- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01378806
Family Partners for Health (WEIGHT)
12 de julho de 2012 atualizado por: University of North Carolina, Chapel Hill
Children and Parents Partnering Together to Manage Their Weight
Young children who are overweight or at risk for overweight are at increased risk for becoming obese as young adults and developing type 2 diabetes and cardiovascular disease.
To date, there have been no interdisciplinary interventions that targeted predominantly ethnic minority low-income children and parents and taught them to work together to improve nutrition and exercise.
Using a two-group, repeated measures experimental design, this proposed study will test a 12-week intensive intervention on nutrition, exercise and coping skills (Phase I) and 9 months of continued monthly contact (Phase II) to help overweight 2nd, 3rd, and 4th grade children and their parents improve self-efficacy, health behaviors, weight status, and adiposity.
The study will take this intervention to the community in which children and parents live, working with four schools in Alamance-Burlington County, NC, and four schools in Wilson County in the early evening.
A total of 356 Black, Hispanic, and White children with a BMI >85th percentile and 356 parents with a BMI >25 kg/m2 will be inducted over 3 ½ years and randomized by school to either the experimental or control group.
Data will be collected at Time 1 (Baseline), Time 2 (Post Phase I-Intensive Intervention), Time 3 (Post Phase II-Continued Contact), and Time 4 (6-Month Follow-Up).
Data collected will include scores on the Health Promoting Lifestyle Profile II in the parents; eating self-efficacy in the children (CATCH) and parents (Eating Self-Efficacy Scale) and exercise self-efficacy in the children (CATCH) and parents (Exercise Self-Efficacy); health behaviors in the children and parents (3 Day 24-Hour Food Recall and 4 Day Accelerometry Measurement); weight status in the children (BMI percentile) and parents (BMI); and adiposity in the children and parents (waist circumference and triceps and subscapular skinfolds).
Data analysis will use general linear mixed models to test the hypotheses.
Decreasing overweight in children and parents is urgently needed, and helping children and parents to work together to improve their nutrition and exercise patterns by making small lifestyle pattern changes may decrease future health care costs and decrease morbidity and mortality.
The knowledge to be gained from this study may provide a foundation for extending this intervention to other Black, Hispanic, and White children and parents in other communities to assist them to manage their weight.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
718
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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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7460
- The University of North Carolina at Chapel Hill
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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
7 anos e mais velhos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria: Inclusion criteria for children include:
- ability to speak, write, and read in English
- a BMI > 85th percentile for age and gender
- at least one parent or guardian with a BMI >25
- assent and their parent or guardian's consent to their participation
Inclusion criteria for parents or guardians include:
- ability to speak, write, and read in English
- a BMI >25
- a 2nd, 3rd or 4th grade child with a BMI > 85th percentile for age and gender
- reside with the child; and consent to join the study
Exclusion Criteria: Parents and children will be excluded if either has a:
- history of a heart murmur
- congenital heart disease
- family history of sudden death
- history of psychological problems such as claustrophobia that would prevent participation in group classes
- participation in another clinical trial or intervention
- Asians will be excluded since there is a higher level of risk at a lower BMI than for Blacks, Hispanics, and Whites
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: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Intervention
A 12-week intensive intervention on nutrition and exercise education and coping skills training (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own.
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A 12-week intensive intervention on nutrition and exercise education and coping skills (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in body mass index in adults and body mass index percentile in children.
Prazo: Baseline to 18 months.
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Height and weight measures will be taken in adults and children to calculate body mass index in adults and body mass index percentile in children.
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Baseline to 18 months.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in adiposity for adults and children as measured by change in waist circumference, triceps, and subscapular skinfold measures.
Prazo: Baseline to 18 months.
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Waist circumference and triceps and subscapular skinfold measures.
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Baseline to 18 months.
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Change in health behaviors as measured by nutrition and exercise in adults and children.
Prazo: Baseline to 18 months.
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nutrition and exercise behaviors in adults and children based on questionnaire scores.
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Baseline to 18 months.
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Change in self-efficacy in adults and children as measured by belief that they can improve their eating and exercise behaviors.
Prazo: Baseline to 18 months.
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eating and exercise self-efficacy in adults and children based on questionnaire scores.
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Baseline to 18 months.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Diane C Berry, PhD, ANP-BC, University of North Carolina, Chapel Hill
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
- Berry DC, McMurray RG, Schwartz TA, Adatorwovor R. Benefits for African American and white low-income 7-10-year-old children and their parents taught together in a community-based weight management program in the rural southeastern United States. BMC Public Health. 2018 Sep 10;18(1):1107. doi: 10.1186/s12889-018-6006-4.
- Berry DC, McMurray RG, Schwartz TA, Hall EG, Neal MN, Adatorwovor R, Adatorwover R. A cluster randomized controlled trial for child and parent weight management: children and parents randomized to the intervention group have correlated changes in adiposity. BMC Obes. 2017 Dec 4;4:39. doi: 10.1186/s40608-017-0175-z. eCollection 2017. Erratum In: BMC Obes. 2018 Jan 26;5:3. Adatorwover R [corrected to Adatorwovor R].
- McMurray RG, Berry DC, Schwartz TA, Hall EG, Neal MN, Li S, Lam D. Relationships of physical activity and sedentary time in obese parent-child dyads: a cross-sectional study. BMC Public Health. 2016 Feb 6;16:124. doi: 10.1186/s12889-016-2795-5.
- Berry DC, McMurray R, Schwartz TA, Skelly A, Sanchez M, Neal M, Hall G. Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study. BMC Public Health. 2012 Mar 30;12:250. doi: 10.1186/1471-2458-12-250.
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 abril de 2007
Conclusão Primária (Real)
1 de outubro de 2011
Conclusão do estudo (Real)
1 de outubro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
2 de junho de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de junho de 2011
Primeira postagem (Estimativa)
22 de junho de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
13 de julho de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de julho de 2012
Última verificação
1 de julho de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 07-0436
- R0100254-05 (Número de outro subsídio/financiamento: NINR)
- 5-34696 (Outro identificador: The University of North Carolina at Chapel)
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 .