Piloting a Novel Intuitive Eating Intervention for College Women With Disordered Eating
9. August 2019 aktualisiert von: Virginia Commonwealth University
The purpose of this research study is to pilot test a new intervention that helps young adult women learn adaptive eating and exercise strategies, increase their body acceptance, decrease unhealthy weight control behaviors and prevent future eating and problems.
This intervention is experimental, and the study will test its feasibility, acceptability, and effectiveness.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The intervention, Intuitive Eating, is an eating approach that addresses important risk factors and promotes adaptive eating attitudes and behaviors.
It has three central tenets: 1) unconditional permission to eat when hungry, 2) eating for physical rather than emotional reasons, and 3) eating according to hunger and satiety cues.
Intuitive Eating has ten principles that focus on rejecting the dieting mentality, honoring hunger cues, decreasing restrictive behaviors that lead to deprivation and bingeing, challenging rigid food rules, increasing awareness of satiety, discovering the satisfaction of food, coping with emotions without food, respecting and accepting one's body, using exercise as self-care, and balancing nutrition with satisfaction.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
71
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Virginia
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Richmond, Virginia, Vereinigte Staaten, 23298
- Virginia Commonwealth University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 25 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Weiblich
Beschreibung
Inclusion Criteria:
- Not currently pregnant
- Enrolled in postsecondary education at VCU
- Have body image or eating concerns
Exclusion Criteria:
- Eating disorder threshold risk
- Men
- Pregnant women
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Intuitive Eating Group Intervention
Intuitive eating intervention delivered in a group format with 8-10 women, led by 2 facilitators.
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Participants in the group intervention will attend eight weekly, 90-minute sessions involving group activities and discussions.
They will complete homework between sessions to reinforce learning.
The intervention focuses on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health.
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Experimental: Intuitive Eating Guided Self-Help
Participants in this condition engage in 8 weeks of self-study of the intuitive eating intervention have ~20 minute weekly phone call with a study interventionist.
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Participants in the GSH condition will follow the intuitive eating content through self-guided study, with eight weekly scheduled phone calls with an interventionist (~20 minutes each).
Interventionists will review homework assignments, answer questions, and reinforce adherence.
The intervention materials are the same as the group and also focus on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in diagnostic eating disorder symptoms
Zeitfenster: Baseline to 16 weeks
|
The Eating Disorder Diagnostic Scale (EDDS) is a brief self-report measure that screens for the presence of subthreshold or threshold levels of ED symptoms.
It yields a symptom composite score, to be used as the primary outcome measure.
Items assessing body dissatisfaction, overvaluation of shape/weight, and impairment are measured on a 0 to 6-point scale with higher ratings indicating greater body dissatisfaction.
Items evaluating the presence of compensatory behaviors and binge eating are rated yes/no and participants indicate the frequency these behaviors have occurred in the prior 3 months.
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Baseline to 16 weeks
|
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Change in global eating disorder symptoms
Zeitfenster: Baseline to 16 weeks
|
The EDE-Q is a 28-item self-report version of the Eating Disorder Examination that measures frequency of disordered eating cognitions and behaviors experienced in the previous 28 days.
Participants rate the number of days behaviors have occurred in the last 28 days, with 0 = no days and 6 = every day.
Yes/no questions identify the presence of compensatory and binge behaviors and participants indicate the frequency of these behaviors over the last 28 days.
Higher EDE-Q scores indicate greater eating pathology.
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Baseline to 16 weeks
|
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Changes in intuitive eating
Zeitfenster: Baseline to 16 weeks
|
The Intuitive Eating Scale-2 (IES-2) is a 23-item self-report measure of intuitive eating with three subscales: Unconditional Permission to Eat, Eating for Physical Rather Than Emotional Reasons, and Reliance on Hunger and Satiety Cues.
Items are rated on a 1 to 5-point scale with higher scores indicating higher levels of intuitive eating.
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Baseline to 16 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in body appreciation
Zeitfenster: Baseline to 16 weeks
|
The Body Appreciation Scale-2 (BAS-2) is a 10-item measure of positive body image.
Specifically, it assesses body appreciation, which reflects acceptance of and favorable opinions and respect towards one's body and a rejection of the narrow beauty ideals promoted through mass media.
Items are rated on a 5-point scale with higher scores indicating greater body appreciation.
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Baseline to 16 weeks
|
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Changes in dietary restraint
Zeitfenster: Baseline to 16 weeks
|
The Dutch Restrained Eating Scale (DRES) contains 10 items that measure dietary restraint for the purpose of weight loss.
Items are rated on a 5-point scale with higher scores reflecting greater dietary restraint.
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Baseline to 16 weeks
|
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Changes in body functionality appreciation
Zeitfenster: Baseline to 16 weeks
|
The Functionality Appreciation Scale (FAS) is a 7-item scale that measures appreciation for the functionality of one's body, which is believed to help offset appearance concerns.
Items are rated on a 5-point scale with higher scores reflecting greater appreciation for the functionality of one's body.
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Baseline to 16 weeks
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Changes in interoceptive awareness
Zeitfenster: Baseline to 16 weeks
|
The Interoceptive Awareness subscale of the EDI-3 has 10 items that measure an individual's attunement to their internal state, including perceptions of emotions, hunger, and satiety.
Items are rated on a 6-point scale, with higher scores reflecting greater deficits in interoceptive awareness.
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Baseline to 16 weeks
|
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Changes in intuitive exercise
Zeitfenster: Baseline to 16 weeks
|
The Intuitive Exercise Scale (IEXS) measures adaptive exercise behaviors that are guided by physical cues and flexibility rather than rigid rules or feelings of obligation.
Items are rated on a 5-point scale, with higher scores reflecting more intuitive exercise behaviors.
|
Baseline to 16 weeks
|
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Changes in weight bias internalization
Zeitfenster: Baseline to 16 weeks
|
The Modified Weight Bias Internalization Scale (WBIS-M) is a modified version of the Weight Bias Internalization Scale that was adapted for use with individuals across the weight spectrum.
The WBIS-M measures the degree to which individuals apply weight-based stereotypes to themselves and use those to guide their weight self-evaluations.
Items are rated on a 7-point scale, with higher scores reflecting greater degrees of weight bias internalization.
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Baseline to 16 weeks
|
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Changes in satisfaction with life
Zeitfenster: Baseline to 16 weeks
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The Satisfaction with Life Scale (SWLS) is a 5-item scale that assesses global life satisfaction.
Items are scored on a 7-point scale, with higher scores reflecting greater life satisfaction.
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Baseline to 16 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
14. September 2018
Primärer Abschluss (Tatsächlich)
19. Juni 2019
Studienabschluss (Tatsächlich)
19. Juni 2019
Studienanmeldedaten
Zuerst eingereicht
27. Juli 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. August 2018
Zuerst gepostet (Tatsächlich)
2. August 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. August 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. August 2019
Zuletzt verifiziert
1. August 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- HM20012263
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
IPD will be available by researcher request only after study completion.
Interested researchers can email the primary study contact.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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