Piloting a Novel Intuitive Eating Intervention for College Women With Disordered Eating
9 agosto 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
71
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Virginia
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Richmond, Virginia, Stati Uniti, 23298
- Virginia Commonwealth University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 25 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Femmina
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in diagnostic eating disorder symptoms
Lasso di tempo: Baseline to 16 weeks
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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
Lasso di tempo: Baseline to 16 weeks
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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
Lasso di tempo: Baseline to 16 weeks
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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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in body appreciation
Lasso di tempo: Baseline to 16 weeks
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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
Lasso di tempo: Baseline to 16 weeks
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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
Lasso di tempo: Baseline to 16 weeks
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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
Lasso di tempo: Baseline to 16 weeks
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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
Lasso di tempo: Baseline to 16 weeks
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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.
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Baseline to 16 weeks
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Changes in weight bias internalization
Lasso di tempo: Baseline to 16 weeks
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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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
14 settembre 2018
Completamento primario (Effettivo)
19 giugno 2019
Completamento dello studio (Effettivo)
19 giugno 2019
Date di iscrizione allo studio
Primo inviato
27 luglio 2018
Primo inviato che soddisfa i criteri di controllo qualità
1 agosto 2018
Primo Inserito (Effettivo)
2 agosto 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 agosto 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 agosto 2019
Ultimo verificato
1 agosto 2019
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- HM20012263
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
IPD will be available by researcher request only after study completion.
Interested researchers can email the primary study contact.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .