NCT01766453

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. 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

December 11, 2012

Last Update Submit

May 18, 2015

Conditions

Keywords

South AsianCardiovascularExerciseObesityVisceral Adipose Tissue

Outcome Measures

Primary Outcomes (1)

  • Visceral adipose tissue

    Visceral adipose tissue will be assessed with multi-slice computed tomography

    12 weeks

Secondary Outcomes (3)

  • Cardiometabolic risk factors

    12 weeks

  • Body Composition

    12 weeks

  • Maximal Aerobic Fitness

    12 weeks

Study Arms (3)

Non exercise control

NO INTERVENTION

Non exercise control will undergo baseline testing and follow up testing but will not participate in an exercise intervention.

Standard Exercise

EXPERIMENTAL

The standard exercise group will attend exercise sessions under the supervision of a Certified Personal Trainer. Intensity will increase every four weeks by 10% from 50-80% of maximal heart rate to ensure that exercise is progressive in nature. Participants will be provided with a heart rate monitor during their exercise sessions and have the option to perform the aerobic training on a treadmill, upright bike, elliptical machine or recumbent bike as long as heart rate is kept within the prescribed training intensity. Intensity, duration, resting and exercise heart rates will be recorded for each exercise session for the duration of the intervention to ensure compliance to the exercise program.

Behavioral: Standard Exercise

Bhangra Dance Exercise

EXPERIMENTAL

Bhangra dance classes taught be a certified instructor progressing in difficulty over the 12 week period. Bhangra dance is an Indian folk dance that consists of jumping and kicking of a high intensity. This group will attend exercise sessions under the supervision of a Bhangra Dance Instructor. The intensity of bhangra dance will be tracked through heart rate monitors worn by participants.

Behavioral: Bhangra dance exercise

Interventions

Aerobic exercise with a progressive increase in intensity over 12 weeks.

Standard Exercise

Bhangra Dance classes taught by an instructor.

Bhangra Dance Exercise

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simon Fraser University

Vancouver, British Columbia, V6B5K3, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Scott A Lear, PhD

    Simon Fraser University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2012

First Posted

January 11, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations