- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00709501
Disseminating Effective Habits for Long-Term Weight Loss
Visão geral do estudo
Status
Condições
Descrição detalhada
Overweight and obesity are serious threats to public health. Over the last 20 years, the percentage of overweight and obese Americans, as well as the rate of diabetes, have grown tremendously (Cowie, Rust et al. 2006).
Few individuals are successful at long-term weight loss. Long-term weight loss is an elusive, yet sought after goal for many Americans (2000). Fewer than 5% of adults are successful in maintaining a 20 pound weight loss for at least 2 years (Klem, Wing et al. 1997). While medications can be effective, they produce only small amounts of weight loss, carry a significant cost and appear to be effective only while being taken (2000). Surgery is an effective option, though the procedure has tremendous costs and potential complications (2000). This points to the need for innovative and effective treatments that helps individuals over the longer-term.
Some, but not all, web-based treatments for weight loss have been shown to be effective. A recent study by Tate and colleagues showed that individuals who received counseling emails from a human or automated emails from a computer lost more weight than individuals who received neither(7.3 kg lost v. 4.9 kg and 2.6 kg, respectively) (Tate, Jackvony et al. 2006) (Tate, Jackvony et al. 2003). The feedback in the emails was based on diet and physical activity information that the individuals entered online. Dr. Harvey-Berino and colleagues has shown that social support delivered via the Internet can help weight loss efforts to the same degree as in person support (Harvey-Berino, Pintauro et al. 2004). Other studies have been mixed in their effects (Williamson, Walden et al. 2006) (Gold, Burke et al. 2007) (Wing, Tate et al. 2006), though there has generally been an effect from human feedback delivered via a computer. Other than the recent study by Tate and colleagues, no fully automated website has been effective at producing weight loss. It is our belief that fully automated systems are needed to meet the needs, in a cost-effective manner, of the 80 million overweight Americans who will need life-long help in losing weight and in maintaining their weight loss.
During an earlier phase of the study, 50 in-depth interviews were conducted with individuals who have been successful at losing weight and keeping it off. These individuals were asked specifically about which habits they use to maintain their weight loss, how these habits are implemented and how barriers to using these habits are overcome. These interviews were transcribed and the data entered into a website, to be used as part of the intervention to be tested in this clinical trial.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State College of Medicine General Clinical Research Center
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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:
- Age 21-65
- BMI 27-40 kg/m2
- Fluently speaks and reads English
- Access to the Internet at home or at work
- Valid email address
- Access to a scale for weekly weigh-ins
- Agree not to seek additional weight loss treatment
- Agree to come back regardless of amount of weight lost
- Participant in NCT00377208
Exclusion Criteria:
- Current, planned, or previous pregnancy within 12 months
- Planned or past weight loss surgery
- Recent weight loss of >= 15 lbs in the past 6 months
History of:
- Myocardial infarction
- Stroke
- Type 1 and Type 2 diabetes
- Unstable angina
- Congestive heart failure
- Inability to exercise due to severe arthritis or other musculoskeletal problems
- Cancer (except non-melanoma skin cancer)
- Evidence of severe cognitive impairment or major psychiatric illness
- Plans to move in the next 6 months
- Answering yes to any question on the Physical Activity Readiness Questionnaire (PAR-Q)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 1
Participants in the intervention condition are encouraged to access the Achieve Together website at least once each week. During each login, the following activities will occur:
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Comparison of weight change among those participants in the weight loss intervention (immediate access to the weight loss website) and those participants in the control group (delayed access to the weight loss website).
access to the Achieve Together website immediately (Arm 1) or delayed (Arm 2)
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Sem intervenção: 2
Participants in the control condition will have to wait 12 weeks before accessing the Achieve Together website.
These participants will be a given a log where they can document weekly weight measurements (this part did not happen).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Body weight
Prazo: 3 months
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Weight will be measured using a calibrated, digital scale
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3 months
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Blood Pressure Control
Prazo: 3-Months
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3-Months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Physical Activity, using the International Physical Activity Questionnaire
Prazo: 3 months
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Results are still being analyzed
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3 months
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Block 2005 FFQ for assessment of diet and physical activity
Prazo: 3 Months
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3 Months
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IWQOL-Lite, a validated, 31-item, self-report measure of obesity-specific
Prazo: 3 Months
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3 Months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christopher N Sciamanna, M.D., MPH, Penn State College of Medicine
Publicações e 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
- 28160
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 .