Lawrence Latino Diabetes Prevention Project

NCT ID: NCT00810290

Last Updated: 2010-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2008-07-31

Brief Summary

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.

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

University of Massachusetts Medical School

Principal Investigators

Ira S Ockene, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

Lawrence Senior Center

Lawrence, Massachusetts, United States

Countries

United States

References

Olendzki BC, Ma Y, Hebert JR, Pagoto SL, Merriam PA, Rosal MC, Ockene IS. Underreporting of energy intake and associated factors in a Latino population at risk of developing type 2 diabetes. J Am Diet Assoc. 2008 Jun;108(6):1003-8. doi: 10.1016/j.jada.2008.03.006.

Reference Type: BACKGROUND

PMID: 18502234 (View on PubMed)

Ockene IS, Tellez TL, Rosal MC, Reed GW, Mordes J, Merriam PA, Olendzki BC, Handelman G, Nicolosi R, Ma Y. Outcomes of a Latino community-based intervention for the prevention of diabetes: the Lawrence Latino Diabetes Prevention Project. Am J Public Health. 2012 Feb;102(2):336-42. doi: 10.2105/AJPH.2011.300357. Epub 2011 Dec 15.

Reference Type: DERIVED

PMID: 22390448 (View on PubMed)

Merriam PA, Tellez TL, Rosal MC, Olendzki BC, Ma Y, Pagoto SL, Ockene IS. Methodology of a diabetes prevention translational research project utilizing a community-academic partnership for implementation in an underserved Latino community. BMC Med Res Methodol. 2009 Mar 13;9:20. doi: 10.1186/1471-2288-9-20.

Reference Type: DERIVED

PMID: 19284663 (View on PubMed)

Other Identifiers

DK67549

Identifier Type: -

Identifier Source: secondary_id

H-11214

Identifier Type: -

Identifier Source: org_study_id