Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease

NCT01277614 | Completed DMC

• 1 other identifier: FMS-STA-08-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Triglycerides; Blood Pressure; Diabetes

Keywords

lifestyle; diet; exercise

Outcome Measures

Primary Outcomes (3)

• decrease waist circumference

  6 months

• decrease fasting blood glucose

  6 months

• decrease body mass index

  6 months

Study Arms (2)

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.

Behavioral: Therapeutic lifestyle

Health Literature

PLACEBO COMPARATOR

Behavioral: Therapeutic lifestyle

Interventions

Therapeutic lifestyle 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.

Also known as: diet counseling, exercise

Health Literature; Lifestyle counseling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having 2 or more metabolic syndrome components

You may not qualify if:

• having less than 2 metabolic syndrome components

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

Dan Ramdath

Saint Augustine, Mount Hope, TTO, Trinidad and Tobago

Location

Related 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.

  BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dan D Ramdath, PhD

  The University of The West Indies

  STUDY DIRECTOR

• Debbie G Hilaire, MSc, RD

  The University of The West Indies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 17, 2011

Record last verified: 2011-01

Locations

TR (1)