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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: healthy lifestyle program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>12 week intervention | Behavioral: healthy lifestyle program<br>* 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)<br>* Other names: 12 week program 'Lekker Actief';|
| No Intervention: Control Group<br>No walking program | |

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional ability, well-being, Social identity and leadership, Aged, older adults, Physical activity, sedentary behaviour, sleep, social support and motivation, Quality of life