- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02512419
Developing a Text-Message Enhanced Physical Activity Intervention for Latino Men
21 de junho de 2019 atualizado por: Dr.Bess Marcus, University of California, San Diego
The aim of this study is to build upon our tailored print intervention by developing new text-delivered intervention materials to complement our print-based physical activity (PA) intervention.
In Phase 1 we will conduct 6 focus groups with Mexican and Mexican American (MA) men to determine content, frequency, and types of text messages desired, and to identify cultural themes to incorporate into existing and new materials.
Themes from the focus groups and sample text messages will be presented to a confirmatory focus group panel.
Phase 2 will be a 6-month pilot randomized controlled trial with Mexican and MA men (N=60) to test the text-enhanced, Spanish language, individually tailored PA intervention vs. publicly available, Spanish language health education materials, including information on PA, diet, and stress management.
This will be followed by post-intervention qualitative interviews to solicit suggestions for improvements to help further refine the program.
The proposed pilot will support a future R01 to establish the efficacy of this multi-media, multi-level PA intervention for Mexican and MA men.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
The proposed research addresses serious public health concerns (inactivity, health disparities) in a large, rapidly growing population of Mexican American (MA) men who are markedly less physically active than men of other ethnicities and suffer from higher prevalence of conditions related to sedentary lifestyle.
While this population is clearly in need of physical activity (PA) interventions, to date none have specifically targeted MA men.
In fact, the majority of PA interventions for Latinos have exclusively included women and/or are designed around female preferences.The proposed study will address the needs and barriers to PA in MA men by developing text message-delivered intervention materials based on Social Cognitive Theory (SCT) to complement an individually tailored, theory-based print material PA intervention for Spanish speaking Mexican and MA men.
Text messaging could be a particularly effective and appealing channel for increasing PA in this target population as it allows for participant interaction, real-time accountability, and immediate feedback, features which MA men in the demonstration trial of our print intervention specifically requested.
Text-based interventions have been shown to improve a number of health behaviors, including PA.
A recent review of texting interventions found that they were generally well received and effective in reducing inactivity, weight, and waist circumference,5 and a meta-analysis found a moderate effect size (g = 0.54) for using mobile devices to increase PA.
However, few of these trials targeted underserved populations, and none specifically targeted Latinos.
Cell phone ownership is high in Latino adults (86% vs. 84% in non-Latino Whites), and Latinos are actually the most likely to use mobile phones for text messaging, with 85% reporting regularly sending and receiving texts (compared to 79% of Whites).
Thus this is a familiar, convenient channel for delivering new intervention materials.
Additionally, as Latinos also face environmental barriers to PA, in the current proposal we will enhance the individually tailored psychosocial print-based materials by developing materials targeting barriers in home and work environments.
This multi-media, multi-level approach has potential for broad reach at relatively low cost, which could help reduce health disparities.
Tipo de estudo
Intervencional
Inscrição (Real)
48
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.
Locais de estudo
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California
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La Jolla, California, Estados Unidos, 92093-0628
- University of California San Diego
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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
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion Criteria:
- Male
- Generally healthy (If asthma, controlled high blood pressure and/or controlled type II diabetes, may be able to participate with physician consent)
- Sedentary (Less than 60 minutes per week of moderate or vigorous physical activity)
- Mexican and/or Mexican American (self-identified)
- Must be able to read and write Spanish fluently
- 18 - 65 years of age
- Planning on living in the area for the next 6 months
- Own a cell phone capable of sending and receiving text messages
Exclusion Criteria:
- Body Mass Index(BMI) greater than 45
- Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise
- Exercise is against advice of doctor
- Heart disease/treatment
- Heart murmur
- Angina/chest pain or Angina/chest pain with exertion
- Palpitations
- Stroke/Transient Ischemic Attacks
- Peripheral Vascular Disease
- Type I Diabetes
- Uncontrolled Type II Diabetes
- Chronic Infectious Disease - HIV, Hepatitis
- Chronic liver disease
- Cystic Fibrosis
- Abnormal EKG on last EKG performed
- Emphysema, Chronic bronchitis, Chronic Obstructive Pulmonary Disease
- Seizure in past year
- Surgery in past year on heart, lung, joint, orthopedic surgery
- Surgery pending in next year on lung, joint, orthopedic surgery
- Unusual/concerning shortness of breath
- Asthma (may be able to participate with physician consent)
- High blood pressure/high blood pressure medication (may be able to participate with physician consent)
- Use of beta blockers
- Abnormal Medical Stress Test
- Musculoskeletal problems
- Fainting/dizziness more than 3 times in past year OR interferes with daily activities OR causes loss of balance
- Cancer treatment in past 3 months
- Hospitalized for psychiatric disorder in past 3 years or suicidal
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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Experimental: Text-Enhanced Physical Activity Intervention Arm
The Spanish-language PA intervention is based on Social Cognitive Theory (SCT) and Transtheoretical Model (TTM), and emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals).
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Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men.
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Comparador Ativo: Health Education Control Arm
The health education control arm will receive the publicly available NHBLI Spanish-language booklets on heart-healthy behaviors for Latinos, which include information on PA, diet, and stress management.
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Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.
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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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Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+
Prazo: Baseline and 6 months
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Participants will wear an Actigraph GT3X+ accelerometer, which measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure.
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Baseline and 6 months
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Self Reported Min/Week of MVPA
Prazo: baseline and 6 months
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Self reported physical activity (collected via 7 day PAR)
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baseline and 6 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
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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
1 de julho de 2015
Conclusão Primária (Real)
31 de outubro de 2017
Conclusão do estudo (Real)
31 de dezembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
29 de julho de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de julho de 2015
Primeira postagem (Estimativa)
30 de julho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de julho de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de junho de 2019
Última verificação
1 de junho de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Activo R21
- R21NR014911 (Concessão/Contrato do NIH dos EUA)
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