Lawrence Latino Diabetes Prevention Project

Metabolic Syndrome Clinical Trial

— LLDPP  

Official title:

Lawrence Latino Diabetes Prevention Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810290
• Other study ID #: H-11214
• Secondary ID: DK67549
• Status: Completed
• Phase: N/A
• First received: December 17, 2008
• Last updated: February 4, 2010
• Start date: July 2004
• Est. completion date: July 2008

Study information

• Verified date: February 2010
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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.

Locations

Country	Name	City	State
United States	Lawrence Senior Center	Lawrence	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Olendzki BC, Ma Y, Hébert 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss.		1 year	No
Primary	HgbA1c		1 year	No
Secondary	Change in fasting blood sugar.		1 year	No
Secondary	Changes in LDL- and HDL-cholesterol.		1 year	No
Secondary	Change in blood pressure.		1 year	No
Secondary	Change in depression.		1 year	No
Secondary	Change in quality of life.		1 year	No