- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02496637
A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen
9. oktober 2018 opdateret af: University of Minnesota
A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen: A Randomized Clinical Trial
The proposed study is a randomized clinical trial investigating the effects of a weight gain and eating dysregulation prevention intervention among college freshmen women.
It will compare Appetite Awareness Training (AAT) to a standard nutritional education group and a no treatment control group.
Appetite Awareness Training approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
All female freshmen students residing in the university dorms were recruited to participate in this study.
After completing the baseline assessment, eligible participants were randomly assigned to one of the three arms.
Those in the AAT condition received guided administration of AAT over the course of three weekly group sessions, with an additional booster session three weeks after completion (week 6).
The standard treatment comparison group received four similarly timed group sessions of psychoeducational/nutrition information facilitated by a registered dietician.
A manualized approach to administration of the intervention was created based on the AAT treatment and was strictly followed in order to standardize the implementation of the prevention groups.
The no-treatment control group only participated in the assessments.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
130
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Minnesota
-
Duluth, Minnesota, Forenede Stater, 55812
- University of Minnesota Duluth
-
-
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 til 20 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Incoming University of Minnesota Duluth freshmen women residing in on campus dormitories
Exclusion Criteria:
- Males, non-dormitory residing, non-freshmen.
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Appetite Awareness
Appetite Awareness Training (AAT) is an approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues
|
Appetite Awareness Training (AAT) is an approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues
|
|
Aktiv komparator: Nutrition Education
Nutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information.
|
Nutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information.
|
|
Ingen indgriben: No Treatment Control
No intervention, assessment only
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Body Weight measured in pounds
Tidsramme: Baseline, 6 weeks, 4 months
|
Baseline, 6 weeks, 4 months
|
|
Change in Appetite Awareness as assessed by the Interoceptive Awareness Questionnaire (appetite subscale)
Tidsramme: Baseline, 6 weeks, 4 months
|
Baseline, 6 weeks, 4 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Body Image as assessed by the Satisfaction and Dissatisfaction with Body Parts Scale
Tidsramme: 6 weeks, 4 months
|
6 weeks, 4 months
|
|
Change in Weight Management self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire
Tidsramme: 6 weeks, 4 months
|
6 weeks, 4 months
|
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)
1. august 2015
Primær færdiggørelse (Faktiske)
1. oktober 2017
Studieafslutning (Faktiske)
1. oktober 2017
Datoer for studieregistrering
Først indsendt
6. juli 2015
Først indsendt, der opfyldte QC-kriterier
9. juli 2015
Først opslået (Skøn)
14. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. oktober 2018
Sidst verificeret
1. oktober 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1506S74643
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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