- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03027518
WILD 5 Wellness: A 30-Day Intervention
24. april 2018 opdateret af: Beloit College
The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in Beloit College students.
This program is called "WILD 5 Wellness: A 30-Day Intervention".
Results for this study will be quantified through the use of standardized self-report questionnaires administered prior to and after students complete the WILD 5 program (Group 1) or 30 days of inactive participation (Group 2), and again approximately 30 days later when the initially inactive group (Group 2) will have just completed their active participation in the WILD 5 program and the first WILD 5 group (Group 1) will be approximately 30 days out from completion of their WILD 5 active portion.
Data will be collected to evaluate participants' adherence and response to each element of WILD 5, a 5-pronged 30-day wellness intervention.
It is expected that this 30-day integrated, prescriptive, and trackable program will be found to be an efficacious wellness intervention for Beloit College students as compared to the control (inactive) group of students not participating in the Active program.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
88
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Wisconsin
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Beloit, Wisconsin, Forenede Stater, 53511
- Beloit College
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Beloit College student enrolled in one or more of the following Spring 2017 academic courses:
- Anthropology 201 01 "Research Designs: Sophomore Seminar in Anthropology"
- Health and Society 240 B1 "Sophomore Seminar in Health and Society"
- Spanish 218 "Health and Culture in the Spanish-Speaking World"
- Biology 373 "Neuroscience Research"
- Biology 215 "Emerging Diseases"
Exclusion Criteria:
- Individuals who are <18 years old
- Individuals who are acutely suicidal and/or actively psychotic
- Individuals who are pregnant or plan to get pregnant during the next 60 days, or who are not registered in one of the courses listed above.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: Group 1
Group 1 will be active in the WILD 5 Wellness program the first 30 days and inactive the 2nd 30 days.
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Participants will be asked to voluntarily engage in integrated, prescriptive, and trackable wellness interventions combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
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Andet: Group 2
Group 2 will be inactive in the WILD 5 Wellness program the first 30 days and active the 2nd 30 days.
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Participants will be asked to voluntarily engage in integrated, prescriptive, and trackable wellness interventions combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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WILD 5 Wellness Scale (W5WS), Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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WILD 5 Wellness Elements (W5WE), Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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WILD 5 Wellness Effort Scale (W5WES), Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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WHO (World Health Organization) 5 Well-Being Index (1998 version), Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Social Connectedness Scale (SCS), Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Sleep Condition Indicator (SCI), Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Sheehan Disability Scale (SDS), Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Patient Health Questionnaire (PHQ-9), Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Mindful Attention Awareness Scale (MAAS), Day to Day Experiences, Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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MIND ( Mediterranean-DASH Intervention for Neurodegenerative Delay)Diet, Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Generalized Anxiety Disorder (GAD-7), Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Eating and Appraisal Due to Emotions and Stress Questionnaire (EADES), Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Cognitive and Physical Functioning Questionnaire (CPFQ), Assessing Change
Tidsramme: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
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Post Program Participant Questionnaire
Tidsramme: The end of the 30 day active participation in WILD 5 Wellness for each group (1 and 2)
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The end of the 30 day active participation in WILD 5 Wellness for each group (1 and 2)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
6. februar 2017
Primær færdiggørelse (Faktiske)
18. april 2017
Studieafslutning (Faktiske)
5. december 2017
Datoer for studieregistrering
Først indsendt
17. januar 2017
Først indsendt, der opfyldte QC-kriterier
19. januar 2017
Først opslået (Skøn)
23. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. april 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. april 2018
Sidst verificeret
1. april 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 302
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Sunnybrook Health Sciences CentreSunnybrook Research InstituteRekruttering
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National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH); Department of Health and Human ServicesSuspenderet
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