- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
Bronx, New York, Estados Unidos, 10461
- Study was conducted exclusively online
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
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.
|
Sin intervención: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Intuitive Eating
Periodo de tiempo: Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
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.
|
Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
Disordered Eating
Periodo de tiempo: Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
Revised Three Factor Eating Questionnaire (TFEQ-r18)
|
Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Body Appreciation
Periodo de tiempo: Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
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.
|
Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
Dichotomous Thinking Around Food
Periodo de tiempo: Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
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.
|
Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
Psychological Flexibility
Periodo de tiempo: Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
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.
|
Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
Food Intake
Periodo de tiempo: Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
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.
|
Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
Body Mass Index (BMI)
Periodo de tiempo: Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
Weight/Height used to calculate BMI
|
Baseline (Time 1) through study completion, 10 weeks (Time 2)
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20200516
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Intuitive Eating Treatment
-
University of EdinburghNHS TaysideTerminadoAnorexia nerviosa | Bulimia nerviosa | Trastorno por atracón | Otro trastorno alimentario o alimentario especificadoReino Unido
-
University of OklahomaTerminadoAumento de peso | Trastorno de alimentación Neonatal | Lactante de muy bajo peso al nacerEstados Unidos
-
University of GlasgowTerminadoEnfermedad de Crohn | Modificación DietéticaReino Unido
-
Rennes University HospitalInstitut NuMeCan, INRAE 1341Terminado