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Low-risk lifestyle behaviours defined as:

1) Healthy body weight (Minimum: BMI \<30kg/m2 or WC of \<88 in females or \<92 in males); 2) Healthy diet (healthy diet, diet score with higher fruits \& vegetables to Mediterranean dietary pattern); 3) Regular physical activity (20 minutes ≥ 1 time/week ); 4) Smoking cessation (never smoked to smoking cessation \>12 months); 5) Moderate alcohol intake (up to 30g/day); 6) Adequate sleep (\>6 hours)

Low-risk lifestyle behaviours

JOHN L SIEVENPIPER, MD, PHD, FRCPC

Public health policy is universal in recommending the adoption of low risk low-risk lifestyle behaviors for health promotion and prevention of chronic or non-communicable diseases (NCDs).These behaviors generally include achieving and maintaining a healthy body weight, healthy diet, regular physical activity, smoking cessation, moderate alcohol intake, and adequate sleep. While there is a general consensus that adherence to any one of these low-risk lifestyle behaviors is associated with benefit, it is not clear if adherence to multiple behaviors would result in a larger benefit across different groups of people, conditions, and chronic disease outcomes. The Canadian Cardiovascular Society (CCS), as part of the Dyslipidemia Guidelines Update, commissioned a series of systematic reviews and meta-analyses (a type of knowledge synthesis) using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to quantify the benefit of adherence to multiple low-risk lifestyle behaviors in relation to patient-important chronic disease outcomes (risk of cardiovascular disease, diabetes, cancer, and death) and assesses the quality and strength of the evidence for this benefit.

Rationale:

International health authorities universally recommend adherence to low-risk lifestyle behaviors for health promotion and prevention of chronic or non-communicable diseases (NCDs). Systematic reviews and meta-analyses of prospective cohort studies have shown that adherence to any one low-risk lifestyle behavior, including a healthy body weight, healthy diet, regular physical activity, smoking cessation, moderate alcohol intake, or adequate sleep, is associated with less risk of chronic disease. Although individual prospective cohort studies have shown that adherence to a combination of these low-risk lifestyle behaviors is associated with an even greater benefit, there are no systematic reviews and meta-analyses assessing whether it holds across different definitions of low-risk lifestyle behaviors, levels of exposure, populations, geographical regions, background risks, and chronic disease outcomes. To inform recommendations for the role of low-risk lifestyle behaviors in chronic disease prevention, the Canadian Cardiovascular Society (CCS), as part of the Dyslipidemia Guidelines Update, commissioned a series of systematic reviews and meta-analyses using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach of the association between adherence to a combination of low-risk lifestyle behaviors and (1) cardiovascular disease (CVD), (2) diabetes, (3) cancer, and (4) all-cause mortality outcomes.

Objectives:

1. To conduct a series of systematic reviews and meta-analyses of the association between adherene to a combination of low-risk lifestyle behaviors and 4 chronic disease outcomes (1) cardiovascular disease (cardiovascular disease (CVD) incidence and mortality, coronary heart disease \[CHD\] incidence and mortality, and stroke incidence and mortality), (2) diabetes, (3) cancer (cancer incidence and cancer mortality), and (4) all-cause mortality.
2. To assess the quality and strength of the evidence using GRADE.

Design:

The planning and conduct of the proposed systematic reviews and meta-analyses will follow the Cochrane handbook for systematic reviews of interventions. The reporting will follow the Meta-Analysis Of Observational Studies in Epidemiology (MOOSE) and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statements.

Data sources:

MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (Clinical Trials; CENTRAL) will be searched using appropriate search terms. These searches will be supplemented by manual hand searches of the bibliographies of included studies and existing review articles.

Study selection:

Prospective cohort studies investigating the relation of at-least three low-risk lifestyle behaviors, one of which must include a healthy diet, with incident cardiovascular disease, diabetes, cancer or all-cause mortality will be included. Studies will be excluded if low-risk lifestyle behaviors are combined with biomarkers.

Data extraction:

Two independent reviewers or more will independently extract relevant information about study design, sample size, subject characteristics, low risk lifestyle behaviors, duration/person-years of follow-up, adjustments of models. Risk ratios for clinical outcomes will be extracted or derived from clinical event data across quantiles of exposure.

Risk of bias:

Two independent reviewers or more will assess risk of bias of (ROB) of each of the included prospective cohort studies using the Newcastle-Ottawa Scale (NOS) by . Up to 9 points can be awarded based on cohort selection (max 4 points), the comparability of cohort design and analysis (max 4 points), and adequacy of the outcome measures (max 3 points). Studies that receive ≥6 points will be considered as higher quality.

