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

6 novembre 2020 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

1266

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 3 anni a 60 anni (Bambino, Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Altri nomi:
  • Lunch is in the Bag
  • LiitB
Nessun intervento: Control
Parents received no specific nutrition education intervention at the ECE center, other than usual practice.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks
Lasso di tempo: Baseline, 6 weeks, 22 weeks, 28 weeks
Servings of fruit, vegetable, whole grain in the lunch sack
Baseline, 6 weeks, 22 weeks, 28 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Nutrient evaluation of the lunch sack: change in nutrient contents from baseline to 6 weeks, 22 weeks, and 28 weeks
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

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

Pubblicazioni e link utili

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Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2008

Completamento primario (Effettivo)

1 maggio 2013

Completamento dello studio (Effettivo)

1 maggio 2013

Date di iscrizione allo studio

Primo inviato

3 febbraio 2011

Primo inviato che soddisfa i criteri di controllo qualità

7 febbraio 2011

Primo Inserito (Stima)

9 febbraio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 novembre 2020

Ultimo verificato

1 novembre 2020

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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