Diabetes Management in Low-Income Hispanic Patients

Phase 2

Completed

• Conditions: Glycemic Control; Type 2 Diabetes
• Interventions: Behavioral: Cognitive Behavioral Intervention

• Registration Number: NCT00848315
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

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.

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 Timeline

• Study Start: 2004-07
• Primary Completion: 2008-06
• Study Completion: 2008-07
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Cognitive Behavioral Intervention	Cognitive Behavioral Intervention

Primary Outcome Measures

Name	Time	Method
The primary outcome is improvement in metabolic control (HbA1c).	The primary outcome was evaluated at 4- and 12-months following randomization.

Secondary Outcome Measures

Name	Time	Method
Efficacy of the intervention	4- and 12-months following the intervention

Trial Locations

Locations (5)

Family Health Center; 🇺🇸 Worcester, Massachusetts, United States

Northgate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Brightwood Health Center; 🇺🇸 Springfield, Massachusetts, United States

Plumley Village; 🇺🇸 Worcester, Massachusetts, United States

High Street Health Center; 🇺🇸 Springfield, Massachusetts, United States