Clinical trial NCT01292434: Lunch is in the Bag: Helping Parents Increase Fruit, Vegetables, and Whole Grains in Preschool Sack Lunches
Official title: Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Behavior
Keywords: Diet
Obesity
Child Preschool
Treatment Outcome
Body Mass Index
Intervention Studies
Randomized Controlled Trial
Child Day Care Centers
Schools Nursery
Child Care
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
First posted: 2011-02-09
Enrollment: 1266
Sex: ALL
Minimum age (years): 3
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks
timeFrame: Baseline, 6 weeks, 22 weeks, 28 weeks
Secondary outcomes:
measure: Nutrient evaluation of the lunch sack: change in nutrient contents from baseline to 6 weeks, 22 weeks, and 28 weeks
timeFrame: baseline, 6 weeks 22 weeks, 28 weeks
measure: Increase in body mass index from baseline to 28 weeks
timeFrame: baseline, 28 weeks
measure: Change in parental psychosocial variables from baseline to 6 weeks, 22 weeks, and 28 weeks
timeFrame: baseline, 6 weeks, 22 weeks, 28 weeks
measure: Change in food availability at home from baseline to 6 weeks, 22 weeks, and 28 weeks
timeFrame: baseline, 6 weeks, 22 weeks, 28 weeks
measure: Change in measured temperature of foods in the lunch sack from from baseline to 6 weeks, 22 weeks, and 28 weeks
timeFrame: baseline, 6 weeks, 22 weeks, 28 weeks
measure: Change in nutrition environment at the center from baseline to 6 weeks, 22 weeks, and 28 weeks
timeFrame: baseline, 6 weeks, 22 weeks, 28 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas School of Public Health Austin Regional Campus
state: Texas
city: Austin
country: United States
facility: Department of Nutritional Sciences, College of Human Ecology, University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Deanna M Hoelscher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Austin
name: Margaret E. Briley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Third Coast Research & Development, Inc.
name: Cindy R. Roberts-Gray, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1080/19325037.2012.10599230. Epub 2012 May 1.
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.
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.
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 and whole grain foods: A group-randomized controlled trial. Prev Med. 2015 Dec;81:1-8. doi: 10.1016/j.ypmed.2015.07.005. Epub 2015 Jul 17.
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.2015.05.017. Epub 2015 Jul 17.
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 early care and education centers. Int J Behav Nutr Phys Act. 2016 Jan 8;13:3. doi: 10.1186/s12966-015-0326-x.
citation: Romo-Palafox MJ, Ranjit N, Sweitzer SJ, Roberts-Gray C, Byrd-Williams CE, Briley ME, Hoelscher DM. Adequacy of Parent-Packed Lunches and Preschooler's Consumption Compared to Dietary Reference Intake Recommendations. J Am Coll Nutr. 2017 Mar-Apr;36(3):169-176. doi: 10.1080/07315724.2016.1240634. Epub 2017 Jan 12.
citation: Roberts-Gray C, Sweitzer SJ, Ranjit N, Potratz C, Rood M, Romo-Palafox MJ, Byrd-Williams CE, Briley ME, Hoelscher DM. Structuring Process Evaluation to Forecast Use and Sustainability of an Intervention: Theory and Data From the Efficacy Trial for Lunch Is in the Bag. Health Educ Behav. 2017 Aug;44(4):559-569. doi: 10.1177/1090198116676470. Epub 2016 Nov 17.