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Lunch is in the Bag: Helping Parents Increase Fruit, Vegetables, and Whole Grains in Preschool Sack Lunches (LIITB)

6 de novembro de 2020 atualizado por: Deanna Hoelscher, The University of Texas Health Science Center, Houston

Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches

Lunch is in the Bag is an intervention designed to increase fruits, vegetables, and whole grains in sack lunches prepared for preschool children. Lunch is in the Bag includes 5 weeks of parent handouts, classroom activities related to topics in the handouts, parent and child activities to reinforce behavioral constructs, and a one week booster 22 weeks later.

The primary study hypothesis is that Lunch is in the Bag will increase fruit, vegetables, and whole grains in sack lunches. Additional hypotheses are that lunches at child care centers where the program is used will have higher dietary quality than centers without the program and that children at the centers where the program is used will have a smaller increase in body mass index than children at centers with the program.

The study will also look at the child's home environment and the childcare center. Hypotheses for this research question include

  1. Children at centers with Lunch is in the Bag will have greater frequency of eating fruits, vegetables, and whole grains at home than those at centers without the program.
  2. Compared to parents at centers without the program, parents of children at centers with Lunch is in the Bag will have

    1. Greater knowledge, expected benefits, support, intentions, and belief in their ability for packing fruit, vegetables, and whole grain in their child's sack lunch daily.
    2. Availability of fruit, vegetable, and whole grain in the home pantry.
    3. Number of lunches with temperature in the safe range at time of service.

Visão geral do estudo

Status

Concluído

Descrição detalhada

Lunch is in the Bag is a behaviorally-based, multilevel intervention to increase the availability of fruits, vegetables and whole grains in sack lunches for preschool children. The Lunch is in the Bag program was designed to fit within the limited time available for parents at childcare centers, and includes 5 weeks of parent handouts, classroom activities related to topics in the handouts, parent and child activities to reinforce behavioral constructs, and a one week booster 22 weeks later.

The primary aim of this proposal is to determine if Lunch is in the Bag program improves the nutrient composition of sack lunches parents pack for children. The primary hypothesis for this aim:

- At 6-week and 28-week follow-up periods, compared to children's lunches at the comparison centers, children's lunches in the intervention group will, on average, contain more servings of: a) fruit; b) vegetables; c) whole grains.

The secondary hypotheses for this aim:

  1. At 6-week and 28-week follow-up periods, compared to children's lunches at the comparison centers, children's lunches at the intervention centers on average will have higher dietary quality relative to the Dietary Reference Intakes (DRI) for energy, dietary fiber, carbohydrate, saturated fat, trans fat, vitamin A, calcium, iron, and zinc.
  2. At 28-week follow-up periods, children at intervention centers will have smaller increase in BMI compared to children in comparison centers.

The secondary aim of this study is to examine effects of the intervention on psychosocial, behavioral, and environmental supports in the child's home environment. Hypotheses for this aim:

At 6-week and 28-week follow-up periods,

  1. Compared to children at the comparison centers, children at the intervention centers on average will have greater frequency of eating fruits, vegetables, and whole grain foods at home.
  2. Compared to parents of children at the comparison centers, parents of children at the intervention centers on average will have greater

    1. Behavioral capability/knowledge, perceived behavioral control/self-efficacy, expected benefits/attitudes, subjective norms/social support, and intentions for packing fruit, vegetable, and whole grain in the child's lunch sack daily.
    2. Amount of parent-child cooperation in lunch packing decisions and behaviors.
    3. Availability of fruit, vegetable, and whole grain in the home pantry.
    4. Number of lunches with temperature in the safe range at time of service.

Additional aims include the evaluation of factors affecting implementation and adaption of the program.

Childcare centers (n=40) that require parents to send sack lunches from home will be randomized to intervention and control groups. Families (n=800) will be enrolled as parent-child dyads comprised of the primary lunch packer and one 3 to 5 year old child per family. Outcome measures will be assessed at (1) baseline, (2) immediately after the five-week intervention (6 weeks), (3) 3 months later immediately before a "booster" activity (23 weeks), and (4) 5 weeks after the booster (28 weeks). Mediation analyses will be guided by the Theory of Planned Behavior (TPB) and Social Cognitive Theory (SCT), with particular attention to the reciprocal influences of the child's eating behavior and the parent's food packing behavior and perceptions of child food preferences. Qualitative and process data collection will be conducted throughout the intervention. Data from this study will enable us to determine the efficacy and feasibility of a parent-based intervention implemented through childcare centers to increase the availability of fruits, vegetables, and whole grains in diets of preschool children. The ultimate goal for this work is the development of new strategies for the promotion of healthy eating practices in children through childcare centers, which will decrease their risk of cancer and other chronic diseases later in life.