Outcomes:

Each of the four proposed systematic reviews and meta-analyses will assess a different chronic disease outcome: cardiovascular disease (CVD incidence and mortality, CHD incidence and mortality, and stroke incidence and mortality), (2) diabetes, (3) cancer (cancer and cancer mortality), and (4) all-cause mortality.

Data synthesis:

Risk estimates of extreme comparisons (all who adhered to low-risk behaviors versus none) will be pooled using inverse variance random effects models and expressed as risk ratios (RR) with 95% confidence intervals (CIs). Between-cohort heterogeneity will be assessed by the Cochran Q (chi-square) statistic and quantified by the I2 statistic. The significance level will be set at p\<0.10 and an I2 ≥ 50% will be considered evidence of substantial heterogeneity. To explore sources of heterogeneity, the investigators will conduct sensitivity analyses, in which each study is systematically removed with recalculation of the summary estimates. If there are \>=10 studies, then the investigators will also explore sources of heterogeneity using a priori subgroup analyses by underlying disease status, sex, number of lifestyle factors, follow-up (\<10 years, ≥10 years), level of adjustment of models, NOS, ascertainment of outcome, and individual domains of NOS Meta-regression analyses will assess the significance of categorical and continuous subgroups analyses. Dose-response analyses will be undertaken using random-effects generalized least squares trend estimation models (GLST) to assess linear relationships and spline curve modeling (the MKSPLINE procedure) to assess non-linear relationships. If ≥10 cohort comparisons are available, then publication bias will be assessed by visual inspection of funnel plots and formally tested with the Egger and Begg tests at a significance level of p≤ 0.10. If publication bias is suspected, then the investigators will attempt to adjust for funnel plot asymmetry by imputing the missing study data using the Duval and Tweedie trim and fill method.

Quality of evidence:

Evidence profiles will be produced the overall strength and quality of the evidence will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. This system grades the evidence as "high quality", "moderate quality", "low quality", or "very low quality". The included prospective cohort studies will start at "low quality" by default and then be downgraded or upgraded based on pre-specified criteria. Criteria to downgrade will include study limitations (weight of studies show risk of bias by NOS), inconsistency (substantial unexplained inter-study heterogeneity, I2\>50% and P\<0.10), indirectness (presence of factors relating to the population, exposures, and outcomes that limit generalizability), imprecision (95% CI are wide or cross a minimally important difference of 10% \[RR 0.9- 1.1\]), and publication bias (significant evidence of small-study effects). Criteria to upgrade will include a large magnitude effect (RR\>2 or RR\<0.5 in the absence of plausible confounders), a dose-response gradient, and attenuation by plausible confounding effects.

Knowledge translation plan:

The results will be disseminated through interactive presentations at local, national, and international scientific meetings and publication in high impact factor journals. Target audiences will include the public health and scientific communities with interest in nutrition, physical activity, lifestyle modification, diabetes, cancer and cardiovascular disease. Feedback will be incorporated and used to improve the public health message and key areas for future research will be defined.

Significance:

The proposed project will aid in knowledge translation related to the effects of low-risk lifestyle behaviours on cardiovascular disease, diabetes, cancer, and all-cause mortality, strengthening the evidence-base for recommendations and improving health outcomes through informing consumers and public health policy makers, stimulating industry innovation, and guiding future research.

Role of the funding sources:

The funding source will have no role in the research question, design, analysis, results and interpretation of the results of this study.

Meta-Analyses of Low-risk Lifestyle Behaviours and Patient Important Outcomes

Relation of Low-risk Lifestyle Behaviours With Cardiovascular Disease, Diabetes, Cancer and All-Cause Mortality: A Series of Systematic Reviews and Meta-analyses of Prospective Cohort Studies

Cardiovascular disease incidence and mortality, coronary heart disease incidence and mortality, stroke incidence and mortality

Canadian Institutes of Health Research (CIHR)

The Physicians' Services Incorporated Foundation

Canadian Diabetes Association

Canadian Cardiovascular Society

Banting & Best Diabetes Centre

University of Toronto

Associate Professor

Neoplasms

Neoplasm Metastasis

Neoplastic Processes

No intervention. Participants will be given access to a web-based submission portal.

Intervention control: participants will have access to food information in the shape of a Nutrition Facts table through FoodFlip©. Participants will have access to a submission portal linked to their study ID through the app.

