Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Triglycerides; Blood Pressure; Diabetes
• Interventions: Behavioral: Therapeutic lifestyle

• Registration Number: NCT01277614
• Lead Sponsor: The University of The West Indies

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.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Last Update Submitted: 2011-01-14
• Study First Posted: 2011-01-17
• Last Update Posted: 2011-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• having 2 or more metabolic syndrome components

Exclusion Criteria

• having less than 2 metabolic syndrome components

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Therapeutic lifestyle	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.
Health Literature	Therapeutic lifestyle	-

Primary Outcome Measures

Name	Time	Method
decrease waist circumference	6 months
decrease fasting blood glucose	6 months
decrease body mass index	6 months

Trial Locations

Locations (1)

Dan Ramdath; 🇹🇹 St. Augustine, Mt. Hope, Trinidad and Tobago