- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07699588
Longitudinal Study of Neighborhood Social Event Attendance at Renovated Parks and Changes in Sleep, Stress, and Well-being
Community-engaged Intervention to Optimize the Impact of Renovated Neighborhood Parks on Community Wellbeing
The goal of this study is to learn whether participating in community social and cultural events in renovated neighborhood parks can improve sleep, stress, mood, and overall well-being in adults aged 18 and older who live near participating parks.
The main questions the study aims to answer are:
- Does participation in community park events lead to improvements over time in sleep, stress, mood, and other aspects of well-being?
- Are greater levels of event participation associated with greater improvements in these outcomes?
Participants will:
- Wear a wearable ring device (Oura Ring) most of the time for about six months to measure sleep and physical health indicators
- Attend free community events at or near their neighborhood park, such as social, cultural, or physical activity programs
- Complete online surveys at the beginning and end of the study about well-being and mental health
- Complete brief weekly surveys on mood and study park use
- Attend two in-person visits for basic physical measurements (e.g., height, weight, blood pressure) and device setup/return
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10027
- Center for Systems and Community Design, City University of New York Graduate School of Public Health and Health Policy
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Be 18 years of age or older
- Live within 1 mile of a participating neighborhood park site
- Be able to read and understand English
- Have regular access to a smartphone
- Be willing and able to wear a wearable ring device continuously for approximately 6 months
- Plan to attend at least one community park event during the study period
Exclusion Criteria:
- Those that do not meet above inclusion criteria
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Participation in Community Park Events
Participants are adults living near participating neighborhood parks who are enrolled in a study evaluating the health and well-being effects of participation in community-based park events.
Participants are encouraged and incentivized to attend free social, cultural, and physical activity events over the study period.
In addition, participants wear a wearable device and complete surveys to assess changes in sleep, physiological indicators, and psychosocial well-being over time.
|
Participants are encouraged to attend free community-based events, including social, cultural, and physical activity programming held in their local neighborhood parks.
These events are organized and implemented by the research team in collaboration with local vendors and are designed to promote community engagement and support health and well-being.
Actual attendance may vary across participants, and participation is supported through incentives.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total sleep duration
Periodo de tiempo: From enrollment until one month after park events conclude
|
Total sleep duration (in seconds) will be measured using a wearable ring device and will be computed as the sum of total sleep in REM (rapid eye movement), deep, and light sleep stages.
Sleep duration will be converted to hours and minutes for analysis.
The outcome will assess within-participant change in average nightly sleep duration over time.
|
From enrollment until one month after park events conclude
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total time in bed
Periodo de tiempo: From enrollment until one month after park events conclude
|
Total time in bed (in seconds) will be measured using a wearable ring device and will be computed as the sum of total sleep in REM (rapid eye movement), deep, and light sleep stages, plus time awake.
Total time in bed will be converted to hours and minutes for analysis.
|
From enrollment until one month after park events conclude
|
|
Sleep efficiency
Periodo de tiempo: From enrollment until one month after park events conclude
|
Proportion of time spent asleep while in bed (total sleep duration / total time in bed).
|
From enrollment until one month after park events conclude
|
|
REM (Rapid Eye Movement) sleep duration
Periodo de tiempo: From enrollment until one month after park events conclude
|
Total sleep in the REM (rapid eye movement) stage (in seconds) measured using a wearable ring device.
REM sleep duration will be converted to hours and minutes for analysis, as well as the proportion of total sleep (REM sleep duration / total sleep duration).
|
From enrollment until one month after park events conclude
|
|
Deep sleep duration
Periodo de tiempo: From enrollment until one month after park events conclude
|
Total sleep in the deep sleep stage (in seconds) measured using a wearable ring device.
Deep sleep duration will be converted to hours and minutes for analysis, as well as proportion of total sleep duration (deep sleep duration / total sleep duration).
|
From enrollment until one month after park events conclude
|
|
Light sleep duration
Periodo de tiempo: From enrollment until one month after park events conclude
|
Total sleep in the light stage (in seconds) measured using a wearable ring device.
