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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Picture good health/Imaginate una buena salud; Behavioral: Diabetes lecture

• Registration Number: NCT01288300
• Lead Sponsor: University of Chicago

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-02
• Study Start: 2011-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-23
• Last Update Posted: 2013-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• over the age of 18
• able to speak either English or Spanish
• self-report of diagnosis of diabetes by a doctor

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive diabetes self-management intervention	Picture good health/Imaginate una buena salud	Diabetes education, self-empowerment training, exercise, patient navigator
Control	Diabetes lecture	Diabetes self-management lecture

Primary Outcome Measures

Name	Time	Method
Changes in glycosylated hemoglobin (Hba1c)from baseline at 3 and 6 months	baseline to 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.

Secondary Outcome Measures

Name	Time	Method
Changes in low density lipoprotein from baseline to 3 and 6 month follow up	baseline to 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
Changes in diabetes self-empowerment from baseline to 3 and 6 months	baseline to 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
Changes in systolic blood pressure at baseline, 3 and 6 months	baseline to 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.
Changes in diabetes self-care from baseline to 3 and 6 months	baseline to 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

Trial Locations

Locations (3)

Our Lady of Tepeyac Church; 🇺🇸 Chicago, Illinois, United States

Centro de Salud y Esperanza; 🇺🇸 Chicago, Illinois, United States

St. Agnes of Bohemia Church; 🇺🇸 Chicago, Illinois, United States