South Asian Yoga and Exercise Trial

Obesity Clinical Trial

— SAYET  

Official title:

Utility of a Culturally Relevant or a Standard Exercise Program to Reduce Visceral Adipose Tissue and Cardiovascular Disease Risk in Abdominally Obese Postmenopausal South Asian Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766453
• Other study ID #: SFU
• Status: Completed
• Phase: N/A
• First received: December 11, 2012
• Last updated: May 18, 2015
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Simon Fraser University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

South Asians have one of the highest rates of heart disease of all populations and a unique and deleterious obesity phenotype of increased body fat and inner-abdominal compared to those of European background. We have subsequently identified that this unique phenotype accounts for much of the increased heart disease risk in South Asians, with the greater amounts of inner abdominal fat being particularly implicated. In addition, South Asians in Canada have substantially lower levels of leisure-time physical activity.

At present, we do not know the answers to the following questions:

1. Is a conventional (standard) physical activity program that has proven effective at reducing inner abdominal fat and heart disease risk factors in populations of European background be effective in South Asians?

2. Is an alternative physical activity program commonly practiced by South Asians (such as bhangra dance) be effective at reducing inner abdominal fat and heart disease risk factors in South Asians? In this study, we will perform a randomized controlled trial of three conditions—gym-based standard exercise program (SE),bhangra dance exercise program (BE) and non-exercise control (NE).We will recruit 75 post-menopausal South Asian women with abdominal obesity and assign them randomly to one of the three groups (25 per group).

We anticipate that both the SE and BE programs will be superior to the NE group in terms of reducing VAT and CVD risk factors. Such findings will demonstrate that exercise is an effective method that favourably modifies the obesity phenotype of excess VAT in South Asians, and should be central to health promotion and disease prevention strategies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Post-menopausal South Asian women defined as not menstruating for the previous 12 consecutive months as assessed by self report

• Waist circumference >80 cm (women), as identified as South Asian cut offs by International Diabetes Federation109

• Able to read and write and understand English

• Previously sedentary (<150 minutes of physical activity per week as assessed by accelerometry)

• Weight stable (<2kg of weight change over the past 6 weeks)

Exclusion Criteria:

• Taking medication that may affect study outcomes (lipid-lowering, antihypertensive, or hypoglycemic medications)

• Unable to provide informed consent

• Individuals > 136 kg (physical limitation of DXA scanner table)

• Smokers (given the confounding association between smoking and adiposity)

• Unable to participate in exercise sessions due to physical limitations or contra-indications to regular exercise as indicated on the baseline maximal exercise stress test

• Individuals with known CVD or other known comorbidities (HIV, immune compromised condition, type 1 or 2 diabetes mellitus)

• Another member of the household already participating in study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Standard Exercise
Aerobic exercise with a progressive increase in intensity over 12 weeks.
• Bhangra dance exercise
Bhangra Dance classes taught by an instructor.

Locations

Country	Name	City	State
Canada	Simon Fraser University	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Simon Fraser University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visceral adipose tissue	Visceral adipose tissue will be assessed with multi-slice computed tomography	12 weeks	No
Secondary	Cardiometabolic risk factors	Blood will be drawn and assessed for lipids, glucose, insulin, CRP, adiponectin and ALT	12 weeks	No
Secondary	Body Composition	DEXA scans will be used to assess body fat distribution and lean body mass	12 weeks	No
Secondary	Maximal Aerobic Fitness	A Bruce protocol treadmill test with metabolic data will be used to assess aerobic fitness	12 weeks	No