Family Genetics Health Education and Healthy Behaviors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01498276
First received: December 21, 2011
Last updated: March 14, 2014
Last verified: August 2013
  Purpose

Background:

- Family-based approaches to reduce disease risk and promote healthy behaviors may be better than targeting individuals. Risk assessments based on family health history may help educate families on disease risks and encourage them to change physical activity and food choices. Specifically, researchers want to better understand the role of mothers in teaching healthy behaviors to their families.

Objectives:

  • To determine mothers influence on diet and health-related behaviors.
  • To study an intervention tool that connects family health history and disease risk.

Eligibility:

- 18 years of age who have at least one child living at home.

Design:

  • Participants will complete a survey over the phone. The survey will take 30 to 40 minutes to complete. The survey will collect family health history on heart disease, diabetes, colorectal cancer, and breast cancer.
  • Researchers will give participants a Family Health Package (FHP). The FHP will provide information on family health history and disease risk. It will also recommend behaviors that can reduce health risks.
  • Two weeks after sending the FHP, participants will complete a phone survey about the FHP materials and their social networks.
  • Some participants will be invited to focus groups. The focus groups will explore diet and health behavior. They will look at food purchasing and preparation and meal sharing. The groups will also discuss attitudes toward healthy eating and physical activity. Each focus group will last 1 to 2 hours.
  • Participants will be asked to complete an electronic survey regarding participants health status, causal health beliefs, risk perceptions, and intentions to communicate health information.
  • Then, participants will have the opportunity to use the electronic version of the FHP, which will assess family health history.
  • After using the FHeP, participants will complete a short electronic survey to identify knowledge and understanding gained from the use of the application, changes in communication intentions, and suggestions for improvements to the application.
  • Upon completion of the electronic portion of the study, a study team member will conduct a semi-structured interview to allow the participants to qualitatively evaluate their user experience, including satisfaction and usefulness.
  • This study process will take approximately 60-90 minutes.

Condition
Diabetes
Cancer
Heart Disease

Study Type: Observational
Official Title: The Role of the Family Genetics Health Educator in Influencing Health Promoting Behaviors

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Participants comprehension of an intervention tool outlining family health history and risk assessment to be used in a subsequent intervention study.

Secondary Outcome Measures:
  • Efficacy of utilizing mothers to educate family members of disease risk and motivate healthy behaviors.

Estimated Enrollment: 215
Study Start Date: December 2011
Detailed Description:

Lifestyle behaviors, such as diet and physical activity, have been linked to the development of a number of diseases, including cancer, diabetes, and heart disease. Adopting a healthy diet and other preventative health practices are effective ways to reduce associated diseases. However, cancer, diabetes, and heart disease are etiologically complex with multiple risk factors (e.g., genetic, environmental, lifestyle) that tend to cluster in families. Thus, families are an important social context for intervention and lifestyle-focused disease prevention. Our previous research indicates that intergenerational encouragement can motivate behavior change and parents and women tend to be natural encouragers of health behaviors. Therefore, a mixed-method pilot study will be conducted to explore how dietary habits and healthy behaviors are transmitted across family generations and the motivational influence of family health history regarding diseases associated with overweight and diet on improving health behaviors. This pilot study will also assess participants comprehension of an intervention tool outlining family health history and disease risk assessment that will be used in a larger intervention study.

Participants for the paper-based Family Health Package (FHP) Evaluation Phase will be recruited from an existing database developed by the Immersive Virtual Environment Testing Area (IVETA) within the Social and Behavioral Research Branch, NHGRI, consisting of mothers in the Washington, DC area, and through local advertisement and posting on clinicaltrials.gov. Participants will complete a survey interview, providing us with a detailed family health history. From this information, we will create a paper-based FHP that will be sent to participants, consisting of a pedigree, disease risk algorithms, and health guidelines. Participants will be invited to complete a follow-up survey interview, and focus groups will be conducted with a subset of participants. Two initial focus groups will provide feedback on the feasibility and acceptability of the FHP materials. After incorporating revisions, an additional focus group will evaluate the FHP materials. All of the focus groups will also explore diet and health behavior through semi-structured questions. Thematic analysis will identify factors such as influences on health behaviors across generations and the potential impact parents have on initiating and maintaining food choices within their household and the influence of their family of origin on these choices. Additional evaluations may be conducted, as necessary, to improve the FHP and reach diverse populations.

The paper-based version of the FHP will be translated into an electronic version, the Family Health ePortal (FHeP). Participants for the electronic Family Health ePortal (FHeP) Evaluation Phase will be recruited from the general population through local advertisement and posting on clinicaltrials.gov. Eligible participants will be consented and invited to access the FHeP. The initial FHeP Evaluation Phase participants will access the FHeP individually to provide feedback on the feasibility and acceptability of the FHeP materials through surveys and a semi-structured interview. After incorporating revisions, subsequent participants will be asked to invite their family members to access the FHeP and evaluate the FHeP materials. FHeP participants will provide demographic, diet, and health behavior information through pre- and post-test surveys as well as survey items within the FHeP. Additional evaluation waves may be conducted, as necessary, to improve the FHeP and increase reach to diverse populations.

We anticipate that the outcomes of the pilot study will 1) provide us with an effective intervention tool for health education and minimizing disease risk within the family, and 2) inform future intervention research. Further study can be directed toward providing mothers with appropriate tools to act as family genetics health educators in order to disseminate disease risk information and encourage health promoting behaviors.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

FHP Evaluation Phase

Eligible participants for the FHP Evaluation Phase will be invited to participate in the study if they meet the following criteria:

  1. have at least one child
  2. be able to read and speak English
  3. indicate a willingness to participate in a focus group.

FHeP Individual Evaluation Phase

Eligible participants will be invited to participate in the study if they meet the following criteria:

  1. able to read, write, and speak English
  2. able to visit the Clinical Center on the Bethesda, MD main campus for one visit
  3. adult
  4. demonstrate basic computer literacy

EXCLUSION CRITERIA:

NHGRI employees and those who are adopted will be excluded from the study.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498276

Contacts
Contact: Andrea F Goergen (301) 443-8185 goergena@mail.nih.gov
Contact: Laura M. Koehly, Ph.D. (301) 451-3999 koehlyl@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: Andrea Goergen    301-443-8185    goergena@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Laura M. Koehly, Ph.D. National Human Genome Research Institute (NHGRI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01498276     History of Changes
Other Study ID Numbers: 120023, 12-HG-0023
Study First Received: December 21, 2011
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Breast Cancer
Colorectal Cancer
Heart Disease
Diabetes
Family History
Family Health History
Disease Risk Assessment

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014