- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01583140
Seamos Saludables - Physical Activity Intervention Study for Latinas
Culturally and Linguistically Adapted Physical Activity Intervention for Latinas (Seamos Saludables)
In this study the investigators are specifically targeting Latina women because they are more likely to be inactive and, therefore, are at higher risk for developing chronic conditions like obesity, diabetes, or cardiovascular disease. Through focus groups and cognitive interviews with Latinas in the Providence area, the investigators have modified our print-based intervention, already tested and proven to be effective in English-speaking communities, to be culturally and linguistically appropriate for the Latina community.
The objective of Seamos Saludables is to determine whether this culturally tailored print intervention will produce greater increases in physical activity levels among Latina women than a program focused on general health topics. Participants are randomly assigned to one of two groups (exercise and general wellness) and attend 4 clinic visits to complete baseline and follow-up assessments.
The investigators hypothesize that at the end of treatment, intervention participants will report significantly more minutes of at least moderate intensity physical activity per week than the wellness contact control participants.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Brown University Institute for Community Health Promotion
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Females
- Generally healthy
- Sedentary (Less than 60 minutes per week of mod or vigorous physical activity)
- Latina (self-defined)
- Must be able to read and write Spanish fluently
- 18 - 65 years of age
- Planning on living in the area for the next 12 months
Exclusion Criteria:
- Pregnant or planning on becoming pregnant
- 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/TIA
- Peripheral vascular disease
- Diabetes I or II
- Chronic Infectious Disease - HIV, Hepatitis
- Chronic liver disease
- Cystic fibrosis
- Abnormal EKG on last EKG performed
- Emphysema, Chronic bronchitis, COPD
- 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
- High blood pressure/high blood pressure medication
- 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
- 3 or more alcoholic beverages 5 or more days per week
Plano de estudo
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: Exercise Intervention
Culturally-modified, individually tailored physical activity print materials
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Participants in the Physical Activity Intervention arm of the study receive culturally-modified, individually tailored physical activity print materials.
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Comparador Ativo: Control
Bilingual health education booklets
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Participants in the Wellness Control arm of the study receive a variety of print materials focused on general health topics.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months
Prazo: 6 and 12 months
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The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities including time spent sleeping and in moderate, hard, and very hard activity.
The 7-Day PAR is used across many studies in physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other more objective measures of activity levels, along with sensitivity to changes in both moderate and intensive levels of physical activity.
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6 and 12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Bess H Marcus, Ph.D., University of California, San Diego
Publicações e links úteis
Publicações Gerais
- Pekmezi DW, Neighbors CJ, Lee CS, Gans KM, Bock BC, Morrow KM, Marquez B, Dunsiger S, Marcus BH. A culturally adapted physical activity intervention for Latinas: a randomized controlled trial. Am J Prev Med. 2009 Dec;37(6):495-500. doi: 10.1016/j.amepre.2009.08.023.
- Benitez TJ, Dunsiger S, Marquez B, Larsen B, Pekmezi D, Marcus BH. Increases in Muscle-Strengthening Activities Among Latinas in Seamos Saludables. Health Educ Behav. 2022 Jun;49(3):446-454. doi: 10.1177/10901981221074908. Epub 2022 Feb 28.
- Larsen B, Gilmer T, Pekmezi D, Napolitano MA, Marcus BH. Cost effectiveness of a mail-delivered individually tailored physical activity intervention for Latinas vs. a mailed contact control. Int J Behav Nutr Phys Act. 2015 Nov 11;12:140. doi: 10.1186/s12966-015-0302-5.
- Marcus BH, Dunsiger SI, Pekmezi D, Larsen BA, Marquez B, Bock BC, Gans KM, Morrow KM, Tilkemeier P. Twelve-month physical activity outcomes in Latinas in the Seamos Saludables trial. Am J Prev Med. 2015 Feb;48(2):179-182. doi: 10.1016/j.amepre.2014.08.032. Epub 2014 Nov 6.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- SALUDABLES-2009
- 5R01NR011295 (Concessão/Contrato do NIH dos EUA)
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 .
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