Clinical trial NCT01288300: Health and Faith (Salud y Fe): Community-Based Diabetes Pilot Intervention
Official title: Health and Faith (Salud y Fe): Community-Based Diabetes Pilot Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-02-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in glycosylated hemoglobin (Hba1c)from baseline at 3 and 6 months
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Changes in systolic blood pressure at baseline, 3 and 6 months
timeFrame: baseline to 6 months
measure: Changes in low density lipoprotein from baseline to 3 and 6 month follow up
timeFrame: baseline to 6 months
measure: Changes in diabetes self-care from baseline to 3 and 6 months
timeFrame: baseline to 6 months
measure: Changes in diabetes self-empowerment from baseline to 3 and 6 months
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Centro de Salud y Esperanza
state: Illinois
city: Chicago
country: United States
facility: Our Lady of Tepeyac Church
state: Illinois
city: Chicago
country: United States
facility: St. Agnes of Bohemia Church
state: Illinois
Study officials:
affiliation: University of Chicago
name: Arshiya A Baig, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baig AA, Stutz MR, Fernandez Pineros P, Benitez A, Gao Y, Quinn MT, Solomon MC, Sanchez-Johnsen L, Burnet DL, Chin MH; Little Village Community Advisory Board. Using photovoice to promote diabetes self-management in Latino patients. Transl Behav Med. 2019 Nov 25;9(6):1151-1156. doi: 10.1093/tbm/ibz082.
citation: Baig AA, Benitez A, Locklin CA, Gao Y, Lee SM, Quinn MT, Solomon MC, Sanchez-Johnsen L, Burnet DL, Chin MH; Little Village Community Advisory Board. Picture Good Health: A Church-Based Self-Management Intervention Among Latino Adults with Diabetes. J Gen Intern Med. 2015 Oct;30(10):1481-90. doi: 10.1007/s11606-015-3339-x. Epub 2015 Apr 29.