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Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease

This study has been completed.
Sponsor:
Information provided by:
The University of The West Indies
ClinicalTrials.gov Identifier:
NCT01277614
First received: January 14, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Triglycerides
Blood Pressure
Diabetes
 Behavioral: Therapeutic lifestyle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Control Trial for the Implementation of Lifestyle Modifications to Reduce the Burden of Chronic Disease Among University Staff

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of The West Indies:

Primary Outcome Measures:
  • decrease waist circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • decrease fasting blood glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • decrease body mass index [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
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.
 Behavioral: Therapeutic lifestyle
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.
Other Names:
  • diet counseling
  • exercise
Placebo Comparator: Health Literature Behavioral: Therapeutic lifestyle
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.
Other Names:
  • diet counseling
  • exercise

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • having 2 or more metabolic syndrome components

Exclusion Criteria:

  • having less than 2 metabolic syndrome components
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277614

Locations
Trinidad and Tobago
Dan Ramdath
St. Augustine, Mt. Hope, Trinidad and Tobago, TTO
Sponsors and Collaborators
The University of The West Indies
Investigators
Study Director: Dan D Ramdath, PhD The University of The West Indies
Principal Investigator: Debbie G Hilaire, MSc, RD The University of The West Indies
  More Information

No publications provided

Responsible Party: Professor Dan Ramdath, The University of the West Indies
ClinicalTrials.gov Identifier: NCT01277614     History of Changes
Other Study ID Numbers: FMS-STA-08-01
Study First Received: January 14, 2011
Last Updated: January 14, 2011
Health Authority: Trinidad and Tobago : Ministry of Health

Keywords provided by The University of The West Indies:
lifestyle
diet
exercise

Additional relevant MeSH terms:
Chronic Disease
Metabolic Syndrome X
Disease Attributes
Pathologic Processes
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013