Clinical trial NCT00810290: Lawrence Latino Diabetes Prevention Project
Official title: Lawrence Latino Diabetes Prevention Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome
Latino health
Community participatory research
Translational Research
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-12-18
Enrollment: 312
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Weight loss.
timeFrame: 1 year
measure: HgbA1c
timeFrame: 1 year
Secondary outcomes:
measure: Change in fasting blood sugar.
timeFrame: 1 year
measure: Changes in LDL- and HDL-cholesterol.
timeFrame: 1 year
measure: Change in blood pressure.
timeFrame: 1 year
measure: Change in depression.
timeFrame: 1 year
measure: Change in quality of life.
timeFrame: 1 year
Other outcomes:
Locations:
city: Lawrence
country: United States
facility: Lawrence Senior Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Ira S Ockene, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.