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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288300
• Other study ID #: 10-526-A
• Secondary ID: 1K23DK087903-01A
• Status: Completed
• Phase: N/A
• First received: January 27, 2011
• Last updated: September 23, 2013
• Start date: March 2011
• Est. completion date: April 2013

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• Picture good health/Imaginate una buena salud
Diabetes education, self-empowerment training, exercise, patient navigator
• Diabetes lecture
Diabetes self-management lecture

Locations

Country	Name	City	State
United States	Centro de Salud y Esperanza	Chicago	Illinois
United States	Our Lady of Tepeyac Church	Chicago	Illinois
United States	St. Agnes of Bohemia Church	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No