The Effect of a Traditional Dietary Intervention on Diabetes Mellitus and Cardiovascular Disease Risk Factors in a First Nation Community: A Pilot Study
Condition: Type 2 Diabetes Mellitus; Cardiovascular Disease; Obesity
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

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?
    

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 study. Those who meet the inclusion criteria will be stratified according to
      diagnoses (normal glucose tolerance or impaired glucose tolerance) and randomized to one of
      three diet groups for a 6 month period.

      The following is a description of the 3 study arms/diets:

      Group 1: The (Food choice) Control Group

      Group 2 (The "Traditional Food" [TD] Group) will receive instruction to follow a diet that
      reflects the traditional nutrient intake pattern of this population. Briefly, participants
      will be encouraged to consume, wild meats (i.e. moose, duck, rabbit, and beaver), fish, local
      berries and other foods obtained from the land ("bush foods"). When these foods are not
      available, acceptable store bought substitutes will be encouraged (i.e. low fat beef & pork,
      skinless chicken, canned/frozen fish, store bought fruit and frozen berries). Traditional
      preparation methods will also be encouraged (i.e. boiling, smoking, and BBQing), and
      non-traditional foods (i.e. high saturated fat, high carbohydrate, processed foods, high
      sodium foods, "junk foods", convenience foods or foods including trans fats) and preparation
      methods (i.e. frying) will be strongly discouraged. The diet has been developed by a
      Registered Dietitian (RD) with the feedback of Sandy Lake First Nation community members, Dr.
      Anthony Hanley and with the assistance of tools and documents obtained from Health Canada's
      website.

      Group 3 (The "Healthy Store-bought Food" [HSF] Group) will receive instruction to follow a
      diet that reflects the results of nutritional epidemiological research on diabetes prevention
      in this and other populations. Participants will be encouraged to consume a diet comprised of
      foods as per the Canadian Food Guide to Healthy Eating, Health Canada. It is estimated that
      HSF group participants will have a macronutrient profile that reflects current "Acceptable
      Macronutrient Distribution Range (AMDR)", as per the Institute of Medicine (2005) and Health
      Canada (2007) if they adhere to the education provided. Recommendations will promote a high
      fibre, low trans- and saturated fat diet including whole grains, fruit and vegetables, mono-
      and poly-unsaturated fat sources, lean meat and poultry and a low fat dairy profile. "Junk
      food" (i.e. soda pop, chips, and chocolate bars) will not be forbidden, however will be
      regarded as a "choose less often" food. Convenience/Ready-Made foods will be allowed,
      however, healthier choices will be highlighted during the education sessions.

      All three groups will be provided with education on serving size and portion control to
      promote compliance and to ensure that all groups are obtaining useful nutritional information
      by participating in the study. A major component of the SLHDP is to promote capacity building
      and long term healthy lifestyle in the community. Portion control will be treated as a
      controlled variable and will promote identical caloric intake between and within groups.

      Nutrition Education and Lifestyle Data Collection:

      Community support staff will be trained by the Research Coordinator/ Registered Dietitian
      (RD) to conduct baseline and follow-up sessions when the RD is not stationed in Sandy Lake.
      The Research Coordinator/ RD will be available 9am-5pm (week days)for nutrition consult and
      information support. During follow-up sessions data will be collected (see outcome measures)
      and data collection tools, food provisions and education will be provided.

      Metabolic/Anthropometric Data Collection:

      A Community (member) Registered Practical Nurse will be responsible for the metabolic and
      anthropometric data collection (see outcome measures). This RPN has held this role since the
      beginning of the SLHDP.
    

Intervention name(s): Dietary Intervention (Macronutrient composition)
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): high protein diet = traditional diet; high fiber diet = healthy store-bought diet; high carbohydrate diet = healthy store-bought diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
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