The Effect of a Traditional Dietary Intervention on Diabetes Mellitus and Cardiovascular Disease Risk Factors in a First Nation Community: A Pilot Study - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Dietary Fiber Obesity

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
Blood pressure (BP) and heart rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Non-traditional CVD risk factors: serum C-reactive protein (CRP) and adiponectin. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Anthony Hanley, PhD, PI This link exits the ClinicalTrials.gov site

Website run by local community staff; no direct ties to UofT This link exits the ClinicalTrials.gov site

Thomas Wolever, study affiliate This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Anthony Hanley, PhD, University of Toronto
ClinicalTrials.gov Identifier:	NCT00707460 History of Changes
Other Study ID Numbers:	22419, MOP44076
Study First Received:	June 26, 2008
Last Updated:	January 18, 2010
Health Authority:	Canada: Ethics Review Committee

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:

Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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