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Lawrence Latino Diabetes Prevention Project

Lawrence Latino Diabetes Prevention Project

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00810290
Acronym
LLDPP
Enrollment
312
Registered
2008-12-18
Start date
2004-07-31
Completion date
2008-07-31
Last updated
2010-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome, Latino health, Community participatory research, Translational Research

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.

Interventions

BEHAVIORALlifestyle 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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Weight loss.1 year
HgbA1c1 year

Secondary

MeasureTime frame
Change in blood pressure.1 year
Change in fasting blood sugar.1 year
Change in quality of life.1 year
Change in depression.1 year
Changes in LDL- and HDL-cholesterol.1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026