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

Sponsor:	University of Chicago
Collaborator:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):	Arshiya Baig, University of Chicago
ClinicalTrials.gov Identifier:	NCT01288300

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

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.

Secondary Outcome 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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288300

Contacts

Contact: Arshiya A Baig, MD, MPH

773 834 4760

abaig@uchicago.edu

Locations

United States, Illinois
St. Agnes of Bohemia Church	Recruiting
Chicago, Illinois, United States
Contact: Arshiya A Baig, MD, MPH
Principal Investigator: Arshiya A Baig, MD, MPH
Our Lady of Tepeyac Church	Recruiting
Chicago, Illinois, United States
Contact: Arshiya A Baig, MD, MPH 737-834-4760 abaig@uchicago.edu
Centro de Salud y Esperanza	Recruiting
Chicago, Illinois, United States
Contact: Arshiya A Baig, MD, MPH 773-834-4760 abaig@uchicago.edu

Sponsors and Collaborators

University of Chicago

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

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 3, 2011
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 23, 2012