The Manitoba Personalized Lifestyle Research (TMPLR) Study

Lifestyle factors, such as diet, physical activity and sleep, are associated with the development of many chronic diseases. The objective of The Manitoba Personalized Lifestyle Research (TMPLR) study is to understand how these lifestyle factors interact with each other and additional factors, such as an individual's genetics and gut microbiome, to influence health. This is an exploratory cross-sectional observational cohort study of adults, with extensive phenotyping by objective health and lifestyle assessments, and retrospective assessment of early life experiences, with retrospective and prospective utilization of secondary data from administrative health records. A planned non-random convenience sample of 840 Manitobans aged 30-46 recruited from the general population, stratified by sex (equal males and females), body mass index (BMI; 60% of participants with a BMI >25 kg/m2), and geography (25% from rural areas,). These stratifications were selected based on Manitoba demographics. Body composition and bone density will be measured by dual energy x-ray absorptiometry. Blood pressure, pulse wave velocity, and augmentation index will be measured on two consecutive days. Chronic disease risk biomarkers will be measured in blood and urine samples. DNA will be extracted for genetic analysis. A fecal sample will be collected for microbiome analysis.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Diseases; Diabetes; Chronic Kidney Diseases

Detailed Description

Lifestyle factors, such as diet, physical activity and sleep, are associated with the development of many chronic diseases. The objective of The Manitoba Personalized Lifestyle Research (TMPLR) study is to understand how these lifestyle factors interact with each other and additional factors, such as an individual's genetics and gut microbiome, to influence health. This is an exploratory cross-sectional observational cohort study of adults, with extensive phenotyping by objective health and lifestyle assessments, and retrospective assessment of early life experiences, with retrospective and prospective utilization of secondary data from administrative health records. A planned non-random convenience sample of 840 Manitobans aged 30-46 recruited from the general population, stratified by sex (equal males and females), body mass index (BMI; 60% of participants with a BMI >25 kg/m2), and geography (25% from rural areas,). These stratifications were selected based on Manitoba demographics. Lifestyle factors assessed will include dietary pattern, physical activity, cardiovascular fitness and sleep. Additional factors such as medical history, socio-economic status, alcohol and tobacco consumption, cognition, stress and anxiety, and early life experiences will also be documented. A maternal survey will be performed. Body composition and bone density will be measured by dual energy x-ray absorptiometry. Blood pressure, pulse wave velocity, and augmentation index will be measured on two consecutive days. Chronic disease risk biomarkers will be measured in blood and urine samples. DNA will be extracted for genetic analysis. A fecal sample will be collected for microbiome analysis. Participants may provide their Manitoba Personal Health Information Number (PHIN) to link their study data with administrative health records.Lifestyle factors, such as diet, physical activity and sleep, are associated with the development of many chronic diseases. The objective of The Manitoba Personalized Lifestyle Research (TMPLR) study is to understand how these lifestyle factors interact with each other and additional factors, such as an individual's genetics and gut microbiome, to influence health. This is an exploratory cross-sectional observational cohort study of adults, with extensive phenotyping by objective health and lifestyle assessments, and retrospective assessment of early life experiences, with retrospective and prospective utilization of secondary data from administrative health records. A planned non-random convenience sample of 840 Manitobans aged 30-46 recruited from the general population, stratified by sex (equal males and females), body mass index (BMI; 60% of participants with a BMI >25 kg/m2), and geography (25% from rural areas,). These stratifications were selected based on Manitoba demographics. Lifestyle factors assessed will include dietary pattern, physical activity, cardiovascular fitness and sleep. Additional factors such as medical history, socio-economic status, alcohol and tobacco consumption, cognition, stress and anxiety, and early life experiences will also be documented. A maternal survey will be performed. Body composition and bone density will be measured by dual energy x-ray absorptiometry. Blood pressure, pulse wave velocity, and augmentation index will be measured on two consecutive days. Chronic disease risk biomarkers will be measured in blood and urine samples. DNA will be extracted for genetic analysis. A fecal sample will be collected for microbiome analysis. Participants may provide their Manitoba Personal Health Information Number (PHIN) to link their study data with administrative health records.

