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

January 27, 2011
September 23, 2013
March 2011
April 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01288300 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Health and Faith (Salud y Fe): Community-Based Diabetes Pilot Intervention
Health and Faith (Salud y Fe): Community-Based Diabetes Pilot Intervention

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes
  • Behavioral: Picture good health/Imaginate una buena salud
    Diabetes education, self-empowerment training, exercise, patient navigator
  • Behavioral: Diabetes lecture
    Diabetes self-management lecture
  • Active Comparator: Comprehensive diabetes self-management intervention
    Diabetes education, self-empowerment training, exercise, patient navigator
    Intervention: Behavioral: Picture good health/Imaginate una buena salud
  • Control
    Diabetes self-management lecture
    Intervention: Behavioral: Diabetes lecture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01288300
10-526-A, 1K23DK087903-01A1
No
University of Chicago
University of Chicago
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Arshiya A Baig, MD, MPH University of Chicago
University of Chicago
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP