Lunch is in the Bag: Helping Parents Increase Fruit, Vegetables, and Whole Grains in Preschool Sack Lunches (LIITB)
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|ClinicalTrials.gov Identifier: NCT01292434|
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : March 10, 2016
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
- 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.
Compared to parents at centers without the program, parents of children at centers with Lunch is in the Bag will have
- 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.
- Availability of fruit, vegetable, and whole grain in the home pantry.
- Number of lunches with temperature in the safe range at time of service.
|Condition or disease||Intervention/treatment||Phase|
|Dietary Behavior||Behavioral: Lunch is in the Bag behavioral intervention||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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
No Intervention: Control
Parents received no specific nutrition education intervention at the ECE center, other than usual practice.
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292434
|United States, Texas|
|University of Texas School of Public Health Austin Regional Campus|
|Austin, Texas, United States, 78701|
|Department of Nutritional Sciences, College of Human Ecology, University of Texas at Austin|
|Austin, Texas, United States, 78712|
|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.|