- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07593677
Motivating Activity Through Text Communications - Helping Adults Increase Movement (MATCH AIM)
Motivating Activity Through Text - Comparing Human and AI Messages (MATCH AIM) Trial
The goal of this clinical trial is to compare the effect of different types of text messages on physical activity levels of middle-aged and older adults and to determine whether these messages are effective in adults age 40 and older who are engaging in less than 90 minutes per week of moderate or higher intensity physical activity. The main questions it aims to answer are:
- Which types of motivational messages show the greatest effects on changes in daily step counts in a 3-month precision text messaging intervention?
- What are the effects of personalized text messages on automatic affective evaluations, habit strength (experienced automaticity), exercise identity, working memory capacity, and processing speed?
Participants will:
- Wear a Fitbit activity tracker continuously for 3 months and are encouraged to continue wearing it through 6 months.
- Wear an activPAL activity monitor on their thigh for 7-day assessment periods at the beginning of the study, at 3 months, and at 6 months.
- Complete 3 cognitive assessments ("brain games") per day on their smartphone during the 7-day assessment periods at baseline, 3 months, and 6 months.
- Be asked to set goals to increase their daily steps over the first 3 months of the study.
- Receive up to 4 motivational text messages per day for 3 months to encourage physical activity.
- Keep study-related apps (Fitbit app, AIM app, MetricWire app) open in the background on their smartphone.
- Complete questionnaires at the beginning of the study, at 3 months, and at 6 months
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ann M Mehringer
- Número de telefone: 734-647-6050
- E-mail: amehring@umich.edu
Locais de estudo
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- Recrutamento
- University of Michigan
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Investigador principal:
- David E Conroy, PhD
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Contato:
- David E Conroy, PhD
- Número de telefone: 734-647-8404
- E-mail: deconroy@umich.edu
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Contato:
- Ann M Mehringer
- Número de telefone: 734-647-6050
- E-mail: amehring@umich.edu
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Be 40 years of age or older
- Own a smartphone running an Android or iOS operating system
- Have proficiency with the English language
- Be capable of providing informed consent
- Be able to perform moderate physical activity without restrictions
- Be willing to complete the entire 6-month protocol
- Be willing to establish a 12-hour window - beginning no later than 9:45 am and ending no later than 9:45 pm - for receiving text messages.
Exclusion Criteria:
- Residing outside of the continental United States
- Self-reporting 90 minutes or more of moderate-to-vigorous intensity physical activity per week
- contraindications to normal physical activity as identified on the Physical Activity Readiness Questionnaire (PAR-Q)
- Mobility restrictions that interfere with unassisted physical activity
- Being pregnant or planning to become pregnant during the study
- Planning to undergo surgery during the course of the study protocol
- Having a prior diagnosis of Alzheimer's disease or a related dementia
- Evidence of mild cognitive impairment as indicated by a mini-Montreal Cognitive Assessment (MoCA) test score of 12 or higher
- Concurrent participation in another study involving weight loss or physical activity
- Failure to respond to at least 85% of Ecological Momentary Assessment (EMA) prompts during the 7-day qualification phase.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Validated library of text messages
Participants in this arm will receive motivational text messages that have been written and used in previous studies.
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Participants will receive up to 4 motivational text messages per day during a self-selected 12-hour window. These messages focus on two content areas: 1) Move more, and 2) sit less. Delivery of these messages occurs in two phases:
|
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Experimental: Newly created text messages
Participants in this arm will receive motivational text messages that have not been used in previous studies.
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Participants will receive up to 4 motivational text messages per day during a self-selected 12-hour window. These messages focus on two content areas: 1) Move more, and 2) sit less. Delivery of these messages occurs in two phases:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Daily Step Count
Prazo: The activPAL is worn on the thigh for a 7-day assessment period before the intervention begins (baseline), after 3 months of intervention, and then again 3 months after the intervention is complete. The total time frame is 6 months.
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The primary outcome measure is the average daily step count, which is assessed using a blinded, research-grade activPAL activity monitor, worn on the thigh for a 7-day assessment period.
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The activPAL is worn on the thigh for a 7-day assessment period before the intervention begins (baseline), after 3 months of intervention, and then again 3 months after the intervention is complete. The total time frame is 6 months.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mechanisms of Behavior Change for Adherence: Habit Strength
Prazo: These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
|
Habit Strength will be assessed using the Behavioral Automaticity Index from the Self-Report Habit Index to measure how automatic the exercise behavior has become.
Scores are calculated as the average item responses and range from 1 to 7 with higher scores reflecting greater experienced automaticity (i.e., stronger habits).
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These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
|
|
Mechanisms of Behavior Change for Adherence: Exercise Identity (Reflective)
Prazo: These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
|
Exercise Identity will be assessed using the Exercise Identity Scale to see how much participants view themselves as "exercisers".
Scores are based on the average item response and range from 1 to 7 with higher scores representing a stronger exercise identity.
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These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
|
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Mechanisms of Behavior Change for Adherence: Automatic Affective Evaluations
Prazo: These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
|
Automatic Affective Evaluations will be assessed using a Single-Category Implicit Association Test (SCIAT) to assess non-conscious attitudes toward physical activity.
Scores are standardized mean differences of response times between blocks of trials where physical activity is paired with unpleasant attributes and blocks of trials where physical activity is paired with pleasant attributes.
Higher scores indicate more favorable automatic affective evaluations of physical activity.
|
These secondary outcomes are collected at the same major time points as the primary outcome: baseline (month 0), post-intervention (month 3), and follow-up (month 6).
|
|
Ambulatory Cognitive Function: Processing Speed
Prazo: These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month).
|
Processing Speed will be assessed with the Mobile Monitoring of Cognitive Change (M2C2) Symbol Search Task.
Scores are based on response times for accurate trials so there is no fixed range for scores.
Shorter response times indicate faster (better) processing speed; longer response times indicate slower (worse) processing speed.
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These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month).
|
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Ambulatory Cognitive Function: Working Memory Capacity
Prazo: These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month).
|
Working Memory Capacity will be measured using the M2C2 Grid Memory Task.
Scores are based on response accuracy measured as a Euclidean distance score.
Shorter distance scores indicate more working memory capacity; longer distance scores indicate less working memory capacity.
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These secondary outcomes are collected at the same major time points as the primary outcome: Baseline (month 0), post-intervention (month 3), and follow-up (6 month).
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David E Conroy, PhD, University of Michigan
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HUM00262651
- P30AG086637 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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