- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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).
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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New York
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Bronx, New York, Stany Zjednoczone, 10461
- Study was conducted exclusively online
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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Brak interwencji: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Intuitive Eating
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Body Appreciation
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 20200516
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- ANALITYCZNY_KOD
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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