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The Effect of a Traditional Dietary Intervention on Diabetes Mellitus and Cardiovascular Disease Risk Factors in a First Nation Community: A Pilot Study (SLHDP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00707460
First Posted: June 30, 2008
Last Update Posted: January 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Toronto
  Purpose

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 carbohydrate/high fiber) effects risk factors for type 2 diabetes mellitus and/or cardiovascular disease in a remote fly in First Nations community (Sandy Lake First Nation).

This pilot has been developed in conjunction with Sandy Lake First Nation to answer the research question: Will a traditional diet or a diet based upon current Canadian dietary recommendations result in decreasing risk for type 2 diabetes in Sandy Lake?


Condition Intervention Phase
Type 2 Diabetes Mellitus Cardiovascular Disease Obesity Behavioral: Dietary Intervention (Macronutrient composition) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Objective 3: Pilot Dietary Trial; The Sandy Lake Health & Diabetes Project (SLHDP): Understanding and Addressing Metabolic Syndrome, Diabetes and Associated Complications in Aboriginal Canadians

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Pilot Study: no formal primary outcome measure. There is no noted safety issue for this study; although adverse/side effects and/or symptoms will be closely monitored by the RPN and community research staff. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Indicators of glycemic control: fasting blood glucose, insulin resistance, fasting serum insulin, liver function tests, urine creatinine, sodium and other urinary nutritional indicators (from the same urine sample) and full lipid profile. [ Time Frame: 6 months ]
  • Blood pressure (BP) and heart rate [ Time Frame: 6 months ]
  • Non-traditional CVD risk factors: serum C-reactive protein (CRP) and adiponectin. [ Time Frame: 6 months ]
  • Anthropometric measurements: change in body mass (kg)/BMI over the study period, change in percent body fat and percent lean body mass (bio-electrical impedance analysis [BIA]), and waist and hip circumference. [ Time Frame: 6 months ]
  • Compliance of the sample using three day diet records and appointment attendance. Participants' barriers to compliance will be assessed via the questionnaire(s), diet records and study chart notes. [ Time Frame: 6 months ]
  • Future dietary intervention feasibility will be assessed by 24-hour recalls/ diet records, appointment attendance, participant and community staff feedback, and questionnaire completion. [ Time Frame: 6 months ]

Estimated Enrollment: 60
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Please, see design section for details.
Behavioral: Dietary Intervention (Macronutrient composition)

The Traditional Diet and Healthy Store-Bought arms differ from the control group and one another by their macronutrient composition. Please, see design section for more detail on this item.

All groups are exposed to nutrition education on serving size and portion size.

Other Names:
  • high protein diet = traditional diet
  • high fiber diet = healthy store-bought diet
  • high carbohydrate diet = healthy store-bought diet
Experimental: 2

Traditional Diet

Please, see design section for details.

Behavioral: Dietary Intervention (Macronutrient composition)

The Traditional Diet and Healthy Store-Bought arms differ from the control group and one another by their macronutrient composition. Please, see design section for more detail on this item.

All groups are exposed to nutrition education on serving size and portion size.

Other Names:
  • high protein diet = traditional diet
  • high fiber diet = healthy store-bought diet
  • high carbohydrate diet = healthy store-bought diet
Experimental: 3

Healthy Store-bought Diet

Please, see design section for details.

Behavioral: Dietary Intervention (Macronutrient composition)

The Traditional Diet and Healthy Store-Bought arms differ from the control group and one another by their macronutrient composition. Please, see design section for more detail on this item.

All groups are exposed to nutrition education on serving size and portion size.

Other Names:
  • high protein diet = traditional diet
  • high fiber diet = healthy store-bought diet
  • high carbohydrate diet = healthy store-bought diet

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707460


Locations
Canada, Ontario
Sandy Lake Health & Diabetes Project Research Office
Sandy Lake, Ontario, Canada, P0V 1V0
Sponsors and Collaborators
University of Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
Study Director: Thomas MS Wolever, DM, PhD University of Toronto
  More Information

Additional Information:
Responsible Party: Anthony Hanley, PhD, University of Toronto
ClinicalTrials.gov Identifier: NCT00707460     History of Changes
Other Study ID Numbers: 22419
MOP44076
First Submitted: June 26, 2008
First Posted: June 30, 2008
Last Update Posted: January 20, 2010
Last Verified: January 2010

Keywords provided by University of Toronto:
Diabetes
Cardiovascular
Obesity
First.Nation
Aboriginal (Health)
Dietary
Intervention
Nutrition
Traditional (Diet)
Sandy Lake (Health & Diabetes Project)
(High) protein
(High) fibre (er)
(Low) carbohydrate

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases