- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00939081
Community Based Obesity Prevention Among Blacks
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Long-term promotion of physical activity is necessary to achieve obesity prevention. This represents a particular challenge for our intervention design, as few studies have demonstrated positive long-term physical activity promotion outcomes among Black women. We have demonstrated the utility of pedometers among low income, ethnically diverse populations. The efficacy of pedometer utilization for the prevention of weight gain, however, hinges on long-term utilization of the devices. We hypothesize that recommendation for the step count attainment may affect individual's long-term utilization of pedometers, as well as physical activity levels and BMI.
This study is a 24-week experimental trial to examine whether intervention recommendations promote long-term adherence to a pedometer-based physical activity regimen. A two-group, block design will be used in the proposed study. Eligible women will be randomly assigned to one of two experimental conditions (n=75 per condition): 1) receiving a 10,000 steps/day recommendation and 3 health education sessions or 2) receiving an adaptive recommendation and an obesity prevention intervention. The adaptive step recommendation will update participants' recommended step counts, starting at 7,000 steps/day, then 8,000 steps/day, then finally 10,000 steps/day. Participants in the adaptive recommendation group will be provided with 3 educational sessions and will be asked to report their daily progress on weight maintenance goals via text message.
Participants will be provided pedometers and will be asked to wear them every day of the 24-week trial period.
Assessments (including self-report survey and anthropometric measurements) will be conducted at baseline, 12 weeks and 24 weeks post-baseline.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Duke University
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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:
- Female
- Ages 25 and over
- BMI 25 and over
- English fluency
- Not currently pregnant
- No restrictions to ambulatory activity
Exclusion Criteria:
- Current pregnancy
- Childbearing in the past 12 months
- History of myocardial infarction or stroke in last 2 years
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 10,000 step/day recommendation
Participants will receive a standard 10,000 step/day recommendation and 3 education sessions: at baseline, at 3 months and at 6 months.
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Participants will receive a standard 10,000 step/day recommendation and 3 education sessions: at baseline, at 3 months and at 6 months.
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Experimental: Adaptive recommendation
The adaptive recommendation will update the participant's recommended step count attainment from 7,000 to 8,000, then 10,000 steps/day.
The SMS-based self-monitoring system will collect three data points each day from participants in this group: 1) total number of steps/d recorded by the pedometer during the previous day (steps/d); 2) performance on 2nd weight loss goal; and 3) performance on 3rd weight loss goal.
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Participants in this group receive 3 education sessions: at baseline, at 3 months and at 6 months.
The adaptive recommendation will update the participant's recommended step count attainment from 7,000 to 8,000, then 10,000 steps/day.
The SMS-based self-monitoring system will collect three data points each day from participants in this group: 1) total number of steps/d recorded by the pedometer during the previous day (steps/d); 2) performance on 2nd weight loss goal; and 3) performance on 3rd weight loss goal.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Adherence to the pedometer-based physical activity regimen
Prazo: 24 weeks post baseline
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24 weeks post baseline
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Change in physical activity
Prazo: 24 weeks post baseline
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24 weeks post baseline
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Change in BMI
Prazo: 24 weeks post baseline
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24 weeks post baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gary Bennett, PhD, Duke University
Publicações e links úteis
Links úteis
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2794
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