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Park Prescription Trial

27 juin 2017 mis à jour par: Dr Falk Mueller-Riemenschneider, National University of Singapore
The purpose of this study is to test the effectiveness of prescribing park use (i.e., ''Park Prescription'') to insufficiently active individuals. It is hypothesized that Park Prescription will motivate the target population to increase physical activity and thereby improve their physical and mental health.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

BACKGROUND: There are substantial international research findings supporting the role that natural environments play in enhancing human health and the prevention of chronic diseases. Also, there is evidence highlighting the (cost-) effectiveness of prescribing physical activity to promote one's physical activity and health. However, there is a lack of methodologically rigorous studies that have looked into the effectiveness of combining these two promising approaches; i.e., physical activity prescription with a focus on the use of parks and green spaces: Park Prescription.

AIMS: This Randomized Controlled Trial (RCT) will investigate the concept of Park Prescription as a health promoting intervention for individuals. The primary objective is to investigate the effectiveness of a park prescription interventions to increase participant's time spent in moderate to vigorous physical activity (MVPA). Main secondary objectives are to assess; A) improvement in physical health (e.g., blood sugar and blood pressure) and health behaviour (e.g., sitting time); B) improvement in mental health (e.g., quality of life); 3) intervention implementation fidelity and the association with park use and perceived study participant satisfaction.

METHODOLOGY: Participants aged between 40 and 65 years will be recruited from the Singapore Population Health Community Screening Programme conducted by Alexandra Health Pte Ltd. They will be randomly assigned to one of the following two arms; 1) park prescription + participation in a weekly structured physical activity program conducted in the park, and 2) control group. Participants will be enrolled in the study for a period of 6 months. They will have to complete a baseline assessment, 3-month and 6-month follow-up. The investigators aim to recruit 80 participants in each arm, making a total of 160 study participants.

Type d'étude

Interventionnel

Inscription (Réel)

160

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Singapore, Singapour, 768828
        • Khoo Teck Puat Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

Subjects must meet all of the inclusion criteria as listed below to participate in the study.

Study participants must:

  1. be not currently sufficiently active (less than 150 minutes per week of exercise);
  2. complete and pass the PAR-Q+*;
  3. have a blood pressure of less or equal to (<=) 139 mmHG (systolic) over less or equal to (<=) 89 mmHG (diastolic);
  4. have fasting glucose levels of less or equal to (<=) 6.0 mmol/l);
  5. be Singaporean or Permanent Residents;
  6. be able to write and read;
  7. provide informed consent.

Exclusion Criteria:

All subjects meeting any of the following exclusion criteria will be excluded from participation:

  1. pregnant women;
  2. people who have severe medical conditions prohibiting participation in physical activity as assessed by the PAR-Q (including, heart disease, lung disease, diabetes);
  3. people who have a blood pressure of >139 mmHG (systolic) over >89 mmHG (diastolic);
  4. people who have fasting glucose levels of >6.0 mmol/l);
  5. those with physical disabilities or lower limb disorders.

    • The Physical Activity Readiness Questionnaire (PAR-Q) is a self-guided, nine question screening tool that can quickly identify conditions or risk factors that require further assessment before engaging in physical activity. See: British Columbia Ministry of Health Department of National Health and Welfare: Physical Activity Readiness Questionnaire. Canada: 1992.For the current study, we are using an amended version of the PAR-Q.

The PAR-Q+ also includes an additional section to formally assess subjects' age, whether they have physical disabilities or lower limb disorders, and their physical activity status.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Park prescription
The participants in this group will receive a brief counseling on physical activity together with a park prescription that highlights the importance of engaging in at least 150 minutes of physical activity per week and the possibility of engaging in physical activity in the park. In addition, they are invited to join in a structured and supervised physical activity program in the park. The structured physical activity program will take place in public parks located in the participants' neighbourhood. Participants will receive text messages for reminder and registration purposes approximately once a week. Also, participants will receive a sheet to monitor their weekly physical activity, information about parks in their neighborhood, and a counseling phone call half-way through the study.
Please refer to the information included in the arm description.
Aucune intervention: Control
The participants in this group will not be given any park prescription or be invited to participate in the weekly program in the park. However, they will receive all the information materials provided to the experimental group after the study has ended.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Hours/week spent in Moderate to Vigorous Physical Activity (MVPA) assessed objectively with accelerometry
Délai: At 6 months follow-up
At 6 months follow-up

Mesures de résultats secondaires

Mesure des résultats
Délai
Fasting glucose levels (mmol/l)
Délai: At 6 months follow-up
At 6 months follow-up
Total cholesterol (mmol/l)
Délai: At 6 months follow-up
At 6 months follow-up
LDL (mmol/l)
Délai: At 6 months follow-up
At 6 months follow-up
HDL (mmol/l)
Délai: At 6 months follow-up
At 6 months follow-up
Triglycerides (mmol/l)
Délai: At 6 months follow-up
At 6 months follow-up
Blood pressure (mmHG)
Délai: At 6 months follow-up
At 6 months follow-up
Body Mass Index (kg/m^2)
Délai: At 6 months follow-up
At 6 months follow-up
Waist circumference (cm)
Délai: At 6 months follow-up
At 6 months follow-up
Hours/week spent in Moderate to Vigorous Physical Activity (MVPA) assessed by self-report
Délai: At 6 months follow-up
At 6 months follow-up
Hours/week spent in sedentary behaviour assessed by self-report
Délai: At 6 months follow-up
At 6 months follow-up
Psychological distress assessed with Kessler-10
Délai: At 6 months follow-up
At 6 months follow-up
Physical and mental health functioning assessed with SF-12
Délai: At 6 months follow-up
At 6 months follow-up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Falk Mueller-Riemenschneider, Assist Prof, Saw Swee Hock School of Public Health, National University of Singapore

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2016

Achèvement primaire (Réel)

1 juin 2017

Achèvement de l'étude (Réel)

1 juin 2017

Dates d'inscription aux études

Première soumission

23 novembre 2015

Première soumission répondant aux critères de contrôle qualité

24 novembre 2015

Première publication (Estimation)

26 novembre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 juin 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 juin 2017

Dernière vérification

1 juin 2017

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur En bonne santé

Essais cliniques sur Park Prescription

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