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Impact of Type 2 Diabetes Peer Counseling on Behavioral, Metabolic, and Health Outcomes Among Latinos (DIALBEST)

This study has been completed.
Sponsor:
Collaborators:
Hartford Hospital
Hispanic Health Council, Inc.
Information provided by:
University of Connecticut
ClinicalTrials.gov Identifier:
NCT01299844
First received: February 15, 2011
Last updated: February 17, 2011
Last verified: February 2011
History of Changes
  Purpose

The objectives of this study are:

  • To develop a comprehensive culturally tailored model of diabetes management that integrates the work of community-based peer counselors and clinical specialists into a multi-disciplinary health care team serving the Latino community.
  • To implement an intervention that provides education and support to Latino adults diagnosed with Type 2 diabetes in both clinical and home settings.
  • To evaluate this intervention for its impact on program adherence, and improved outcomes sustained over time as reflected by metabolic, clinical, cognitive and behavioral measures.

Condition Intervention
Diabetes Mellitus, Non-Insulin-Dependent
 Behavioral: Diabetes Peer Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Type 2 Diabetes Peer Counseling on Behavioral, Metabolic, and Health Outcomes Among Latinos

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: Change in Baseline in HbA1c at 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diabetes Knowledge Test Score [ Time Frame: Change from Baseline in Diabetes Knowledge Test Score at 6 Months ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: December 2006
Study Completion Date: September 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Care
Experimental: Diabetes Peer Counseling Behavioral: Diabetes Peer Counseling
16 Home visits from a bilingual/bicultural diabetes peer counselor.
Other Name: DIALBEST

Detailed Description:

A randomized two group longitudinal design with clinical measurements and behavioral assessments collected at baseline, 3,6,12 and 18 months will be used. It is hypothesized that participants in the home-based peer-counseling intervention will have greater reductions and will better maintain their reductions in their HbA1c levels compared to participants in the standard of care hospital based program currently in place. Additional secondary hypotheses state the participants in the home-based peer-counseling intervention will have improved lipid profile values, cholesterol levels, and BMI compared to participants in the standard of care hospital based program.

Participants in the home-based peer-counseling intervention will monitor their glucose more regularly (defined by the mean and variance in number of monitored days per month) than participants in the standard of care hospital based program. Lastly, participants in the home-based peer-counseling intervention will have a higher rate of program participation (defined by adherence to appointments and referrals) and completion than participants in the standard of care hospital based program.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Latinos older than 21
  • Diagnosed with type 2 diabetes
  • Referred to the "Amigos en Salud" program at Hartford Hospital
  • Residents of Hartford

Exclusion Criteria:

  • Advanced renal failure
  • Advanced heart disease
  • Diagnosis of major psychological disorder or mental condition
  • Limb amputation(s) that prevent following study's exercise recommendations
  • Any other health condition that prevents individual from consuming all their meals orally
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299844

Locations
United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269-4017
Sponsors and Collaborators
University of Connecticut
Hartford Hospital
Hispanic Health Council, Inc.
Investigators
Principal Investigator: Rafael Pérez-Escamilla, PhD University of Connecticut
  More Information

No publications provided

Responsible Party: Rafael Pérez-Escamilla, Ph.D., Director, Center for Eliminating Health Disparities among Latinos
ClinicalTrials.gov Identifier: NCT01299844     History of Changes
Other Study ID Numbers: H05-351
Study First Received: February 15, 2011
Last Updated: February 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut:
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013