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

November 6, 2020 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Lunch is in the Bag behavioral intervention
Multi-component behavior-based activities, includes: parent handouts, teacher training, age-appropriate child classroom activities, parent/child activity stations
Other Names:
  • Lunch is in the Bag
  • LiitB
No Intervention: Control
Parents received no specific nutrition education intervention at the ECE center, other than usual practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks
Time Frame: Baseline, 6 weeks, 22 weeks, 28 weeks
Servings of fruit, vegetable, whole grain in the lunch sack
Baseline, 6 weeks, 22 weeks, 28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrient evaluation of the lunch sack: change in nutrient contents from baseline to 6 weeks, 22 weeks, and 28 weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

University of Texas at Austin

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 3, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LitB-UT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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