Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain (Momentum)
7 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
120
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Charlotte Hagerman, PhD
- Número de telefone: 14109372035
- E-mail: chagerman@ori.org
Locais de estudo
-
-
Oregon
-
Springfield, Oregon, Estados Unidos, 97477
- Recrutamento
- Oregon Research Institute Community and Evaluation Services
-
Contato:
- Charlotte Hagerman, PhD
- Número de telefone: 4109372035
- E-mail: chagerman@ori.org
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
State negative affect
Prazo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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
|
|
State shame
Prazo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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
|
|
State Motivation
Prazo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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
|
|
State Self-Efficacy
Prazo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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
|
|
Current confidence in the effectiveness of weight control behaviors
Prazo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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
|
|
State self-compassion
Prazo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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
|
|
State mindfulness
Prazo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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
|
|
State acceptance
Prazo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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
|
|
Self-serving interpretation of weight gain
Prazo: Whenever participants regain weight during the 6 month study period
|
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
|
|
Daily Calorie Tracking (Yes/No)
Prazo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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
|
|
Daily MVPA
Prazo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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
|
|
Likelihood of weighing in the following day
Prazo: Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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
|
|
Calorie Tracking Frequency
Prazo: 6 months (duration of study period)
|
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)
|
|
Average Weekly MVPA
Prazo: 6 months (duration of study period)
|
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)
|
|
Frequency of Weighing In
Prazo: 6 months (duration of study period)
|
Total number of days that participants weighed themselves on a wireless smart scale during the study period.
|
6 months (duration of study period)
|
|
Weight change
Prazo: End of treatment (6 months after baseline)
|
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)
|
|
Intervention acceptability
Prazo: End of treatment (6 months after baseline)
|
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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mindfulness (Hypothesized intervention mediator)
Prazo: Mid-Treatment (3 months after baseline)
|
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)
|
|
Acceptance (Hypothesized intervention mediator)
Prazo: Mid-Treatment (3 months after baseline)
|
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)
|
|
Self-compassion (Hypothesized intervention mediator)
Prazo: Mid-Treatment (3 months after baseline)
|
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)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
14 de julho de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
12 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de julho de 2026
Primeira postagem (Real)
16 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- K01HL172254 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .