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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Diabetes self-management program for Hispanics and their families
* Behavioral: General health educational program for Hispanics and their families


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for participants: 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 Inclusion criteria for family members/relatives are: Family member is over 18 Reside in the same household as the participant with diabetes Must be able to speak either English or Spanish Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Diabetes self-management and family support | Behavioral: Diabetes self-management program for Hispanics and their families<br>* The intervention group received an 8-weekly culturally tailored diabetes self-management and family support education program delivered in Spanish<br>|
| Active Comparator: Attention control group<br>General health information | Behavioral: General health educational program for Hispanics and their families<br>* The attention control group received 8-weekly education program on general health information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Hispanic adults, Diabetes self-management, Family-based intervention