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Piloting a Novel Intuitive Eating Intervention for College Women With Disordered Eating

9. august 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

71

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298
        • Virginia Commonwealth University

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:

  • Not currently pregnant
  • Enrolled in postsecondary education at VCU
  • Have body image or eating concerns

Exclusion Criteria:

  • Eating disorder threshold risk
  • Men
  • Pregnant women

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intuitive Eating Group Intervention
Intuitive eating intervention delivered in a group format with 8-10 women, led by 2 facilitators.
Adfærdsmæssigt: Group Intervention
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.
Eksperimentel: 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.
Adfærdsmæssigt: Guided Self-Help
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in diagnostic eating disorder symptoms
Tidsramme: 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.
Baseline to 16 weeks
Change in global eating disorder symptoms
Tidsramme: 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.
Baseline to 16 weeks
Changes in intuitive eating
Tidsramme: 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.
Baseline to 16 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in body appreciation
Tidsramme: 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.
Baseline to 16 weeks
Changes in dietary restraint
Tidsramme: 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.
Baseline to 16 weeks
Changes in body functionality appreciation
Tidsramme: 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.
Baseline to 16 weeks
Changes in interoceptive awareness
Tidsramme: 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.
Baseline to 16 weeks
Changes in intuitive exercise
Tidsramme: 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
Changes in weight bias internalization
Tidsramme: 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.
Baseline to 16 weeks
Changes in satisfaction with life
Tidsramme: Baseline to 16 weeks
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.
Baseline to 16 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Virginia Commonwealth University

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)

14. september 2018

Primær færdiggørelse (Faktiske)

19. juni 2019

Studieafslutning (Faktiske)

19. juni 2019

Datoer for studieregistrering

Først indsendt

27. juli 2018

Først indsendt, der opfyldte QC-kriterier

1. august 2018

Først opslået (Faktiske)

2. august 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • HM20012263

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

IPD will be available by researcher request only after study completion. Interested researchers can email the primary study contact.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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