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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Flanders
-
Leuven, Flanders, Bélgica, 3000
- KULeuven
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Intervention Group
12 week intervention
|
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)
Outros nomes:
|
|
Sem intervenção: Control Group
No walking program
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in sleep
Prazo: 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)
|
Pretest (week 0), posttest (week 12) and follow up (month 15)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in objectively perceived physical activity
Prazo: Pretest (week 0), posttest (week 12) follow up (month 15)
|
Quantity : measured in minutes and hours by accelerometry
|
Pretest (week 0), posttest (week 12) follow up (month 15)
|
|
Change in subjectively perceived physical activity
Prazo: Pretest (week 0), posttest (week 12) follow up (month 15)
|
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
Prazo: Pretest (week 0), posttest (week 12) follow up (month 15)
|
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
Prazo: Pretest (week 0), posttest (week 12) follow up (month 15)
|
measured by self-reported questionnaire (HAQ-DI : Health Assessment Questionnaire)
|
Pretest (week 0), posttest (week 12) follow up (month 15)
|
|
change in wellbeing
Prazo: Pretest (week 0), posttest (week 12) follow up (month 15)
|
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
Prazo: Pretest (week 0), posttest (week 12)
|
measured by self-reported questionnaire (ILI : Identity Leadership Inventory)
|
Pretest (week 0), posttest (week 12)
|
|
motivation
Prazo: Pretest (week 0), posttest (week 12)
|
measured by self-reported questionnaire (BREQ3 : Behavioural Regulation In Exercise Questionnaire)
|
Pretest (week 0), posttest (week 12)
|
|
Social support
Prazo: Pretest (week 0), posttest (week 12)
|
measured by self-reported questionnaire (De Bourdeaudhuij & Salis, 2002)
|
Pretest (week 0), posttest (week 12)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Julie Vanderlinden, phds, KU Leuven
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Lekker Actief
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .