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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03576209
Enrollment
1000
Registered
2018-07-03
Start date
2018-03-01
Completion date
2020-08-31
Last updated
2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Ability, Leadership, Motivation, Quality of Life, Sleep, Social Identity, Social Support, Well-being

Keywords

Physical activity, sedentary behaviour, sleep, Quality of life, functional ability, well-being, Social identity and leadership, social support and motivation, Aged, older adults

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.

Interventions

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)

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in sleepPretest (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)

Secondary

MeasureTime frameDescription
Change in subjectively perceived physical activityPretest (week 0), posttest (week 12) follow up (month 15)Quantity : measured by self-reported questionnaires (IPAQ : International Physical Activity Questionnaire)
change in wellbeingPretest (week 0), posttest (week 12) follow up (month 15)well-being : measured by self-reported questionnaire (WEMWBS : Warwick-Edinburgh Mental Well-being scale)
change in quality of lifePretest (week 0), posttest (week 12) follow up (month 15)measured by self-reported questionnaire (SF-12 : Short Form Health Survey)
Change in objectively perceived physical activityPretest (week 0), posttest (week 12) follow up (month 15)Quantity : measured in minutes and hours by accelerometry
Social identity and leadershipPretest (week 0), posttest (week 12)measured by self-reported questionnaire (ILI : Identity Leadership Inventory)
motivationPretest (week 0), posttest (week 12)measured by self-reported questionnaire (BREQ3 : Behavioural Regulation In Exercise Questionnaire)
Social supportPretest (week 0), posttest (week 12)measured by self-reported questionnaire (De Bourdeaudhuij & Salis, 2002)
change in functional abilityPretest (week 0), posttest (week 12) follow up (month 15)measured by self-reported questionnaire (HAQ-DI : Health Assessment Questionnaire)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026