Confident Moves Intervention Efficacy Trial: Obesity Care Settings
28 de maio de 2026 atualizado por: Seungmin Lee, Iowa State University
The objective of this study is to evaluate the efficacy of the Confident Moves (CM) intervention on device-measured physical activity (PA) and the whole person health index in adults with obesity, compared to standard obesity care alone.
Confident Moves (CM) is a web-based physical activity (PA)-promoting research intervention developed by the study team to support adults with obesity.
CM is not a medical or clinical treatment; rather, it is designed to promote daily PA through structured, self-paced online learning activities.
The intervention has been previously pilot-tested in a feasibility study, which demonstrated its acceptability, safety, and feasibility and informed refinements to study procedures.
CM aims to strengthen participants' confidence, knowledge, and behavioral skills related to PA across multiple everyday contexts.
The intervention is delivered through a secure, ISU-managed website, with access limited to enrolled participants and authorized research personnel.
Only study staff have access to participant data, and data are used solely for research purposes.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
348
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: Seungmin Lee, PhD
- Número de telefone: 515-294-8257
- E-mail: seunglee@iastate.edu
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
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Age 18-64 years
- Body Mass Index (BMI) ≥ 25 kg/m²
- Access to a technological device (e.g., computer, smartphone) capable of supporting the online intervention
- Not currently enrolled in another physical activity (PA) intervention (except standard obesity care programs at participating centers)
- Willingness to wear a wrist worn accelerometer for two separate 7 day monitoring periods
- Willingness to respond to study related communications (e.g., email, text, phone call)
Exclusion Criteria:
- Failure to meet one or more of the inclusion criteria
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 |
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Sem intervenção: Standard Care Group
Participants assigned to the standard care group will receive only the obesity centers' standard obesity care program during the data collection period.
They will be provided with login credentials to access the CM website for data collection at wave 1 (W1), wave 2 (W2), and wave 3 (W3).
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Experimental: CM Group
Participants assigned to the Confident Moves (CM) group also will receive the obesity centers' program and will be provided with 4 weeks of continuous (24-hour) access to the CM intervention during the data collection period.
Access to the CM intervention will become available between W1 and W2, and those in this group will be notified via email.
They will be encouraged to actively engage with the intervention, including completing at least 26 intervention challenges.
They will be provided with login credentials to access the CM website for both the CM intervention and data collection at W1, W2, and W3.
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Confident Moves (CM) is a web-based physical activity (PA) intervention designed to integrate with obesity care and support daily PA in adults with obesity.
A 2025 feasibility trial supported the development of a future randomized controlled trial and identified areas for refinement.
Grounded in social cognitive theory, CM targets self-efficacy through structured learning activities such as games, videos, lectures, and self-reflection, incorporating behavior change techniques like goal setting and action planning.
The online program includes seven components addressing multiple PA domains and mindfulness, delivered over 4 weeks with flexible access.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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ActiGraph wGT3X-BT
Prazo: At W1 (Week 1-4) and W3 (Week 13-16)
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Device-measured physical activity (PA) will be assessed at W1 and W3 using the ActiGraph wGT3X-BT (Pensacola, FL, USA), a tri-axial research-grade accelerometer.
Devices will collect data at 30 Hz and be reintegrated into 60-s epochs.
Non-wear will be defined as ≥90 consecutive minutes of zero counts, allowing ≤2 min of nonzero counts if surrounded by ≥30 min of zeros.
Data will be considered valid if participants have ≥3 days with ≥10 h/day of wear, no device malfunction, and consistency with logs.
Moderate-to-vigorous PA (MVPA) will be defined as ≥3,941 counts/min using wrist-specific vector magnitude cut-points validated in free-living adults.
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At W1 (Week 1-4) and W3 (Week 13-16)
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Whole Person Health Index (WPHI) scale
Prazo: At W1 (Week 1-4) and W3 (Week 13-16)
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The Whole Person Health Index (WPHI) will be measured at W1 and W3 using a 9-item self-reported scale developed by the National Center for Complementary and Integrative Health, in collaboration with the Centers for Disease Control and Prevention.
The WPHI assesses overall health across physical, psychological, and social domains, reflecting a whole person health framework beyond disease-specific outcomes.
Items assess general health, quality of life, social/family connections, diet, physical activity, stress management, sleep, meaning/purpose, and ability to manage health, rated on a 5-point Likert scale (1=poor to 5=excellent).
The WPHI is validated and used in observational and clinical studies, including the 2025 National Health Interview Survey.
Total scores range from 9 to 45, with higher scores indicating better health outcomes.
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At W1 (Week 1-4) and W3 (Week 13-16)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Physical Activity Self-Efficacy (PASE) scale
Prazo: [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]
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Physical Activity Self-Efficacy (PASE) will be assessed at W1 and W2 using a 36-item self-reported scale measuring confidence in achieving recommended weekly physical activity (PA).
PASE evaluates self-efficacy across four domains: occupational, transport, domestic, and leisure PA.
Occupational and leisure domains include moderate- and vigorous-intensity activities, whereas transport and domestic domains include moderate-intensity activities only.
Items are rated on a 5-point scale (0 = no confidence to 4 = complete confidence), consistent with standard self-efficacy measures.
Total scores range from 0 to 144, with higher scores indicating greater PA self-efficacy.
