Familial Overweight: Comparing Use of Strategies (FOCUS)
19 de maio de 2015 atualizado por: Brian Saelens, Seattle Children's Hospital
Behavioral Skill Adherence in Pediatric Obesity Treatment
The purpose of this study is to compare the efficacy of two different approaches (prescribed & self-directed) to the treatment of childhood obesity and their relative impact on child weight status, physical activity, and diet.
Visão geral do estudo
Descrição detalhada
Pediatric obesity is a highly prevalent problem, requiring both treatment and prevention efforts to reduce cardiovascular disease risk and metabolic consequences among affected children and the child population.
The efficacy of family-based behavioral pediatric obesity treatment is likely compromised by non-optimal parent and child behavioral skills use (BSU).
In pediatric obesity treatment trials, BSU assessment is infrequent, incomplete, and has unknown reliability.
Poor and incomplete BSU measurement precludes improving behavioral interventions for pediatric obesity.
Furthermore, different approaches to help families initiate and sustain BSU during and following treatment have not been tested.
This study aims to investigate 1) prospective relations between BSU measured during and following treatment and change in child weight status, physical activity, and diet, and 2) differences in BSU trajectory between two different implementation approaches during and following treatment.
Eighty-two parent-child (7-11 y.o.) pairs will participate in a 20-week treatment with follow-up at 3 and 6 months.
Participants will be randomly assigned to receive either a prescriptive or self-directed implementation approach to family-based behavioral pediatric obesity treatment.
BSU (monitoring, contingency management, environmental control) will be reported or assessed at pre-treatment, at the 5th, 10th, and 15th treatment sessions, at post-treatment and at the 3-month and 6-month follow-ups by the parent, interventionist, and supplemental evaluator.
Prospective associations between BSU, measured multiple times and by multiple informant/formats, and change in child weight status (z-BMI) and weight-related behaviors (diet, physical activity) over the course of treatment and throughout follow up will be examined.
This proposal will provide important information about the type of BSU and its measurement that is most related to short- and long-term treatment efficacy, and provide pilot data on the relative efficacy of different implementation approaches to initiate and sustain BSU in pediatric obesity intervention.
Tipo de estudo
Intervencional
Inscrição (Real)
72
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
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98101
- Seattle Children's Hospital Research Institute
-
-
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 a 11 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Child age: 7-11 years.
- English-speaking.
- Parent is willing and able to actively participate in treatment.
- Overweight child: at or above 85th percentile for age- and gender-specific BMI, but not more than 175% above median BMI for age and gender.
- Overweight parent: BMI≥ 25.
- Live within 50 miles of Children's Hospital and Regional Medical Center.
Exclusion Criteria:
- Medical condition known to promote obesity (e.g. Prader-Willi syndrome, Cushing's syndrome).
- Already involved with another weight control program.
- Consistently engaging in weight-affecting behaviors (e.g. child: smoking)
- Significant diagnosed obesity-related co-morbidities (e.g. Type 2 diabetes)
- Taking weight-affecting medications (e.g. Ritalin)
- Participating parent or child: an existing thought disorder, suicidality, substance abuse disorder, or other psychological or medical conditions that may preclude full participation.
- Participating parent or child: Disability or illness that would preclude them from engaging in at least moderate intensity physical activity.
- Participating parent or child: Current or prior diagnosed eating disturbance.
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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Prescribed Skills
Behavioral skills are all prescribed and considered necessary tools expected to be used consistently, completely, and uniformly by all participants throughout treatment
|
Treatment will be delivered over a 20-week period.
Participating children and at least one of their parents will attend weekly in-person clinic sessions.
Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors.
Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes.
In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves.
Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed".
Children and parents will be weighed at each clinic visit.
|
|
Experimental: Self-Directed Skills
Behavioral skills are considered a tool box from which families are encouraged to select skills that best apply to that family's situation in attempts to help their child make eating and activity change.
|
Treatment will be delivered over a 20-week period.
Participating children and at least one of their parents will attend weekly in-person clinic sessions.
Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors.
Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes.
In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves.
Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed".
Children and parents will be weighed at each clinic visit.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Child weight status, physical activity, & diet.
Prazo: 6 Months
|
6 Months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Secondary outcomes will include parents' BMI, and parents' physical activity and eating behaviors and covariates will include child age, gender, and household income.
Prazo: 6 Months
|
6 Months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Brian E Saelens, PhD, Seattle Children's Hospital Research Institute
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 maio de 2008
Conclusão Primária (Real)
1 de dezembro de 2012
Conclusão do estudo (Real)
1 de dezembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
3 de setembro de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de setembro de 2008
Primeira postagem (Estimativa)
4 de setembro de 2008
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
21 de maio de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de maio de 2015
Última verificação
1 de maio de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HD54871 (completed)
- 1R21DK095676 (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 .