Dietary BehaviorLIITBNCT01292434
Lunch is in the Bag: Helping Parents Increase Fruit, Vegetables, and Whole Grains in Preschool Sack Lunches
A study testing Lunch is in the Bag behavioral intervention in people with Dietary Behavior, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 3 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Behavior
- What is being tested?
- Lunch is in the Bag behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,266 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas School of Public Health Austin Regional Campus
Austin, Texas, 78701
Department of Nutritional Sciences, College of Human Ecology, University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches
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.
Read more
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.
Read the 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:
- 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.
- 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,
- 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.
- Compared to parents of children at the comparison centers, parents of children at the intervention centers on average will have greater
- 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.
- Amount of parent-child cooperation in lunch packing decisions and behaviors.
- Availability of fruit, vegetable, and whole grain in the home pantry.
- 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.
- Conditions
- Dietary Behavior
- Being tested
- Lunch is in the Bag behavioral intervention
- Keywords
- Diet, Obesity, Child Preschool, Treatment Outcome, Body Mass Index, Intervention Studies, Randomized Controlled Trial, Child Day Care Centers, Schools Nursery, Child Care
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lunch is in the Bag behavioral interventionBehavioural
Also called Lunch is in the Bag, LiitB
Multi-component behavior-based activities, includes: parent handouts, teacher training, age-appropriate child classroom activities, parent/child activity stations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Nutrient analysis of the contents of all foods in the child's lunch sack
Measured: baseline, 6 weeks 22 weeks, 28 weeks
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.
Measured: baseline, 28 weeks
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.
Measured: baseline, 6 weeks, 22 weeks, 28 weeks
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.
Measured: 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
Temperature of foods at time of service at the childcare center, as measured by a temperature gun.
Measured: baseline, 6 weeks, 22 weeks, 28 weeks
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.
Measured: baseline, 6 weeks, 22 weeks, 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startJun 2008
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dietary BehaviorStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,266 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin
- Responsible party
- Principal investigator, Deanna Hoelscher, The University of Texas Health Science Center, Houston
- Investigators
- Deanna M Hoelscher, PhD, Principal investigator, The University of Texas Health Science Center, HoustonMargaret E. Briley, PhD, Principal investigator, University of Texas at AustinCindy R. Roberts-Gray, PhD, Principal investigator, Third Coast Research & Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292434
- Sponsor's protocol ID
- LitB-UT-01
- Acronym
- LIITB
- Status last verified
- Nov 2020
- First submitted
- 3 Feb 2011
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 23243631Sweitzer 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.
PubMed 24971674Sweitzer 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.
PubMed 25975458Sharma 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.
PubMed 26190371Romo-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.
PubMed 26190228Roberts-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.
PubMed 26746876Romo-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.
PubMed 28080325Roberts-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.
PubMed 27864471
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lunch in the Bag: Packing More Fruit, Vegetables, Grain in Preschool Sack Lunches
- ClinicalTrials.gov ID
- NCT01292434
- Acronym / sponsor ID
- LIITB / LitB-UT-01
- Conditions
- Dietary Behavior
- