SleepNCT03576209
Effects of a Healthy Lifestyle Program on Health Outcomes in Older Adults
A study testing healthy lifestyle program in people with Sleep and Quality of Life, run by KU Leuven at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Quality of Life, Functional Ability
- What is being tested?
- healthy lifestyle program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -aged 55+ years
Who cannot join
- -Participants who are physically unable to participate in weekly meetings (PAR-Q : Physical activity readiness scale) (Thomas et al., 1992)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
Read the detailed description
This trial will consist of 3 visits : Pretest and posttest.
- Pretest measurements (week 0)
- 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)
- 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
- Sleep, Quality of Life, Functional Ability, Well-being, Social Identity, Leadership
- Being tested
- healthy lifestyle program
- Keywords
- Physical activity, sedentary behaviour, sleep, Quality of life, functional ability, well-being, Social identity and leadership, social support and motivation, Aged, older adults
- Medical subject headings
- Social Identification, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
healthy lifestyle programBehavioural
Also called 12 week program 'Lekker Actief'
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | 12 week intervention Receives: Behavioral: healthy lifestyle program |
| Control Group | No intervention | No walking program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep
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)
Measured: Pretest (week 0), posttest (week 12) and follow up (month 15)
Secondary outcomes (8)
Change in objectively perceived physical activity
Quantity : measured in minutes and hours by accelerometry
Measured: Pretest (week 0), posttest (week 12) follow up (month 15)
Change in subjectively perceived physical activity
Quantity : measured by self-reported questionnaires (IPAQ : International Physical Activity Questionnaire)
Measured: Pretest (week 0), posttest (week 12) follow up (month 15)
change in quality of life
measured by self-reported questionnaire (SF-12 : Short Form Health Survey)
Measured: Pretest (week 0), posttest (week 12) follow up (month 15)
change in functional ability
measured by self-reported questionnaire (HAQ-DI : Health Assessment Questionnaire)
Measured: Pretest (week 0), posttest (week 12) follow up (month 15)
change in wellbeing
well-being : measured by self-reported questionnaire (WEMWBS : Warwick-Edinburgh Mental Well-being scale)
Measured: Pretest (week 0), posttest (week 12) follow up (month 15)
Social identity and leadership
measured by self-reported questionnaire (ILI : Identity Leadership Inventory)
Measured: Pretest (week 0), posttest (week 12)
motivation
measured by self-reported questionnaire (BREQ3 : Behavioural Regulation In Exercise Questionnaire)
Measured: Pretest (week 0), posttest (week 12)
Social support
measured by self-reported questionnaire (De Bourdeaudhuij \& Salis, 2002)
Measured: Pretest (week 0), posttest (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start1 Mar 2018
- Primary completion31 Jan 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The described trial is a controlled before-and-after study. In this study, observations are made before and after the implementation of the intervention during 12 weeks, both in groups participating in the program (intervention group) and in groups who are not participating in the program (control groups). 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.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Vanderlinden, KU Leuven
- Investigators
- Julie Vanderlinden, phds, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576209
- Sponsor's protocol ID
- Lekker Actief
- Status last verified
- Jan 2021
- First submitted
- 29 Apr 2018
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When intervention is finished, publication in peer reviewed journals is planned
Publications
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.
PubMed 40217356Vanderlinden 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.
PubMed 35183133
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Effects of a Healthy Lifestyle Program on Health Outcomes in Older Adults.
- ClinicalTrials.gov ID
- NCT03576209
- Acronym / sponsor ID
- Lekker Actief
- Conditions
- Sleep, Quality of Life, Functional Ability, Well-being, Social Identity, Leadership
- Keywords
- Physical activity, sedentary behaviour, sleep, Quality of life, functional ability, well-being, Social identity and leadership, social support and motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This trial will consist of 3 visits : Pretest and posttest.
- Pretest measurements (week 0)
- 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)
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The described trial is a controlled before-and-after study. In this study, observations are made before and after the implementation of the intervention during 12 weeks, both in groups participating in the program (intervention group) and in groups who are not participating in the program (control groups). 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Behavioral: healthy lifestyle program12 week intervention |
| Control Group | No intervention | –No walking program |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -aged 55+ years
Key exclusion criteria (1 listed)
- -Participants who are physically unable to participate in weekly meetings (PAR-Q : Physical activity readiness scale) (Thomas et al., 1992)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| healthy lifestyle programAlso: 12 week program 'Lekker Actief'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) | Behavioural | Intervention Group |
Primary outcome
Change in sleep
Time frame: 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)
8 secondary outcomes
Change in objectively perceived physical activity
Time frame: Pretest (week 0), posttest (week 12) follow up (month 15)
Change in subjectively perceived physical activity
Time frame: Pretest (week 0), posttest (week 12) follow up (month 15)
change in quality of life
Time frame: Pretest (week 0), posttest (week 12) follow up (month 15)
change in functional ability
Time frame: Pretest (week 0), posttest (week 12) follow up (month 15)
change in wellbeing
Time frame: Pretest (week 0), posttest (week 12) follow up (month 15)
Social identity and leadership
Time frame: Pretest (week 0), posttest (week 12)
motivation
Time frame: Pretest (week 0), posttest (week 12)
Social support
Time frame: Pretest (week 0), posttest (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 40217356Vanderlinden 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.
- Derived from this study: PubMed 35183133Vanderlinden 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.
- Individual participant dataSharing planned: Yes. When intervention is finished, publication in peer reviewed journals is planned
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Vanderlinden, phds principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing healthy lifestyle program in people with Sleep and Quality of Life, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep (time frame: Pretest (week 0), posttest (week 12) and follow up (month 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03576209, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.