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NCT Number: NCT01288300

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud y Esperanza, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Picture good health/Imaginate una buena salud

Behavioral

Diabetes education, self-empowerment training, exercise, patient navigator

Diabetes lecture

Behavioral

Diabetes self-management lecture

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

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

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 2, 2011
Registry last updated
Sep 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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