Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277614
• Other study ID #: FMS-STA-08-01
• Status: Completed
• Phase: N/A
• First received: January 14, 2011
• Last updated: January 14, 2011
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: The University of The West Indies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Trinidad and Tobago : Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• having 2 or more metabolic syndrome components

Exclusion Criteria:

• having less than 2 metabolic syndrome components

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure
• Chronic Disease
• Diabetes
• Metabolic Syndrome
• Metabolic Syndrome X
• Triglycerides

Intervention

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.

Locations

Country	Name	City	State
Trinidad and Tobago	Dan Ramdath	St. Augustine	Mt. Hope

Sponsors (1)

Lead Sponsor	Collaborator
The University of The West Indies

Country where clinical trial is conducted

Trinidad and Tobago, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease waist circumference		6 months	No
Primary	decrease fasting blood glucose		6 months	No
Primary	decrease body mass index		6 months	No