- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03744780
A One-Day ACT Workshop for Emotional Eating
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Emotional eating is defined as increased food consumption in response to negative emotions, and has been linked to weight concerns, mental health concerns, and disordered eating behaviours. Effective interventions have been developed that address emotional eating, namely to improve weight loss. Such interventions are based in Acceptance and Commitment Therapy (ACT), which encourages tolerance of internal cues, such as emotions, and external cues, such as food.
Emotional eating, however, is not exclusive to those who struggle with their weight. Many individuals maintain a normal weight despite engaging in emotional eating. These individuals still consume an excess of high calorie (for which they somehow eventually compensate), high fat, and high sugar foods as part of their emotional eating. Unhealthy dietary habits such as these have been shown to be associated with an increased risk of all-cause mortality, as well as health concerns including diabetes and cardiovascular disease. Individuals with normal weight are not eligible for ACT programs described above, despite the increased risk of health concerns associated with emotional eating.
The present study aims to test the feasibility and acceptability of a one-day ACT workshop to reduce emotional eating and improve health that is not focused on weight loss as its primary outcome, and rather targets all individuals who engage in emotional eating.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Quebec
-
Montreal, Quebec, Canadá, H3A1G1
- McGill University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Engaging in emotional eating as per a DEBQ-EE score of 3.25 or higher
- Being over the age of 18
Exclusion Criteria:
- Not meeting the DEBQ-EE 3.25 or higher inclusion criteria
- Being under the age of 18
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: ACT Workshop for Emotional Eating
All participants will be assigned to a one-day intervention using Acceptance and Commitment Therapy (ACT) techniques to help reduce emotional eating.
|
This is a one-day intervention using Acceptance and Commitment Therapy (ACT) technique to target and reduce emotional eating.
The intervention will be modeled after Frayn and Knäuper's (2016) brief emotional eating intervention, which was derived from Forman et al.'s (2013) "Mind Your Health program".
During the workshop, the following topics will be discussed, based on the three processes of ACT: (1) values clarification/commitment, (2) acceptance/distress tolerance, and (3) mindfulness/awareness.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Emotional Eating - 2-weeks Post-intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
Emotional eating, as assessed by the Dutch Eating Behaviour Questionnaire Emotional Eating Subscale (DEBQ-EE).
Participants are asked to rate the frequency with which they engage in particular eating behaviours, on a 5-point Likert-type rating scale from never (1) to very often (5), with higher scores reflecting higher emotional eating.
Only the emotional eating subscale of the DEBQ will be assessed and is calculated by averaging the 13 items that assess emotional eating.
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
Emotional Eating - 3-months Post-Intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
Emotional eating, as assessed by the Dutch Eating Behaviour Questionnaire Emotional Eating Subscale (DEBQ-EE).
Participants are asked to rate the frequency with which they engage in particular eating behaviours, on a 5-point Likert-type rating scale from never (1) to very often (5), with higher scores reflecting higher emotional eating.
Only the emotional eating subscale of the DEBQ will be assessed and is calculated by averaging the 13 items that assess emotional eating.
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Distress Tolerance - 2-weeks Post-Intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
Distress tolerance, as assessed by the Distress Tolerance Scale (DTS).
Participants are asked to indicate the extent to which they agree with statements aimed at assessing distress tolerance, absorption, appraisal, and regulation from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting lower distress tolerance.
Subscale scores are derived by calculating the means of the items that make up each subscale.
Total score is calculating by averaging the four subscales.
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
Distress Tolerance - 3-months Post-Intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
Distress tolerance, as assessed by the Distress Tolerance Scale (DTS).
Participants are asked to indicate the extent to which they agree with statements aimed at assessing distress tolerance, absorption, appraisal, and regulation from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting lower distress tolerance.
Subscale scores are derived by calculating the means of the items that make up each subscale.
Total score is calculating by averaging the four subscales.
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
Food Craving Acceptance and Action - 2-weeks Post-intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
Food craving acceptance and action, as assessed by the Food Craving Acceptance and Action Questionnaire (FAAQ).
Items are rated on a 6-point Likert-type rating scale from 1 (very seldom true) to 6 (always true), with higher scores reflecting higher acceptance.
Total score is derived by summing all items.
Minimum score is 10 and maximum score is 60.
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
Food Craving Acceptance and Action - 3-months Post-intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
Food craving acceptance and action, as assessed by the Food Craving Acceptance and Action Questionnaire (FAAQ).
Items are rated on a 6-point Likert-type rating scale from 1 (very seldom true) to 6 (always true), with higher scores reflecting higher acceptance.
Total score is derived by summing all items.
Minimum score is 10 and maximum score is 60.
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
Mindful Eating - 2-weeks Post-intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
Mindful eating, as assessed by the Mindful Eating Questionnaire (MEQ).
It is a 28-item self-report measure that assesses five domains of mindful eating: disinhibition, external cues, awareness, emotional response and distraction.
Participants are asked to indicate the extent to which extent they agree with each item from 1 ("never" / "rarely") to 4 ("usually"/ "always"), with higher scores reflecting higher levels of mindful eating.
Total score is derived by taking the mean of the five subscales.
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
Mindful Eating - 3-months Post-intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
Mindful eating, as assessed by the Mindful Eating Questionnaire (MEQ).
It is a 28-item self-report measure that assesses five domains of mindful eating: disinhibition, external cues, awareness, emotional response and distraction.
Participants are asked to indicate the extent to which extent they agree with each item from 1 ("never" / "rarely") to 4 ("usually"/ "always"), with higher scores reflecting higher levels of mindful eating.
