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Lawrence Latino Diabetes Prevention Project (LLDPP)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lifestyle intervention
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Latino health, Community participatory research, Translational Research

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lawrence Senior Center

Outcomes

Primary Outcome Measures

Weight loss.
HgbA1c

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2008
Last Updated
February 4, 2010
Sponsor
University of Massachusetts, Worcester
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00810290
Brief Title
Lawrence Latino Diabetes Prevention Project
Acronym
LLDPP
Official Title
Lawrence Latino Diabetes Prevention Project
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic syndrome, Latino health, Community participatory research, Translational Research

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
lifestyle intervention
Intervention Description
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 Outcome Measure Information:
Title
Weight loss.
Time Frame
1 year
Title
HgbA1c
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in fasting blood sugar.
Time Frame
1 year
Title
Changes in LDL- and HDL-cholesterol.
Time Frame
1 year
Title
Change in blood pressure.
Time Frame
1 year
Title
Change in depression.
Time Frame
1 year
Title
Change in quality of life.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira S Ockene, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lawrence Senior Center
City
Lawrence
State/Province
Massachusetts
ZIP/Postal Code
01840
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18502234
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.
Results Reference
background
PubMed Identifier
22390448
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.
Results Reference
derived
PubMed Identifier
19284663
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.
Results Reference
derived

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Lawrence Latino Diabetes Prevention Project

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