• Study Type: Observational
• Enrollment (Actual): 840

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 6C5
      • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 46 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A sample of 800 Manitobans aged 30-46, stratified by sex, BMI, and geography are being recruited. Participants must have lived in Manitoba for a minimum of 5 years. Women who are pregnant or lactating are not eligible to participate. Additionally, because it is expected that very few of the 800 Manitobans who join TMPLR study from the general public will have reduced kidney function (eGFR <30 ml/min), 40 participants (20 female, 20 male, with no set stratification based on BMI or geography) who have severely reduced kidney function are being recruited from the renal health clinic at Seven Oaks General Hospital (Winnipeg, Manitoba).

Description

Inclusion Criteria:

• Participants must have lived in Manitoba for a minimum of 5 years

Exclusion Criteria:

• Women who are pregnant or lactating are not eligible to participate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent fat mass	Measured using dual-energy X-ray absorptiometry	Baseline
Percent lean mass	Measured using dual-energy X-ray absorptiometry	Baseline
Bone mineral density	Measured using dual-energy X-ray absorptiometry, calculated as (mg/cm^2)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food energy intake	Assessed using dietary history questionnaire	Baseline
Macronutrient intake	Assessed using dietary history questionnaire	Baseline
Micronutrient intake	Assessed using dietary history questionnaire	Baseline
Dietary restraint	Score 0-20 from Three-Factor Eating Questionnaire	Baseline
Dietary disinhibition	Score 0-16 from Three-Factor Eating Questionnaire	Baseline
Hunger	Score 0-14 from Three-Factor Eating Questionnaire	Baseline
Montreal cognitive assessment questionnaire	Total score of 30; minimum score 0; maximum score of 30	Baseline
Frailty status, as determined by the Modified Fried Criteria	Patients meeting the criteria for ≥ 3 of the following 7 criteria are deemed frail.; Slowness - After two trials of a 5 m walk, average time>6 s; Weakness - After three grip strength measurements with each hand, maximum value 30 kg if male or 20 kg if female; Weight loss - Self-reported weight loss >4.5 kg (10 lbs) or >5% body weight in past 12 months; Exhaustion - Two-item Center for Epidemiologic Studies Depression (CES-D) scale 1 out of 2; Depression - Five-item Geriatric Depression Scale (5-GDS) 2 out of 5; Low physical activity - Paffenbarger Physical Activity Index <383 kcal per week if male or < 270 kcal per week if female; Cognitive impairment - Montreal Cognitive Assessment (MoCA) score <26 out of 30	Baseline
Weight	Participants change into lightweight scrub tops and bottoms, with shoes removed, to the nearest 0.1 kg using a digital calibrated floor scale	Baseline
Height	Measured, without shoes, to the nearest 0.1 cm using a stadiometer	Baseline
Body mass index (BMI)	Calculated as kg/m^2	Baseline
Waist circumference	Measured in triplicate, to the nearest 0.1 cm at the umbilicus, between the last rib and the iliac crest using a fibreglass tape measure	Baseline
Hip circumference	Measured in triplicate at the widest portion of the buttocks and hips using a fibreglass tape measure	Baseline
Blood pressure	Systolic and diastolic blood pressures are measured in triplicate, on the non-dominant arm in a sitting position using a validated oscillometric blood pressure monitor	Baseline
Pulse wave velocity	Measured on the non-dominant arm in a sitting position using a Mobil-O-Graph PWA Monitor on two consecutive days	Day 1 and Day 2
Augmentation index	Measured on the non-dominant arm in a sitting position using a Mobil-O-Graph PWA Monitor on two consecutive days	Day 1 and Day 2
Gastrointestinal microbiome	Microbiome 16S RNA sequencing	Baseline
Physical activity level	Assessed using accelerometers over a period of 1 week	1 week
Muscle strength	Measured using a hand grip dynamometer	Baseline