Intervention: Participants will have access to food information through FoodFlip© with Health Canada's 'high-in' nutrition symbol. ©. Participants will have access to a submission portal linked to their study ID through the app.

Intervention control: participants will have access to food information such as calories or the Nutrition Facts table through FoodFlip©

FoodFlip© App with no nutrition symbol

Intervention: Participants will have access to food information through FoodFlip© with Canada's 'high-in' NS

FoodFlip© App with 'high-in' nutrition symbol

Mary R L'Abbe, PhD

Hayun Jeong, HBSc

Canada passed mandatory front-of-package labelling (FOPL) regulations where pre-packaged food and beverage products that are high in sugar, saturated fat, and/or sodium are required to display a 'high-in' front-of-pack nutrition symbol (NS). FOPL is an effective tool to inform consumers about products that can harm health and help guide their purchasing decisions. However, as the regulations are limited to the pre-packaged food supply and do not apply to restaurants and other food services, little is known about the potential impact of the NS in such settings. Therefore, the objective of the present study is to investigate the impact of the Canadian FOPL (i.e. the 'high-in' NS) as delivered through a mobile health (mHealth) app in a setting currently not subject to regulations. The study will take place on a post-secondary campus (University of Toronto) hosting students, a population vulnerable to poor dietary choices, nutritional knowledge, and associated weight gain. A 2-week long, randomized controlled trial with a 3-parallel arm study design will be conducted to explore the effect of the 'high-in' NS on students' purchasing behaviours and nutritional knowledge. Eligible participants will be randomly allocated into one of 3 intervention groups: no App control; App control with no NS; App with NS. Questionnaires will be used to assess nutritional knowledge, and receipts will be used to analyze purchasing behaviour.

Poor diets increase the risk of non-communicable diseases (NCDs), one of the major causes of disability and premature mortality in Canada. To help improve the diets of Canadians, Health Canada recently promulgated front-of-pack labelling (FOPL) regulations, which mandate pre-packaged foods and beverages meeting and/or exceeding the thresholds for nutrients of public health concern (i.e., sugars, saturated fat, and/or sodium) to display a 'high-in' front-of-pack nutrition symbol (NS). Moreover, previous studies have shown that FOPL can improve purchasing behaviours of consumers by decreasing purchases of nutrients of public health concern and/or foods carrying 'less healthy' FOPL and increase the nutritional knowledge of consumers. However, the FOPL regulations do not address restaurant foods, which are significant caloric contributors to the Canadian diet and are often high in nutrients of public health concern. Further, FOPL regulations do not address foods sold in other institutional settings, including schools, long-term care homes, and daycares. This policy gap may adversely affect the young adult population - a group notably vulnerable to poor diets and associated weight gain and poor nutritional knowledge. Emerging evidence suggests that FOPL can be an effective tool to communicate nutrition information to promote healthier food choices in food service settings; however, limited data exist on the effectiveness of FOPL on menu items available on post-secondary campuses to influence students' food purchasing behaviours on campus and to improve their nutritional knowledge. Furthermore, nutrition mobile health (mHealth) apps have been shown to have the potential to support behavioural change, improve nutrition knowledge, and develop skills to promote healthy eating behaviours through quick information-sharing capacity, customizable tracking abilities, and interactive components. The L'Abbe Lab has developed a mobile application, FoodFlip©, that provides nutrition information at the point of purchase to influence the decision-making process with high usability and functionality in grocery shopping settings. However, the application of FoodFlip© on purchasing behaviours in post-secondary campus settings is unknown. Therefore, the primary objective of the study is to investigate the effect of the Canadian FOPL (i.e., the 'high-in' nutrition symbol) on purchasing behaviours and nutritional knowledge of post-secondary students on campus, using the FoodFlip© App.

2-week long, single-blinded randomized controlled trial with a 3-parallel arm.

Participants will be allocated into one of 3 groups: (i) no App control; (ii) App without 'high-in' nutrition symbol; (iii) App with Canada's 'high-in' nutrition symbol

Using FoodFlip© to Improve Food Choices Among Post-secondary Students

A Randomized Controlled Trial Using FoodFlip©, a Mobile Phone App, to Promote Healthier Diets and Food Choices Among Post-Secondary Students

Purchasing behaviours will be assessed using receipts and/or records provided by participants over the 2-week study period. Nutritional quality of purchased menu items will be determined using a nutrient profiling model based on the thresholds for Canada's FOPL regulations. Menu items will be assigned a "Menu item score" on a scale of 0 (minimum) to 3 (maximum), with 0 indicating no 'high-in' nutrients and 3 being 'high-in' all 3 nutrients-of-concern. Scores of each menu item purchased will be summed and divided by the total number of purchases to derive the final score for each participant; higher scores mean lower nutritional quality (i.e. worse outcome) and lower scores mean higher nutritional quality (i.e. better outcome). The final scores will then be compared between intervention groups, and change in nutritional quality will be compared within intervention groups at 2 time points: early intervention (end of Week 1) and late intervention (end of study period).