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[Time Frame: At W1 (Week 1-4) and W2 (Week 9)]
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Self-Efficacy to Regulate Physical Activity (SERPA) scale
Prazo: [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]
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Self-efficacy to regulate physical activity (SERPA) will be measured at W1 and W2 using a 13-item version of the SERPA scale. This scale will assess participants' confidence in their ability to overcome barriers to sustaining weekly PA. Previous measurement studies of the SERPA scale indicate a two-factor structure reflecting different types of barriers to PA. Items are rated on a five-point self-efficacy scale (0 = no confidence to 4 = complete confidence). Total scores range from 0 to 52, with higher scores indicating better outcomes. |
[Time Frame: At W1 (Week 1-4) and W2 (Week 9)]
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Self-Efficacy for Whole Person Health (SE-WPH) scale
Prazo: [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]
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Self-Efficacy for Whole Person Health (SE-WPH) will be measured at W1 and W2 using a newly developed 9-item self-reported scale.
The SE-WPH assesses confidence in engaging in and sustaining behaviors that support whole person health across physical, psychological, and social domains, aligned with the Whole Person Health Index (WPHI).
Items reflect key areas including overall health and quality of life, social connections, health behaviors (diet, physical activity, sleep, stress), and health self-management.
Items are rated on a 5-point scale (0 = no confidence to 4 = complete confidence).
Psychometric evaluation (reliability and validity) will be conducted prior to hypothesis testing.
Total scores range from 0 to 36, with higher scores indicating greater self-efficacy.
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[Time Frame: At W1 (Week 1-4) and W2 (Week 9)]
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Self-Efficacy to Engage (SE-E) scale
Prazo: [Time Frame: At W2 (Week 9)]
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Self-Efficacy to Engage (SE-E) will be measured at W2 among participants in the CM group upon access to the intervention, using a previously developed 7-item self-reported scale.
The SE-E assesses confidence in engaging with the online intervention and is conceptually aligned with subjective engagement.
An example item is: "How confident are you in your current ability to pay close attention when engaging with this online intervention?"
Items are rated on a 5-point scale (0 = no confidence to 4 = complete confidence).
Although previously developed, the scale was only used in a feasibility trial; thus, reliability and validity will be evaluated prior to hypothesis testing.
Total scores range from 0 to 28, with higher scores indicating greater engagement self-efficacy.
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[Time Frame: At W2 (Week 9)]
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Physical Activity Outcome Expectations (PAOE) scale
Prazo: [Time Frame: At W1 (Week 1-4), W2 (Week 9), and W3 (Week 13-16)]
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Physical Activity Outcome Expectations (PAOE) will be assessed at W1, W2, and W3 using a modified 13-item self-reported scale capturing beliefs about expected outcomes of physical activity (PA).
The scale was adapted from the Multidimensional Outcome Expectations for Exercise scale, grounded in social cognitive theory and encompassing physical, social, and self-evaluative domains.
Modifications were informed by responses from 30 adults with obesity in a 2025 feasibility trial, using inductive analyses and independent item review to enhance relevance to obesity-specific PA contexts.
An example item is: "Physical activity will improve my stamina for daily activities."
Items are rated on a 5-point scale (1 = strongly disagree to 5 = strongly agree).
Psychometric evaluation will be conducted prior to hypothesis testing.
Total scores range from 13 to 65, with higher scores indicating more positive outcome expectations.
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[Time Frame: At W1 (Week 1-4), W2 (Week 9), and W3 (Week 13-16)]
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Subjective Engagement (SE) scale
Prazo: [Time Frame: W2 (Week 9)]
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Subjective engagement (SE) will be assessed among participants assigned to the CM group after intervention access is provided, using a newly developed subjective engagement scale. This 7-item measure is designed to assess participants' subjective engagement with the web-based intervention, consistent with conceptualizations of engagement in the online behavioral intervention literature. An example item is: "I paid close attention when engaging with this online intervention." Responses will be recorded using a five-point Likert scale (i.e., 0 = not at all to 4 = completely). Because the engagement scale is newly developed, evidence regarding the validity and reliability of scores derived from this measure will be evaluated using data collected at W1. Total scores range from 0 to 28, with higher scores indicating better outcomes. |
[Time Frame: W2 (Week 9)]
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Support from Obesity Care Centers for Physical Activity (SOCC) scale
Prazo: [Time Frame: At W1 (Week 1-4)]
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Support from Obesity Care Centers (SOCC) will be assessed at W1 using a 7-item self-reported scale informed by the 2025 CM feasibility trial.
The SOCC assesses experiences with and perceptions of physical activity (PA)-related support received outside the CM intervention.
It includes a screening item on receipt of PA support, followed by conditional items assessing type of support and satisfaction.
Participants reporting support describe it in open-ended form and rate satisfaction on a 5-point scale (1 = very dissatisfied to 5 = very satisfied).
Additional items assess referrals to PA resources and perceived preferences, needs, and barriers.
Data will be used descriptively to contextualize PA support and inform intervention refinement.
Total scores range from 7 to 35, with higher scores indicating greater perceived support.
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[Time Frame: At W1 (Week 1-4)]
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International Physical Activity Questionnaire-Short Form (IPAQ-SF) scale
Prazo: [Time Frame: At W1 (Week 1-4) and W3 (Week 13-16)]
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Self-reported PA will be measured at W1, W2, and W3 with the short form of International Physical Activity Questionnaire (IPAQ).
This questionnaire assesses the frequency and duration of walking, moderate-, and vigorous-intensity PA over the past 7 days.
Average minutes per day of moderate-to-vigorous physical activity (MVPA) will be calculated based on the IPAQ guidelines.
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[Time Frame: At W1 (Week 1-4) and W3 (Week 13-16)]
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Colaboradores e Investigadores
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Patrocinador
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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 (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
1 de julho de 2027
Conclusão do estudo (Estimado)
1 de agosto de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
21 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de maio de 2026
Primeira postagem (Real)
3 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26-187
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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
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