NCT01292434

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. 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. 2.Compared to parents at centers without the program, parents of children at centers with Lunch is in the Bag will have
  3. 3.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.
  4. 4.Availability of fruit, vegetable, and whole grain in the home pantry.
  5. 5.Number of lunches with temperature in the safe range at time of service.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

4.9 years

First QC Date

February 3, 2011

Last Update Submit

November 6, 2020

Conditions

Keywords

DietObesityChild PreschoolTreatment OutcomeBody Mass IndexIntervention StudiesRandomized Controlled TrialChild Day Care CentersSchools NurseryChild Care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Nutrient evaluation of the lunch sack: change in nutrient contents from baseline to 6 weeks, 22 weeks, and 28 weeks

    baseline, 6 weeks 22 weeks, 28 weeks

  • Increase in body mass index from baseline to 28 weeks

    baseline, 28 weeks

  • Change in parental psychosocial variables from baseline to 6 weeks, 22 weeks, and 28 weeks

    baseline, 6 weeks, 22 weeks, 28 weeks

  • Change in food availability at home from baseline to 6 weeks, 22 weeks, and 28 weeks

    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

    baseline, 6 weeks, 22 weeks, 28 weeks

  • +1 more secondary outcomes

Study Arms (2)

Lunch in the Bag Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Parents received no specific nutrition education intervention at the ECE center, other than usual practice.

Interventions

Multi-component behavior-based activities, includes: parent handouts, teacher training, age-appropriate child classroom activities, parent/child activity stations

Also known as: Lunch is in the Bag, LiitB
Lunch in the Bag Intervention

Eligibility Criteria

Age3 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Texas School of Public Health Austin Regional Campus

Austin, Texas, 78701, United States

Location

Department of Nutritional Sciences, College of Human Ecology, University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (8)

  • 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.

    PMID: 23243631BACKGROUND
  • 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.

    PMID: 24971674BACKGROUND
  • 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.

    PMID: 25975458BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - School of Public Health, Austin Regional Campus

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 9, 2011

Study Start

June 1, 2008

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations