Status:
COMPLETED
The Effect of a Traditional Dietary Intervention on Diabetes Mellitus and Cardiovascular Disease Risk Factors in a First Nation Community: A Pilot Study
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Type 2 Diabetes Mellitus
Cardiovascular Disease
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate whether or not a traditional First Nations diet (high protein) and/or a dietary intervention based upon current Canadian dietary recommendations (high carbohyd...
Detailed Description
Eligible participants will be randomized to one of 3 groups. Potential participants will have an oral glucose tolerance test (OGTT) during the screening visit to evaluate if they are eligible for the ...
Eligibility Criteria
Inclusion
- Age 18-50 years
- Sandy Lake First Nation permanent resident, with total travel outside of the community less than one month per year.
- Aboriginal Ethnicity
- BMI = 23-40 kg/m2
- According to Prochaska and DiClemente's transtheoretical model, also referred to as the Stages of Change Theory, potential participants must be at least at the contemplation stage.
- Willing and able to follow the study protocol
Exclusion
- DM detected by OGTT
- Pregnancy, lactation or intention to become pregnant within six months from recruitment
- Any pre-existing condition compromising macronutrient metabolism, quality of life or ability to participate according to protocol. Individuals with the following conditions will be excluded automatically: heart disease, cerebrovascular disease, diagnosed HIV/AIDS, cancer, emphysema, liver or kidney disease
- Insurmountable language barriers
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00707460
Start Date
May 1 2008
End Date
June 1 2009
Last Update
January 20 2010
Active Locations (1)
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1
Sandy Lake Health & Diabetes Project Research Office
Sandy Lake, Ontario, Canada, P0V 1V0