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OpenTrials
Completed

NCT Number: NCT01299844

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

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.

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs, Connecticut, 06269-4017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Diabetes Peer Counseling

Behavioral

16 Home visits from a bilingual/bicultural diabetes peer counselor.

Other names: DIALBEST

Primary outcomes

  1. Hemoglobin A1c

    Time frame: Change in Baseline in HbA1c at 6 Months

Secondary outcomes

  1. Diabetes Knowledge Test Score

    Time frame: Change from Baseline in Diabetes Knowledge Test Score at 6 Months

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • Hartford Hospital
  • Hispanic Health Council, Inc.

Registry information

Acronym: DIALBEST

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Feb 18, 2011
Registry last updated
Feb 18, 2011

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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