Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain (Momentum)
7 de agosto de 2026 actualizado por: ORI Community and Evaluation Services
This trial will test the effectiveness of a weight loss maintenance intervention designed to help participants respond more adaptively to weight regain.
Participants will be randomly assigned to one of two conditions.
In one condition, participants will receive brief exercises (e.g., written reflections, videos) sent to through a smartphone app immediately after they regain weight or miss a weigh-in.
These exercises will use mindfulness, acceptance, and self-compassion strategies to help participants stay motivated for their long term goals, even when weight regain feels demoralizing.
In the comparison condition, participants will receive weekly reminders of standard weight control strategies strategies.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
120
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: Charlotte Hagerman, PhD
- Número de teléfono: 14109372035
- Correo electrónico: chagerman@ori.org
Ubicaciones de estudio
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Oregon
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Springfield, Oregon, Estados Unidos, 97477
- Reclutamiento
- Oregon Research Institute Community and Evaluation Services
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Contacto:
- Charlotte Hagerman, PhD
- Número de teléfono: 4109372035
- Correo electrónico: chagerman@ori.org
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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:
- Ages 18-70 years
- BMI of 25-50 kg/m2
- Current weight is 3% lower than their highest weight in the past 3 years
- Desire to maintain their weight or lose more
- Ability to engage in PA, as defined as being able to walk two full city blocks without stopping
- Smartphone and Internet access
- Successful completion of all enrollment procedures
- Ability to attend a workshop(s) on a Monday or Tuesday evening
Exclusion Criteria:
- History of bariatric surgery
- History of being diagnosed with an eating disorder
- Currently pregnant, breastfeeding, or planning to become pregnant in the next 24 months
- Enrolled in another formal weight loss/weight maintenance program
- Currently taking a GLP-1 medication.
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: JITAI Condition
Participants in this condition will receive a 6-month weight loss maintenance intervention that uses mindfulness, acceptance, and self-compassion strategies to respond to weight regain.
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For six months, participants will receive a just-in-time adaptive interventions via a smartphone app immediately after they gain weight or they skip a weigh-in (according to a specific algorithm).
Interventions will engage participants in mindfulness, acceptance, and self-compassion-based (MASC) strategies through different modalities (e.g., writing exercises, videos, audio reflections).
They will take approximately 1-10 minutes.
Participants will also attend an introductory workshop, during which they will receive the instructions weigh daily, learn the importance of quickly responding to weight regain, and be introduced to MASC strategies.
They will also attend two booster workshops during the 6-month period.
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Comparador activo: Active Control Condition
Participants in this condition will receive minimal intervention designed to reflect "usual care" for weight loss maintenance.
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For six months, participants will receive weekly, automated messages via a smartphone app with reminders of standard behavioral weight control principles.
Participants will attend an introductory workshop, during which they will receive instructions to weigh daily and learn the importance of responding to weight regain.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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State negative affect
Periodo de tiempo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current negative affect.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State shame
Periodo de tiempo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current shame.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State Motivation
Periodo de tiempo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current feelings of motivation.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State Self-Efficacy
Periodo de tiempo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current self-efficacy.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Current confidence in the effectiveness of weight control behaviors
Periodo de tiempo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current confidence in the effectiveness of weight control behaviors.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State self-compassion
Periodo de tiempo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their state self-compassion.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State mindfulness
Periodo de tiempo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their state mindfulness.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State acceptance
Periodo de tiempo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their state acceptance.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Self-serving interpretation of weight gain
Periodo de tiempo: Whenever participants regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their self-serving interpretation of the weight regain.
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Whenever participants regain weight during the 6 month study period
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Daily Calorie Tracking (Yes/No)
Periodo de tiempo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Whether participants log their calories (at least 800 calories) using a dietary tracking app that day (yes/no).
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Daily MVPA
Periodo de tiempo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Minutes of moderate-to-vigorous physical activity they engage in that day, as tracked by their Fitbit band.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Likelihood of weighing in the following day
Periodo de tiempo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Likelihood that participants weigh themselves the following day on a wireless smart scale (yes/no).
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Calorie Tracking Frequency
Periodo de tiempo: 6 months (duration of study period)
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The number of days that participants logged their calories (at least 800 calories) using a dietary tracking app during the study period.
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6 months (duration of study period)
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Average Weekly MVPA
Periodo de tiempo: 6 months (duration of study period)
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Average total minutes of weekly moderate-to-vigorous physical activity, as tracked by their Fitbit band, during the study period.
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6 months (duration of study period)
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Frequency of Weighing In
Periodo de tiempo: 6 months (duration of study period)
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Total number of days that participants weighed themselves on a wireless smart scale during the study period.
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6 months (duration of study period)
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Weight change
Periodo de tiempo: End of treatment (6 months after baseline)
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Using participants' weights from a wireless scale, their percent weight change from the beginning to the end of the study period will be calculated.
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End of treatment (6 months after baseline)
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Intervention acceptability
Periodo de tiempo: End of treatment (6 months after baseline)
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Intervention acceptability will be operationalized as the percent of participants who indicate that they are "satisfied" or "very satisfied" with the program on an anonymous survey that they complete during their individual interview.
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End of treatment (6 months after baseline)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mindfulness (Hypothesized intervention mediator)
Periodo de tiempo: Mid-Treatment (3 months after baseline)
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Participants will self-report their mindfulness using the Awareness subscale of The Philadelphia Mindfulness Scale.
The range of scores is 1-5, with higher scores indicating greater mindfulness.
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Mid-Treatment (3 months after baseline)
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Acceptance (Hypothesized intervention mediator)
Periodo de tiempo: Mid-Treatment (3 months after baseline)
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Participants will self-report their mindful acceptance using the Acceptance subscale of The Philadelphia Mindfulness Scale.
The range of scores is 1-5, with higher scores indicating greater mindful acceptance.
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Mid-Treatment (3 months after baseline)
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Self-compassion (Hypothesized intervention mediator)
Periodo de tiempo: Mid-Treatment (3 months after baseline)
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Participants will report their self-compassion using the Self-Compassion Scale Short Form.
Scores can range from 1 to 5, with higher scores indicating higher self-compassion.
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Mid-Treatment (3 months after baseline)
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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 julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
12 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de julio de 2026
Publicado por primera vez (Actual)
16 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- K01HL172254 (Subvención/contrato del NIH de EE. UU.)
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. .