Total score is derived by taking the mean of the five subscales.
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
ACT Values Application - 2-weeks Post-intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
Application of ACT values techniques taught during the workshop, as assessed by items developed by the study's authors.
Participants were asked to rate the extent to which they agreed with a number of value-based statements on a scale from 1 (strongly disagree) to 5 (strongly agree).
Values score was derived by taking the mean of the items, with higher scores reflecting greater value-consistent eating behaviors.
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
ACT Values Application - 3-months Post-intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
Application of ACT values techniques taught during the workshop, as assessed by items developed by the study's authors.
Participants were asked to rate the extent to which they agreed with a number of value-based statements on a scale from 1 (strongly disagree) to 5 (strongly agree).
Values score was derived by taking the mean of the items, with higher scores reflecting greater value-consistent eating behaviors.
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
Emotional Eating Frequency - 2-weeks Post-intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
As assessed by a self-report item developed by the study's authors.
Participants were asked to report the number of times they engaged in emotional eating in the past week.
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
Emotional Eating Frequency - 3-months Post-intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
As assessed by a self-report item developed by the study's authors.
Participants were asked to report the number of times they engaged in emotional eating in the past week.
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
Ability to Stop Emotional Eating - 2-weeks Post-intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
As assessed by a single self-report item developed by the study's authors.
Participants were asked to report the number of instances in which they began to engage in emotional eating and were able to stop themselves, on a scale from 1 (none of the time) to 5 (very often).
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
Ability to Stop Emotional Eating - 3-months Post-intervention
Periodo de tiempo: Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
As assessed by a single self-report item developed by the study's authors.
Participants were asked to report the number of instances in which they began to engage in emotional eating and were able to stop themselves, on a scale from 1 (none of the time) to 5 (very often).
|
Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention
|
|
Feasibility Data: Recruitment, Eligibility, Attendance, and Attrition Rates
Periodo de tiempo: Assessed throughout the duration of the study from the recruitment period to the completion of the workshops and follow-up questionnaires (i.e., over a 3-month period).
|
These include recruitment, eligibility, attendance, and attrition rates
|
Assessed throughout the duration of the study from the recruitment period to the completion of the workshops and follow-up questionnaires (i.e., over a 3-month period).
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Oliver G, Wardle J, Gibson EL. Stress and food choice: a laboratory study. Psychosom Med. 2000 Nov-Dec;62(6):853-65. doi: 10.1097/00006842-200011000-00016.
- Forman EM, Butryn ML, Juarascio AS, Bradley LE, Lowe MR, Herbert JD, Shaw JA. The mind your health project: a randomized controlled trial of an innovative behavioral treatment for obesity. Obesity (Silver Spring). 2013 Jun;21(6):1119-26. doi: 10.1002/oby.20169. Epub 2013 May 13. Erratum In: Obesity (Silver Spring). 2014 Mar;22(3):971.
- Geliebter A, Aversa A. Emotional eating in overweight, normal weight, and underweight individuals. Eat Behav. 2003 Jan;3(4):341-7. doi: 10.1016/s1471-0153(02)00100-9.
- Hou L, Li F, Wang Y, Ou Z, Xu D, Tan W, Dai M. Association between dietary patterns and coronary heart disease: a meta-analysis of prospective cohort studies. Int J Clin Exp Med. 2015 Jan 15;8(1):781-90. eCollection 2015.
- Konttinen H, Mannisto S, Sarlio-Lahteenkorva S, Silventoinen K, Haukkala A. Emotional eating, depressive symptoms and self-reported food consumption. A population-based study. Appetite. 2010 Jun;54(3):473-9. doi: 10.1016/j.appet.2010.01.014. Epub 2010 Feb 4.
- Lillis J, Niemeier HM, Thomas JG, Unick J, Ross KM, Leahey TM, Kendra KE, Dorfman L, Wing RR. A randomized trial of an acceptance-based behavioral intervention for weight loss in people with high internal disinhibition. Obesity (Silver Spring). 2016 Dec;24(12):2509-2514. doi: 10.1002/oby.21680. Epub 2016 Nov 2.
- Sami W, Ansari T, Butt NS, Hamid MRA. Effect of diet on type 2 diabetes mellitus: A review. Int J Health Sci (Qassim). 2017 Apr-Jun;11(2):65-71.
- Schwingshackl L, Schwedhelm C, Hoffmann G, Lampousi AM, Knuppel S, Iqbal K, Bechthold A, Schlesinger S, Boeing H. Food groups and risk of all-cause mortality: a systematic review and meta-analysis of prospective studies. Am J Clin Nutr. 2017 Jun;105(6):1462-1473. doi: 10.3945/ajcn.117.153148. Epub 2017 Apr 26.
- van Strien T, van de Laar FA, van Leeuwe JF, Lucassen PL, van den Hoogen HJ, Rutten GE, van Weel C. The dieting dilemma in patients with newly diagnosed type 2 diabetes: does dietary restraint predict weight gain 4 years after diagnosis? Health Psychol. 2007 Jan;26(1):105-12. doi: 10.1037/0278-6133.26.1.105.
- Frayn M, Khanyari S, Knauper B. A 1-day acceptance and commitment therapy workshop leads to reductions in emotional eating in adults. Eat Weight Disord. 2020 Oct;25(5):1399-1411. doi: 10.1007/s40519-019-00778-6. Epub 2019 Sep 20.
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
Otros números de identificación del estudio
- 143-0818
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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. .