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Family Genetics Health Education and Healthy Behaviors

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ClinicalTrials.gov Identifier: NCT01498276
Recruitment Status : Recruiting
First Posted : December 23, 2011
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

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.

Condition or disease
Diabetes Cancer Heart Disease

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 640 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: The Role of the Family Genetics Health Educator in Influencing Health Promoting Behaviors
Actual Study Start Date : January 3, 2012

Group/Cohort
General Population
Members of the general population
Members of under-resourced communities
Participant recruited from under-resourced communities in the Washington, DC area in the Southeastern US



Primary Outcome Measures :
  1. Intergenerational transfer of diet-related behaviors [ Time Frame: interim and end-point ]
    Intergenerational transfer of diet-related behaviors

  2. Participants' comprehension of intervention tool [ Time Frame: interim and end point ]
    Participants' comprehension of intervention tool outlining family health history and risk assessment of etiologically complex health conditions (heart disease, diabetes, breast and colorectal cancer)


Secondary Outcome Measures :
  1. Efficacy of utilizing mothers to educate family members of disease risk and motivate healthy behaviors. [ Time Frame: interim and end-point ]
    Efficacy of utilizing mothers to educate family members of disease risk and motivate healthy behaviors.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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. be able to read and speak English
  2. indicate a willingness to participate in a focus group.

    • 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.)

This information will be gauged from the IVETA database and/or through the initial recruitment discussion. This inclusion criteria has been established as we are interested in examining health behaviors across generations in an efficient and timely manner through surveys and focus groups. Focus group participants will be recruited from the larger sample of participants completing surveys. Therefore, participants will be required to read and speak English as the focus

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:

  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

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

Family Evaluation

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. adult
  3. demonstrate basic computer literacy
  4. willing to invite at least 2 biological family members to participate

    • Those who are adopted will be excluded from the study

FHP Community-based Education Program

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. adult, (greater than or equal to 18 years of age), and
  3. indicate a willingness to participate in the study.

    • Those who are adopted will be excluded from the study.

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 ClinicalTrials.gov identifier (NCT number): NCT01498276


Contacts
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Contact: Mindy J Perilla (866) 585-7192 mindy.perilla@nih.gov
Contact: Laura M. Koehly, Ph.D. (301) 451-3999 koehlyl@mail.nih.gov

Locations
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United States, District of Columbia
Georgetown Office of Minority Health Recruiting
Washington, District of Columbia, United States, 20057
Contact: Chiranjeev Dash    202-687-5367    d422@georgetown.edu   
United States, Florida
Florida A&M University Recruiting
Tallahassee, Florida, United States, 32307
Contact: Torhonda Lee, Ph.D.    850-412-5700    torhonda.lee@famu.edu   
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
National Human Genome Research Institute (NHGRI)
Investigators
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Principal Investigator: Laura M. Koehly, Ph.D. National Human Genome Research Institute (NHGRI)

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Human Genome Research Institute (NHGRI)
ClinicalTrials.gov Identifier: NCT01498276     History of Changes
Other Study ID Numbers: 120023
12-HG-0023
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: August 7, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) ):
FHH (Family Health History)
Family Health History
Disease Risk Assessment
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases