Objective 3: Pilot Dietary Trial; The Sandy Lake Health & Diabetes Project (SLHDP): Understanding and Addressing Metabolic Syndrome, Diabetes and Associated Complications in Aboriginal Canadians
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 6 months
次要结局
- 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)
- Future dietary intervention feasibility will be assessed by 24-hour recalls/ diet records, appointment attendance, participant and community staff feedback, and questionnaire completion.(6 months)