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Healthy Life Centers - Municipal Health Care Service for Lifestyle Changes - a Multicenter Intervention Study

26. februar 2020 opdateret af: Norwegian University of Science and Technology

Healthy Life Centers - Municipal Health Care Service for Lifestyle Changes - a Multicenter Intervention Study on Changes Among Participants and Moderators for Changes Such as the Centers Capacity and Competence and the Participants Motivation

A Healthy Life Center (HLC, 'Frisklivssentrale') is a public community-based health service providing lifestyle support programs for physical activity, smoking cessation and diet, to inhabitants with increased risk for development of non-communicable diseases. HLCs intention is to reach physically inactive people who need guidance to get more physically active, and offer them a lifestyle program for three months or more.

The main aim of this study is to study whether the HLCs, organized according to the Norwegian Directorate of Health's guidelines for municipal healthy life centers, affects the participants short term (3 months) and long term (15 months) physical activity level. Also changes in diet, tobacco use, health related quality of life, physical fitness, anthropometry, self-efficacy, motivation, drug use, use of health services and work participation will be assessed. Secondary aim is to study whether there are any moderators, such as HLCs capacity, expertise, and collaboration with other services, that have significance for participants' change. Also it will be studied whether the HLCs result in larger changes in some subgroups (e.g. socioeconomic) of participants than in others.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1022

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Norge
    • Buskerud County
      • Drammen (plus 9 More Communities), Buskerud County, Norge
        • Frisklivssentrale
    • Nord-Trøndelag County
      • Levanger (plus 4 More Communities), Nord-Trøndelag County, Norge
        • Frisklivssentrale
    • Nordland County
      • Bodo (plus 11 More Communities), Nordland County, Norge
        • Frisklivssentrale
    • Sogn Og Fjordane County
      • Laerdal (plus 6 More Communities), Sogn Og Fjordane County, Norge
        • Frisklivssentrale

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • about to start structural support for lifestyle change (regarding physical activity, diet and/or tobacco cessation
  • referred to a Healthy Life Center (HLC) from either primary physician, from other health care services or social services, or participants seeking contact themselves without a specific referral.

Exclusion Criteria:

  • having participated in an HLC the previous 6 months

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
Eksperimentel: Participators in HLCs
Adults with high risk of non-communicable diseases (musculoskeletal disease, obesity, physical distress) about to start a 3 months structural support for lifestyle change in a Healthy Life Center (HLC) in Norway
Adfærdsmæssigt: Healthy Life Center
Depending on what behavior participants aim to change, they get individual counselling using elements from motivational interviewing, group-based exercise twice a week, diet courses and tobacco secession courses during three months
Andre navne:
  • Frisklivssentralen (Norwegian)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
physical activity
Tidsramme: change from baseline to 3 months
measured by accelerometer (ActiGraph GT3X+) for seven consecutive days
change from baseline to 3 months
physical activity
Tidsramme: change from 3 months to 15 months
measured by accelerometer (ActiGraph GT3X+) for seven consecutive days
change from 3 months to 15 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical activity
Tidsramme: change from baseline to 3 months
assessed by questionnaire
change from baseline to 3 months
Physical activity
Tidsramme: change from 3 months to 15 months
assessed by questionnaire
change from 3 months to 15 months
health related quality of life
Tidsramme: change from baseline to 3 months
assessed by SF-36 questionnaire
change from baseline to 3 months
health related quality of life
Tidsramme: change from 3 months to 15 months
assessed by SF-36 questionnaire
change from 3 months to 15 months
Diet
Tidsramme: change from baseline to 3 months
assessed by questionnaire
change from baseline to 3 months
Diet
Tidsramme: change from 3 months to 15 months
assessed by questionnaire
change from 3 months to 15 months
Tobacco use
Tidsramme: change from baseline to 3 months
assessed by questionnaire
change from baseline to 3 months
Tobacco use
Tidsramme: change from 3 months to 15 months
assessed by questionnaire
change from 3 months to 15 months
Physical fitness
Tidsramme: change from baseline to 3 months
assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill
change from baseline to 3 months
Physical fitness
Tidsramme: change from 3 months to 15 months
assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill
change from 3 months to 15 months
Body weight
Tidsramme: change from baseline to 3 months
measured on a scale digital weight
change from baseline to 3 months
Body weight
Tidsramme: change from 3 months to 15 months
measured on a scale digital weight
change from 3 months to 15 months
Body Mass Index
Tidsramme: change from baseline to 3 months
body height measured by a Seca altimeter
change from baseline to 3 months
Body Mass Index
Tidsramme: change from 3 months to 15 months
body height measured by a Seca altimeter
change from 3 months to 15 months
Waist circumference
Tidsramme: change from baseline to 3 months
measured by Seca measurement tape
change from baseline to 3 months
Waist circumference
Tidsramme: change from 3 months to 15 months
measured by Seca measurement tape
change from 3 months to 15 months
Hip circumference
Tidsramme: change from baseline to 3 months
measured by Seca measurement tape
change from baseline to 3 months
Hip circumference
Tidsramme: change from 3 months to 15 months
measured by Seca measurement tape
change from 3 months to 15 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Norwegian University of Science and Technology

Samarbejdspartnere

Western Norway University of Applied Sciences

Efterforskere

  • Studieleder: Riina Kiik, phd, Norwegian University of Science and Technology
  • Studieleder: Erik Kyrkjebø, phd, Western Norway University of Applied Sciences

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2016

Primær færdiggørelse (Faktiske)

1. december 2019

Studieafslutning (Faktiske)

1. december 2019

Datoer for studieregistrering

Først indsendt

17. januar 2017

Først indsendt, der opfyldte QC-kriterier

17. januar 2017

Først opslået (Skøn)

20. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2016/546-1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Healthy Life Center

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner