Simplifying Diet Tracking in a Digital Weight Loss Intervention
22 de mayo de 2026 actualizado por: Michele Patel, Stanford University
Simplifying Dietary Self-Monitoring in a Digital Weight Loss Intervention
The purpose of this study is to compare two approaches for tracking dietary intake in a 12-month fully digital weight loss intervention: (1) Simplified approach: track Red Zone Foods (e.g., foods high in calories and low in nutritional value) vs. (2) Detailed approach: track all foods and their corresponding calories. In essence, this is a head-to-head comparison of two tracking approaches; the investigators are evaluating whether weight loss is comparable over 12 months, or whether one approach will have greater weight loss.
The investigators will recruit 328 adults. Broadly, adults with overweight or obesity who live in the United States will be eligible. The weight loss intervention will last 12 months. All participants will be asked to track their dietary intake + body weight + steps daily as well as complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1, 6, 12, and 18 months.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
328
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.
Estudio Contacto
- Nombre: Study Team
- Número de teléfono: 650-549-7047
- Correo electrónico: mlp9@stanford.edu
Ubicaciones de estudio
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California
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Palo Alto, California, Estados Unidos, 94304
- Stanford University School of Medicine
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- adults (ages 18+ years)
- body mass index (BMI) 25.0 to 45.0 kg/m^2
- smartphone ownership
- willing to install a mobile app on personal smartphone
- access to a personal email account
- English or Spanish language proficiency
- interest in losing weight through behavioral strategies
- living in the United States
- willing to be randomized
Exclusion Criteria:
- concurrent enrollment in another weight management intervention
- loss of ≥5% weight in the past 6 months
- prior or planned bariatric surgery during the trial period
- current or planned pregnancy during the trial period, or recent pregnancy in the past 6 months
- currently breastfeeding or lactating
- current use of anti-obesity medications
- living with someone else participating in the study
- hospitalization for a mental health condition in the past 12 months
- inability to engage in moderate forms of physical activity akin to brisk walking
- medical or psychiatric contraindication (e.g., end stage renal disease, cancer, schizophrenia, dementia, use of steroids, use of antipsychotic medication)
- if an individual would be better suited for a more intensive or different type of intervention based on a health condition (e.g., individuals with history of an eating disorder or cardiovascular event, uncontrolled hypertension, or uncontrolled diabetes mellitus)
- investigator discretion for safety reasons
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Simplified (Track Red Zone Foods)
Simplified + Core
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Participants randomized to receive this intervention are instructed to track their Red Zone Foods (i.e., foods high in calories and low in nutritional value) daily via a web-based checklist.
Participants receive a daily Red Zone Food goal.
All participants receive a 12-month core behavioral weight loss intervention consisting of the following: goal setting; daily self-monitoring of body weight & steps; weekly behavioral lessons and action plans to promote healthy eating and physical activity; and tailored feedback.
The intervention will be delivered remotely via email and/or text message.
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Experimental: Detailed (Track All Foods/Calories)
Detailed + Core
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All participants receive a 12-month core behavioral weight loss intervention consisting of the following: goal setting; daily self-monitoring of body weight & steps; weekly behavioral lessons and action plans to promote healthy eating and physical activity; and tailored feedback.
The intervention will be delivered remotely via email and/or text message.
Participants randomized to receive this intervention are instructed to track all foods/drinks and their corresponding calories daily via a mobile app.
