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.

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Sleep; Well-being; Motivation; Social Support; Leadership; Functional Ability; Social Identity
• Intervention / Treatment: Behavioral: healthy lifestyle program

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.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Flanders
    • Leuven, Flanders, Belgium, 3000
      • KULeuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; 12 week intervention	Behavioral: 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 Names: 12 week program 'Lekker Actief'
No Intervention: Control Group; No walking program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Pretest (week 0), posttest (week 12) and follow up (month 15)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in objectively perceived physical activity	Quantity : measured in minutes and hours by accelerometry	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)	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)	Pretest (week 0), posttest (week 12) follow up (month 15)
change in functional ability	measured by self-reported questionnaire (HAQ-DI : Health Assessment Questionnaire)	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)	Pretest (week 0), posttest (week 12) follow up (month 15)
Social identity and leadership	measured by self-reported questionnaire (ILI : Identity Leadership Inventory)	Pretest (week 0), posttest (week 12)
motivation	measured by self-reported questionnaire (BREQ3 : Behavioural Regulation In Exercise Questionnaire)	Pretest (week 0), posttest (week 12)
Social support	measured by self-reported questionnaire (De Bourdeaudhuij & Salis, 2002)	Pretest (week 0), posttest (week 12)

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Julie Vanderlinden, phds, KU Leuven

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: April 29, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (Actual): July 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: sleep; Quality of life; Physical activity; well-being; sedentary behaviour; functional ability; Social identity and leadership; social support and motivation; Aged, older adults
• Other Study ID Numbers: Lekker Actief

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: When intervention is finished, publication in peer reviewed journals is planned
• IPD Sharing Time Frame: Study protocol will be published after start of the trial
• IPD Sharing Access Criteria: by Principal Investigator
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No