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

December 17, 2008
February 4, 2010
July 2004
July 2008   (final data collection date for primary outcome measure)
  • Weight loss. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • HgbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00810290 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 hemoglobin A1C levels. [ 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 ]
Not Provided
Not Provided
 
Lawrence Latino Diabetes Prevention Project
Lawrence Latino Diabetes Prevention Project

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Metabolic Syndrome
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
312
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00810290
H-11214, DK67549
No
Ira S. Ockene, M.D., University of Massachusetts Medical School
University of Massachusetts, Worcester
National Institutes of Health (NIH)
Principal Investigator: Ira S Ockene, MD University of Massachusetts, Worcester
University of Massachusetts, Worcester
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP