- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01481948
Food, Fun, & Fitness Internet Program for Girls: Outcome Evaluation (FFFIPG)
18 de janeiro de 2016 atualizado por: Deborah Thompson, Baylor College of Medicine
Using Technology to Prevent Obesity Among African American Girls
The purpose of this project is to reduce health disparities in obesity risk among 8-10 year old African American girls using a culturally sensitive and developmentally appropriate internet-based program with no face-to-face interaction.
This study will conduct an outcome evaluation to test short and longer term effects on obesity risk.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This research will conduct an outcome evaluation on a promising web based obesity prevention program for 8-10 year old African American girls.
A pilot study with 80 girls established its feasibility: recruitment goals were met; attrition rates were < 10%; logon rates to the online program were 74.5%; and statistically significant increases in fruit and vegetable consumption and time spent being physically active were observed.
The outcome evaluation will recruit 400 child-parent pairs to examine short and longer term effects of the program on obesity risk.
It will also conduct mediation analyses to examine pathways of effect.
At the end of the study, the web based program will be hosted on the CNRC web site.
Although the use of the internet as a method for changing health behavior is not new, the use of an internet program alone, with no face to face interaction, is novel.
This is one of the first programs to attempt this, particularly in an at-risk population.
Tipo de estudo
Intervencional
Inscrição (Real)
342
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
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Texas
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Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
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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
8 anos a 10 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- 8-10 years old
- healthy
- African American
- parent willing to participate in data collection
- internet access
- personal email address
Exclusion Criteria:
- mental, physical, or medical conditions that limit fruit-vegetable consumption, physical activity, or ability to fully participate in the program and/or complete baseline and post assessment data collection
- taking medications that influence dietary behaviors, appetite, and/or physical activity
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: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: story plus behaviorial procedures
The girls randomized to this arm of the study will view an interactive story about 6 8-10 year old African American girls who seek to find clues to solve a mystery about the town in which they live.
The episodes will contain information about healthy nutrition and physical activity, as well as basic information about physical activity and kitchen safety tips, developmentally appropriate recipes, and portion sizes.
Girls randomized to this arm of the study will also engage in key behavior change procedures, such as goal setting, problem solving, and self monitoring.
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This is an 8 episode intervention, delivered entirely over the internet.
Each episode, girls will view an interactive story in which 6 8-10 year old African American characters attempt to solve a mystery about their town.
The online program will include information about healthy nutrition (i.e., consuming more fruit, vegetables, water) and physical activity.
There will be two groups; one group (the experimental group) will view the interactive story and participate in key behavior change procedures, such as personal goal setting, problem solving, and self monitoring activities.
The second group (the active comparator group) will view the online stories but will not engage in key behavior change procedures.
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Comparador Ativo: story only
The girls randomized to this arm of the study will view an interactive story about 6 8-10 year old African American girls who seek to find clues to solve a mystery about the town in which they live.
The episodes will contain information about healthy nutrition and physical activity, as well as basic information about physical activity and kitchen safety tips, developmentally appropriate recipes, and portion sizes.
Girls randomized to this arm of the study will not engage in key behavior change procedures, such as goal setting, problem solving, and self monitoring.
|
This is an 8 episode intervention, delivered entirely over the internet.
Each episode, girls will view an interactive story in which 6 8-10 year old African American characters attempt to solve a mystery about their town.
The online program will include information about healthy nutrition (i.e., consuming more fruit, vegetables, water) and physical activity.
There will be two groups; one group (the experimental group) will view the interactive story and participate in key behavior change procedures, such as personal goal setting, problem solving, and self monitoring activities.
The second group (the active comparator group) will view the online stories but will not engage in key behavior change procedures.
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Sem intervenção: Wait list control
This group will participate in data collection only; after the 3rd data collection point, they will be given access to the intervention
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Body mass index percentile
Prazo: 6 months
|
height and weight will be used to calculate BMI percentile
|
6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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fruit and vegetable consumption
Prazo: 3 months
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dietitian-assisted dietary recalls will be collected using the NDSR system; 2 recalls will be collected (1 week day and 1 weekend day)
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3 months
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physical activity
Prazo: 3 months
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Accelerometers will be used to assess physical activity at each time point
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3 months
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self efficacy
Prazo: 3 months
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Standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy
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3 months
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home availability
Prazo: 3 months
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standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability
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3 months
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asking behaviors
Prazo: 3 months
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standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors
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3 months
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fruit and vegetable consumption
Prazo: 6 months
|
dietitian-assisted dietary recalls will be collected using the NDSR system; 2 recalls will be collected at each time point (1 week day and 1 weekend day)
|
6 months
|
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physical activity
Prazo: 6 months
|
Accelerometers will be used to assess physical activity
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6 months
|
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self efficacy
Prazo: 6 months
|
standard measures will be used to assess fruit, vegetable, water, and physical activity self efficacy
|
6 months
|
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home availability
Prazo: 6 months
|
standard measures will be used to assess fruit, vegetable, and physical activity equipment home availability
|
6 months
|
|
asking behaviors
Prazo: 6 months
|
standard measures will be used to assess child fruit, vegetable, water, and physical activity asking behaviors
|
6 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Deborah I Thompson, PhD, Baylor College of Medicine
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Callender C, Liu Y, Moore CE, Thompson D. The baseline characteristics of parents and African American girls in an online obesity prevention program: A feasibility study. Prev Med Rep. 2017 May 19;7:110-115. doi: 10.1016/j.pmedr.2017.05.011. eCollection 2017 Sep.
- Thompson D, Mahabir R, Bhatt R, Boutte C, Cantu D, Vazquez I, Callender C, Cullen K, Baranowski T, Liu Y, Walker C, Buday R. Butterfly Girls; promoting healthy diet and physical activity to young African American girls online: rationale and design. BMC Public Health. 2013 Aug 2;13:709. doi: 10.1186/1471-2458-13-709.
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 janeiro de 2012
Conclusão Primária (Real)
1 de maio de 2015
Conclusão do estudo (Real)
1 de maio de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
21 de novembro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de novembro de 2011
Primeira postagem (Estimativa)
30 de novembro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
20 de janeiro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de janeiro de 2016
Última verificação
1 de janeiro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H-27505
- R01MD005814 (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 .