Diabetes Management in Low-Income Hispanic Patients
1 other identifier
interventional
252
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes
Started Jul 2004
Longer than P75 for phase_2 type-2-diabetes
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 19, 2009
CompletedFirst Posted
Study publicly available on registry
February 20, 2009
CompletedSeptember 13, 2023
September 1, 2023
3.9 years
February 19, 2009
September 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome is improvement in metabolic control (HbA1c).
The primary outcome was evaluated at 4- and 12-months following randomization.
Secondary Outcomes (1)
Efficacy of the intervention
4- and 12-months following the intervention
Study Arms (2)
1
NO INTERVENTIONUsual Care that the Type 2 Diabetes Patients usually receive at the health centers.
2
EXPERIMENTALCognitive Behavioral Intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Northgate Medical Center
Springfield, Massachusetts, 01103, United States
Brightwood Health Center
Springfield, Massachusetts, 01107, United States
High Street Health Center
Springfield, Massachusetts, 01199, United States
Plumley Village
Worcester, Massachusetts, 01608, United States
Family Health Center
Worcester, Massachusetts, 01610, United States
Related Publications (2)
Wang ML, Gellar L, Nathanson BH, Pbert L, Ma Y, Ockene I, Rosal MC. Decrease in Glycemic Index Associated with Improved Glycemic Control among Latinos with Type 2 Diabetes. J Acad Nutr Diet. 2015 Jun;115(6):898-906. doi: 10.1016/j.jand.2014.10.012. Epub 2014 Dec 26.
PMID: 25547339DERIVEDRosal MC, White MJ, Restrepo A, Olendzki B, Scavron J, Sinagra E, Ockene IS, Thompson M, Lemon SC, Candib LM, Reed G. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control. BMC Med Res Methodol. 2009 Dec 9;9:81. doi: 10.1186/1471-2288-9-81.
PMID: 20003208DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Milagros C Rosal, PhD
University of Massachusetts, Worcester
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2009
First Posted
February 20, 2009
Study Start
July 1, 2004
Primary Completion
June 1, 2008
Study Completion
July 1, 2008
Last Updated
September 13, 2023
Record last verified: 2023-09