- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00998348
Study of Parenting Intervention to Prevent Child Obesity
13 de junho de 2013 atualizado por: Dianne S. Ward, University of North Carolina, Chapel Hill
Healthy Child Weight Through Improved Parent Practices and Environmental Change
This purpose of this project is to determine whether this 8-month parenting for healthy weight intervention is able to help parents improve their parenting skills and make positive changes in the nutrition and physical activity environment at home.
Visão geral do estudo
Descrição detalhada
The early years between ages 3-7 are critical in the development of obesity.
The importance of the family in the development of children's eating and activity behaviors has been emphasized by experts, yet to date no obesity prevention interventions incorporating a strong family focus with emphasis on improved parenting practices have been developed.
The work proposed here will address this gap by testing the efficacy of an 8-mo parenting intervention designed to change both social and physical aspects of the home environment, which in turn will reduced % body fat in children.
Subjects will be 280 families (one parent and one child from each) with at least one preschool-age child (2-5 years old).
Following baseline measures, pairs will be randomized into intervention or control.
The intervention will teach more effective parenting skills (child management, communication, routines, etc.), then apply these skills to specific practices that encourage healthier behaviors.
The intervention will include group sessions and tailored phone calls facilitated by a registered dietitian who has also received training in parent education.
Group sessions will use multiple teaching strategies and include separate child activities.
Tailored calls will use motivational interviewing techniques to help parents overcome barriers to behavior change.
The intervention is guided by Darling and Steinberg's Integrative Model of parenting, which highlights the importance of parenting values, style and practices in child socialization, and Deci and Ryan's Self-Determination Theory, which suggests ways to foster autonomous motivation to adopt new behaviors.
The resulting intervention will help parents learn skills to reduce their parenting-related stress and create home environments that support healthy-weight behaviors.
The primary outcome, % body fat in children, will be assessed using anthropometry and a validated prediction equation (Dezenberg, 1999).
Analyses will include baseline measurements of the outcome as a covariate.
Secondary measures include child and parent diet and physical activity, parenting style and practices, and home environment.
Maintenance effect will be assessed following a 6-mo no-intervention period.
A comprehensive analysis is included to test for mediation effects.
This intensive intervention will create the exposure necessary to make life-altering changes in weight-related behaviors.
Plans build on extensive formative work conducted by our experienced researchers.
Tipo de estudo
Intervencional
Inscrição (Real)
324
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, 27599-7426
- Center for Health Promotion and Disease Prevention, 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
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Families must have at least one child age 2-5 years. The scientific rationale for focusing on this young population is that this age range includes the period often referred to as the "adiposity rebound," which has been identified as one of the critical periods for obesity development. Additionally, children of this age are still subject to strong parent and family influences which may be amenable to intervention.
- At least one parent or caregiver in the household must be overweight (BMI ≥25); however, this does not have to be the participating parent. The scientific rationale for focusing on families with at least one overweight parent is that having an overweight parent increases the child's risk of becoming overweight.
- Parents must be willing to participate in measures and intervention activities, and give consent for child's and his/her own participation.
Exclusion Criteria:
- Parents who are unable to speak English or comprehend standard age-level materials will be excluded. Currently funds are not available to translate and provide the program in Spanish or other languages.
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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: Comparison Group
The comparison group will receive children's picture books (1 per month for the duration of the 8-month program).
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Experimental: Parenting Program
The parenting program is an 8-month obesity prevention intervention for parents with preschool-age children.
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The parenting program is an 8-month intervention for parents with preschool-age children designed to teach strategies and skills that help parents better manage their day to day stresses of parenting while also promoting healthy lifestyle behaviors.
Topics will include stress management, child management, family routines, emotion regulation, and coparenting.
In later sessions parents will be encouraged to draw on these general parenting skills to promote healthier nutrition and physical practices at home.
The intervention will be delivered through in-person group sessions (n=12) and tailored one-on-one telephone calls (n=11).
A complementary child program will be delivered to children while parents are attending the group sessions.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds.
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Child BMI and Child BMI z-score based on measured child height, weight, and parent-reported date of birth
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Parent BMI based on measured height and weight
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Parent and child dietary intake measured with 3 unannounced dietary recalls collected via telephone interview (will not include foods eaten by child while outside of parent's care)
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Parent and child physical activities assessed via 7-days of accelerometer monitoring (using the AciGraph GT3X monitor programed with 60-s epochs for adults and 15-s epochs for children)
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Parenting-related stress assessed with the Parental Stress Index - Short Form (Abidin, 1995)
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Autonomous motivation to change behaviors (parenting practices, feeding practices, and physical activity practices) will be assessed using modified versions of the Treatment Self-Regulation Questionnaire (Williams GC, 1996)
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Self-efficacy for general parenting will be assessed with the Parenting Sense of Competence Scale (Johnston C, 1989)
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Self-efficacy for implementing healthy nutrition and physical activity practices will be assessed with an instrument recently developed by the PI.
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Parents' perceived social support and connectedness with regard to positive parenting and healthy feeding and physical activity practices will be assessed using modified versions of the Social Provisions Scale (Cutrona, 1987)
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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The Alabama Parenting Questionnaire - Preschool Revision (Clerkin, 2007)will be used to assess general parenting practices, specifically the use of positive parenting, inconsistent parenting, and punitive parenting
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Difficulties in Emotion Regulation (Gratz, 2004) will be used to assess parental skills at regulating their own emotions
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Coping with Children's Negative Emotions (Fabes, 1990) will be used to assess parental skill at helping the child deal with and manage his/her negative emotions
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Confusion, Hubbub, and Order Scale (Matheny, 1995) will be used to assess the degree of order versus confusion in the home environment
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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The Parenting Convergence Scale (Ahrons, 1981) will be used to assess parental skill with coparenting
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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The Caregiver Feeding Style Questionnaire (Hughes SO, 2005) will be used to assess the two dimensions of parenting: demandingness and responsiveness as they relate to feeding practices
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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The Parental Feeding Style Questionnaire (Wardle, 2002) will be used to assess parents' use of emotional feeding, instrumental feeding, encouraging to eat, and control over eating
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Nine subscales from the Comprehensive Feeding Practices Questionnaire (Musher-Eizenman, 2007) will be used to assess child control, encouraging balance/variety, involvement, modeling, monitoring, pressure to eat, restriction for health or weight control,
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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One sub-scale from the Preschooler Feeding Questionnaire (Baughcum, 2001) will be used to assess structure during feeding interactions
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Two items slightly modified from the Child Feeding Questionnaire (Birch, 2001) will be used to determine parent perceptions of child weight and concern about child becoming overweight
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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A variety of newly developed items drawn from the literature will be used to assess parent practices around child physical activity
Prazo: baseline, 8 months and 14 months
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baseline, 8 months and 14 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dianne S Ward, EdD, 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.
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 julho de 2009
Conclusão Primária (Real)
1 de dezembro de 2011
Conclusão do estudo (Real)
1 de junho de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
16 de outubro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de outubro de 2009
Primeira postagem (Estimativa)
20 de outubro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
17 de junho de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de junho de 2013
Última verificação
1 de junho de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 08-0354
- 1R01HL091093-01A1 (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 .
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