Piloting a Novel Intuitive Eating Intervention for College Women With Disordered Eating
9 de agosto de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
71
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 25 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
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Experimental: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in diagnostic eating disorder symptoms
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in body appreciation
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de septiembre de 2018
Finalización primaria (Actual)
19 de junio de 2019
Finalización del estudio (Actual)
19 de junio de 2019
Fechas de registro del estudio
Enviado por primera vez
27 de julio de 2018
Primero enviado que cumplió con los criterios de control de calidad
1 de agosto de 2018
Publicado por primera vez (Actual)
2 de agosto de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de agosto de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
9 de agosto de 2019
Última verificación
1 de agosto de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HM20012263
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
IPD will be available by researcher request only after study completion.
Interested researchers can email the primary study contact.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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 Comportamientos alimentarios desordenados
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Western University, CanadaAún no reclutandoeTRE (Early Time Restricted Eating) con BCAA | eTRE (Early Time Restricted Eating)Canadá
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Western University, CanadaDesconocidoeTRE (Early Time Restricted Eating) | lTRE (Late Time Restricted Eating)Canadá
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Western University, CanadaAún no reclutandoeTRE (Early Time Restricted Eating) | eTRE con BISC (Subida de Escaleras Breve e Intensa)Canadá
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