Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain (Momentum)
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
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
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
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Ages 18-75 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
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / 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. |
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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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). |
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. |
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). |
Whenever participants skip a weigh-in or regain weight during the 6 month 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. |
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. |
End of treatment (6 months after baseline)
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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. |
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. |
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. |
6 months (duration of study period)
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Medidas de resultado secundarias
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. |
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. |
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. |
Mid-Treatment (3 months after baseline)
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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