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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Flanders
-
Leuven, Flanders, Bélgica, 3000
- KULeuven
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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)
Otros nombres:
|
|
Sin intervención: Control Group
No walking program
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in sleep
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in objectively perceived physical activity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Pretest (week 0), posttest (week 12)
|
measured by self-reported questionnaire (ILI : Identity Leadership Inventory)
|
Pretest (week 0), posttest (week 12)
|
|
motivation
Periodo de tiempo: 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
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Lekker Actief
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .