A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community
TRIAD-2 Center for Health Disparities Research: A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community
2 other identifiers
interventional
186
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Jun 2012
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 3, 2014
CompletedFirst Posted
Study publicly available on registry
April 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
February 2, 2021
CompletedMay 24, 2022
May 1, 2022
2.9 years
April 3, 2014
March 28, 2019
May 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Hemoglobin A1C
Glycemic control in %.
Week 0 (Baseline)
Hemoglobin A1c
Glycemic control
Month 2 (post-intervention)
Hemoglobin A1c
Glycemic control
Month 3 (one month post-intervention)
Hemoglobin A1c
Glycemic control
Month 9 (6 months post-intervention)
Secondary Outcomes (4)
Health-related Quality of Life (SF-12)
Week 0 (Baseline)
Health-related Quality of Life (SF-12)
Month 2 (post-intervention)
Health-related Quality of Life (SF-12)
Month 3 (one month post-intervention)
Health-related Quality of Life (SF-12)
Month 9 (6 months post-intervention)
Study Arms (2)
Intervention group
EXPERIMENTALDiabetes self-management and family support
Attention control group
ACTIVE COMPARATORGeneral health information
Interventions
The intervention group received an 8-weekly culturally tailored diabetes self-management and family support education program delivered in Spanish
The attention control group received 8-weekly education program on general health information
Eligibility Criteria
You may qualify if:
- Community-dwelling
- Self-identification as Hispanic
- Age 18 years or older
- Self-identification as having a medical diagnosis of type 2 diabetes
- An adult family member willing to participate in the study.
- Must be able to speak either English or Spanish
- Family member is over 18
- Reside in the same household as the participant with diabetes
- Must be able to speak either English or Spanish
You may not qualify if:
- We will exclude Hispanic adults and family members who are:
- diagnosed with type 1 diabetes
- report prior (within the past year) or current participation in other diabetes self-management intervention programs
- cognitively impaired (not oriented to time, place, or person, or with known dementia)
- Pregnant at the time of T1 (baseline) data collection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University College of Nursing
Columbus, Ohio, 43231, United States
Related 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.
PMID: 26957533RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study used a quasi-experimental design.
Results Point of Contact
- Title
- Dr. Jie Hu
- Organization
- The Ohio State University
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Hu, PhD
Ohio State University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 3, 2014
First Posted
April 15, 2014
Study Start
June 1, 2012
Primary Completion
May 1, 2015
Study Completion
April 1, 2016
Last Updated
May 24, 2022
Results First Posted
February 2, 2021
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share