Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease

The University of The West Indies

Status: Completed

Conditions: Diabetes; Blood Pressure; Triglycerides; Metabolic Syndrome

Treatments: Behavioral: Therapeutic lifestyle

Study type: Interventional

Funder types: Other

Identifiers

NCT01277614

FMS-STA-08-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• having 2 or more metabolic syndrome components

Exclusion criteria

• having less than 2 metabolic syndrome components

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups, including a placebo group

Lifestyle counseling

Experimental group

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.

Treatment:

Behavioral: Therapeutic lifestyle

Health Literature

Placebo Comparator group

Treatment:

Behavioral: Therapeutic lifestyle