- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03972540
Effect of Mindful Eating on Weight Management in Breast Cancer Survivors
31 de mayo de 2019 actualizado por: Elisabeth Lilian Pia Sattler, Ph.D., B.S. Pharm, University of Georgia
Effect of a Mindful Eating Intervention on Weight Management in Overweight and Obese Postmenopausal Breast Cancer Survivors
This pilot study examined changes in anthropometric measures as a result of and feasibility/ acceptability of a mindful eating intervention for overweight and obese postmenopausal breast cancer survivors.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Being overweight is associated with increased risk for chronic disease and premature death in breast cancer survivors.
This pilot study examined changes in anthropometric measures as a result of and feasibility/ acceptability of a mindful eating intervention for overweight and obese postmenopausal breast cancer survivors.
The one-group pre-posttest study design included eight weekly group-based mindful eating sessions on strategies to intentionally and attentively consume food.
Anthropometrics, blood pressure, mindfulness, nutritional intake, and physical activity were collected at baseline and 12-weeks follow-up.
Data on feasibility and acceptability were collected at study completion.
Tipo de estudio
Intervencionista
Inscripción (Actual)
13
Fase
- No aplica
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
50 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Postmenopausal female
- Breast cancer survivor (in remission)
- Completed cancer treatment at the time of study enrollment
- Body Mass Index (BMI) equal or greater than 25 kg/m²
Exclusion Criteria:
- None.
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: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Mindful eating intervention
The mindful eating intervention was taught by a mindfulness-based stress reduction instructor certified by the Center of Mindfulness at the University of Massachusetts Medical School.
|
A Mindful Eating Workshop™ workbook was used for standardization and reproducibility of these sessions.
The group sessions were focused on teaching applied strategies to consume food with intention and attention and aimed at improving emotional relationships with food.
Intervention sessions were held once a week in the evening for 2 hours per session over 8 weeks.
The intervention was delivered in a large conference room on the University of Georgia campus.
Participants were required to attend seven out of eight sessions.
If participants missed a session, they met with the instructor 30 minutes before the beginning of the following week's session to receive individual instruction on content of the missed session.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Body Mass Index
Periodo de tiempo: Change measured between weeks 1 and 12
|
At the baseline and follow-up visits, trained study staff measured participants' weight and height using a standardized protocol.
Height (measured by a stadiometer to the nearest 0.1 cm) and weight (measured by a scale to the nearest 0.1 kg) was used to calculate BMI (weight in kg divided by height in m²).
|
Change measured between weeks 1 and 12
|
Blood Pressure
Periodo de tiempo: Change measured between weeks 1 and 12
|
At the baseline and follow-up visits, trained study staff measured participants' systolic/diastolic blood pressure using a standardized protocol to the nearest mmHg.
In order to ensure reliability, all measurements were taken 3 times and average values were used for analyses.
|
Change measured between weeks 1 and 12
|
Waste and Hip Circumference
Periodo de tiempo: Change measured between weeks 1 and 12
|
At the baseline and follow-up visits, trained study staff measured participants' waist and hip circumference by tape measure to the nearest 0.1 centimeter.
|
Change measured between weeks 1 and 12
|
Body Fat Percentage
Periodo de tiempo: Change measured between weeks 1 and 12
|
At the baseline and follow-up visits, trained study staff measured participants' body fat percentage using a bioelectrical impedance analyzer (BIA).
|
Change measured between weeks 1 and 12
|
Feasibility of Conducting the Intervention
Periodo de tiempo: Measured at week 12
|
Feasibility was assessed by tracking participant accrual and retention rates.
|
Measured at week 12
|
Acceptability of the Intervention
Periodo de tiempo: Measured at week 12
|
To measure acceptability, participants were asked to complete a 5-question feedback survey to evaluate the mindful eating intervention at the follow-up study visit.
Specifically, the open-ended survey questions asked participants about (1) their experience with intervention, (2) how the intervention affected diet and exercise management, (3) positive aspects about the intervention, (4) negative aspects about the intervention, and (5) suggested changes to the intervention.
Qualitative data analysis techniques were used to identify themes within the data.
|
Measured at week 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mindful Eating Measures
Periodo de tiempo: Change measured between weeks 1 and 12
|
Changes in mindfulness resulting from the intervention were measured using the validated Mindful Attention Awareness Scale (MAAS).
The MAAS questionnaire is a 15-item scale that was designed to assess mindfulness and receptive awareness throughout an individual's daily life.
Scores from the MAAS range from 1 to 6, with higher scores associated with higher mindfulness.
The MAAS was validated for use in cancer populations against the Profile of Mood States (POMS) scale that is widely used in clinical settings.
Higher MAAS scores were significantly correlated with lower POMS scores, further confirming the construct validity of the MAAS questionnaire for assessing mindfulness in cancer populations.
The questionnaire was self-administered to the participants pre and post intervention.
|
Change measured between weeks 1 and 12
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Nutritional Intake
Periodo de tiempo: Change measured between weeks 1 and 12
|
Habitual nutritional intake was measured using an electronic version of the Block Food Frequency Questionnaire, a 127-item food and beverage recall instrument referencing the consumption over the past month.
Dietary intake data was describes as daily energy consumption (kcal), consumption of macronutrients (fat, protein, carbohydrate; grams/day), and intake of sweets (% of daily intake) to compare intake before intervention start with intake during the intervention.
|
Change measured between weeks 1 and 12
|
Physical Activity
Periodo de tiempo: Change measured between weeks 1 and 12
|
Participants' physical activity levels (average daily steps; moderate-to-vigorous physical activity (MVPA) minutes) were tracked throughout the study period using FitBit® Flex accelerometers.
Total daily steps and MVPA minutes were averaged for the first and the last week of the intervention to examine changes.
|
Change measured between weeks 1 and 12
|
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)
9 de mayo de 2016
Finalización primaria (Actual)
29 de julio de 2016
Finalización del estudio (Actual)
31 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
24 de mayo de 2019
Primero enviado que cumplió con los criterios de control de calidad
31 de mayo de 2019
Publicado por primera vez (Actual)
3 de junio de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
31 de mayo de 2019
Última verificación
1 de mayo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00002818
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .
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