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- Ensaio Clínico NCT01282775
Interventions to Control Obesity in Community Colleges (CDC WAY to Health)
Interventions to Control Obesity in Community Colleges
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Despite the fact that obesity is at epidemic proportions and costs US employers an estimated $78.5 billion annually; national data indicate that less than 25% of employers are offering disease management programs to address obesity. Effective weight loss programs that are adaptable to busy work environments and maintain employee interest are needed, but few rigorous tests of these programs have been attempted.
In collaboration with the North Carolina Community College System, NC Blue Cross Blue Shield, and the State Health Plan for Teachers and State Employees, this three year group-randomized weight loss intervention studies approximately 1020 overweight/obese employees nested within 17 community colleges. Campuses are randomly assigned to receive one of three promising, state-of-the-art, theory-linked interventions: Environment/Usual Care (E); Web-based Weight Loss Program + Environment (WEB+E) or Web + Environment +Incentives (WEB+E+I). College is the unit of randomization and intervention; employee is the unit of analysis. Follow-up weigh-in assessments are completed at 3, 6, and 12 months.
After formative research in Year 1 to adapt interventions for community college employees, the effects of these interventions are rigorously tested on 12-month weight loss (primary outcome). Most secondary outcomes (weight loss behaviors, moderate-vigorous physical activity; total calories, percent body fat, fruit/vegetable intake, absenteeism, productivity, medical expenditures, and quality of life) are assessed at baseline, 6 and 12 months; along with potential mediators/moderators of weight loss outcomes. Process tracking data measures fidelity, dose delivered/received and acceptability/satisfaction with the interventions. Extensive cost- and cost-effectiveness analysis, including return on investment, is undertaken. If proven effective, this strong partnership between community colleges, the State Health Plan, and the research team, will help guide program adoption and institutionalization/dissemination throughout the community college campus system.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase inicial 1
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- BMI greater than or equal to 25
Exclusion Criteria:
- Type I diabetes
- Pregnant or lactating
- Had a recent weight loss of 20 pounds or more
- Currently taking weight loss medication or unwilling to stop
- Undergone or scheduled weight loss surgery
- Experienced a malignancy requiring chemotherapy or radiation in the past five years
- No internet access
- Answered "yes" to the PAR-Q items and did not return a required physician's consent
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 |
|---|---|
|
Sem intervenção: Environment / Usual Care
|
|
|
Outro: WEB+ Environment
Web-based weight loss program (WEB) + Environment - Participants have access to a proven Web-based weight loss program with weekly lessons focused on lifestyle behavior changes
|
Participants receive weekly lessons via the Web along with additional tools for weight loss support
Outros nomes:
|
|
Outro: WEB + Cash Incentive for Weight Loss
Web-based Weight Loss Program + Cash Incentive for Weight Loss - participants have access to a proven web-based weight loss program plus they are paid cash based on the percent weight lost at 12 months compared to baseline.
|
Participants receive weekly lessons via the Web along with additional tools for weight loss support
Outros nomes:
Participants are paid cash based on the percent weight lost at 3, 6, and 12 months.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
weight change
Prazo: 3, 6, and 12 months
|
participants weight change will be analyzed at 12 months compared to baseline
|
3, 6, and 12 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
moderate vigorous physical activity
Prazo: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
total calories
Prazo: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
percent body fat
Prazo: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
fruit/veg intake
Prazo: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
absenteeism
Prazo: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
quality of life
Prazo: 3, 6, and 12 months
|
3, 6, and 12 months
|
|
medical expenditures
Prazo: 12 months
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Laura A Linnan, ScD, CHES, UNC Chapel Hill
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
- 04-0509
- DP000102 (Número de outro subsídio/financiamento: Centers for Disease Control)
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