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

NCT00707460 | Completed Phase 1

• 2 other identifiers: 22419MOP44076
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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?

Conditions

Type 2 Diabetes Mellitus; Cardiovascular Disease; Obesity

Keywords

Diabetes; Cardiovascular; Obesity; First.Nation; Aboriginal (Health); Dietary; Intervention; Nutrition; Traditional (Diet); Sandy Lake (Health & Diabetes Project); (High) protein; (High) fibre (er); (Low) carbohydrate

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (6)

• 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.

  6 months

• Blood pressure (BP) and heart rate

  6 months

• Non-traditional CVD risk factors: serum C-reactive protein (CRP) and adiponectin.

  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.

  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.

  6 months

Study Arms (3)

1

ACTIVE COMPARATOR

Please, see design section for details.

Behavioral: Dietary Intervention (Macronutrient composition)

2

EXPERIMENTAL

Traditional Diet Please, see design section for details.

Behavioral: Dietary Intervention (Macronutrient composition)

3

EXPERIMENTAL

Healthy Store-bought Diet Please, see design section for details.

Behavioral: Dietary Intervention (Macronutrient composition)

Interventions

Dietary Intervention (Macronutrient composition) BEHAVIORAL

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.

Also known as: high protein diet = traditional diet, high fiber diet = healthy store-bought diet, high carbohydrate diet = healthy store-bought diet

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Sandy Lake Health & Diabetes Project Research Office

Sandy Lake, Ontario, P0V 1V0, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Obesity; Diabetes Mellitus

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Thomas MS Wolever, DM, PhD

  University of Toronto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 20, 2010

Record last verified: 2010-01

Locations

CA (1)