- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05031611
Intuitive Eating for Disordered Eating (IERCT)
A Web-based Intuitive Eating Intervention for Young Women With Disordered Eating: A Pilot Randomized Controlled Trial
Purpose: Research on intuitive eating is growing, but there are few interventions demonstrating the effect of learning to eat intuitively for people with disordered eating. Young women in particular are at high-risk for developing disordered eating. This study aimed to test the outcomes of a novel intuitive eating intervention for young women with disordered eating.
Methods: This study is the first randomized controlled trial introducing intuitive eating to a sample of participants with disordered eating. Participants with current eating disorders were excluded from this study. Women (n=123) ages 18-30 with high levels of disordered eating participated in this study and were randomized to either a treatment (10-week web-based intervention) or control group (10-week waitlist).
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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New York
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Bronx, New York, Vereinigte Staaten, 10461
- Study was conducted exclusively online
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Female
- Between 18 and 30 years of age
- Located in the United States or Canada
- No eating disorder
- No previous participation in an intuitive eating intervention
- Score greater than or equal to 25 on the TFEQ-r18 at baseline
Exclusion Criteria:
- Gender not female
- Younger than 18 years of age
- Older than 30 years of age
- Located outside the United States or Canada
- Score less than 25 on the TFEQ-r18 at baseline
- Previously participated in an intuitive eating intervention
- Current eating disorder
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Intuitive Eating Treatment
The intervention was a novel 10-week program aimed at promoting IE through pre-recorded videos, reading material, and bi-weekly discussion sessions. The intervention introduced the following modules sequentially: Unconditional Permission to Eat, Reliance to Hunger and Fullness Cues, Body-Food Choice Congruence, Gentle Nutrition, and Joyful Movement. Every other week, a new module was introduced. Participants were taught the concept of this module through video and reading, then prompted to practice it over the week. On opposite weeks, the module last introduced was discussed in greater detail through video, and participants were given the opportunity to discuss amongst one another and have all questions answered by the researchers. |
Participants received a brief web-based intervention for disordered eating which focused on a style of eating behavior called "intuitive eating".
Please see arm description for more details.
|
Kein Eingriff: Waitlist Control
Waitlist control group participants completed a series of questionnaires at the beginning and end of a 10-week interval, to compare changes in those who completed the intervention versus those who did not.
This group was subsequently invited to participate in the intervention after their time on the wait-list.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Intuitive Eating
Zeitfenster: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Intuitive eating was measured by the Intuitive Eating Scale, 2nd edition (IES-2).
Scores on this scale range from 1 to 5, with higher scores indicating greater levels of Intuitive Eating.
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Disordered Eating
Zeitfenster: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Revised Three Factor Eating Questionnaire (TFEQ-r18)
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Body Appreciation
Zeitfenster: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Body appreciation was measured by the Body Appreciation Scale, 2nd edition (BAS-2).
Scores on this scale range from 13 to 65, with higher scores indicating greater levels of body appreciation.
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Dichotomous Thinking Around Food
Zeitfenster: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Dichotomous thinking around food was measured by the Dichotomous Thinking Scale (DT).
Scores on this scale range from 11 to 44, with higher scores indicating greater levels of dichotomous thinking around food.
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Psychological Flexibility
Zeitfenster: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Psychological flexibility was measured by the Acceptance and Action Questionnaire, 2nd edition (AAQ-2).
Scores on this scale range from 7 to 49, with higher scores indicating greater psychological flexibility.
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Food Intake
Zeitfenster: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Food intake was measured by the NHANES Food Frequency Questionnaire (NHANES-FFQ), which collects data on respondents' food intake.
Participants are asked to recall the frequency in which they consumed various food items over the past 3 days.
Frequencies are grouped by food type (i.e., vegetables, fruits, dairy, etc.) and summed.
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Body Mass Index (BMI)
Zeitfenster: Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Weight/Height used to calculate BMI
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Baseline (Time 1) through study completion, 10 weeks (Time 2)
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 20200516
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IPD-Sharing-Zeitrahmen
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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