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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01288300
First received: January 27, 2011
Last updated: September 23, 2013
Last verified: September 2013
  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: Parallel 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:


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


Enrollment: 100
Study Start Date: March 2011
Study Completion Date: April 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Arshiya A Baig, MD, MPH University of Chicago
  More Information

No publications provided

Responsible Party: 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 23, 2013
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 October 19, 2014