Nutritional knowledge will be assessed using an online questionnaire developed and validated by the L'Abbe Lab. Questionnaire will be completed by participants at 1) baseline and 2) end-of-study. This short (10-15 min) survey of 30 short questions will include questions assessing health literacy and nutritional knowledge that have been adapted from validated questionnaires. Correct answers will be coded as "1" while incorrect answers will be coded as "0", with a maximum of 30 points. Higher scores indicate higher nutritional knowledge (i.e. better outcome), and lower scores indicate lower nutritional knowledge (i.e. worse outcome). Between intervention groups differences in nutritional knowledge will be assessed using ANOVA, while changes in nutritional knowledge from baseline to end-of-study will be compared within intervention groups using Mann-Whitney U-tests.

Professor Emeritus, CM, PhD

Flavonoid

Herbal and Botanical

Anthocyanidin

Blueberry

Participants undergo a washout on days -7 to -1 and then consume blueberry extract confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry powder confection on day 8.

Participants undergo a washout on days -7 to -1 and then consume blueberry powder confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry extract confection on day 8.

Blueberry Powder Food Product

Dietary Intervention

Questionnaire Administration

Yael Vodovotz

This trial studies how well a group of compounds found in blueberries called anthocyanins are absorbed into the body from 2 different types of blueberry confections (blueberry extract and whole blueberry powder). Blueberries contain several compounds which may be beneficial for human health and prevention of disease. These compounds can be consumed as part of a complex matrix in the whole fruit or also in a simplified matrix in the form of a fruit extract. Studying the absorption and metabolism of these compounds may help researchers understand how they influence health and disease, as well as determining the role of the food matrix on absorption of berry phytochemical.

PRIMARY OBJECTIVES:

I. Compare urinary flavonoids composition, compliance and sensory acceptability of 2 blueberry-based amorphous functional confections one containing blueberry extract and the other of a whole blueberry powder) formulated to deliver the 320 mg of anthocyanins.

II. Assess the effect of blueberry source (extract versus \[vs\] whole fruit powder) on urinary metabolomics profile.

OUTLINE: Participants are randomized to of 2 groups.

GROUP I: Participants undergo a washout on days -7 to -1 and then consume blueberry extract confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry powder confection on day 8.

GROUP II. Participants undergo a washout on days -7 to -1 and then consume blueberry powder confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry extract confection on day 8.

Metabolism and Absorption of Anthocyanins From Extract and Whole Blueberry Powder Confections in Healthy Adults

Comparison of Bioavailability and Urinary Metabolite Profile After Consumption of Blueberry Extract and Whole Blueberry Powder Confections in Healthy Men and Women

Means +/- SD (standard deviation) will be used to express the results from acceptability tests, and differences in acceptability of the two confections will be determined using paired t tests using the SPSS statistical software package.

Will measure bioavailability of the various berry interventions using high performance liquid chromatography (HPLC) analysis of blueberry phytochemicals and metabolites in urine at the day 1 timepoint, after consumption of the test product. Baseline comparisons for anthocyanins found in urine between trials will be performed a paired t-test. Total anthocyanins in 24-hour urine after consumption of one blueberry treatment will be compared to each participant's baseline urine and to total anthocyanins after consumption of the blueberry treatment in a paired t-test.

Will measure bioavailability of the various berry interventions using high performance liquid chromatography (HPLC) analysis of blueberry phytochemicals and metabolites in urine at the day 8 timepoints. Baseline comparisons for anthocyanins found in urine between trials will be performed a paired t-test. Total anthocyanins in 24-hour urine after consumption of one blueberry treatment will be compared to each participant's baseline urine and to total anthocyanins after consumption of the blueberry treatment in a paired t-test.

Ohio State University Comprehensive Cancer Center

Principal Investigator

The exposure consists in the long-term average dietary intake of the polyamine spermidine

Spermidine content of natural diet

Stefan Kiechl, MD

This study seeks to test the potential association between spermidine content in diet and mortality in humans.

