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Seamos Saludables - Physical Activity Intervention Study for Latinas

24 de janeiro de 2013 atualizado por: Dr.Bess Marcus, University of California, San Diego

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

Descrição detalhada

In the U.S., Latinos report higher rates of inactivity and related health conditions (e.g., hypertension,hypercholesteremia, obesity, heart disease, stroke, diabetes) than non-Hispanic whites. Furthermore, Latino women (Latinas) report higher rates of sedentary behavior than Latino men. Due to cultural factors, socioeconomic circumstances, differences in educational background, and language barriers, Latinos in general, and especially Latinas, have limited access to public health interventions that promote physically active lifestyles. To address this public health crisis, effective interventions that leverage state-of-the-art theory and methods are needed. The investigators research group has 20 years experience developing and evaluating individually tailored computer expert system-driven physical activity interventions (based on Social Cognitive Theory and the Transtheoretical Model). In the investigators recent pilot study (R21NR009864), the investigators culturally and linguistically adapted the existing tailored intervention for sedentary Latinas and conducted a small randomized trial of the modified program (N=94). Six month (post-intervention) assessments are still ongoing, but three month data have been collected on 87 participants (93% retention). Intervention participants increased their physical activity from a mean of 17 minutes per week (SD=25.8) at baseline to 92 minutes (SD=69.8) at three months, whereas contact control participants reported increasing their physical activity from 12 minutes per week (SD=21.8) at baseline to 64 minutes (SD=84.3) at three months. The trends in the means at 3 months lend preliminary support for the efficacy of the intervention and the high retention rates, especially for a study targeting a hard-to-reach group like Latinas, bode well for its feasibility and acceptability. For the current proposal, the investigators will build on these encouraging results by conducting an adequately powered (N=312) randomized controlled trial to test the efficacy of the culturally and linguistically modified, individually tailored print intervention compared with a wellness contact control condition (e.g., cardiovascular health information from NHLBI in Spanish). Data will be collected at baseline, 6, and 12 months using well-established physical activity measures (7-Day PAR, Actigraphs), as well as a comprehensive set of psychosocial questionnaires. 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. The investigators will also examine the maintenance of treatment effects at 12 months, costs of delivering the tailored intervention program, and potential mediators and moderators of the intervention-physical activity relationship. In the proposed study the investigators seek to promote physical activity among this at-risk population using a high-reach, low-cost strategy, which has great potential for adoption on a larger scale and thus high potential for reducing existing health disparities in the U.S.

Tipo de estudo

Intervencional

Inscrição (Real)

312

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

    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • Brown University Institute for Community Health Promotion

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

Fêmea

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

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: Exercise Intervention
Culturally-modified, individually tailored physical activity print materials
Participants in the Physical Activity Intervention arm of the study receive culturally-modified, individually tailored physical activity print materials.
Comparador Ativo: Control
Bilingual health education booklets
Participants in the Wellness Control arm of the study receive a variety of print materials focused on general health topics.

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
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.
6 and 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Bess H Marcus, Ph.D., University of California, San Diego

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 outubro de 2009

Conclusão Primária (Real)

1 de setembro de 2012

Conclusão do estudo (Real)

1 de setembro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

6 de março de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de abril de 2012

Primeira postagem (Estimativa)

23 de abril de 2012

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

28 de janeiro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de janeiro de 2013

Última verificação

1 de janeiro de 2013

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 .

Ensaios clínicos em Physical Activity Intervention

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