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Completed

NCT Number: NCT03576209

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

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Key information

Conditions

Sleep Behavior Functional Ability Leadership Motivation Motor Activity Quality of Life Social Behavior Social Identification Social Identity Social Support Well-Being

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KULeuven

Leuven, Flanders, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Healthy Lifestyle Program

Behavioral

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 names: 12 week program 'Lekker Actief'

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change in objectively perceived physical activity

    Time frame: Pretest (week 0), posttest (week 12) follow up (month 15)

    Quantity : measured in minutes and hours by accelerometry

  2. Change in subjectively perceived physical activity

    Time frame: Pretest (week 0), posttest (week 12) follow up (month 15)

    Quantity : measured by self-reported questionnaires (IPAQ : International Physical Activity Questionnaire)

  3. change in quality of life

    Time frame: Pretest (week 0), posttest (week 12) follow up (month 15)

    measured by self-reported questionnaire (SF-12 : Short Form Health Survey)

  4. change in functional ability

    Time frame: Pretest (week 0), posttest (week 12) follow up (month 15)

    measured by self-reported questionnaire (HAQ-DI : Health Assessment Questionnaire)

  5. change in wellbeing

    Time frame: Pretest (week 0), posttest (week 12) follow up (month 15)

    well-being : measured by self-reported questionnaire (WEMWBS : Warwick-Edinburgh Mental Well-being scale)

  6. Social identity and leadership

    Time frame: Pretest (week 0), posttest (week 12)

    measured by self-reported questionnaire (ILI : Identity Leadership Inventory)

  7. motivation

    Time frame: Pretest (week 0), posttest (week 12)

    measured by self-reported questionnaire (BREQ3 : Behavioural Regulation In Exercise Questionnaire)

  8. Social support

    Time frame: Pretest (week 0), posttest (week 12)

    measured by self-reported questionnaire (De Bourdeaudhuij & Salis, 2002)

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 3, 2018
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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