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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

TRIAD-2 Center for Health Disparities Research: A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114814
• Other study ID #: P20MD002289-06
• Secondary ID: 2P20MD002289-06
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: April 2016

Study information

• Verified date: May 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to compare the efficacy of an intervention and an attention control group in producing changes in diabetes self-management, glycemic control (HbA1c) and health related quality of life in Hispanics with type 2 diabetes.

Hypothesis: The experimental group who receive an 8 week intervention program would 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), HbA1c levels, and psychological outcomes of health-related quality of life.

Description:

A total of 186 participants and their family members were recruited, 103 in the experimental group and 83 in the attention control group.

An intervention consisted 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 were collected at baseline, immediately post-intervention, and at 3 and 6 month follow-up visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: April 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Diabetes self-management program for Hispanics and their families
The intervention group received an 8-weekly culturally tailored diabetes self-management and family support education program delivered in Spanish
• General health educational program for Hispanics and their families
The attention control group received 8-weekly education program on general health information

Locations

Country	Name	City	State
United States	The Ohio State University College of Nursing	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	National Institute on Minority Health and Health Disparities (NIMHD), University of North Carolina, Greensboro

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hu J, Amirehsani KA, Wallace DC, McCoy TP, Silva Z. A Family-Based, Culturally Tailored Diabetes Intervention for Hispanics and Their Family Members. Diabetes Educ. 2016 Jun;42(3):299-314. doi: 10.1177/0145721716636961. Epub 2016 Mar 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C	Glycemic control in %.	Week 0 (Baseline)
Primary	Hemoglobin A1c	Glycemic control	Month 2 (post-intervention)
Primary	Hemoglobin A1c	Glycemic control	Month 3 (one month post-intervention)
Primary	Hemoglobin A1c	Glycemic control	Month 9 (6 months post-intervention)
Secondary	Health-related Quality of Life (SF-12)	The Medical Outcomes Study Short Form Health Survey Version 2 (SF-12). Physical Components Summary (PCS) and Mental Components Summary (MCS) were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life.	Week 0 (Baseline)
Secondary	Health-related Quality of Life (SF-12)	Medical Outcomes Study Short Form Health Survey Version 2 (SF-12) Physical Components Summary (PCS) and Mental Components Summary (MCS) scores were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life.	Month 2 (post-intervention)
Secondary	Health-related Quality of Life (SF-12)	Medical Outcomes Study Short Form Health Survey Version 2 (SF-12) Physical Components Summary (PCS) and Mental Components Summary (MCS) scores were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life.	Month 3 (one month post-intervention)
Secondary	Health-related Quality of Life (SF-12)	The Medical Outcomes Study Short Form Health Survey, the SF-12 PCS and MCS scores were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life	Month 9 (6 months post-intervention)

External Links

•   A Family-Based, Culturally Tailored Diabetes Intervention for Hispanics and Their Family Members