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

September 23, 2013 updated by: University of Chicago

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: Control
Diabetes self-management lecture
Behavioral: Diabetes lecture
Diabetes self-management lecture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in glycosylated hemoglobin (Hba1c)from baseline at 3 and 6 months
Time Frame: 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.
baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in systolic blood pressure at baseline, 3 and 6 months
Time Frame: 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.
baseline to 6 months
Changes in low density lipoprotein from baseline to 3 and 6 month follow up
Time Frame: 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
baseline to 6 months
Changes in diabetes self-care from baseline to 3 and 6 months
Time Frame: 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
baseline to 6 months
Changes in diabetes self-empowerment from baseline to 3 and 6 months
Time Frame: 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
baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

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

Investigators

  • Principal Investigator: Arshiya A Baig, MD, MPH, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

January 27, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (Estimate)

February 2, 2011

Study Record Updates

Last Update Posted (Estimate)

September 24, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-526-A
  • 1K23DK087903-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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