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OpenTrials
Completed

NCT Number: NCT00848315

Diabetes Management in Low-Income Hispanic Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brightwood Health Center, Springfield, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with T2DM (documented in the medical chart);
  • HbA1c level > 7.5;
  • 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;
  • Hispanic origin;
  • > 18 years old;
  • Telephone in home or easy access to one;
  • Able to understand and participate in the study protocol;
  • Functionally capable of meeting the activity goals;
  • 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);
  • Physician approval to participate in the study.

Exclusion criteria

  • History of diabetic ketoacidosis
  • Gestational diabetes
  • Unable or unwilling to provide informed consent;
  • Plans to move out of the area within the 12-month study period;
  • Required intermittent glucocorticoid therapy within the past 3 months;
  • Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 mos
  • Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease);
  • 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.

Treatment and study plan

Cognitive Behavioral Intervention

Behavioral

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

Primary outcomes

  1. The primary outcome is improvement in metabolic control (HbA1c).

    Time frame: The primary outcome was evaluated at 4- and 12-months following randomization.

Secondary outcomes

  1. Efficacy of the intervention

    Time frame: 4- and 12-months following the intervention

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Feb 20, 2009
Registry last updated
Sep 13, 2023

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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