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Completed

NCT Number: NCT01277614

Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease

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.

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Key information

Conditions

Metabolic Syndrome Behavior Blood Pressure Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Triglycerides

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dan Ramdath

Saint Augustine, Mount Hope, TTO, Trinidad and Tobago

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • having 2 or more metabolic syndrome components

Exclusion criteria

  • having less than 2 metabolic syndrome components

Treatment and study plan

Therapeutic lifestyle

Behavioral

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

Primary outcomes

  1. decrease waist circumference

    Time frame: 6 months

  2. decrease fasting blood glucose

    Time frame: 6 months

  3. decrease body mass index

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

The University of The West Indies

Other

Registry information

Official study title

A Randomized Control Trial for the Implementation of Lifestyle Modifications to Reduce the Burden of Chronic Disease Among University Staff

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 17, 2011
Registry last updated
Jan 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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