Tipo de estudo

Intervencional

Inscrição (Real)

1266

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

    • Texas
      • Austin, Texas, Estados Unidos, 78701
        • University of Texas School of Public Health Austin Regional Campus
      • Austin, Texas, Estados Unidos, 78712
        • Department of Nutritional Sciences, College of Human Ecology, University of Texas at Austin

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

3 anos a 60 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • One parent (or guardian)-child dyad per family
  • The parent or guardian member of the dyad is the person primarily responsible for packing the child's lunch and is able to read English language materials written at the 6th grade level
  • The child member of the dyad is age 3 to 5 and participates in daily care during a full day that includes the hours when children eat their lunch

Exclusion Criteria:

  • None

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
Experimental: Lunch in the Bag Intervention
Lunch is in the Bag behavioral intervention: Parents receive a behavioral intervention that includes handouts/newsletters sent to parents from the early care and education (ECE) center, classroom activities and projects, an implementation support calendar, and teacher training.
Multi-component behavior-based activities, includes: parent handouts, teacher training, age-appropriate child classroom activities, parent/child activity stations
Outros nomes:
  • Lunch is in the Bag
  • LiitB
Sem intervenção: Control
Parents received no specific nutrition education intervention at the ECE center, other than usual practice.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks
Prazo: Baseline, 6 weeks, 22 weeks, 28 weeks
Servings of fruit, vegetable, whole grain in the lunch sack
Baseline, 6 weeks, 22 weeks, 28 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Nutrient evaluation of the lunch sack: change in nutrient contents from baseline to 6 weeks, 22 weeks, and 28 weeks
Prazo: baseline, 6 weeks 22 weeks, 28 weeks
Nutrient analysis of the contents of all foods in the child's lunch sack
baseline, 6 weeks 22 weeks, 28 weeks
Increase in body mass index from baseline to 28 weeks
Prazo: baseline, 28 weeks
Child's body mass index at 28 weeks compared to baseline obtained by direct measure of child's height and weight.
baseline, 28 weeks
Change in parental psychosocial variables from baseline to 6 weeks, 22 weeks, and 28 weeks
Prazo: baseline, 6 weeks, 22 weeks, 28 weeks
Variables measuring parents' behavioral capability/knowledge, perceived behavioral control/self efficacy, expected benefits/attitudes, subjective norms/social support, and intentions for packing fruit, vegetable, and whole grain in the child's lunch sack daily, measured by a parent questionnaire.
baseline, 6 weeks, 22 weeks, 28 weeks
Change in food availability at home from baseline to 6 weeks, 22 weeks, and 28 weeks
Prazo: baseline, 6 weeks, 22 weeks, 28 weeks
Amount of fruit, vegetable, and whole grain available in the child's house measured by home inventory tool.
baseline, 6 weeks, 22 weeks, 28 weeks
Change in measured temperature of foods in the lunch sack from from baseline to 6 weeks, 22 weeks, and 28 weeks
Prazo: baseline, 6 weeks, 22 weeks, 28 weeks
Temperature of foods at time of service at the childcare center, as measured by a temperature gun.
baseline, 6 weeks, 22 weeks, 28 weeks
Change in nutrition environment at the center from baseline to 6 weeks, 22 weeks, and 28 weeks
Prazo: baseline, 6 weeks, 22 weeks, 28 weeks
Childcare center's environment regarding support for children's intake of recommended amounts of energy, fruits, vegetables, and whole grains.
baseline, 6 weeks, 22 weeks, 28 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Margaret E. Briley, PhD, University of Texas at Austin
  • Investigador principal: Cindy R. Roberts-Gray, PhD, Third Coast Research & Development, Inc.

Publicações e links úteis

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Publicações Gerais

Links úteis

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 junho de 2008

Conclusão Primária (Real)

1 de maio de 2013

Conclusão do estudo (Real)

1 de maio de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

3 de fevereiro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de fevereiro de 2011

Primeira postagem (Estimativa)

9 de fevereiro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de novembro de 2020

Última verificação

1 de novembro de 2020

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

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