Diabetes Management in Low-Income Hispanic Patients

September 11, 2023 updated by: University of Massachusetts, Worcester
The overall goal of this randomized clinical trial (RCT) is to test the efficacy of a culturally- and literacy-tailored cognitive-behavioral intervention designed to enhance adherence to diabetes self-management behaviors and improve glycemic control among low-income Hispanic individuals with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomly assigned to a Usual Care condition or to the Cognitive Behavioral Intervention condition. The unit of randomization and analysis is the patient. The intervention is implemented by a nutritionist, a nurse diabetes educator and an assistant, and patients are encouraged to bring a family member or friend living in the same household to facilitate home-based support for the intervention. The intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate pts.

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • Northgate Medical Center
      • Springfield, Massachusetts, United States, 01107
        • Brightwood Health Center
      • Springfield, Massachusetts, United States, 01199
        • High Street Health Center
      • Worcester, Massachusetts, United States, 01608
        • Plumley Village
      • Worcester, Massachusetts, United States, 01610
        • Family health center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosed with T2DM (documented in the medical chart);
  2. HbA1c level > 7.5;
  3. Currently treated with diet, oral hypoglycemics or insulin. If currently on insulin, must have a history of prior therapy with diet alone or oral hypoglycemic agents;
  4. Hispanic origin;
  5. > 18 years old;
  6. Telephone in home or easy access to one;
  7. Able to understand and participate in the study protocol;
  8. Functionally capable of meeting the activity goals;
  9. Understands and can provide informed consent (English or Spanish; for illiterate pts we will require that a representative of the pt also understands and signs the consent form on behalf of the pt);
  10. Physician approval to participate in the study.

Exclusion Criteria:

  1. History of diabetic ketoacidosis
  2. Gestational diabetes
  3. Unable or unwilling to provide informed consent;
  4. Plans to move out of the area within the 12-month study period;
  5. Required intermittent glucocorticoid therapy within the past 3 months;
  6. Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 mos
  7. Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease);
  8. Has a medical or psychiatric illness (i.e., dementia, psychiatric hospitalization or suicidality within past 5 years or takes an atypical neuroleptic medication). We will not exclude individuals with a diagnosis of depression or pts taking anti-depressants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Usual Care that the Type 2 Diabetes Patients usually receive at the health centers.
Experimental: 2
Cognitive Behavioral Intervention
Behavioral: Cognitive Behavioral Intervention
The intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate patients.
Other Names:
  • Diabetes Self-Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome is improvement in metabolic control (HbA1c).
Time Frame: The primary outcome was evaluated at 4- and 12-months following randomization.
The primary outcome was evaluated at 4- and 12-months following randomization.

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy of the intervention
Time Frame: 4- and 12-months following the intervention
4- and 12-months following the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Milagros C Rosal, PhD, University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimated)

February 20, 2009

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R18DK065985 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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