- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04052529
Tracking Our Lives Study
Impact of Using Self-monitoring Smartphone Applications on College Students' Well-being
College women are at risk for eating disorders, which have profound health impacts. Cross-sectional studies have shown that the use of dietary self-monitoring is associated with eating disorder risk among college students. However, causality cannot be established with cross-sectional studies.
This study utilizes a randomized controlled trial design to examine how the use of a popular dietary self-monitoring smartphone application impacts college females' well-being, including eating disorder risk. We hypothesize those who are randomized to dietary self-monitoring will have a greater increase in eating disorder risk compared to the control group.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- University of Michigan Ann Arbor undergraduate student
- Daily access to a smartphone
- Female gender
- At least 18 years of age
- Fluent in English
Exclusion Criteria:
- Self-reported history of any medical condition that impacts the types or amount of food eaten
- Self-reported recent use of dietary self-monitoring
- Self-reported history of an active or past eating disorder
- Eating Disorder Examination Questionnaire Short Form (EDE-QS) score ≥ 2, indicating high eating disorder risk
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Intervention
Participants are instructed to use a popular dietary self-monitoring application on their smartphone for one month.
|
Participants use a popular smartphone application to track their food and drink intake for one month.
|
Sin intervención: Control
Participants are not asked to use the smartphone application.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Eating Disorder Risk
Periodo de tiempo: 30 days
|
Eating disorder risk will be measured on a survey via the Eating Disorder Examination Questionnaire Short Form (EDE-QS).
The EDE-QS is a validated 12 question scale.
Each question has a score range 0-3, and the average of all scores is the overall score.
A higher score indicates higher risk.
|
30 days
|
Eating Disorder Risk
Periodo de tiempo: 30 days
|
Measured via survey using the validated SCOFF questionnaire which consists of five questions.
Each question is a yes/no and a yes receives one point with a total score ranging from 0-5.
Higher scores indicate higher risk.
Modified to ask about pounds instead of stone as a measure of weight.
|
30 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Weight-Related Self-Monitoring
Periodo de tiempo: 30 days
|
Measured via survey that includes single item measures asking about physical activity self-monitoring and self-weighing frequency.
|
30 days
|
Body Image
Periodo de tiempo: 30 days
|
Assessed via survey using the validated 6 question Body Image States Scale (BISS).
Scores are the mean of the six items, three of which are reverse coded.
Higher scores mean better body image states.
|
30 days
|
Weight Stigma
Periodo de tiempo: 30 days
|
Measured via survey using five single item questions.
|
30 days
|
Dietary Intake
Periodo de tiempo: 30 days
|
Single item survey questions adapted from the Youth Risk Behavior Surveillance System
|
30 days
|
Physical Activity
Periodo de tiempo: 30 days
|
Single item survey questions adapted from the Youth Risk Behavior Surveillance System and an open ended question for amount of time physically active.
|
30 days
|
Weight perception
Periodo de tiempo: 30 days
|
Assessed using two questions on a survey pertaining to BMI category and weight.
|
30 days
|
Body changing intentions
Periodo de tiempo: 30 days
|
Assessed using single item question on a survey asking how, if at all, participants wanted to change their body.
|
30 days
|
Social Media Use
Periodo de tiempo: 30 days
|
Use of common social media sites assessed using five single item measures on a survey.
|
30 days
|
Weight
Periodo de tiempo: 30 days
|
Blind weights taken on research grade laboratory scale.
|
30 days
|
Subjective Quality of Life
Periodo de tiempo: 30 days
|
Assessed using the Brunnsviken Brief Quality of Life Scale (BBQ) on a survey.
The BBQ has 12 questions, each ranging from 0-4.
Higher scores indicate higher subjective quality of life.
|
30 days
|
Anxiety
Periodo de tiempo: 30 days
|
State anxiety as measured via survey using the short-form of the state scale of the Spielberger State-Trait Anxiety Inventory.
The scale consists of 6 questions with a range of scores 1-4 for each question.
Three positive questions are reverse coded and scores are added together with higher scores indicating higher state anxiety.
|
30 days
|
Depression Symptoms
Periodo de tiempo: 30 days
|
Measured via survey using the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10).
The CESD-R-10 is a 10 item scale with each question having the possibility of a score 0-3.
Two questions are reverse coded, then scores from each question are added to give an overall score.
Higher scores indicate more depressive symptoms.
|
30 days
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
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
- HUM00161687
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. .
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