Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-31 @ 2:12 PM
Study NCT ID:
NCT01292434
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2011-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lunch is in the Bag: Helping Parents Increase Fruit, Vegetables, and Whole Grains in Preschool Sack Lunches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2011-02-03', 'studyFirstSubmitQcDate': '2011-02-07', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'Servings of fruit, vegetable, whole grain in the lunch sack'}], 'secondaryOutcomes': [{'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', 'description': "Nutrient analysis of the contents of all foods in the child's lunch sack"}, {'measure': 'Increase in body mass index from baseline to 28 weeks', 'timeFrame': 'baseline, 28 weeks', 'description': "Child's body mass index at 28 weeks compared to baseline obtained by direct measure of child's height and weight."}, {'measure': 'Change in parental psychosocial variables from baseline to 6 weeks, 22 weeks, and 28 weeks', 'timeFrame': 'baseline, 6 weeks, 22 weeks, 28 weeks', 'description': "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."}, {'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', 'description': "Amount of fruit, vegetable, and whole grain available in the child's house measured by home inventory tool."}, {'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', 'description': 'Temperature of foods at time of service at the childcare center, as measured by a temperature gun.'}, {'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', 'description': "Childcare center's environment regarding support for children's intake of recommended amounts of energy, fruits, vegetables, and whole grains."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diet', 'Obesity', 'Child Preschool', 'Treatment Outcome', 'Body Mass Index', 'Intervention Studies', 'Randomized Controlled Trial', 'Child Day Care Centers', 'Schools Nursery', 'Child Care'], 'conditions': ['Dietary Behavior']}, 'referencesModule': {'references': [{'pmid': '23243631', 'type': 'BACKGROUND', '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.'}, {'pmid': '24971674', 'type': 'BACKGROUND', '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."}, {'pmid': '25975458', 'type': 'BACKGROUND', '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."}, {'pmid': '26190371', 'type': 'RESULT', '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.'}, {'pmid': '26190228', 'type': 'RESULT', '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."}, {'pmid': '26746876', 'type': 'RESULT', '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."}, {'pmid': '28080325', 'type': 'DERIVED', '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."}, {'pmid': '27864471', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'https://sph.uth.edu/research/centers/dell/project.htm?project=8f5592fc-46aa-475f-a414-3ef239c513fe', 'label': 'Project Website'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nThe study will also look at the child's home environment and the childcare center. Hypotheses for this research question include\n\n1. 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.\n2. Compared to parents at centers without the program, parents of children at centers with Lunch is in the Bag will have\n\n 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.\n 2. Availability of fruit, vegetable, and whole grain in the home pantry.\n 3. Number of lunches with temperature in the safe range at time of service.", 'detailedDescription': '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.\n\nThe 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:\n\n\\- 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.\n\nThe secondary hypotheses for this aim:\n\n1. 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.\n2. At 28-week follow-up periods, children at intervention centers will have smaller increase in BMI compared to children in comparison centers.\n\nThe 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:\n\nAt 6-week and 28-week follow-up periods,\n\n1. 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.\n2. Compared to parents of children at the comparison centers, parents of children at the intervention centers on average will have greater\n\n 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.\n 2. Amount of parent-child cooperation in lunch packing decisions and behaviors.\n 3. Availability of fruit, vegetable, and whole grain in the home pantry.\n 4. Number of lunches with temperature in the safe range at time of service.\n\nAdditional aims include the evaluation of factors affecting implementation and adaption of the program.\n\nChildcare 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* One parent (or guardian)-child dyad per family\n* 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\n* 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\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT01292434', 'acronym': 'LIITB', 'briefTitle': 'Lunch is in the Bag: Helping Parents Increase Fruit, Vegetables, and Whole Grains in Preschool Sack Lunches', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches', 'orgStudyIdInfo': {'id': 'LitB-UT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lunch in the Bag Intervention', 'description': '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.', 'interventionNames': ['Behavioral: Lunch is in the Bag behavioral intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Parents received no specific nutrition education intervention at the ECE center, other than usual practice.'}], 'interventions': [{'name': 'Lunch is in the Bag behavioral intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Lunch is in the Bag', 'LiitB'], 'description': 'Multi-component behavior-based activities, includes: parent handouts, teacher training, age-appropriate child classroom activities, parent/child activity stations', 'armGroupLabels': ['Lunch in the Bag Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78701', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas School of Public Health Austin Regional Campus', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Department of Nutritional Sciences, College of Human Ecology, University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Deanna M Hoelscher, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}, {'name': 'Margaret E. Briley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Austin'}, {'name': 'Cindy R. Roberts-Gray, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Third Coast Research & Development, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Texas at Austin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor - School of Public Health, Austin Regional Campus', 'investigatorFullName': 'Deanna Hoelscher', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}