This prospective community-based cohort study includes 829 participants aged 45-84 years, 49.9% of which are male. Diet is assessed by repeated dietician-administered validated food-frequency questionnaires (2540 assessments) in 1995, 2000, 2005, and 2010. Nutrient intakes including spermidine are calculated using USDA standard databases. Clinical events (all-cause mortality and cause-specific mortality) are recorded from 1995 to 2015.

The primary endpoint of all-cause mortality is related to the exposure of long-term average spermidine intake by Cox proportional hazards models with time-varying covariates. Additional analyses employ the Fine and Gray proportional subdistribution hazards model and flexible Royston-Parmar spline-based models. Comprehensive sensitivity analyses are performed to guard against potential biases associated with nutritional epidemiology.

Spermidine Intake and All-cause Mortality

Association Between Dietary Spermidine Intake and Mortality in the Population-based Bruneck Study

We do not plan to share individual participant data.

Death due to cardiovascular disease, cancer, or other causes

Krankenhaus Bruneck

University of Graz

Paracelsus Medical University

Institut National de la Santé Et de la Recherche Médicale, France

King's College London

Universitaet Innsbruck

Medical University Innsbruck

A.Univ.-Prof. Dr.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Mothers participated in educational/behavior change sessions to promote HPV vaccination among their 9-12 year old daughters

Mothers and daughters participated in educational/behavior change sessions to promote healthy eating and appropriate nutrition label interpretation

Mothers assigned to this arm participated in educational/behavior change sessions to promote HPV vaccination among their unvaccinated 9-12 year old daughters

HPV Vaccination

Mothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels

Healthy Eating

The overall goal of this study to promote HPV vaccine uptake among daughters of Latina immigrants between the ages of 9 and 12.

Objective: Implementation and examination of the efficacy of a culturally relevant, community-based HPV vaccination intervention among daughters of Latina immigrants 9-12 years of age in Alabama.

Methods: Group-randomized controlled trial evaluating two interventions: 1) promotion of HPV vaccination and 2) promotion of healthy eating using "place of residence" as the unit of randomization. Between May 2013 and October 2017, forty locations with 317 mother-daughter dyads were enrolled.

HPV Vaccination Among Daughters of Latina Immigrants

Daughters of mothers assigned to the HPV vaccination arm will more likely to complete the recommended HPV doses at 7-month follow-up than daughters of mothers assigned to the healthy eating arm.

Mothers and daughters assigned to the healthy eating arm will be more likely to eat fried food less than once per week, consume at least three portions of fruit/vegetables per day and have less than one sweetened beverage per day at 7-months than mothers and daughters assigned to the HPV vaccination arm

Mothers and daughters assigned to the healthy eating arm will be more likely to read nutrition labels sometimes/always and correctly interpret nutrition labels than mothers and daughters assigned to the HPV vaccination arm

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Meta-Analyses of Low-risk Lifestyle Behaviours and Patient Important Outcomes	NCT03234101	Cardiovascular ... Diabetes Cancer Mortality	Low-risk lifest...	-	University of Toronto
Using FoodFlip© to Improve Food Choices Among Post-secondary Students	NCT06033911	Healthy Diet	FoodFlip© App w... FoodFlip© App w...	18 Years -	University of Toronto
Meta-Analyses of Low-risk Lifestyle Behaviours and Patient Important Outcomes	NCT03234101	Cardiovascular ... Diabetes Cancer Mortality	Low-risk lifest...	-	University of Toronto
Metabolism and Absorption of Anthocyanins From Extract and Whole Blueberry Powder Confections in Healthy Adults	NCT04329962	Healthy Diet Nutrition Aspec...	Blueberry Powde... Dietary Interve... Questionnaire A...	18 Years - 65 Years	Ohio State University Comprehensive Cancer Center
Using FoodFlip© to Improve Food Choices Among Post-secondary Students	NCT06033911	Healthy Diet	FoodFlip© App w... FoodFlip© App w...	18 Years -	University of Toronto
Spermidine Intake and All-cause Mortality	NCT03378843	Healthy Diet Mortality	Spermidine cont...	45 Years - 84 Years	Medical University Innsbruck
HPV Vaccination Among Daughters of Latina Immigrants	NCT04154319	Cervical Cancer Healthy Diet	HPV Vaccination Healthy Eating	18 Years -	University of Alabama at Birmingham
Meta-Analyses of Low-risk Lifestyle Behaviours and Patient Important Outcomes	NCT03234101	Cardiovascular ... Diabetes Cancer Mortality	Low-risk lifest...	-	University of Toronto

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