Clinical trial NCT03576209: Effects of a Healthy Lifestyle Program on Health Outcomes in Older Adults
Official title: Prospective Study on Effects of a Healthy Lifestyle Program on Health Outcomes in Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Quality of Life
Functional Ability
Well-being
Social Identity
Leadership
Social Support
Motivation
Keywords: Physical activity
sedentary behaviour
sleep
Quality of life
functional ability
well-being
Social identity and leadership
social support and motivation
Aged, older adults
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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, 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)

  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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in sleep
timeFrame: Pretest (week 0), posttest (week 12) and follow up (month 15)
Secondary outcomes:
measure: Change in objectively perceived physical activity
timeFrame: Pretest (week 0), posttest (week 12) follow up (month 15)
measure: Change in subjectively perceived physical activity
timeFrame: Pretest (week 0), posttest (week 12) follow up (month 15)
measure: change in quality of life
timeFrame: Pretest (week 0), posttest (week 12) follow up (month 15)
measure: change in functional ability
timeFrame: Pretest (week 0), posttest (week 12) follow up (month 15)
measure: change in wellbeing
timeFrame: Pretest (week 0), posttest (week 12) follow up (month 15)
measure: Social identity and leadership
timeFrame: Pretest (week 0), posttest (week 12)
measure: motivation
timeFrame: Pretest (week 0), posttest (week 12)
measure: Social support
timeFrame: Pretest (week 0), posttest (week 12)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KULeuven
state: Flanders
Study officials:
affiliation: KU Leuven
name: Julie Vanderlinden, phds
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.