- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01277614
Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease
A Randomized Control Trial for the Implementation of Lifestyle Modifications to Reduce the Burden of Chronic Disease Among University Staff
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mt. Hope
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St. Augustine, Mt. Hope, Trinidad and Tobago, TTO
- Dan Ramdath
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- having 2 or more metabolic syndrome components
Exclusion Criteria:
- having less than 2 metabolic syndrome components
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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:
|
Placebo Comparator: Health Literature
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
decrease waist circumference
Time Frame: 6 months
|
6 months
|
decrease fasting blood glucose
Time Frame: 6 months
|
6 months
|
decrease body mass index
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Investigators
- Study Director: Dan D Ramdath, PhD, The University of the West Indies
- Principal Investigator: Debbie G Hilaire, MSc, RD, The University of the West Indies
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMS-STA-08-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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