NCT01577719

Brief Summary

People who originate from the Indian subcontinent known as South Asians are the fastest growing group of non-white Canadians. They suffer an excess prevalence of abdominal obesity, type 2 diabetes and heart disease. They also develop these risk factors at significantly lower body weight and at younger ages compared to people of European origin. The purpose of SAHARA (South Asian HeArt Risk Assessment) Pilot, is to recruit 400 South Asians from Ontario, who use the internet, email and other multimedia devices. Among these participants the investigators will compare the effectiveness of a 6-month interactive multi-media health behaviour intervention to usual care in reducing cardiac risk factors. This intervention enables participants to set their health goals and provides health messaging and feedback designed to improve their smoking, dietary habits and physical activity. In addition, the investigators will test if knowledge of genetic risk for heart attack influences behaviour change and their heart health risk factor profile. The information generated from SAHARA will enable individuals, physicians, health professionals, and policy makers to develop risk factor modification programs to prevent cardiovascular disease in this high-risk group.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

3.4 years

First QC Date

April 11, 2012

Last Update Submit

June 8, 2016

Conditions

Cardiovascular DiseasesDiabetesAbdominal Obesity

Keywords

CardiovascularPreventionEthnicityCultureInternetText Message

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of a 6 month culturally-specific multi-media intervention on Heart Health Risk

    To test the effectiveness of a 6 month culturally-specific multi-media intervention which provides health messaging and feedback regarding optimal strategies for individuals greater than 30 years to improve their dietary habits, sedentary behaviours, physical activity, and tobacco use.

    Baseline and at 6 months from randomization

Secondary Outcomes (2)

  • Influence of knowledge of personal genetic risk for Myocardial Infarction on health behaviours

    Baseline and at 6 months from randomization

  • Change in the MI risk score and clinical events

    Baseline and at 6 months from randomization

Study Arms (2)

Multimedia Lifestyle Improvement

ACTIVE COMPARATOR

Multimedia lifestyle intervention

Behavioral: Multimedia Lifestyle Improvement

Usual Care

PLACEBO COMPARATOR

usual care

Behavioral: Usual Care

Interventions

Multimedia Lifestyle ImprovementBEHAVIORAL

* Online Goal setting to improve diet, physical activity or smoking behaviours * regular health messaging related to the participant's goal, sent by email or text messaging, based on participant preference. * Bi-weekly email reminder to report back on the current lifestyle goal and choose the next goal for upcoming 2 weeks.

Multimedia Lifestyle Improvement
Usual CareBEHAVIORAL

Participant will be refered to SAHARA study website to get information on healthy lifestyle and to get regular update for the course of follow-up.

Usual Care

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • South Asian Ancestry (originating from India, Pakistan, Bangladesh and Sri Lanka);
  • Greater than or equal to 30 years of age;
  • No previous cardiovascular disease

You may not qualify if:

  • Not residents of Ontario

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Population Health Research Institute

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

  • Samaan Z, Schulze KM, Middleton C, Irvine J, Joseph P, Mente A, Shah BR, Pare G, Desai D, Anand SS; SAHARA Investigators. South Asian Heart Risk Assessment (SAHARA): Randomized Controlled Trial Design and Pilot Study. JMIR Res Protoc. 2013 Aug 20;2(2):e33. doi: 10.2196/resprot.2621.

    PMID: 23965279DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusObesity, Abdominal

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sonia Anand, MD, PhD

    McMaster University; Hamilton Health Sciences; Population Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 16, 2012

Study Start

June 1, 2009

Primary Completion

November 1, 2012

Last Updated

June 9, 2016

Record last verified: 2016-06

Locations

CA(1)