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A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community

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ClinicalTrials.gov Identifier: NCT02114814
Recruitment Status : Unknown
Verified April 2014 by Jie Hu, University of North Carolina, Greensboro.
Recruitment status was:  Recruiting
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jie Hu, University of North Carolina, Greensboro

Brief Summary:

The aim of this study is to compare the efficacy of an intervention and an attention control group in producing changes in diabetes self-management, A1C and health related quality of life in Hispanics with type 2 diabetes.

Hypothesis: The experimental group who receive an 8 week intervention program will show significantly greater improvements than an attention control group at 1 and 6 months after the intervention in: behavioral influences of diabetes knowledge, diabetes self-efficacy, and family support, outcomes of self-reported management of diabetes (physical activity, diet, medications, and glucose monitoring), A1C levels, and psychological outcomes of health-related quality of life.


Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Experimental: Diabetes Self Management Behavioral: General Health Education Not Applicable

Detailed Description:

A total of 156 participants will be recruited, 78 in the experimental group (39 participants with diabetes and 39 family members) and 78 in the attention control group (39 participants with diabetes and 39 family members). This will allow for an estimated attrition of 10% in each group.

An intervention will consist of eight weekly interactive modules, for a total of 12 hours, and based on modules from National Standards for Diabetes Self-Management Education, and the National Diabetes Education Program. Data will be collected at baseline, immediately post-intervention, and at 3 and 6 month follow-up visits.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community
Study Start Date : November 2011
Estimated Primary Completion Date : April 2016

Arm Intervention/treatment
Experimental: Diabetes Self Management
Diabetes Self Management
Behavioral: Experimental: Diabetes Self Management
Active Comparator: General Health Education
General Health education
Behavioral: General Health Education



Primary Outcome Measures :
  1. Hemoglobin A1C (HbA1C) [ Time Frame: 9 Months ]
    Fingerstick HbA1C performed at Time1, Time2, Time3 and Time4.

  2. Behavioral outcomes of self-reported management of diabetes [ Time Frame: 9 months ]
    Measured at Time1, Time2, Time3 and Time4 with the International Physical Activity Questionnaire (IPAQ) and pedometer.

  3. Health-related quality of life [ Time Frame: 9 months ]
    Measured at Time1, Time2, Time3 and Time4 using the SF-12 Health Survey.

  4. Behavioral outcomes of self-reported management of diabetes [ Time Frame: 9 months ]
    Measured at Time1, Time2, Time3 and Time4 with the Diabetes Self-Care Activities (SDSCA).

  5. Diabetes knowledge [ Time Frame: 9 months ]
    Measured at Time1, Time2, Time3 and Time4 with the Spoken Knowledge of Diabetes in Low Literacy Patients with Diabetes (SKILLD).

  6. Family support [ Time Frame: 9 months ]
    Measured at Time1, Time2, Time3 and Time4 with the Diabetes Family Support Behavior Checklist (DFBC-II).

  7. Diabetes Self-efficacy [ Time Frame: 9 months ]
    Measured at Time1, Time2, Time3, and Time4 with the Stanford Self-Efficacy for Diabetes.

  8. Behavioral outcomes of self-reported management of diabetes [ Time Frame: 9 months ]
    Measured at Time1, Time2, Time3 and Time4 with the Behavioral Risk Factor Surveillance System (BRFSS) diet.



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

Inclusion Criteria for participants:

  1. Community-dwelling
  2. Self-identification as Hispanic
  3. Age 18 years or older
  4. Self-identification as having a medical diagnosis of type 2 diabetes
  5. An adult family member willing to participate in the study.
  6. Must be able to speak either English or Spanish

Inclusion criteria for family members/relatives are:

  1. Family member is over 18
  2. Reside in the same household as the participant with diabetes
  3. Must be able to speak either English or Spanish

Exclusion Criteria:

We will exclude Hispanic adults and family members who are:

  1. diagnosed with type 1 diabetes
  2. report prior (within the past year) or current participation in other diabetes self-management intervention programs
  3. cognitively impaired (not oriented to time, place, or person, or with known dementia)
  4. Pregnant at the time of T1 (baseline) data collection

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): NCT02114814


Contacts
Contact: Jie Hu, PhD 336-256-1025 j_hu2@uncg.edu
Contact: Christina Hussami, BA 336-334-5217 crhussam@uncg.edu

Locations
United States, North Carolina
UNCG Recruiting
Greensboro, North Carolina, United States, 27412
Contact: Jie Hu, PhD    336-334-5217    j_hu2@uncg.edu   
Sponsors and Collaborators
University of North Carolina, Greensboro
National Institutes of Health (NIH)

Additional Information:
Publications:
Centers for Disease Control and Prevention. National diabetes fact sheet, 2011. 2011; http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf
Centers for Disease Control and Prevention. Data & trends: Percentage of adults aged 18 years or older with diagnosed diabetes performing daily self-monitoring of blood glucose. Race/Ethnicity, United States 2010; http://www.cdc.gov/diabetes/statistics/preventive/tBloodSugRace.htm
National Diabetes Education Program. National Diabetes Education Program. 2011; http://ndep.nih.gov/
North Carolina State Center for Health Satitics. Racial and ethnic health disparities in North Carolina: Report card 2010. 2010; http://www.schs.state.nc.us/SCHS/pdf/MinRptCard_WEB_062210.pdf
American Diabetes Association. Stress. 2010; http://www.diabetes.org/living-with-diabetes/complications/stress.html
American Diabetes Association. Making healthy food choices. 2010; http://www.diabetes.org/food-and-fitness/food/what-can-i-eat/making-healthy-food-choices.html
American Diabetes Association. Diabetes food pyramid. 2010; http://www.diabetes.org/food-and-fitness/food/planning-meals/diabetes-food-pyramid.html
American Diabetes Association. Managing stress and diabetes. 2010; http://www.diabetes.org/living-with-diabetes/parents-and-kids/everyday-life/managing-stress-and-diabetes.html
National Diabetes Education Program. 4 steps to control your diabetes: For life. 2009; http://ndep.nih.gov/publications/PublicationDetail.aspx?PubId=4
National Diabetes Education Program. Take care of your heart: Manage your diabetes. 2011; http://ndep.nih.gov/media/TCH_AsAm_flyer_Eng.pdf
Bassett DR, Strath SJ. Use of pedometers to assess physical activity. In: Welk GJ, ed. Physical activity assessments for health-related research. Champaign, Ill: Human Kinetics Publications Inc.; 2002

Responsible Party: Jie Hu, Principal Investigator, University of North Carolina, Greensboro
ClinicalTrials.gov Identifier: NCT02114814     History of Changes
Other Study ID Numbers: P20MD002289-02 ( U.S. NIH Grant/Contract )
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014

Keywords provided by Jie Hu, University of North Carolina, Greensboro:
Diabetes
Hispanic
Adult
Family Member

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