NCT03234101

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 3, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

July 24, 2017

Last Update Submit

August 1, 2017

Conditions

Keywords

Systematic review and meta-analysisEvidence-based medicine (EBM)Evidence-based nutrition (EBN)Clinical practice guidelinesProspective cohort studiesLow-risk lifestyle behavioursHealthy DietExercisePhysical activityBody weightSleepalcoholSmokingCardiovascular diseaseCoronary heart diseaseStrokeDiabetesCancerCardiovascular disease mortalityCoronary heart disease mortalityStroke mortalityAll-cause mortality

Outcome Measures

Primary Outcomes (4)

  • Cardiovascular disease

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

    Up to 20 years

  • Diabetes

    Diabetes incidence

    Up to 20 years

  • Cancer

    Cancer incidence and mortality

    Up to 20 years

  • All-cause mortality

    Up to 20 years

Interventions

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)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All individuals, both children and adults, regardless of health status.

You may qualify if:

  • Prospective cohort studies or case-cohort studies
  • Duration \>= 1 year
  • Assessment of exposures of adherence to at-least three low-risk lifestyle behaviors, one of which must include a healthy diet
  • Ascertainment of clinical outcome data for cardiovascular disease, diabetes, cancer, or all-cause mortality by level of exposure

You may not qualify if:

  • Ecological, cross-sectional, and retrospective observational studies, clinical trials, and non-human studies
  • Duration \< 1 year
  • No viable exposures data
  • No viable clinical outcome data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (12)

  • Stampfer MJ, Hu FB, Manson JE, Rimm EB, Willett WC. Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med. 2000 Jul 6;343(1):16-22. doi: 10.1056/NEJM200007063430103.

    PMID: 10882764BACKGROUND
  • Sumamo E, Ha C, Korownyk C, Vandermeer B, Dryden DM. Lifestyle Interventions for Four Conditions: Type 2 Diabetes, Metabolic Syndrome, Breast Cancer, and Prostate Cancer [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 May 26. Available from http://www.ncbi.nlm.nih.gov/books/NBK254022/

    PMID: 25473696BACKGROUND
  • Hu FB, Manson JE, Stampfer MJ, Colditz G, Liu S, Solomon CG, Willett WC. Diet, lifestyle, and the risk of type 2 diabetes mellitus in women. N Engl J Med. 2001 Sep 13;345(11):790-7. doi: 10.1056/NEJMoa010492.

    PMID: 11556298BACKGROUND
  • Loef M, Walach H. The combined effects of healthy lifestyle behaviors on all cause mortality: a systematic review and meta-analysis. Prev Med. 2012 Sep;55(3):163-70. doi: 10.1016/j.ypmed.2012.06.017. Epub 2012 Jun 24.

    PMID: 22735042BACKGROUND
  • Mozaffarian D, Afshin A, Benowitz NL, Bittner V, Daniels SR, Franch HA, Jacobs DR Jr, Kraus WE, Kris-Etherton PM, Krummel DA, Popkin BM, Whitsel LP, Zakai NA; American Heart Association Council on Epidemiology and Prevention, Council on Nutrition, Physical Activity and Metabolism, Council on Clinical Cardiology, Council on Cardiovascular Disease in the Young, Council on the Kidney in Cardiovasc. Population approaches to improve diet, physical activity, and smoking habits: a scientific statement from the American Heart Association. Circulation. 2012 Sep 18;126(12):1514-63. doi: 10.1161/CIR.0b013e318260a20b. Epub 2012 Aug 20.

    PMID: 22907934BACKGROUND
  • Higgins JPT, a.G.S. Cochrane Handbook for Systematic Reviews and Interventions, version 5.1.0 Updated March 2011. . Accessed at http://handbook.cochrane.org/ on September 25, 2014.

    BACKGROUND
  • Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000 Apr 19;283(15):2008-12. doi: 10.1001/jama.283.15.2008.

    PMID: 10789670BACKGROUND
  • Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA; PRISMA-P Group. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015 Jan 1;4(1):1. doi: 10.1186/2046-4053-4-1.

    PMID: 25554246BACKGROUND
  • Wells GA, S.B., O'Connell D, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp.

    BACKGROUND
  • Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schunemann HJ; GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008 Apr 26;336(7650):924-6. doi: 10.1136/bmj.39489.470347.AD.

    PMID: 18436948BACKGROUND
  • Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics. 1994 Dec;50(4):1088-101.

    PMID: 7786990BACKGROUND
  • Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997 Sep 13;315(7109):629-34. doi: 10.1136/bmj.315.7109.629.

    PMID: 9310563BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusNeoplasmsMotor ActivityBody WeightSmokingCoronary DiseaseStroke

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • JOHN L SIEVENPIPER, MD, PHD, FRCPC

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 31, 2017

Study Start

June 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 3, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations