Clinical trial NCT01277614: Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease
Official title: A Randomized Control Trial for the Implementation of Lifestyle Modifications to Reduce the Burden of Chronic Disease Among University Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Triglycerides
Blood Pressure
Diabetes
Keywords: lifestyle
diet
exercise
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* having 2 or more metabolic syndrome components

Exclusion Criteria:

* having less than 2 metabolic syndrome components

Primary outcomes:
measure: decrease waist circumference
timeFrame: 6 months
measure: decrease fasting blood glucose
timeFrame: 6 months
measure: decrease body mass index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Augustine
country: Trinidad and Tobago
facility: Dan Ramdath
state: Mt. Hope
Study officials:
affiliation: The University of The West Indies
name: Dan D Ramdath, PhD
role: STUDY_DIRECTOR
affiliation: The University of The West Indies
name: Debbie G Hilaire, MSc, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.