NCT01288300

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable diabetes

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

2.1 years

First QC Date

January 27, 2011

Last Update Submit

September 23, 2013

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Changes in glycosylated hemoglobin (Hba1c)from baseline at 3 and 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 Outcomes (4)

  • Changes in systolic blood pressure at baseline, 3 and 6 months

    baseline to 6 months

  • Changes in low density lipoprotein from baseline to 3 and 6 month follow up

    baseline to 6 months

  • Changes in diabetes self-care from baseline to 3 and 6 months

    baseline to 6 months

  • Changes in diabetes self-empowerment from baseline to 3 and 6 months

    baseline to 6 months

Study Arms (2)

Comprehensive diabetes self-management intervention

ACTIVE COMPARATOR

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

Behavioral: Picture good health/Imaginate una buena salud

Control

OTHER

Diabetes self-management lecture

Behavioral: Diabetes lecture

Interventions

Picture good health/Imaginate una buena saludBEHAVIORAL

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

Comprehensive diabetes self-management intervention
Diabetes lectureBEHAVIORAL

Diabetes self-management lecture

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over the age of 18
  • able to speak either English or Spanish
  • self-report of diagnosis of diabetes by a doctor

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centro de Salud y Esperanza

Chicago, Illinois, United States

Location

Our Lady of Tepeyac Church

Chicago, Illinois, United States

Location

St. Agnes of Bohemia Church

Chicago, Illinois, United States

Location

Related Publications (2)

  • Baig AA, Stutz MR, Fernandez Pineros P, Benitez A, Gao Y, Quinn MT, Solomon MC, Sanchez-Johnsen L, Burnet DL, Chin MH; Little Village Community Advisory Board. Using photovoice to promote diabetes self-management in Latino patients. Transl Behav Med. 2019 Nov 25;9(6):1151-1156. doi: 10.1093/tbm/ibz082.

    PMID: 31162592DERIVED

  • Baig AA, Benitez A, Locklin CA, Gao Y, Lee SM, Quinn MT, Solomon MC, Sanchez-Johnsen L, Burnet DL, Chin MH; Little Village Community Advisory Board. Picture Good Health: A Church-Based Self-Management Intervention Among Latino Adults with Diabetes. J Gen Intern Med. 2015 Oct;30(10):1481-90. doi: 10.1007/s11606-015-3339-x. Epub 2015 Apr 29.

    PMID: 25920468DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Arshiya A Baig, MD, MPH

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 2, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

September 24, 2013

Record last verified: 2013-09

Locations

US(3)