The DNA-Based Lifestyle Enhancement Trial

NCT03583983 | Completed

• 1 other identifier: 20170928
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Behavior; Genetic Information; Cardiovascular Risk Factor

Keywords

Physical Activity; Dietary Habits; Genetic Scores; Cardiovascular Health

Outcome Measures

Primary Outcomes (3)

• Change in Physical Activity Levels (Strength Training)

  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.

  Baseline and 3 months follow-up

• Change in Physical Activity Levels (Aerobic Exercise)

  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.

  Baseline and 3 months follow-up

• Change in Dietary Healthiness

  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.

  Baseline and 3 months follow-up

Secondary Outcomes (9)

• Change in Triglycerides

  Baseline and 3 months follow-up

• Change in C-Reactive Protein

  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

Study Arms (2)

Personalized Health Recommendations

OTHER

Behavioral: Personalized Health Recommendations

No Health Recommendations

OTHER

Behavioral: Generic Health Recommendations

Interventions

Personalized Health Recommendations BEHAVIORAL

Includes 3-month gym membership, personalized exercise and meal plans, and genetic information related to health and wellness traits. The genetic information provided to study participants will consist of scores ranging from 0 to 100 based on the population percentile of the combined effects of many genetic variants, herein referred to as polygenic scores (PGS). PGS for approximately twenty traits related to health, fitness and nutrition will be provided to study participants. These traits are chosen for their relevance to healthy lifestyle habits (e.g. genetic predisposition to adiposity or muscle strength), entertainment value (e.g. preference for mornings) or both (e.g. bitterness taste perception, which while entertaining can also help guide vegetable choices).

Personalized Health Recommendations

Generic Health Recommendations BEHAVIORAL

Includes 3-month gym membership and generic recommendations (Canada Food Guide / Health Canada Physical Activity guidelines)

No Health Recommendations

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• GeneBlueprint Corp: collaborator
• Federal Economic Development Agency for Southern Ontario (FedDev Ontario): collaborator
• GoodLife Fitness: collaborator
• Southlake Regional Health Centre: collaborator

Study Sites (1)

Hamilton Health Sciences (Juravinski Hospital, General Hospital, MUMC)

Hamilton, Ontario, L8L2X2, Canada

Location

MeSH Terms

Conditions

Health Behavior; Motor Activity; Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal

Study Officials

• Guillaume Pare, MSc,MD,FRCPC

  Hamilton Health Sciences, McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 12, 2018
• Study Start: March 7, 2018
• Primary Completion: December 30, 2018
• Study Completion: January 3, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)