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Effects of a Healthy Lifestyle Program on Health Outcomes in Older Adults

15. januar 2021 opdateret af: Julie Vanderlinden, KU Leuven

Prospective Study on Effects of a Healthy Lifestyle Program on Health Outcomes in Older Adults.

Medical condition or disease under investigation : Quantitative and qualitative aspects of sleep, quality of life, functional ability and well-being in older adults (>55years)

Purpose of clinical trial : To study the prospective effects of a healthy lifestyle program on quantitative and qualitative aspects of sleep, quality of life, functional ability and well-being in older adults.

Primary objective : Measure the effects of the intervention on quantitative and qualitative aspects of sleep

Secondary objective (s) : Measure the effects of the intervention on physical activity, quality of life, functional ability and well-being Social identity and leadership, social support and motivation

Trial Design : Intervention study : controlled before-and-after study

Sample Size : total sample size : 1.000 participants

Summary of eligibility criteria : Older adults aged above 55years

Included in intervention group : adults who are participating in the healthy lifestyle promotion program 'Lekker Actief', organized by OKRA

Included in control group : waitlist controls or controls (adults, members of OKRA, not participating in the health promotion program 'Lekker Actief')

Maximum duration of treatment of a subject :

  • Start of Health promotion program 'Lekker Actief' : September 2018
  • Measurements with accelerometers will start prior to the health promotion program 'Lekker Actief' : July 2018
  • End of Health promotion program 'Lekker Actief' : December 2019
  • Duration of Health promotion program 'Lekker Actief': 12 weeks
  • Maximal duration : July 2018-December 2019

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This trial will consist of 3 visits : Pretest and posttest.

  • Pretest measurements (week 0)

    o Accelerometry : a subsample of participants form intervention and control groups (n=400) will be asked to wear an accelerometer (type GT3X) during 7 entire days prior to baseline measurements. (Timing : July 2018-July 2019)

    o Baseline measurements : during the start up moment of the program all participants from intervention and control groups will be asked : (Timing : July 2018-July 2019)

    • To fill out the self-reported questionnaire (survey) : the survey is composed of existing validated scales : IPAQ, PSQI, SF-12, WEMWBS, HAQ-DI. (references of validated scales are provided in the 'outcome measures' section)
    • To perform a walk test over 20 meters in order to determine the individual stride length
    • To perform a 6 minute walking test in order to self-report perceived exertion and physical fitness (by Borg Scale) and to determine the individual entry level of the program (entry levels vary between 1-12)
    • To wear the Pedometer (Omron® Walking Style one 2.0) on a daily basis and register the amount of daily steps in their personal registration forms

  • Posttest measurements (week 12)

    • Accelerometry : a subsample of participants form intervention and control groups (n=400) will be asked to wear an accelerometer (type GT3X®) during 7 days prior to posttest measurements. (Timing : September 2018 - December 2019)
    • Posttest measurements : at the end of the program all participants will be asked :

(Timing : September 2018 - December 2019)

  • To fill out the self-reported questionnaire (survey). In addition to the pretest questionnaire, the validated scales ILI, Mael and Ashford (1992) and BREQ-3 will be added and will be filled out only by participants of the intervention groups
  • To perform a 6 minute walking test in order to self-report perceived exertion and physical fitness (by Borg Scale)
  • To inform the investigators on the amount of daily steps (measured with pedometer type : Omron® Walking Style one 2.0) during the 12 week program o Focus groups : a subsample will be invited to take part in focus groups. During these focus groups, participants will be encouraged to discuss the program and possible effects in small groups (5 participants per group). A semi-structured interview guide will be used to guide the discussions.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1000

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Belgien
    • Flanders
      • Leuven, Flanders, Belgien, 3000
        • KULeuven

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

55 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

-aged 55+ years

Exclusion Criteria:

-Participants who are physically unable to participate in weekly meetings (PAR-Q : Physical activity readiness scale) (Thomas et al., 1992)

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Intervention Group
12 week intervention
Adfærdsmæssigt: healthy lifestyle program
Participants (intervention group) are following a 12 week health promotion program. They will count daily steps by pedometers and participate in weekly organised walks (within socio-cultural organisation)
Andre navne:
  • 12 week program 'Lekker Actief'
Ingen indgriben: Control Group
No walking program

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in sleep
Tidsramme: Pretest (week 0), posttest (week 12) and follow up (month 15)
Change in quantity of sleep : measured in minutes and hours by accelerometry and self-reported questionnaires (PSQI : Pittsburgh Sleep Quality Index (PSQI)) Change in quality of sleep : measured by self-reported questionnaire (PSQI)
Pretest (week 0), posttest (week 12) and follow up (month 15)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in objectively perceived physical activity
Tidsramme: Pretest (week 0), posttest (week 12) follow up (month 15)
Quantity : measured in minutes and hours by accelerometry
Pretest (week 0), posttest (week 12) follow up (month 15)
Change in subjectively perceived physical activity
Tidsramme: Pretest (week 0), posttest (week 12) follow up (month 15)
Quantity : measured by self-reported questionnaires (IPAQ : International Physical Activity Questionnaire)
Pretest (week 0), posttest (week 12) follow up (month 15)
change in quality of life
Tidsramme: Pretest (week 0), posttest (week 12) follow up (month 15)
measured by self-reported questionnaire (SF-12 : Short Form Health Survey)
Pretest (week 0), posttest (week 12) follow up (month 15)
change in functional ability
Tidsramme: Pretest (week 0), posttest (week 12) follow up (month 15)
measured by self-reported questionnaire (HAQ-DI : Health Assessment Questionnaire)
Pretest (week 0), posttest (week 12) follow up (month 15)
change in wellbeing
Tidsramme: Pretest (week 0), posttest (week 12) follow up (month 15)
well-being : measured by self-reported questionnaire (WEMWBS : Warwick-Edinburgh Mental Well-being scale)
Pretest (week 0), posttest (week 12) follow up (month 15)
Social identity and leadership
Tidsramme: Pretest (week 0), posttest (week 12)
measured by self-reported questionnaire (ILI : Identity Leadership Inventory)
Pretest (week 0), posttest (week 12)
motivation
Tidsramme: Pretest (week 0), posttest (week 12)
measured by self-reported questionnaire (BREQ3 : Behavioural Regulation In Exercise Questionnaire)
Pretest (week 0), posttest (week 12)
Social support
Tidsramme: Pretest (week 0), posttest (week 12)
measured by self-reported questionnaire (De Bourdeaudhuij & Salis, 2002)
Pretest (week 0), posttest (week 12)

Samarbejdspartnere og efterforskere

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

Sponsor

KU Leuven

Efterforskere

  • Ledende efterforsker: Julie Vanderlinden, phds, KU Leuven

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

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. marts 2018

Primær færdiggørelse (Faktiske)

31. januar 2020

Studieafslutning (Faktiske)

31. august 2020

Datoer for studieregistrering

Først indsendt

29. april 2018

Først indsendt, der opfyldte QC-kriterier

21. juni 2018

Først opslået (Faktiske)

3. juli 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Lekker Actief

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

When intervention is finished, publication in peer reviewed journals is planned

IPD-delingstidsramme

Study protocol will be published after start of the trial

IPD-delingsadgangskriterier

by Principal Investigator

IPD-deling Understøttende informationstype

  • Studieprotokol

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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