Evaluating the Impact of Personalized Recommendations on Healthy Behaviours and Cardio-metabolic Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 2
- 主要终点
- Change in Dietary Healthiness
研究概览
简要总结
Despite the known cardiovascular benefits of regular physical activity and having a balanced diet, it has proven challenging to change health behaviours towards favourable lifestyles. The overarching aim of the study is to test the effect of providing personalized genetic information along with diet and exercise plans on adherence to healthy lifestyle habits and cardio-metabolic risk. There is tremendous public interest in genetics and some evidence that providing genetic information can help improve health habits. However, no intervention to date has examined the effect of comprehensive genetic testing using cutting-edge polygenic score (PGS) prediction and an interactive health portal on health behaviours and cardio-metabolic risk. The investigators hypothesize that providing participants with detailed genetic information about genetic determinants of fitness and nutrition traits will help motivate people to adopt healthy lifestyle habits. The primary objective is to test the effect of providing genetic information and interactive recommendations for diet and exercise on adoption of healthy behaviours. The secondary objective is to evaluate the effects of the personalized health recommendations on cardio-metabolic risk markers, such as dyslipidemia, inflammatory markers, and fasting glucose.
详细描述
Cardiovascular disease (CVD) is a leading cause of death and disability worldwide, accounting for 17.9 million deaths and the loss of 348 million disability-adjusted life years in 2015 alone. Diabetes and obesity are very strong risk factors for CVD. Individuals with diabetes and obesity have an 82.75% life-time risk for developing CVD. While treatments do exist for both obesity (e.g. bariatric surgery) and diabetes (e.g. pharmaceutical control of blood sugar levels), these only partially attenuate risk of adverse health outcomes and they do not address prevention and upstream causes of cardiovascular diseases, namely sedentary lifestyle and unhealthy diet. Despite the known cardiovascular benefits of regular physical activity and having a balanced diet, it has proven challenging to change health behaviours towards favourable lifestyles. Indeed, the prevalence of obesity is increasing in Canada as less than 80% of adults follow the current recommendation of 150 minutes of moderate-to-vigorous physical activity per week and approximately less than 60% of adults consume fruits and vegetables 5 or more times a day. The overarching aim of the study is to test the effect of providing personalized genetic information along with diet and exercise plans on adherence to healthy lifestyle habits and cardio-metabolic risk. There is tremendous public interest in genetics and some evidence that providing genetic information can help improve health habits. However, no intervention to date has examined the effect of comprehensive genetic testing using cutting-edge polygenic score (PGS) prediction and an interactive health portal on health behaviours and cardio-metabolic risk.
The investigators hypothesize that providing participants with detailed genetic information about genetic determinants of fitness and nutrition traits will help to motivate people to adopt healthy lifestyle habits. The primary objective is to test the effect of providing genetic information and interactive recommendations for diet and exercise on adoption of healthy behaviours. The secondary objective is to evaluate the effects of the personalized health recommendations on cardio-metabolic risk markers, such as dyslipidemia, inflammatory markers, and fasting glucose.
The investigators propose to conduct a randomized controlled trial investigating whether personalized lifestyle recommendations including genetic information motivates Hamilton Health Sciences employees to adopt healthy lifestyle changes. Study participation will be open to Hamilton Health Sciences employees. Recruitment will begin in March 2017. Eligible and consenting individuals will be enrolled. Enrollment will occur in a staggered fashion. The intervention group will receive (1) a free 3-month GoodLife Fitness gym membership providing access to any Ontario GoodLife Fitness facility, (2) professional trainer-approved workout plans, (3) dietitian-approved meal plans, and (4) genetic information pertaining to their health and fitness. The control group will also receive a GoodLife Fitness membership to ensure that all study participants are granted similar ease-of-access to perform physical activities and generic health recommendations (Canadian Food Guide / Health Canada Physical Activity Recommendations) but will not receive the personalized component of the intervention (workout plans, meal plans or genetic information) until the end of their trial period. Participants will be randomized to treatment or control groups using a minimization scheme for adaptive randomization, which will serve to balance age, gender, and ethnicity across groups as participants are enrolled. Thus, randomization will be performed in a single-blind fashion wherein the study team is unaware of whom is receiving the intervention or control. All study participants will be monitored over the course of 3 months beginning with their baseline assessment and ending with their 3-month follow-up assessment. At these two timepoints, study participants will be assessed for behavioural (physical activity levels and diet healthiness), fitness markers (blood pressure, resting heart rate, body fat %, and other anthropometric measurements) and biological markers (lipids, insulin sensitivity, and inflammation) of cardio-metabolic disease.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants will be randomized to intervention or control groups using a minimization scheme which will adaptively weight probabilities of treatment assignment based on the distribution of age (> 40 vs. < 40), gender (male vs. female), and ethnicity (European/African/East Asian/South Asian/Latino/Other). This design has been adopted to minimize unintended covariate biases, which can plague smaller trials. Randomization will be implemented through a centralized database. The intervention will be delivered via automated e-mails, minimizing direct personal contact with the intervention group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hamilton Health Science employees living in Southern Ontario who are capable and willing to follow an exercise and diet program for 3 months as well as fitness and blood assessments
排除标准
- •Insulin-dependent diabetes
- •History of cardiovascular disease (stroke, heart attack, coronary artery bypass graft (CABG) surgery, coronary angioplasty, peripheral artery disease)
- •Injury or condition impeding ability to engage in physical activity (e.g. osteoarthritis, COPD)
- •Pregnant or breast-feeding or planning to be pregnant
- •Anyone on medication that interacts with foods
- •Anyone planning to be on vacation for > 2 weeks in the next 3 months.
- •Dietary restrictions (e.g. vegetarianism, gluten sensitivity, etc.)
- •History of bone marrow transplant
研究组 & 干预措施
No Health Recommendations
干预措施: Generic Health Recommendations (Behavioral)
Personalized Health Recommendations
干预措施: Personalized Health Recommendations (Behavioral)
结局指标
主要结局
Change in Dietary Healthiness
时间窗: Baseline and 3 months follow-up
Dietary healthiness will be ascertained using the dietary risk score developed by the INTERHEART study which was found to explain 30% of the population attributable risk for acute myocardial infarction. Briefly, the dietary risk score takes into account consumption of meat, salty snacks, fried foods, fruits and vegetables. The point score ranges from 0 to 6 with higher scores indicating a less healthy diet.
Change in Physical Activity Levels (Strength Training)
时间窗: Baseline and 3 months follow-up
Physical activity levels (strength training) will be defined by frequency of strength training per week. Strength training is one of the domains of physical activity recognized by the Canadian Physical Activity Guidelines, which recommend at least two sessions of strength training per week. Accordingly, physical activity levels will be ascertained through the following survey question: "In the last 3 months, how many times per week did you perform strength training?" The minimum value for this outcome would be 0 and there is no theoretical maximum though we expect most values to be below 7 since 7 would represent strength training on a daily basis. Higher values indicate higher levels of physical activity and vice versa.
Change in Physical Activity Levels (Aerobic Exercise)
时间窗: Baseline and 3 months follow-up
Physical activity levels (aerobic exercise) will be defined by frequency of aerobic exercise per week. Aerobic exercise is one of the domains of physical activity recognized by the Canadian Physical Activity Guidelines, which recommend at least 150 minutes of moderate to vigorous physical activity per week. Accordingly, physical activity levels will be ascertained through the following survey question: "In the last 3 months, how many times per week did you perform aerobic exercises training?" The minimum value for this outcome would be 0 and there is no theoretical maximum though we expect most values to be below 7 since 7 would represent aerobic exercise on a daily basis. Higher values indicate higher levels of physical activity and vice versa.
次要结局
- Change in C-Reactive Protein(Baseline and 3 months follow-up)
- Change in Triglycerides(Baseline and 3 months follow-up)
- Change in Fasting Glucose(Baseline and 3 months follow-up)
- Change in Blood Pressure(Baseline and 3 months follow-up)
- Change in Resting Heart Rate(Baseline and 3 months follow-up)
- Change in Body Fat %(Baseline and 3 months follow-up)
- Change in Body Mass Index(Baseline and 3 months follow-up)
- Change in Cardio-metabolic Risk Score(Baseline and 3 months follow-up)
- Change in Circumference of Body Parts(Baseline and 3 months follow-up)