Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease

NCT ID: NCT01277614

Last Updated: 2011-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2010-12-31

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.

Conditions

Metabolic Syndrome; Triglycerides; Blood Pressure; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapeutic lifestyle

Intervention Type: 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.

Health Literature

Group Type: PLACEBO_COMPARATOR

Therapeutic lifestyle

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

diet counseling; exercise

Eligibility Criteria

Inclusion Criteria

• having 2 or more metabolic syndrome components

Exclusion Criteria

• having less than 2 metabolic syndrome components

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of The West Indies

OTHER

Sponsor Role: lead

Responsible Party

The University of the West Indies

Principal Investigators

Dan D Ramdath, PhD

Role: STUDY_DIRECTOR

The University of The West Indies

Debbie G Hilaire, MSc, RD

Role: PRINCIPAL_INVESTIGATOR

The University of The West Indies

Locations

Dan Ramdath

Saint Augustine, Mount Hope, Trinidad and Tobago

Countries

Trinidad and Tobago

References

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.

Reference Type: BACKGROUND

Other Identifiers

FMS-STA-08-01

Identifier Type: -

Identifier Source: org_study_id