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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
Deanna Hoelscher, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01292434
First received: February 3, 2011
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.

Condition Intervention Phase
Diet
Behavioral: Behaviorally-based nutrition intervention
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Servings of fruit, vegetable, whole grain in the lunch sack


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Nutrient analysis of the contents of all foods in the child's lunch sack

  • Increase in body mass index from baseline to 28 weeks [ Time Frame: baseline, 28 weeks ] [ Designated as safety issue: No ]
    Child's body mass index at 28 weeks compared to baseline obtained by direct measure of child's height and weight.

  • Change in parental psychosocial variables from baseline to 6 weeks, 22 weeks, and 28 weeks [ Time Frame: baseline, 6 weeks, 22 weeks, 28 weeks ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Amount of fruit, vegetable, and whole grain available in the child's house measured by home inventory tool.

  • 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 ] [ Designated as safety issue: Yes ]
    Temperature of foods at time of service at the childcare center, as measured by a temperature gun.

  • 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 ] [ Designated as safety issue: No ]
    Childcare center's environment regarding support for children's intake of recommended amounts of energy, fruits, vegetables, and whole grains.


Estimated Enrollment: 920
Study Start Date: June 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parent and Child Receiving Intervention Behavioral: Behaviorally-based nutrition intervention
Multi-component behavior-based activities, includes: parent handouts, teacher training, age-appropriate child classroom activities, parent/child activity stations
Other Name: Lunch is in the Bag

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   3 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292434

Locations
United States, Texas
Department of Nutritional Sciences, College of Human Ecology, University of Texas at Austin
Austin, Texas, United States, 78712
University of Texas School of Public Health Austin Regional Campus
Austin, Texas, United States, 78701
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
University of Texas at Austin
Investigators
Principal Investigator: Deanna M Hoelscher, PhD The University of Texas Health Science Center, Houston
Principal Investigator: Margaret E. Briley, PhD University of Texas at Austin
Principal Investigator: Cindy R. Roberts-Gray, PhD Third Coast Research & Development, Inc.
  More Information

No publications provided

Responsible Party: Deanna Hoelscher, Professor - School of Public Health, Austin Regional Campus, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01292434     History of Changes
Other Study ID Numbers: LitB-UT-01
Study First Received: February 3, 2011
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by The University of Texas Health Science Center, Houston:
Diet
Obesity
Child Preschool
Treatment Outcome
Body Mass Index
Intervention Studies
Randomized Controlled Trial
Child Day Care Centers
Schools Nursery
Child Care

ClinicalTrials.gov processed this record on October 23, 2014