Family Genetics Health Education and Healthy Behaviors

NCT01498276 | Completed

• 2 other identifiers: 12002312-HG-0023
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetes; Cancer; Heart Disease

Keywords

FHH (Family Health History); Natural History; Family Health History; Disease Risk Assessment

Outcome Measures

Primary Outcomes (2)

• Participants' comprehension of an intervention tool

  Participants' comprehension of intervention tool outlining family health history and risk assessment of etiologically complex health conditions (heart disease, diabetes, breast and colorectal cancer)

  interim and end-point

• Intergenerational transfer of diet-related behaviors

  Intergenerational transfer of diet-related behaviors

  interim and end-point

Secondary Outcomes (1)

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

  interim and end-point

Study Arms (2)

General population

Members of the general population

Members of under-resourced communities

Participants recruited from under-resourced communities in the Washington, DC area AND in the Southeastern US

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment strategies vary depending upon the substudy in which we are seeking participation. For example, participants may be recruited from the general population. We also seek to enroll members of under-resourced communities. A database that will assist with recruitment in one substudy includes mothers with young children in the Washington, DC area.

You may qualify if:

• FHP Evaluation Phase
• Eligible participants for the FHP Evaluation Phase will be invited to participate in the study if they meet the following criteria:
• be able to read and speak English
• age \>= 18 years
• indicate a willingness to participate in a focus group/discussion.
• The urban FHP evaluation phase (Washington, DC Metro area) also requires participants to have at least one child. (The rural FHP evaluation, Southeastern US, does not.)
• groups will be conducted in English. As this is a pilot study, it is not feasible to recruit large numbers of participants in order to do the focus groups and provide versions of the survey in alternate languages.
• Those who are adopted will be excluded from the study
• FHeP Individual Evaluation Phase
• Individual Evaluation
• Eligible participants will be invited to participate in the study if they meet the followingcriteria:
• able to read, write, and speak English,
• able to visit the Clinical Center on the Bethesda, MD main campus for one visit
• adult
• demonstrate basic computer literacy

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead

Study Sites (2)

Georgetown Office of Minority Health

Washington D.C., District of Columbia, 20057, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Koehly LM, Morris BA, Skapinsky K, Goergen A, Ludden A. Evaluation of the Families SHARE workbook: an educational tool outlining disease risk and healthy guidelines to reduce risk of heart disease, diabetes, breast cancer and colorectal cancer. BMC Public Health. 2015 Nov 13;15:1120. doi: 10.1186/s12889-015-2483-x.

  PMID: 26566980 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Diabetes Mellitus; Neoplasms; Heart Diseases; Hypocalciuric hypercalcemia, familial, type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases

Study Officials

• Laura M Koehly, Ph.D.

  National Human Genome Research Institute (NHGRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 23, 2011
• Study Start: January 3, 2012
• Last Updated: June 8, 2026

Record last verified: 2025-10-28

Locations

US (2)