- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01043614
Peer Education, Exercising and Eating Right - Obesity Prevention in Freshmen Women (ProjectPEER)
Project PEER: Peer Education, Exercising and Eating Right
Project PEER utilizes a randomized controlled study design to investigate the combined effects of an exercise and nutrition intervention that is based on self-efficacy principles and delivered primarily by peer educators to reduce the risk for obesity in female college freshman over one academic year (N = 300). The control group will receive minimal interaction from the research team, paralleling the typical freshman experience on the UIUC campus. Recruitment will take place in two waves (consecutive fall terms with n = 150).
During the final year (Fall 2010) of the project, a General Education course will be offered that targets weight management. Importantly, the discussion groups for this course will be taught by peer educators trained using the peer resources further refined during the PEER project. In addition to conventional measures of content knowledge assessed in the college classroom when obtaining class credit, personal physical activity and nutrition behaviors along with behavioral determinants (self-efficacy, self-regulatory skills and outcome expectations) will also be assessed.
Primary Aim 1: To determine the effectiveness of a peer-delivered self efficacy-based behavioral intervention to enhance nutrition and physical activity behaviors and subsequently weight management success in female university freshman over one academic year. We hypothesize that freshmen randomized to the intervention group will be more successful in losing or maintaining weight than the control group through a combination of diet and physical activity strategies.
Primary Aim 2: To examine the role played by social cognitive factors in changing nutrition and physical activity behaviors across one academic year. We hypothesize that self-efficacy will have both a direct influence on behavior and an indirect effect through its influence on self-regulatory skills and outcome expectations.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Illinois
-
Urbana, Illinois, Estados Unidos, 61801
- University of Illinois at Urbana-Champaign
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Female
- In first year on campus, enrolled full-time, and in residence on the UIUC campus
- Aged 17-19 yrs (minors will be required to obtain parental signature on the IRB form)
- Free from any chronic disease/condition that would alter ability to exercise or preclude diet manipulation such as diabetes, hypertension or pregnancy.
- Free from an eating disorder as assessed using the Eating Disorder Inventory
- Free from any medications that would alter adiposity or psychological outcomes
- Sedentary or participation in non-professional recreational activity
- Non-smoking
- Body mass index (BMI) between the 50th and 95th BMI-for-age percentile
Exclusion Criteria:
- Male
- Status other than freshman or enrolled for entire year
- Not living on campus
- Smoking
- Pregnant
- Competitive athlete
- Chronic condition that would alter ability to exercise or preclude diet manipulation such as diabetes, hypertension
- Eating disorder as assessed using the Eating Disorder Inventory
- Taking medications that would alter adiposity or psychological outcomes
- Participation in competitive athletics
- BMI outside parameters
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 |
|---|---|
|
Experimental: Peer group education
Small groups of female college freshmen facilitated by peer educators
|
An exercise and nutrition intervention that is based on self-efficacy principles and delivered primarily by peer educators to reduce the risk for obesity in female college freshman over one academic year
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Anthropometric measures (eg; weight, hip/ waist dimensions)
Prazo: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
|
Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Self-efficacy measures for physical activity, nutrition
Prazo: Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
|
Baseline, 3 mo, 8 mo, 1 y and 2 y follow up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ellen M Evans, PhD, Uiversity of Illinois at Urbana- Champaign
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
- 2007-04574
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 .