Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)
20 december 2017 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
29
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Virginia
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Richmond, Virginia, Förenta staterna, 23298
- Virginia Commonwealth University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 25 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: INSPIRERA
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Acceptability of intervention
Tidsram: 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
|
|
Feasibility of the intervention
Tidsram: 8 weeks
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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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Eating disorder behaviors
Tidsram: 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.
|
Baseline to 14 weeks
|
|
Risk for obesity (BMI)
Tidsram: 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.
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Baseline to 14 weeks
|
|
Appearance Ideals
Tidsram: 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.
|
Baseline to14 weeks
|
|
Emotion Regulation Difficulties
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
5 september 2017
Primärt slutförande (Faktisk)
8 december 2017
Avslutad studie (Faktisk)
8 december 2017
Studieregistreringsdatum
Först inskickad
27 september 2017
Först inskickad som uppfyllde QC-kriterierna
20 oktober 2017
Första postat (Faktisk)
23 oktober 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 december 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 december 2017
Senast verifierad
1 december 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HM20011075
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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