Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT03674957
Status:
TERMINATED
Last Update Posted:
2023-03-22
First Post:
2018-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Manitoba Personalized Lifestyle Research (TMPLR) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood (plasma, serum, red blood cells, white blood cells) samples, fecal samples, urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 840}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2018-04-12', 'studyFirstSubmitQcDate': '2018-09-14', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent fat mass', 'timeFrame': 'Baseline', 'description': 'Measured using dual-energy X-ray absorptiometry'}, {'measure': 'Percent lean mass', 'timeFrame': 'Baseline', 'description': 'Measured using dual-energy X-ray absorptiometry'}, {'measure': 'Bone mineral density', 'timeFrame': 'Baseline', 'description': 'Measured using dual-energy X-ray absorptiometry, calculated as (mg/cm\\^2)'}], 'secondaryOutcomes': [{'measure': '(ASA24) dietary assessment tool', 'timeFrame': 'Baseline', 'description': '(ASA24) dietary assessment tool'}, {'measure': 'Food energy intake', 'timeFrame': 'Baseline', 'description': 'Assessed using dietary history questionnaire'}, {'measure': 'Macronutrient intake', 'timeFrame': 'Baseline', 'description': 'Assessed using dietary history questionnaire'}, {'measure': 'Micronutrient intake', 'timeFrame': 'Baseline', 'description': 'Assessed using dietary history questionnaire'}, {'measure': 'Dietary restraint', 'timeFrame': 'Baseline', 'description': 'Score 0-20 from Three-Factor Eating Questionnaire'}, {'measure': 'Dietary disinhibition', 'timeFrame': 'Baseline', 'description': 'Score 0-16 from Three-Factor Eating Questionnaire'}, {'measure': 'Hunger', 'timeFrame': 'Baseline', 'description': 'Score 0-14 from Three-Factor Eating Questionnaire'}, {'measure': 'Pittsburgh sleep quality index', 'timeFrame': 'Baseline', 'description': 'Pittsburgh sleep quality index'}, {'measure': 'Montreal cognitive assessment questionnaire', 'timeFrame': 'Baseline', 'description': 'Total score of 30; minimum score 0; maximum score of 30'}, {'measure': 'Frailty status, as determined by the Modified Fried Criteria', 'timeFrame': 'Baseline', 'description': 'Patients meeting the criteria for ≥ 3 of the following 7 criteria are deemed frail.\n\n1. Slowness - After two trials of a 5 m walk, average time\\>6 s\n2. Weakness - After three grip strength measurements with each hand, maximum value 30 kg if male or 20 kg if female\n3. Weight loss - Self-reported weight loss \\>4.5 kg (10 lbs) or \\>5% body weight in past 12 months\n4. Exhaustion - Two-item Center for Epidemiologic Studies Depression (CES-D) scale 1 out of 2\n5. Depression - Five-item Geriatric Depression Scale (5-GDS) 2 out of 5\n6. Low physical activity - Paffenbarger Physical Activity Index \\<383 kcal per week if male or \\< 270 kcal per week if female\n7. Cognitive impairment - Montreal Cognitive Assessment (MoCA) score \\<26 out of 30'}, {'measure': 'Childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics)', 'timeFrame': 'Baseline', 'description': 'Childhood retrospective circumstances questionnaire (adapted from the US Panel Study'}, {'measure': 'Weight', 'timeFrame': 'Baseline', 'description': 'Participants change into lightweight scrub tops and bottoms, with shoes removed, to the nearest 0.1 kg using a digital calibrated floor scale'}, {'measure': 'Height', 'timeFrame': 'Baseline', 'description': 'Measured, without shoes, to the nearest 0.1 cm using a stadiometer'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Baseline', 'description': 'Calculated as kg/m\\^2'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline', 'description': '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'}, {'measure': 'Hip circumference', 'timeFrame': 'Baseline', 'description': 'Measured in triplicate at the widest portion of the buttocks and hips using a fibreglass tape measure'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline', 'description': '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'}, {'measure': 'Pulse wave velocity', 'timeFrame': 'Day 1 and Day 2', 'description': 'Measured on the non-dominant arm in a sitting position using a Mobil-O-Graph PWA Monitor on two consecutive days'}, {'measure': 'Augmentation index', 'timeFrame': 'Day 1 and Day 2', 'description': 'Measured on the non-dominant arm in a sitting position using a Mobil-O-Graph PWA Monitor on two consecutive days'}, {'measure': 'Blood total cholesterol', 'timeFrame': 'Baseline', 'description': 'Blood total cholesterol'}, {'measure': 'Blood low-density lipoprotein cholesterol', 'timeFrame': 'Baseline', 'description': 'Blood low-density lipoprotein cholesterol'}, {'measure': 