Health and Faith (Salud y Fe): Community-Based Diabetes Pilot Intervention
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes |
Behavioral: Picture good health/Imaginate una buena salud Behavioral: Diabetes lecture |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Health and Faith (Salud y Fe): Community-Based Diabetes Pilot Intervention |
- Changes in glycosylated hemoglobin (Hba1c)from baseline at 3 and 6 months [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]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.
- Changes in systolic blood pressure at baseline, 3 and 6 months [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]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 low density lipoprotein from baseline to 3 and 6 month follow up [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]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-care from baseline to 3 and 6 months [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Comprehensive diabetes self-management intervention
Diabetes education, self-empowerment training, exercise, patient navigator
|
Behavioral: Picture good health/Imaginate una buena salud
Diabetes education, self-empowerment training, exercise, patient navigator
|
|
Control
Diabetes self-management lecture
|
Behavioral: Diabetes lecture
Diabetes self-management lecture
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |
| St. Agnes of Bohemia Church | |
| Chicago, Illinois, United States | |
| Our Lady of Tepeyac Church | |
| Chicago, Illinois, United States | |
| Centro de Salud y Esperanza | |
| Chicago, Illinois, United States | |
| Principal Investigator: | Arshiya A Baig, MD, MPH | University of Chicago |
More Information
No publications provided
| Responsible Party: | Arshiya Baig, Assistant Professor, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01288300 History of Changes |
| Other Study ID Numbers: | 10-526-A, 1K23DK087903-01A1 |
| Study First Received: | January 27, 2011 |
| Last Updated: | September 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013