Lawrence Latino Diabetes Prevention Project

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lawrence Latino Diabetes Prevention Project

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss. |  | 1 year | 
| HgbA1c |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting blood sugar. |  | 1 year | 
| Changes in LDL- and HDL-cholesterol. |  | 1 year | 
| Change in blood pressure. |  | 1 year | 
| Change in depression. |  | 1 year | 
| Change in quality of life. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic syndrome, Latino health, Community participatory research, Translational Research