Participants receive a daily calorie goal.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Weight Change from Baseline to 12 Months
Periodo de tiempo: Baseline, 12 Months
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mean change in body weight (kg); assessed objectively via e-scale using standardized procedures (e.g., place the scale on a hard surface; collect weight in the morning, without clothing, prior to eating/drinking)
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Baseline, 12 Months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Weight Change from Baseline to 1 Month
Periodo de tiempo: Baseline, 1 Month
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mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
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Baseline, 1 Month
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Weight Change from Baseline to 6 Months
Periodo de tiempo: Baseline, 6 Months
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mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
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Baseline, 6 Months
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Weight Change from Baseline to 18 Months
Periodo de tiempo: Baseline, 18 Months
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mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
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Baseline, 18 Months
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Caloric Intake Change from Baseline to 12 Months
Periodo de tiempo: Baseline, 12 Months
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mean change in daily caloric intake (kilocalories); assessed via the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24): 2 separate diet recalls per time point: 1 week day, 1 weekend day
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Baseline, 12 Months
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Diet Quality Change from Baseline to 12 Months
Periodo de tiempo: Baseline, 12 Months
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mean change in diet quality; assessed via the Healthy Eating Index, calculated from ASA24 data; score range: 0 to 100, with higher scores indicating better diet quality
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Baseline, 12 Months
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Step Count Change from Baseline to 12 Months
Periodo de tiempo: Baseline, 12 Months
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mean change in step count; assessed objectively via activity tracker
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Baseline, 12 Months
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Health-Related Quality of Life (Physical Health) Change from Baseline to 12 Months
Periodo de tiempo: Baseline, 12 Months
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mean change in health-related quality of life (Physical Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life
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Baseline, 12 Months
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Health-Related Quality of Life (Mental Health) Change from Baseline to 12 Months
Periodo de tiempo: Baseline, 12 Months
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mean change in health-related quality of life (Mental Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life
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Baseline, 12 Months
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Engagement in Self-Monitoring Dietary Intake
Periodo de tiempo: daily during the 12-month intervention
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operationalized as average percentage of days in the 12-month intervention of self-monitoring dietary intake (Red Zone Foods for Simplified arm vs. all foods/calories for Detailed arm); assessed via e-checklist for Simplified arm and via app for Detailed arm; will report median (IQR) if data are non-normally distributed
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daily during the 12-month intervention
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Engagement in Self-Monitoring Weight
Periodo de tiempo: daily during the 12-month intervention
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operationalized as average percentage of days in the 12-month intervention of self-monitoring body weight; assessed via e-scale; will report median (IQR) if data are non-normally distributed
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daily during the 12-month intervention
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Engagement in Self-Monitoring Steps
Periodo de tiempo: daily during the 12-month intervention
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operationalized as average percentage of days in the 12-month intervention of self-monitoring steps; assessed via activity tracker; will report median (IQR) if data are non-normally distributed
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daily during the 12-month intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Michele L. Patel, PhD, Stanford University
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 (Estimado)
1 de mayo de 2027
Finalización primaria (Estimado)
30 de abril de 2030
Finalización del estudio (Estimado)
31 de octubre de 2030
Fechas de registro del estudio
Enviado por primera vez
14 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de mayo de 2026
Publicado por primera vez (Actual)
22 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
- intervención conductual
- obesidad
- exceso de peso
- salud móvil
- tratamiento de la obesidad
- ECA
- intervención
- pérdida de peso
- salud digital
- autocontrol
- dieta
- control de peso
- intervención digital
- IMC
- peso corporal
- ensayo clínico aleatorizado
- adultos
- eficacia comparativa
- estilo de vida
- no inferioridad
- cambio de comportamiento
- manejo de la obesidad
- Reducción de peso
- intervención para bajar de peso
- intervención remota
- seguimiento
- ensayo de no inferioridad
- pista
- intervención independiente
- self-monitor
- red zone foods
- calorie counting
- comparative effectiveness trial
- standalone
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 87051
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
The de-identified dataset and metadata will be made available through a public repository.
It will include the primary outcome (weight change), secondary outcomes, and participant level characteristics.
Data will be available in an Excel spreadsheet, whereby each row corresponds to a unique participant's data, and columns represent the different variables mentioned, by time point.
Marco de tiempo para compartir IPD
The shared dataset and metadata will be preserved and made publicly available to share for at least 3 years following completion of the project, in accordance with NIH regulations.
They will be made available upon publication of the primary outcomes paper in a peer-reviewed journal, or at the end of the grant period (whichever comes first).
Criterios de acceso compartido de IPD
Publicly available.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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. .