- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03579264
Experience and Health Impact of University Students Accessing a Digital Nutrition, Fitness and Mindfulness Platform
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
When individuals look after their own health using online applications they can expect similar or even better health outcomes compared to those obtained by using conventional methods. These kind of tools are popular among University students. Due to the many changes and challenges that students face in the first year of University, this sector of our population is at higher risk of presenting nutritional problems, anxiety, depression and suicidal thoughts.
Recently, a Canadian online application called My Viva Plan® became available. This program is based on preventive self-care and it includes three key pillars of health: nutrition, fitness, and mindfulness. Changes in dietary choices, quality of life and stress will be evaluated in a sample of 100 undergraduate students who are in their first year of university. Students will be randomized into the following two groups; students who will use the program vs. students who will not use the program. Questionnaires regarding physical activity, mindfulness and mental well-being will be evaluated at baseline, week 6 and week 12. Body composition characteristics using bioelectrical impedance analysis will be collected at the start and end of the study (baseline and week 12).
The objective is to determine if the use of an online application based on preventive self-care will result in better food choices, better quality of life, and reduced stress in first year university students.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2E1
- University of Alberta
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- First-year undergraduate university students attending the University of Alberta's North Campus
- Students who are able to complete study assessments in their first year of university
- 17-30 years of age
Exclusion Criteria:
- Students with self-reported eating disorders
- Students with self-reported untreated depression, anxiety or other mood disorders
- Students who do not own a device to access the internet (i.e. tablet, computer, laptop, smart phone)
- Students who are not able to communicate in English
- Pregnant or lactating women
- Individuals with pace-makers or electronic implantable devices
Studieplan
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 |
---|---|
Ingen indgriben: Standard Arm
No use of My Viva Plan.
|
|
Eksperimentel: Intervention Arm
Use of My Viva Plan.
|
Use of the online platform, My Viva Plan, to support health and wellness.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Stress
Tidsramme: Baseline, week 12
|
To assess the change in self reported stress from baseline to week 12 using the Stress Indicators Questionnaire by the International Counselling Team.
|
Baseline, week 12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Dietary Choices
Tidsramme: Baseline, week 12
|
To assess the change in dietary choices from baseline to week 12 using three-day food records collected at baseline and week 12.
|
Baseline, week 12
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Carla Prado, PhD, University of Alberta
Publikationer og nyttige links
Generelle publikationer
- Lieffers JRL, Quintanilha M, Trottier CF, Johnson ST, Mota JF, Prado CM. Experiences with and Perception of a Web-Based Mindfulness, Nutrition, and Fitness Platform Reported by First-Year University Students: A Qualitative Study. J Acad Nutr Diet. 2021 Dec;121(12):2409-2418.e3. doi: 10.1016/j.jand.2021.04.019. Epub 2021 Jun 10.
- Trottier CF, Lieffers JRL, Johnson ST, Mota JF, Gill RK, Prado CM. The Impact of a Web-Based Mindfulness, Nutrition, and Physical Activity Platform on the Health Status of First-Year University Students: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Mar 10;10(3):e24534. doi: 10.2196/24534.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Pro00079680
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 Fysisk aktivitet
-
University of ValenciaAktiv, ikke rekrutterendeAutismespektrumforstyrrelse | Attention Deficit Hyper ActivitySpanien
-
NYU Langone HealthAfsluttetAttention Deficit Hyper ActivityForenede Stater
-
Texas Woman's UniversityAfsluttetIntellektuel handicap | Autismespektrumforstyrrelse | Motoriske lidelser | Motorforsinkelse | Sanseforstyrrelser | Attention Deficit Hyper Activity
-
Cingulate TherapeuticsPremier Research Group plcAktiv, ikke rekrutterendeADHD | Attention Deficit Hyperactivity Disorder | ADHD - kombineret type | Attention Deficit Hyperactivity Disorder kombineret | Attention Deficit Hyper Activity | Opmærksomhedsunderskud hyperaktivitetForenede Stater
-
Cingulate TherapeuticsRekrutteringADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder med hyperaktivitet | ADHD - kombineret type | Attention Deficit Hyperactivity Disorder kombineret | Attention Deficit Hyper Activity | Opmærksomhedsunderskud hyperaktivitetForenede Stater
-
Affiliated Hospital to Academy of Military Medical...Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Peking...RekrutteringAldersinterval ≥16 år, køn ubegrænset | Histopatologi bekræftet diffust stort B-celle lymfom eller højgradigt B-celle lymfom | Modtaget tidligere førstelinjekemoterapi for DLBCL eller HGBL, kunne ikke nå CR i fire cyklusser eller tilbagefald | Mindst én positiv læsion ifølge 2014 Lugano-kriterierne... og andre forholdKina
Kliniske forsøg med My Viva Plan
-
University of AlbertaRevive Wellness Inc.Rekruttering
-
Venus ConceptAfsluttet
-
Venus ConceptAfsluttetRynke | RhytiderForenede Stater
-
Venus ConceptAfsluttetAcne ar - blandet atrofisk og hypertrofisk | RynkeForenede Stater
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development...Afsluttet
-
Venus ConceptAfsluttetRynke | RhytiderForenede Stater
-
Venus ConceptAfsluttetAcne arForenede Stater
-
Venus ConceptAfsluttetAcne ar - blandet atrofisk og hypertrofiskForenede Stater
-
University of MichiganThe Craig H. Neilsen FoundationAktiv, ikke rekrutterendeAccept- og forpligtelsesterapi for kronisk smerte ved SCI: Udvikling og test af et e-sundhedsprogramRygmarvsskaderForenede Stater
-
University of Turin, ItalyAfsluttetKognitiv svækkelse | Skrøbelige ældres syndrom | Fysisk afhængighedItalien