Lawrence Latino Diabetes Prevention Project (LLDPP)

This study has been completed.
Sponsor:
Collaborator:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 August 25, 2014