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Completed

NCT Number: NCT00810290

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lawrence Senior Center

Lawrence, Massachusetts, 01840, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Intervention

Behavioral

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.

Primary outcomes

  1. Weight loss.

    Time frame: 1 year

  2. HgbA1c

    Time frame: 1 year

Secondary outcomes

  1. Change in fasting blood sugar.

    Time frame: 1 year

  2. Changes in LDL- and HDL-cholesterol.

    Time frame: 1 year

  3. Change in blood pressure.

    Time frame: 1 year

  4. Change in depression.

    Time frame: 1 year

  5. Change in quality of life.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: LLDPP

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Dec 18, 2008
Registry last updated
Feb 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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