'Blood high-density lipoprotein cholesterol', 'timeFrame': 'Baseline', 'description': 'Blood high-density lipoprotein cholesterol'}, {'measure': 'Blood triglycerides', 'timeFrame': 'Baseline', 'description': 'Blood triglycerides'}, {'measure': 'Blood glucose', 'timeFrame': 'Baseline', 'description': 'Blood glucose'}, {'measure': 'Blood insulin', 'timeFrame': 'Baseline', 'description': 'Blood insulin'}, {'measure': 'Blood urea', 'timeFrame': 'Baseline', 'description': 'Blood urea'}, {'measure': 'Blood creatinine', 'timeFrame': 'Baseline', 'description': 'Blood creatinine'}, {'measure': 'Blood high sensitivity C-reactive protein', 'timeFrame': 'Baseline', 'description': 'Blood high sensitivity C-reactive protein'}, {'measure': 'Blood aspartate aminotransferase', 'timeFrame': 'Baseline', 'description': 'Blood aspartate aminotransferase'}, {'measure': 'Blood alanine aminotransferase', 'timeFrame': 'Baseline', 'description': 'Blood alanine aminotransferase'}, {'measure': 'Blood T regulatory cells', 'timeFrame': 'Baseline', 'description': 'Blood T regulatory cells'}, {'measure': 'Blood leptin', 'timeFrame': 'Baseline', 'description': 'Blood leptin'}, {'measure': 'Blood glucagon', 'timeFrame': 'Baseline', 'description': 'Blood glucagon'}, {'measure': 'Urinary melatonin', 'timeFrame': 'Baseline', 'description': 'Urinary melatonin'}, {'measure': 'Red blood cell fatty acids', 'timeFrame': 'Baseline', 'description': 'Red blood cell fatty acids'}, {'measure': 'Plasma fatty acids', 'timeFrame': 'Baseline', 'description': 'Plasma fatty acids'}, {'measure': 'Blood non-cholesterol sterols', 'timeFrame': 'Baseline', 'description': 'Blood non-cholesterol sterols'}, {'measure': 'Blood vitamin C levels', 'timeFrame': 'Baseline', 'description': 'Blood vitamin C levels'}, {'measure': 'Fractional cholesterol synthesis rate', 'timeFrame': 'Baseline', 'description': 'Fractional cholesterol synthesis rate'}, {'measure': 'Triglyceride synthesis rate', 'timeFrame': 'Baseline', 'description': 'Triglyceride synthesis rate'}, {'measure': 'Gastrointestinal microbiome', 'timeFrame': 'Baseline', 'description': 'Microbiome 16S RNA sequencing'}, {'measure': 'Physical activity level', 'timeFrame': '1 week', 'description': 'Assessed using accelerometers over a period of 1 week'}, {'measure': 'Muscle strength', 'timeFrame': 'Baseline', 'description': 'Measured using a hand grip dynamometer'}, {'measure': 'Cardiorespiratory fitness', 'timeFrame': 'Baseline', 'description': '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'}, {'measure': 'Functional walking ability', 'timeFrame': 'Baseline', 'description': 'Assessed using a 5-meter gait speed test'}, {'measure': 'Sleep', 'timeFrame': '1 week', 'description': 'Average hours of sleep per night; measured using accelerometers over a period of 1 week'}, {'measure': 'Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors', 'timeFrame': 'Baseline', 'description': '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".\n\nWhole genome genotyping will be conducted with a state of the art genotyping array.'}, {'measure': 'Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors.', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Early life experiences by self report', 'timeFrame': 'Baseline', 'description': 'Assessed using the childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics'}, {'measure': 'Early life experiences by maternal report', 'timeFrame': 'Baseline', 'description': "Assessed using a mother's questionnaire (adapted from the Nurses' Health Study)"}, {'measure': 'Early life health conditions from linked administrative health records, from the Manitoba Population Healthy Research Data Repository', 'timeFrame': 'Baseline', 'description': 'Examples of health records include: prescriptions, physician diagnoses and hospital discharge abstracts'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Cardiovascular Diseases', 'Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '31604781', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '46 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have lived in Manitoba for a minimum of 5 years\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating are not eligible to participate'}, 'identificationModule': {'nctId': 'NCT03674957', 'briefTitle': 'The Manitoba Personalized Lifestyle Research (TMPLR) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'The Manitoba Personalized Lifestyle Research (TMPLR) Study', 'orgStudyIdInfo': {'id': 'HS18951(H2015:367)'}}, 'contactsLocationsModule': {'locations': [{'zip': 'R3T 6C5', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Peter JH Jones, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Manitoba', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}