Metabolic SyndromeNCT01277614
Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease
A study testing Therapeutic lifestyle in people with Metabolic Syndrome and Triglycerides, run by The University of The West Indies at 1 site in Trinidad and Tobago.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Triglycerides, Blood Pressure
- What is being tested?
- Therapeutic lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteTrinidad and Tobago
- Study dates
- Sep 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having 2 or more metabolic syndrome components
Who cannot join
- having less than 2 metabolic syndrome components
Trial locations and contacts
1 site in 1 country.
Trinidad and Tobago1 site
Dan Ramdath
Saint Augustine, Mount Hope, TTO
About this study
Official title: A Randomized Control Trial for the Implementation of Lifestyle Modifications to Reduce the Burden of Chronic Disease Among University Staff
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.
Read the 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
- Being tested
- Therapeutic lifestyle
- Keywords
- lifestyle, diet, exercise
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic lifestyleBehavioural
Also called diet counseling, exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | 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. Receives: Behavioral: Therapeutic lifestyle |
| Health Literature | Placebo comparator | Not described Receives: Behavioral: Therapeutic lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease waist circumference
Measured: 6 months
decrease fasting blood glucose
Measured: 6 months
decrease body mass index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Investigators
- Dan D Ramdath, PhD, Study director, The University of The West IndiesDebbie G Hilaire, MSc, RD, Principal investigator, The University of The West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277614
- Sponsor's protocol ID
- FMS-STA-08-01
- Status last verified
- Jan 2011
- First submitted
- 14 Jan 2011
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial for the Implementation of Lifestyle Modifications to Reduce the Burden of Chronic Disease Among University Staff
- ClinicalTrials.gov ID
- NCT01277614
- Acronym / sponsor ID
- FMS-STA-08-01
- Conditions
- Metabolic Syndrome, Triglycerides, Blood Pressure, Diabetes
- Keywords
- lifestyle, diet, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Therapeutic lifestyleThis 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. |
| Health Literature | Placebo comparator | Behavioral: Therapeutic lifestyle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- having 2 or more metabolic syndrome components
Key exclusion criteria (1 listed)
- having less than 2 metabolic syndrome components
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic lifestyleAlso: diet counseling, exerciseThis 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. | Behavioural | Health Literature, Lifestyle counseling |
Primary outcome
decrease waist circumference
Time frame: 6 months
decrease fasting blood glucose
Time frame: 6 months
decrease body mass index
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2011.
- BackgroundEzenwaka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan D Ramdath, PhD study director
The University of The West Indies
Debbie G Hilaire, MSc, RD principal investigator
The University of The West Indies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic lifestyle in people with Metabolic Syndrome and Triglycerides, run by The University of The West Indies at 1 site in Trinidad and Tobago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Trinidad and Tobago. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease waist circumference (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01277614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2011.