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

NCT03576209 | Completed DMC

• 1 other identifier: Lekker Actief
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in objectively perceived physical activity

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

• Change in subjectively perceived physical activity

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

• change in quality of life

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

• change in functional ability

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

• change in wellbeing

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

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

12 week intervention

Behavioral: healthy lifestyle program

Control Group

NO INTERVENTION

No walking program

Interventions

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)

Also known as: 12 week program 'Lekker Actief'

Intervention Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 55+ years

You may not qualify if:

• Participants who are physically unable to participate in weekly meetings (PAR-Q : Physical activity readiness scale) (Thomas et al., 1992)

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KULeuven

Leuven, Flanders, 3000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 40217356 DERIVED

• 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.

  PMID: 35183133 DERIVED

MeSH Terms

Conditions

Social Identification; Motor Activity

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Julie Vanderlinden, phds

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2018
• First Posted: July 3, 2018
• Study Start: March 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: August 31, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Study protocol will be published after start of the trial
• Access Criteria: by Principal Investigator

Locations

BE (1)