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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Flanders
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Leuven、Flanders、ベルギー、3000
- KULeuven
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Intervention Group
12 week intervention
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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)
他の名前：
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介入なし：Control Group
No walking program
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in sleep
時間枠：Pretest (week 0), posttest (week 12) and follow up (month 15)
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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)
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Pretest (week 0), posttest (week 12) and follow up (month 15)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in objectively perceived physical activity
時間枠：Pretest (week 0), posttest (week 12) follow up (month 15)
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Quantity : measured in minutes and hours by accelerometry
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Pretest (week 0), posttest (week 12) follow up (month 15)
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Change in subjectively perceived physical activity
時間枠：Pretest (week 0), posttest (week 12) follow up (month 15)
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Quantity : measured by self-reported questionnaires (IPAQ : International Physical Activity Questionnaire)
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Pretest (week 0), posttest (week 12) follow up (month 15)
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change in quality of life
時間枠：Pretest (week 0), posttest (week 12) follow up (month 15)
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measured by self-reported questionnaire (SF-12 : Short Form Health Survey)
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Pretest (week 0), posttest (week 12) follow up (month 15)
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change in functional ability
時間枠：Pretest (week 0), posttest (week 12) follow up (month 15)
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measured by self-reported questionnaire (HAQ-DI : Health Assessment Questionnaire)
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Pretest (week 0), posttest (week 12) follow up (month 15)
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change in wellbeing
時間枠：Pretest (week 0), posttest (week 12) follow up (month 15)
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well-being : measured by self-reported questionnaire (WEMWBS : Warwick-Edinburgh Mental Well-being scale)
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Pretest (week 0), posttest (week 12) follow up (month 15)
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Social identity and leadership
時間枠：Pretest (week 0), posttest (week 12)
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measured by self-reported questionnaire (ILI : Identity Leadership Inventory)
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Pretest (week 0), posttest (week 12)
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motivation
時間枠：Pretest (week 0), posttest (week 12)
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measured by self-reported questionnaire (BREQ3 : Behavioural Regulation In Exercise Questionnaire)
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Pretest (week 0), posttest (week 12)
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Social support
時間枠：Pretest (week 0), posttest (week 12)
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measured by self-reported questionnaire (De Bourdeaudhuij & Salis, 2002)
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Pretest (week 0), posttest (week 12)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Julie Vanderlinden, phds、KU Leuven
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- Lekker Actief
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- 研究プロトコル
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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