Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)
20. december 2017 opdateret af: Virginia Commonwealth University
The aims of the current study are: 1) to pilot a manualized intervention (INSPIRE - Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise) to determine feasibility and acceptability, and 2) to evaluate the preliminary effectiveness of INSPIRE on physical and psychological variables.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of the current study is to implement an evidence-based prevention program to promote positive health behaviors among young adult women.
It will be one of the first to intentionally execute a prevention program targeting well-established risk factors for both obesity and eating disorders in this high-risk population.
Intervention content focuses on promoting body size diversity and emphasizing positive health and behavior change in order to reduce stigmatization and remain sensitive to weight-related issues.
The manual was developed by integrating two successful existing prevention programs and expanding on previous prevention efforts.
Specifically, the diversity of beauty ideals were highlighted to enhance relevance among ethnic minority women, and distress tolerance and emotion regulation skills training were included to target the maladaptive coping mechanisms young adults use to manage the stress associated with transitioning to college.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
29
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Virginia
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Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University
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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 til 25 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Currently enrolled in postsecondary education at Virginia Commonwealth University
Exclusion Criteria:
- BMI ≥ 30 kg/m2
- Meet criteria for eating disorder threshold risk
- Pregnancy
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: INSPIRERE
|
Eight week program of weekly group sessions with homework assignments addressing beauty ideals, establishing a healthy relationship with food and exercise, and tolerating and managing uncomfortable emotions.
Participants will complete questionnaires are separate time points (one week before the program, one week after the program, and 1 month after the program) to evaluate the impact of the program on various behavioral and psychological outcomes.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Acceptability of intervention
Tidsramme: 8 weeks
|
Acceptability of the intervention will be assessed via aggregation of the ordinal-level items on the weekly participation satisfaction surveys.
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8 weeks
|
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Feasibility of the intervention
Tidsramme: 8 weeks
|
Feasibility of the intervention will be assessed via aggregation of the ordinal-level items on the weekly therapist feasibility surveys.
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8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Eating disorder behaviors
Tidsramme: Baseline to 14 weeks
|
Change in disordered eating behaviors will be assessed with the Eating Disorder Examination Questionnaire.
Participants will complete this one week before the program, one week after the program, and one month after the program.
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Baseline to 14 weeks
|
|
Risk for obesity (BMI)
Tidsramme: Baseline to 14 weeks
|
Weight will be measured (by trained staff) to the nearest ¼ kg using a digital scale and height will be measured to the nearest cm using a stadiometer; these measurements will be used to calculate BMI (kg/m2).
Measurements will be taken one week before the program, one week after the program, and one month after the program.
|
Baseline to 14 weeks
|
|
Appearance Ideals
Tidsramme: Baseline to14 weeks
|
Changes in appearance ideals will be evaluated with the Body Image-Ideals Questionnaire, a self-report questionnaire that quantifies an individual's perceived discrepancy from and importance of internalized ideals for multiple physical attributes.
Participants will complete this one week before the program, one week after the program, and one month after the program.
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Baseline to14 weeks
|
|
Emotion Regulation Difficulties
Tidsramme: Baseline to14 weeks
|
Changes in difficulty regulating emotions and tolerating distress will be assessed with the Difficulties in Emotion Regulation Scale.
Participants will complete this one week before the program, one week after the program, and one month after the program.
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Baseline to14 weeks
|
|
Healthy Eating
Tidsramme: Baseline to14 weeks
|
Change in dietary intake will be assessed using the Block Food Screener, a self-report questionnaire that surveys the leading sources of fat, fiber, fruits, and vegetables in the diets of North Americans.
Participants will complete this one week before the program, one week after the program, and one month after the program.
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Baseline to14 weeks
|
|
Physical Activity
Tidsramme: Baseline to14 weeks
|
Change in physical activity during the past seven days will be assessed with the Seven-Day Physical Activity Recall.
This measures the frequency and duration of each physical activity performed throughout the day.
Participants will complete this one week before the program, one week after the program, and one month after the program.
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Baseline to14 weeks
|
|
Thin-ideal internalization
Tidsramme: Baseline to14 weeks
|
Change in thin-ideal internalization will be assessed with the Ideal-Body Stereotype Scale - Revised.
Participants will complete this one week before the program, one week after the program, and one month after the program.
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Baseline to14 weeks
|
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Negative Affect
Tidsramme: Baseline to14 weeks
|
Change in negative affect will be assessed using the sadness, guilt, hostility, and fear/anxiety subscales of the Positive and Negative Affect Scale - Revised.
Participants will complete the this one week before the program, one week after the program, and one month after the program.
|
Baseline to14 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
5. september 2017
Primær færdiggørelse (Faktiske)
8. december 2017
Studieafslutning (Faktiske)
8. december 2017
Datoer for studieregistrering
Først indsendt
27. september 2017
Først indsendt, der opfyldte QC-kriterier
20. oktober 2017
Først opslået (Faktiske)
23. oktober 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. december 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. december 2017
Sidst verificeret
1. december 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HM20011075
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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