Lunch is in the Bag: Helping Parents Increase Fruit, Vegetables, and Whole Grains in Preschool Sack Lunches (LIITB)
This study is not yet open for participant recruitment.
Verified February 2011 by The University of Texas Health Science Center, Houston
Sponsor:
The University of Texas Health Science Center, Houston
Collaborator:
University of Texas at Austin
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01292434
First received: February 3, 2011
Last updated: February 7, 2011
Last verified: February 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diet |
Behavioral: Behaviorally-based nutrition intervention |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches |
Further study details as provided by The University of Texas Health Science Center, Houston:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Servings of fruit, vegetable, whole grain in the lunch sack
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Childcare center's environment regarding support for children's intake of recommended amounts of energy, fruits, vegetables, and whole grains.
| Estimated Enrollment: | 920 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Parent and Child Receiving Intervention |
Behavioral: Behaviorally-based nutrition intervention
Multi-component behavior-based activities, includes: parent handouts, teacher training, age-appropriate child classroom activities, parent/child activity stations
Other Name: Lunch is in the Bag
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 3 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292434
Contacts
| Contact: Joey Walker, MPH | 512-482-6172 | joey.l.walker@uth.tmc.edu |
| Contact: Sara Sweitzer, PhD | 512-475-9762 | sjsweitz@mail.utexas.edu |
Locations
| United States, Texas | |
| University of Texas School of Public Health Austin Regional Campus | Not yet recruiting |
| Austin, Texas, United States, 78701 | |
| Contact: Joey L. Walker, MPH 512-482-6172 joey.l.walker@uth.tmc.edu | |
| Contact: Sara Sweitzer, PhD 512-475-9762 sjsweitz@mail.utexas.edu | |
| Principal Investigator: Deanna M. Hoelscher, PhD | |
| Principal Investigator: Margaret E. Briley, PhD | |
| Principal Investigator: Cindy R. Roberts-Gray, PhD | |
| Sub-Investigator: Sara J. Sweitzer, PhD | |
| Sub-Investigator: Nalini Ranjit, PhD | |
| Sub-Investigator: Courtney E. Byrd-Williams, PhD | |
| Department of Nutritional Sciences, College of Human Ecology, University of Texas at Austin | Not yet recruiting |
| Austin, Texas, United States, 78712 | |
| Contact: Sara J Sweitzer, PhD 512-475-9762 sjsweitz@mail.utexas.edu | |
| Principal Investigator: Margaret E. Briley, PhD | |
| Principal Investigator: Deanna M Hoelscher, PhD | |
| Principal Investigator: Cindy R. Roberts-Gray, PhD | |
| Sub-Investigator: Sara J. Sweitzer, PhD | |
| Sub-Investigator: Courtney E Byrd-Williams, PhD | |
| Sub-Investigator: Nalini Ranjit, PhD | |
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
University of Texas at Austin
Investigators
| 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. |
More Information
No publications provided
| Responsible Party: | Deanna M. Hoelscher, Professor and Director, Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT01292434 History of Changes |
| Other Study ID Numbers: | LitB-UT-01 |
| Study First Received: | February 3, 2011 |
| Last Updated: | February 7, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by The University of Texas Health Science Center, Houston:
|
Diet Obesity Child Preschool Treatment Outcome Body Mass Index |
Intervention Studies Randomized Controlled Trial Child Day Care Centers Schools Nursery Child Care |
ClinicalTrials.gov processed this record on May 22, 2013