Tools for Lasting Lifestyle Changes (TLC)
New Tools for Lasting Lifestyle Changes Among Inactive Obese People at Risk of Cardiovascular Disease (TLC)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Interdisciplinary, mixed-method, prospective and single-arm exploratory study aimed to explore study feasibility, responsiveness, participants adherence and adverse events among the participants before deciding to proceed to full-scale evaluation.
Enrollment of max. 20 obese people (BMI>30) with sedentary lifestyle and increased CVD-risk (NORRISK2)..
Participants general health status including cardiopulmonary fitness will be assessed both before and after the intervention (blood pressure, ECG, spirometry, treadmill tests VO2max, blood tests, body composition by Dual-energy X-ray absorptiometry (DEXA) measurements) Participants´ functional capacity assessed by several range of motion tests. Participants nutritional and psychological status assessed by validated questionnaires.
Several blood-tests and ECG will be recorded at three months.
Daily activity level during and six months after the intervention period monitored by Polar M430 pulse watch.
The participants will be interviewed with focus on their prior health, activity habits and intervention experiences at three months and six months after end of the intervention. Two focus-group interviews at end of intervention.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Tromsø, Norge, 9037
- UiT The Arctic University of Norway
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age 55-74 years
- BMI> 30
- Moderate elevated NORRISK 2 score
- Motivation for lifestyle change
- Has agreed to attend and participate in a student study during the study period
Exclusion criteria: 1.External disease with short life expectancy 2.Diseases that limit physical activity in the project 3.Serious mental illness 4. Previous myocardial infarction 5.EKG changes that show severe rhythm disturbance, unstable angina or heart attack
5.EKG changes that show severe rhythm disturbance, unstable angina or heart attack:
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 'Lifestyle counselling and exercise' .
The study is a single-arm study where all participants undergo the same intervention 'Lifestyle counselling and exercise' .
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The program consists of:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change from baseline physical activity at 6 months
Tidsramme: 6 months
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Change from baseline steps counted by activity trackers (Polar M430) at 6 months
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change from baseline central obesity at 6 months
Tidsramme: 6 months
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Change from baseline waist circumference (cm) at 6 months standardized measured
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6 months
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Change from baseline VO2max at 6 months
Tidsramme: 6 months
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Change from baseline VO2max at 6 months measured on treadmill test
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6 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sameline Grimsgaard, MD, MPH, PhD, Professor
Publikationer og nyttige links
Generelle publikationer
- Deraas TS, Hopstock L, Henriksen A, Morseth B, Sand AS, Njolstad I, Pedersen S, Sagelv E, Johansson J, Grimsgaard S. Complex lifestyle intervention among inactive older adults with elevated cardiovascular disease risk and obesity: a mixed-method, single-arm feasibility study for RESTART-a randomized controlled trial. Pilot Feasibility Stud. 2021 Oct 27;7(1):190. doi: 10.1186/s40814-021-00921-0.
- Hopstock LA, Deraas TS, Henriksen A, Martiny-Huenger T, Grimsgaard S. Changes in adiposity, physical activity, cardiometabolic risk factors, diet, physical capacity and well-being in inactive women and men aged 57-74 years with obesity and cardiovascular risk - A 6-month complex lifestyle intervention with 6-month follow-up. PLoS One. 2021 Aug 25;16(8):e0256631. doi: 10.1371/journal.pone.0256631. eCollection 2021.
- Henriksen A, Sand AS, Deraas T, Grimsgaard S, Hartvigsen G, Hopstock L. Succeeding with prolonged usage of consumer-based activity trackers in clinical studies: a mixed methods approach. BMC Public Health. 2020 Aug 27;20(1):1300. doi: 10.1186/s12889-020-09406-w.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2017-1100
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Hjerte-kar-sygdomme
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Ottawa Hospital Research InstituteAfsluttetStress | Crisis Resource Management (CRM) færdigheder | Advanced Cardiovascular Life Support (ACLS) færdighederCanada