Cardiorespiratory fitness	Assessed using a metabolic cart to measure oxygen consumption (VO2; mL O2/kg body weight/minute) during a submaximal YMCA bike protocol performed to 85% of age predicted heart rate max	Baseline
Functional walking ability	Assessed using a 5-meter gait speed test	Baseline
Sleep	Average hours of sleep per night; measured using accelerometers over a period of 1 week	1 week
Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors	This is meant to be achieved through a Genome Wide Association Study (GWAS) of Single Nucleotide Polymorphism (SNPs) associated with the measures of the lifestyle factors assessed in the TMPLR cohort, as listed in "outcome measures". Whole genome genotyping will be conducted with a state of the art genotyping array.	Baseline
Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors.	This is meant to be achieved targeted resequencing of target genes know to effect the metabolic traits assessed. This will aid the detection rare of Single Nucleotide Variations (SNVs) impacting the genes functions. Targeted re-sequencing will be conducted with a state of the art methodology.	Baseline
Early life experiences by self report	Assessed using the childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics	Baseline
Early life experiences by maternal report	Assessed using a mother's questionnaire (adapted from the Nurses' Health Study)	Baseline
Early life health conditions from linked administrative health records, from the Manitoba Population Healthy Research Data Repository	Examples of health records include: prescriptions, physician diagnoses and hospital discharge abstracts	Baseline
(ASA24) dietary assessment tool	(ASA24) dietary assessment tool	Baseline
Pittsburgh sleep quality index	Pittsburgh sleep quality index	Baseline
Childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics)	Childhood retrospective circumstances questionnaire (adapted from the US Panel Study	Baseline
Blood total cholesterol	Blood total cholesterol	Baseline
Blood low-density lipoprotein cholesterol	Blood low-density lipoprotein cholesterol	Baseline
Blood high-density lipoprotein cholesterol	Blood high-density lipoprotein cholesterol	Baseline
Blood triglycerides	Blood triglycerides	Baseline
Blood glucose	Blood glucose	Baseline
Blood insulin	Blood insulin	Baseline
Blood urea	Blood urea	Baseline
Blood creatinine	Blood creatinine	Baseline
Blood high sensitivity C-reactive protein	Blood high sensitivity C-reactive protein	Baseline
Blood aspartate aminotransferase	Blood aspartate aminotransferase	Baseline
Blood alanine aminotransferase	Blood alanine aminotransferase	Baseline
Blood T regulatory cells	Blood T regulatory cells	Baseline
Blood leptin	Blood leptin	Baseline
Blood glucagon	Blood glucagon	Baseline
Urinary melatonin	Urinary melatonin	Baseline
Red blood cell fatty acids	Red blood cell fatty acids	Baseline
Plasma fatty acids	Plasma fatty acids	Baseline
Blood non-cholesterol sterols	Blood non-cholesterol sterols	Baseline
Blood vitamin C levels	Blood vitamin C levels	Baseline
Fractional cholesterol synthesis rate	Fractional cholesterol synthesis rate	Baseline
Triglyceride synthesis rate	Triglyceride synthesis rate	Baseline

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Research Manitoba
• Investigators: Study Director: Peter JH Jones, PhD, University of Manitoba

Publications and helpful links

General Publications

• Mackay D, Mollard RC, Granger M, Bruce S, Blewett H, Carlberg J, Duhamel T, Eck P, Faucher P, Hamm NC, Khafipour E, Lix L, McMillan D, Myrie S, Ravandi A, Tangri N, Azad M, Jones PJ. The Manitoba Personalized Lifestyle Research (TMPLR) study protocol: a multicentre bidirectional observational cohort study with administrative health record linkage investigating the interactions between lifestyle and health in Manitoba, Canada. BMJ Open. 2019 Oct 10;9(10):e023318. doi: 10.1136/bmjopen-2018-023318.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Cardiovascular Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: HS18951(H2015:367)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No