Effects of a Healthy Lifestyle Program on Health Outcomes in Older Adults
NCT ID: NCT03576209
Last Updated: 2021-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1000 participants
INTERVENTIONAL
2018-03-01
2020-08-31
Brief Summary
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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
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Observations are made in intervention and control groups. Participants of the intervention group are registered for participation in this health promotion program 'Lekker Actief' prior to the start of this trial. The control groups are composed of participants who are not participating in the program (not receiving any intervention) or the controls are waitlist controls.
PREVENTION
NONE
Study Groups
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Intervention Group
12 week intervention
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)
Control Group
No walking program
No interventions assigned to this group
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
55 Years
ALL
Yes
Sponsors
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KU Leuven
OTHER
Responsible Party
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Julie Vanderlinden
Principal Investigator
Principal Investigators
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Julie Vanderlinden, phds
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
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KULeuven
Leuven, Flanders, Belgium
Countries
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References
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Vanderlinden J, Biddle GJH, Boen F, van Uffelen JGZ. To be well or not to be well: compositional associations of physical activity, sedentary behaviour and sleep with mental well-being in Flemish adults aged 55+ years. J Act Sedentary Sleep Behav. 2023 May 1;2(1):9. doi: 10.1186/s44167-023-00019-3.
Vanderlinden J, Boen F, Puyenbroeck SV, van Uffelen JGZ. The effects of a real-life lifestyle program on physical activity and objective and subjective sleep in adults aged 55+ years. BMC Public Health. 2022 Feb 19;22(1):353. doi: 10.1186/s12889-022-12780-2.
Other Identifiers
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Lekker Actief
Identifier Type: -
Identifier Source: org_study_id
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