Light sleep duration will be converted to hours and minutes for analysis, as well as proportion of total sleep duration (light sleep duration / total sleep duration).
|
From enrollment until one month after park events conclude
|
|
Sleep timing
Periodo de tiempo: From enrollment until one month after park events conclude
|
The timing of sleep (hour and minute sleep starts to hour and minute sleep ends) measured using a wearable ring device.
|
From enrollment until one month after park events conclude
|
|
Heart rate variability
Periodo de tiempo: From enrollment until one month after park events conclude
|
Heart rate variability (in milliseconds) measured during sleep using a wearable ring device.
|
From enrollment until one month after park events conclude
|
|
Resting heart rate
Periodo de tiempo: From enrollment until one month after park events conclude
|
Resting heart rate (in beats per minute) measured during sleep using a wearable ring device.
|
From enrollment until one month after park events conclude
|
|
Respiratory rate during sleep
Periodo de tiempo: From enrollment until one month after park events conclude
|
Nighttime respiratory rate (in breaths per minute) measured using a wearable ring device.
|
From enrollment until one month after park events conclude
|
|
Skin temperature deviation
Periodo de tiempo: From enrollment until one month after park events conclude
|
Nightly skin temperature deviation (in Celcius) from baseline measured using a wearable ring device.
|
From enrollment until one month after park events conclude
|
|
Well-being (WHO-5 Well-Being Index)
Periodo de tiempo: Weekly assessments from enrollment until one month after park events conclude
|
Self-reported well-being measured using the World Health Organization-Five (WHO-5) Well-Being Index.
Index scores range from 0-25, with higher scores representing higher quality of life.
|
Weekly assessments from enrollment until one month after park events conclude
|
|
Perceived stress (PSS-10)
Periodo de tiempo: At enrollment and one month after park events conclude
|
Self-reported perceived stress measured using the 10-item Perceived Stress Scale (PSS-10).
Scale scores range from 0-40, with higher scores representing higher perceived stress.
|
At enrollment and one month after park events conclude
|
|
Anxiety symptoms (GAD-7)
Periodo de tiempo: At enrollment and one month after park events conclude
|
Self-reported anxiety symptoms measured using the 7-item Generalized Anxiety Disorder scale (GAD-7).
Scale scores range from 0-21, with higher scores representing higher anxiety.
|
At enrollment and one month after park events conclude
|
|
Depressive symptoms (PHQ-9)
Periodo de tiempo: At enrollment and one month after park events conclude
|
Self-reported depressive symptoms measured using the 9-item Patient Health Questionnaire (PHQ-9).
Scale scores range from 0-27, with higher scores representing higher depression severity.
|
At enrollment and one month after park events conclude
|
|
General well-being (General Well-Being Schedule)
Periodo de tiempo: At enrollment and one month after park events conclude
|
Self-reported overall well-being and psychological functioning measured using the 18-item General Well-Being Schedule (GWBS).
Scale scores range from 0-110, with higher scores representing better well-being.
|
At enrollment and one month after park events conclude
|
|
Life satisfaction (SWLS)
Periodo de tiempo: At enrollment and one month after park events conclude
|
Self-reported life satisfaction measured using the Satisfaction With Life Scale (SWLS).
Scale scores range from 5-35, with higher scores representing higher life satisfaction.
|
At enrollment and one month after park events conclude
|
|
Flourishing (Flourishing Scale)
Periodo de tiempo: At enrollment and one month after park events conclude
|
Self-reported psychological flourishing measured using the Flourishing Scale.
Scale scores range from 8-56, with higher scores representing higher meaning and fulfillment.
|
At enrollment and one month after park events conclude
|
|
Loneliness
Periodo de tiempo: At enrollment and one month after park events conclude
|
Self-reported loneliness measured using items from the 20-item UCLA Loneliness Scale.
Scale scores range from 20-80, with higher scores representing greater feelings of loneliness.
|
At enrollment and one month after park events conclude
|
|
Social cohesion
Periodo de tiempo: At enrollment and one month after park events conclude
|
Perceived neighborhood cohesion and trust measured using items from the collective efficacy scale.
Scale scores range from 5-25, with higher scores representing higher social cohesion and trust.
|
At enrollment and one month after park events conclude
|
|
Sense of community
Periodo de tiempo: At enrollment and one month after park events conclude
|
Sense of community measured using the Sense of Community Index (SCI-2).
Scale scores range from 0-72, with higher scores representing a stronger sense of community.
|
At enrollment and one month after park events conclude
|
|
Neighborhood satisfaction (NEWS)
Periodo de tiempo: At enrollment and one month after park events conclude
|
Individual survey item from the Neighborhood environment walkability scale (NEWS): "How satisfied are you with your neighborhood as a good place to live"? with response options: strongly dissatisfied, somewhat dissatisfied, neither satisfied nor dissatisfied, somewhat satisfied, and strongly satisfied.
|
At enrollment and one month after park events conclude
|
|
Place attachment
Periodo de tiempo: At enrollment and one month after park events conclude
|
Survey items developed by the study team.
I would be sorry if the park closed permanently (response options: strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) I would be sorry to move out of my neighborhood (response options: strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) Is there a strong feeling of belonging in your neighborhood?
(response options: not at all, a little, a medium amount, quite a lot, very much)
|
At enrollment and one month after park events conclude
|
|
Body mass index
Periodo de tiempo: At enrollment and one month after park events conclude
|
Body mass index (in kilograms per meters squared) calculated from measured height and weight (weight in kilograms / height in meters squared).
|
At enrollment and one month after park events conclude
|
|
Systolic blood pressure
Periodo de tiempo: At enrollment and one month after park events conclude
|
Systolic blood pressure measured using standard procedures
|
At enrollment and one month after park events conclude
|
|
Diastolic blood pressure
Periodo de tiempo: At enrollment and one month after park events conclude
|
Diastolic blood pressure measured using standard procedures.
|
At enrollment and one month after park events conclude
|
|
Park use frequency
Periodo de tiempo: Weekly assessments from enrollment until one month after park events conclude
|
Self-reported frequency of park use, adapted from previously validated measures: Veitch, J. et al. A natural experiment to examine the impact of park renewal on park-use and park-based physical activity in a disadvantaged neighbourhood: The REVAMP study methods. BMC Public Health 14, 600 (2014). Walker, J. T. et al. Physical activity in the park setting (PA-PS) questionnaire: Reliability in a California statewide sample. J. Phys. Act. Health. https://doi.org/10.1123/jpah.6.s1.s97 (2009). |
Weekly assessments from enrollment until one month after park events conclude
|
|
Park use duration
Periodo de tiempo: Weekly assessments from enrollment until one month after park events conclude
|
Self-reported duration of park use, adapted from previously validated measures: Veitch, J. et al. A natural experiment to examine the impact of park renewal on park-use and park-based physical activity in a disadvantaged neighbourhood: The REVAMP study methods. BMC Public Health 14, 600 (2014). Walker, J. T. et al. Physical activity in the park setting (PA-PS) questionnaire: Reliability in a California statewide sample. J. Phys. Act. Health. https://doi.org/10.1123/jpah.6.s1.s97 (2009). |
Weekly assessments from enrollment until one month after park events conclude
|
|
Park satisfaction
Periodo de tiempo: At enrollment and one month after park events conclude
|
Single survey item asking study participants how satisfied they are with the overall quality of the park.
(Response options: Strongly satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat satisfied, strongly satisfied).
Adapted from previously validated survey items: Veitch, J. et al.
A natural experiment to examine the impact of park renewal on park-use and park-based physical activity in a disadvantaged neighbourhood: The REVAMP study methods.
BMC Public Health 14, 600 (2014).
|
At enrollment and one month after park events conclude
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Weight
Periodo de tiempo: At enrollment and one month after park events conclude.
|
Weight in kilograms measured using standard procedures.
|
At enrollment and one month after park events conclude.
|
|
Height
Periodo de tiempo: At enrollment and one month after park events conclude.
|
Height in meters measured using standard procedures.
|
At enrollment and one month after park events conclude.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Terry T.-K. Huang, PhD, MPH, MBA, Center for Systems and Community Design, City University of New York Graduate School of Public Health and Health Policy
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2022-0549-PHHP
- R01MD018209 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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. .