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Park Prescription Trial

27. juni 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Singapore, Singapore, 768828
        • Khoo Teck Puat Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2016

Primær færdiggørelse (Faktiske)

1. juni 2017

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

23. november 2015

Først indsendt, der opfyldte QC-kriterier

24. november 2015

Først opslået (Skøn)

26. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Park Prescription

Abonner