Health and Faith (Salud y Fe): Community-Based Diabetes Pilot Intervention

Study Overview
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Brief Summary
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Main objective: To improve diabetes outcomes among Mexican-Americans with diabetes through church-based, culturally tailored, diabetes self-management interventions linked to the local healthcare system. Specific Aim: To pilot test a church-based, culturally tailored diabetes self-management intervention to improve diabetes outcomes among low-income Mexican-American with diabetes H1 A church-based diabetes self-care management curriculum partnered with the local healthcare system will improve glycosylated hemoglobin. H2 A church-based diabetes self-care management curriculum partnered with the local healthcare system will improve systolic blood pressure and low-density lipids. H3 A church-based diabetes self-care management curriculum partnered with the local healthcare system will improve diabetes related self-efficacy, self-empowerment and self-care management.

Detailed Description
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Diabetes is a very prevalent and morbid condition affecting Latinos, especially Mexican-Americans in the United States. South Lawndale, a predominately-Mexican neighborhood of Chicago, has a disproportionately high diabetes related mortality rate in comparison to the rest of Chicago and the U.S. Many church-based interventions have shown promise improving health outcomes among minority populations; but data on church-based interventions for Latino populations is scarce. Mobilizing community resources to develop church-based, diabetes self-management interventions may lead to sustainable, culturally tailored interventions, and improve outcomes in Latinos with diabetes. Considering the growth of the Hispanic population and their disproportionate burden of chronic diseases, developing programming aimed at decreasing the health disparities in this population is crucial. Our study proposes to fill this gap.

Official Title
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Health and Faith (Salud y Fe): Community-Based Diabetes Pilot Intervention

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Picture good health/Imaginate una buena salud
* Behavioral: Diabetes lecture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over the age of 18 able to speak either English or Spanish self-report of diagnosis of diabetes by a doctor Exclusion Criteria: cannot give informed consent (e.g. due to intoxication or dementia) do not speak English or Spanish younger than 18 years old. pregnant women undergoing hemodialysis or treatment for cancer unable to attend 3- and 6-month follow up appointments

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comprehensive diabetes self-management intervention<br>Diabetes education, self-empowerment training, exercise, patient navigator | Behavioral: Picture good health/Imaginate una buena salud<br>* Diabetes education, self-empowerment training, exercise, patient navigator<br>|
| Other: Control<br>Diabetes self-management lecture | Behavioral: Diabetes lecture<br>* Diabetes self-management lecture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in glycosylated hemoglobin (Hba1c)from baseline at 3 and 6 months | We will evaluate changes in HbA1c at baseline, at 3 months and then 6 months. We will analyze change in HbA1c from baseline and compare it to the 3 month and 6 month measures. | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in systolic blood pressure at baseline, 3 and 6 months | We will evaluate changes at baseline, at 3 months and then 6 months. We will analyze change from baseline and compare it to the 3 month and 6 month measures. | baseline to 6 months | 
| Changes in low density lipoprotein from baseline to 3 and 6 month follow up | We will evaluate changes from baseline, at 3 months and then 6 months. We will analyze change from baseline and compare it to the 3 month and 6 month measures | baseline to 6 months | 
| Changes in diabetes self-care from baseline to 3 and 6 months | We will evaluate changes from baseline, at 3 months and then 6 months. We will analyze change from baseline and compare it to the 3 month and 6 month measures | baseline to 6 months | 
| Changes in diabetes self-empowerment from baseline to 3 and 6 months | We will evaluate changes from baseline, at 3 months and then 6 months. We will analyze change from baseline and compare it to the 3 month and 6 month measures | baseline to 6 months |