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Lawrence Latino Diabetes Prevention Project (LLDPP)

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00810290
First received: December 17, 2008
Last updated: February 4, 2010
Last verified: February 2010
History of Changes
  Purpose

The Lawrence Latino Diabetes Prevention Project (LLDPP) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a >30% probability of developing diabetes in the next 7.5 years per a predictive equation. The project was conducted in Lawrence, Massachusetts; a predominantly Caribbean-origin urban Latino community. Individuals were identified primarily from a community health center's patient panel, screened for study eligibility, randomized to either a usual care or a lifestyle intervention condition, and followed for one year.


Condition Intervention
Metabolic Syndrome
 Behavioral: lifestyle intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lawrence Latino Diabetes Prevention Project

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Weight loss. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • HgbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in fasting blood sugar. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Changes in LDL- and HDL-cholesterol. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in blood pressure. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in depression. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in quality of life. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 312
Study Start Date: July 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: lifestyle intervention
    A group-based intervention including 13 group sessions complemented by three individual home visits was developed using principles of social learning theory and patient-centered counseling. The intervention was intended to increase awareness of diabetes prevention strategies, foster positive diabetes prevention attitudes (i.e., self-efficacy) and promote healthy lifestyle behaviors in the target Latino population using literacy-sensitive and culturally-tailored strategies and materials.
Detailed Description:

The group format of the intervention included 13 group sessions complemented by 3 individual home contacts over one year and was implemented by individuals from the community with training and supervision by a clinical research nutritionist and a behavioral psychologist. Study measures included demographics, Stern predictive equation components (age, gender, ethnicity, fasting glucose, systolic blood pressure, HDL-cholesterol, body mass index, and family history of diabetes), glycosylated hemoglobin, dietary intake, physical activity, depressive symptoms, social support, and quality of life. Body weight was measured at baseline, 6-months, and one-year; all other measures were assessed at baseline and one-year. All surveys were orally administered in Spanish.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is Latino/Hispanic;
  • Has a 7.5 year likelihood of becoming diabetic of greater than or equal to 30% as predicted by the Stern formula;
  • Is greater than or equal to 25 years of age;
  • Has a BMI greater than or equal to 24 kg m2.

Exclusion Criteria:

  • An inability or unwillingness to give informed consent;
  • Has clinically diagnosed diabetes, or a fasting blood sugar of greater than or equal to 126 mg/dl;
  • Plans to move out of the area within the study period;
  • Has a psychiatric illness which limits ability to participate;
  • Has no telephone;
  • Is unable to walk unaided, or cannot walk five city blocks (1/4 mile) without stopping;
  • Is not cleared for the PA component by the pt's GLFHC primary care provider;
  • Has a medical conditions likely to limit lifespan;
  • Is on medications or has a medical condition that interfere with the assessment for diabetes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810290

Locations
United States, Massachusetts
Lawrence Senior Center
Lawrence, Massachusetts, United States, 01840
Sponsors and Collaborators
University of Massachusetts, Worcester
National Institutes of Health (NIH)
Investigators
Principal Investigator: Ira S Ockene, MD University of Massachusetts, Worcester
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ira S. Ockene, M.D., University of Massachusetts Medical School
ClinicalTrials.gov Identifier: NCT00810290     History of Changes
Other Study ID Numbers: H-11214, DK67549
Study First Received: December 17, 2008
Last Updated: February 4, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Massachusetts, Worcester:
Metabolic syndrome
Latino health
Community participatory research
Translational Research

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013