Clinical trial NCT01766453: South Asian Yoga and Exercise Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: South Asian
Cardiovascular
Exercise
Obesity
Visceral Adipose Tissue
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 75
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Visceral adipose tissue
timeFrame: 12 weeks
Secondary outcomes:
measure: Cardiometabolic risk factors
timeFrame: 12 weeks
measure: Body Composition
timeFrame: 12 weeks
measure: Maximal Aerobic Fitness
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Simon Fraser University
state: British Columbia
Study officials:
affiliation: Simon Fraser University
name: Scott A Lear, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lesser IA, Singer J, Hoogbruin A, Mackey DC, Katzmarzyk PT, Sohal P, Leipsic J, Lear SA. Effectiveness of Exercise on Visceral Adipose Tissue in Older South Asian Women. Med Sci Sports Exerc. 2016 Jul;48(7):1371-8. doi: 10.1249/MSS.0000000000000906.