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Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease

Primary Purpose

Metabolic Syndrome, Triglycerides, Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
Trinidad and Tobago
Study Type
Interventional
Intervention
Therapeutic lifestyle
Sponsored by
The University of The West Indies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring lifestyle, diet, exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • having 2 or more metabolic syndrome components

Exclusion Criteria:

  • having less than 2 metabolic syndrome components

Sites / Locations

  • Dan Ramdath

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lifestyle counseling

Health Literature

Arm Description

This is a 6-month intervention in which participants with 2 or more MS components are randomly assigned to intervention or control group. Intervention comprise individual diet counseling, an exercise plan and monthly lifestyle workshops. Controls receive printed material on healthy eating and lifestyle modification.

Outcomes

Primary Outcome Measures

decrease waist circumference
decrease fasting blood glucose
decrease body mass index

Secondary Outcome Measures

Full Information

First Posted
January 14, 2011
Last Updated
January 14, 2011
Sponsor
The University of The West Indies
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1. Study Identification

Unique Protocol Identification Number
NCT01277614
Brief Title
Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease
Official Title
A Randomized Control Trial for the Implementation of Lifestyle Modifications to Reduce the Burden of Chronic Disease Among University Staff
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of The West Indies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators previously established that there was a high burden of disease among all categories of staff at the University of the West Indies, St. Augustine and in many ways, this group is typical of the working class of the Caribbean population. Many had poor lifestyle behaviors, 23.8% had Metabolic Syndrome (MS) with many having one or more MS components. Since most time is spent at work, the workplace is understandably the most logical location to address issues pertaining to health, disease prevention and wellness and on-site programs have yielded many health and other benefits to employees and employers alike. Onwards of the 1980s, numerous studies have been done on work-site intervention programs and these have shown that if a company is able to identify employees at risk for developing health problems and then intervene, health risks and the resulting medical problems are reduced. Such a program, if tailored to meet the needs of participants, may yield similar benefits among the staff of the University of the West Indies.
Detailed Description
To conduct a randomized controlled intervention of lifestyle modifications among individuals with a high burden of metabolic syndrome components such as high body mass index, high fasting blood glucose and abnormal lipid profile. A 6-month intervention is designed for implementation to detect a 20% reduction in MS components with 90% confidence. Participants (n=148) had 2 or more MS components and will be randomly assigned to intervention or control group. Intervention will comprise individual diet counseling, an exercise plan and monthly lifestyle workshops. Controls will receive printed material on healthy eating and lifestyle modification.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Triglycerides, Blood Pressure, Diabetes
Keywords
lifestyle, diet, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
This is a 6-month intervention in which participants with 2 or more MS components are randomly assigned to intervention or control group. Intervention comprise individual diet counseling, an exercise plan and monthly lifestyle workshops. Controls receive printed material on healthy eating and lifestyle modification.
Arm Title
Health Literature
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic lifestyle
Other Intervention Name(s)
diet counseling, exercise
Intervention Description
This is a 6-month intervention in which participants with 2r more MS components are randomly assigned to intervention or control group. Intervention comprise individual diet counseling, an exercise plan and monthly lifestyle workshops. Controls receive printed material on healthy eating and lifestyle modification.
Primary Outcome Measure Information:
Title
decrease waist circumference
Time Frame
6 months
Title
decrease fasting blood glucose
Time Frame
6 months
Title
decrease body mass index
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: having 2 or more metabolic syndrome components Exclusion Criteria: having less than 2 metabolic syndrome components
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan D Ramdath, PhD
Organizational Affiliation
The University of The West Indies
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Debbie G Hilaire, MSc, RD
Organizational Affiliation
The University of The West Indies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dan Ramdath
City
St. Augustine
State/Province
Mt. Hope
ZIP/Postal Code
TTO
Country
Trinidad and Tobago

12. IPD Sharing Statement

Citations:
Citation
Ezenwaka CE, Nwagbara E, Seales D, Okali F, Sell H, Eckel J.Insulin resistance, leptin and monocyte chemotactic protein-1 levels in diabetic and non-diabetic Afro-Caribbean subjects.Arch Physiol Biochem. 2009 Feb;115(1):22-7. Ezenwaka CE, Nwagbara E, Seales D, Okali F, Hussaini S, Raja B, Wheeler V, Sell H, Avci H, Eckel J. A comparative study of the prevalence of the metabolic syndrome and its components in type 2 diabetic patients in two Caribbean islands using the new International Diabetes Federation definition. Arch Physiol Biochem. 2007 Oct-Dec;113(4-5):202-10. Ezenwaka CE.Serum lipid concentrations and Indices of obesity among adult subjects of the West Indies. Ann Saudi Med. 2002 Jan-Mar;22(1-2):112-4. Ezenwaka CE, Offiah NV.Differences in cardiovascular disease risk factors in elderly and younger patients with type 2 diabetes in the West Indies. Singapore Med J. 2002 Oct;43(10):497-503. Ezenwaka CE, Kalloo R.Indices of obesity, dyslipidemia, and insulin resistance in apparently healthy Caribbean subjects. J Clin Lab Anal. 2003;17(1):6-11.
Results Reference
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Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease

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