- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01680224
Effektivitetsforsøg af et dissonansbaseret fedmeforebyggelsesprogram (Project Health)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Mål 1 vil teste hypotesen om, at Project Health signifikant reducerer stigninger i % kropsfedt i forhold til Healthy Weight-interventionen og videokontroltilstanden under en 2-årig opfølgning; sekundære udfald er BMI, depressive symptomer og spiseforstyrrelsessymptomer. Efterforskerne vil også sammenligne sund vægt med videokontroller.
Mål 2 vil teste hypotesen om, at Projekt Sundhedsdeltagere vil opleve øget kognitiv dissonans (en ubehagelig psykologisk tilstand) med hensyn til at spise usund mad og engagere sig i stillesiddende adfærd, og at ændringer i dissonans medierer programmets forebyggende virkninger af vægtøgning. Efterforskerne vil også teste, om reduceret kalorieindtag og øget fysisk aktivitet medierer effekten af Project Health på ændring i % kropsfedt.
Mål 3 vil teste hypotesen om, at interventionseffekter forstærkes for deltagere med forhøjet utilfredshed med kroppen (hvilket bør øge motivationsændringen) og præference for konsistens (hvilket bør maksimere dissonansinduktion) og afbødes for deltagere, der rapporterer følelsesmæssig spisning og stofbrug (fordi disse faktorer øge risikoen for overspisning).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Oregon
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Corvallis, Oregon, Forenede Stater, 97331
- Oregon State University
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Eugene, Oregon, Forenede Stater, 97403
- Oregon Research Institute
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Eugene, Oregon, Forenede Stater, 94703
- University of Oregon
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Texas
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Austin, Texas, Forenede Stater, 78713
- University of Texas, Austin
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- universitetsstuderende
- Præsenterer med selvrapporterede "vægtbekymringer"
Ekskluderingskriterier:
- Diagnose af spiseforstyrrelse
- Overvægtige
- Undervægtig
- Ikke-engelsktalende
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: FOREBYGGELSE
- Tildeling: TILFÆLDIGT
- Interventionel model: PARALLEL
- Maskning: INGEN
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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ACTIVE_COMPARATOR: Sund vægt
Hovedmålet med Healthy Weight-interventionen er at foretage små, bæredygtige ændringer af input og output på ugentlig basis for at opnå en balance mellem kalorieindtag og -output.
Alle sessioner begynder med en kort gennemgang af, hvad der blev behandlet i den forrige session, præsentation af pædagogiske uddelingskopier, omhyggelig gennemgang af tidligere adfærdsændringsmål og udvikling af sunde adfærdsændringsplaner for næste session.
Hjemmeøvelser til alle sessioner består af at følge individualiserede diæt- og træningsmål og føre en mad- og træningslog for at bestemme områder for fremtidige sunde ændringer.
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EKSPERIMENTEL: Projekt Sundhed
Project Health føjer dissonansfremkaldende aktiviteter, diskussioner og lektieaktiviteter til den sunde vægt grundlæggende intervention.
Hver session begynder med en mundtlig forpligtelse til at deltage (for at understrege den frivillige karakter af deltagelse), inkluderer diskussioner af gennemførte hjemmeøvelsesopgaver og skrive-/delingsøvelser under sessionen (for at skabe ansvarlighed) og afsluttes med hjemmeøvelser (for at øge niveauet af indsats).
Afsluttede hjemmeopgaver videofilmes i efterfølgende sessioner for at øge ansvarligheden.
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PLACEBO_COMPARATOR: Styring
Nogle deltagere vil blive randomiseret til at kontrollere tilstanden, hvorved de vil få en psykoedukativ video ("Verdens vægt") at se.
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Deltagerne vil se en video om overvægt og fedme
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Kropsfedtprocent
Tidsramme: Ændringer i kropsfedt fra baseline til 2-års opfølgning
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Vi vil bruge luftforskydningspletysmografi (ADP) via Bod Pod S/T til at vurdere % kropsfedt.
To mål vil blive gennemsnittet.
Kropsdensitet, beregnet som kropsmasse divideret med estimeret kropsvolumen, bruges til at beregne alders- og kønsjusterede kropsfedtpercentil-score baseret på normative referencedata (McCarthy et al., 2006).
Et pilotvaliditetsstudie (N = 30) afslørede, at direkte DEXA-mål for % kropsfedt korrelerer meget stærkere med ADP-estimater af kropsfedt (r = 0,88)
end med BMI (r = .23).
Ændring i alders- og kønsjusteret kropsfedtpercentil i løbet af den 2-årige opfølgning vil være det primære resultat.
Denne vurdering tager 3-5 minutter at gennemføre.
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Ændringer i kropsfedt fra baseline til 2-års opfølgning
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Spisepatologi
Tidsramme: Baseline og post intervention (6 uger); 6/12/24 måneders opfølgning
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Eating Disorder Diagnostic Interview, et kort semi-struktureret interview, vil vurdere spiseforstyrrelsessymptomer.
Det giver diagnoser for anorexia nervosa, bulimia nervosa og binge eating disorder, som vil give os mulighed for at udelukke deltagere med disse lidelser.
Det giver også et kontinuerligt mål for overordnede spiseforstyrrelsessymptomer.
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Baseline og post intervention (6 uger); 6/12/24 måneders opfølgning
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Negativ påvirkning
Tidsramme: Baseline og post intervention (6 uger); 6/12/24 måneders opfølgninger
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Negativ affekt-underskalaen med 20 punkter i Positive og Negative Affect Schedule (PANAS: Watson et al., 1988) måler generel negativ affektivitet og depressive symptomer.
Ved at bruge et Likert-vurderingssystem vælger deltagerne deres grad af godkendelse af negative affektive elementer såsom "væmmes ved sig selv" og "ensom" (svarmuligheder: 1 = slet ikke; 5 = ekstremt).
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Baseline og post intervention (6 uger); 6/12/24 måneders opfølgninger
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Madtrang/Like
Tidsramme: Baseline, 6 uger (efter intervention), 6/12/24 måneders opfølgninger
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Food Craving Inventory med 28 punkter (FCI; White et al., 2002) vurderer subjektive trang til individuelle fødevarer (pasta, is) og spørger: "I løbet af den seneste måned, hvor ofte har du oplevet en trang til maden?"
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Baseline, 6 uger (efter intervention), 6/12/24 måneders opfølgninger
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Vejevaner
Tidsramme: Baseline og post intervention (6 uger); 6/12/24 mdr. opfølgninger
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Deltagerne vil blive spurgt, hvor ofte de vejede sig "i de sidste to uger" ved hver vurdering.
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Baseline og post intervention (6 uger); 6/12/24 mdr. opfølgninger
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Fysisk aktivitet
Tidsramme: Baseline og post-intervention (6 uger); 6/12/24 måneders opfølgninger
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Accelerometre vil give objektive mål for fysisk aktivitet fra hver deltager ved hver bølgevurdering.
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Baseline og post-intervention (6 uger); 6/12/24 måneders opfølgninger
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Paul Rohde, PhD, Oregon Research Institute
- Studieleder: Heather Shaw, PhD, Oregon Research Institute
- Studieleder: Kyle Burger, PhD, Oregon Research Institute
- Studieleder: Nathan Marti, PhD, Oregon Research Institute
Publikationer og nyttige links
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- HD071900
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