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

Dietary Behavior Clinical Trial

— LIITB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292434
• Other study ID #: LitB-UT-01
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: May 2013

Study information

• Verified date: November 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1266
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Behavior

Intervention

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

Locations

Country	Name	City	State
United States	Department of Nutritional Sciences, College of Human Ecology, University of Texas at Austin	Austin	Texas
United States	University of Texas School of Public Health Austin Regional Campus	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & Publications (6)

Briley ME, Ranjit N, Hoelscher DM, Sweitzer SJ, Almansour F, Roberts-Gray C. Unbundling outcomes of a multilevel intervention to increase fruit, vegetables, and whole grains parents pack for their preschool children in sack lunches. Am J Health Educ. 2012 May;43(3):135-142. Epub 2012 May 1. — View Citation

Roberts-Gray C, Briley ME, Ranjit N, Byrd-Williams CE, Sweitzer SJ, Sharma SV, Palafox MR, Hoelscher DM. Efficacy of the Lunch is in the Bag intervention to increase parents' packing of healthy bag lunches for young children: a cluster-randomized trial in — View Citation

Romo-Palafox MJ, Ranjit N, Sweitzer SJ, Roberts-Gray C, Hoelscher DM, Byrd-Williams CE, Briley ME. Dietary Quality of Preschoolers' Sack Lunches as Measured by the Healthy Eating Index. J Acad Nutr Diet. 2015 Nov;115(11):1779-88. doi: 10.1016/j.jand.2015. — View Citation

Sharma SV, Rashid T, Ranjit N, Byrd-Williams C, Chuang RJ, Roberts-Gray C, Briley M, Sweitzer S, Hoelscher DM. Effectiveness of the Lunch is in the Bag program on communication between the parent, child and child-care provider around fruits, vegetables an — View Citation

Sweitzer SJ, Byrd-Williams CE, Ranjit N, Romo-Palafox MJ, Briley ME, Roberts-Gray CR, Hoelscher DM. Development of a Method to Observe Preschoolers' Packed Lunches in Early Care and Education Centers. J Acad Nutr Diet. 2015 Aug;115(8):1249-59. doi: 10.1016/j.jand.2015.03.012. Epub 2015 May 12. — View Citation

Sweitzer SJ, Ranjit N, Calloway EE, Hoelscher DM, Almansor F, Briley ME, Roberts-Gray CR. Examining How Adding a Booster to a Behavioral Nutrition Intervention Prompts Parents to Pack More Vegetables and Whole Gains in Their Preschool Children's Sack Lunches. Behav Med. 2016;42(1):9-17. doi: 10.1080/08964289.2014.935283. Epub 2014 Oct 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks	Servings of fruit, vegetable, whole grain in the lunch sack	Baseline, 6 weeks, 22 weeks, 28 weeks
Secondary	Nutrient evaluation of the lunch sack: change in nutrient contents from baseline to 6 weeks, 22 weeks, and 28 weeks	Nutrient analysis of the contents of all foods in the child's lunch sack	baseline, 6 weeks 22 weeks, 28 weeks
Secondary	Increase in body mass index from baseline to 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
Secondary	Change in parental psychosocial variables from baseline to 6 weeks, 22 weeks, and 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
Secondary	Change in food availability at home from baseline to 6 weeks, 22 weeks, and 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
Secondary	Change in measured temperature of foods in the lunch sack from from baseline to 6 weeks, 22 weeks, and 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
Secondary	Change in nutrition environment at the center from baseline to 6 weeks, 22 weeks, and 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

External Links

•   Project Website