family health history tool Family Healthware on beliefs concerning the underlying causes and controllability of common diseases. Cross comparisons between the data obtained from who receives the medical risk information and the content of that information will help in understanding the role of beliefs about disease and communication about family risk for disease in the development of shared perceptions of risk and strategies to adopt health promoting behaviors within the family. The role of the familial and cultural context in the communication and strategy development process will also be investigated.

Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diabetes
  • Colon Cancer
  • Cardiovascular Disease
Behavioral: Family Health History
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
December 2010   (final data collection date for primary outcome measure)
  • Member household of existing population-based cohort of Mexican-American households recruited by the Department of Epidemiology at UTMDACC. The existing population based cohort consists of self-identified Mexican-Americans living in predominantly Mexican-American neighborhoods in the Houston area. All individuals in the cohort are 18 years of age or older and had to be able to complete a personal interview.
  • Household includes at least three adults (18 to 70 years of age) who are willing to participate in the study, where at least two of the household participants are related biologically and represent differing generations, and additionally in which one household participant is a spouse or partner of another household participant.
  • Ability for each participating household member to complete one in-home survey instrument via computerized assessment tool or personal interview and to complete two telephone interviews.
  • Ability of all household participants to speak either English or Spanish.


More than two household members are unable to complete the baseline questionnaire using a computerized assessment tool.

18 Years to 70 Years
Contact information is only displayed when the study is recruiting subjects
United States
Egypt,   Tunisia
999907140, 07-HG-N140
Not Provided
Not Provided
National Human Genome Research Institute (NHGRI)
Not Provided
Principal Investigator: Laura M. Koehly, Ph.D. National Human Genome Research Institute (NHGRI)
National Institutes of Health Clinical Center (CC)
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP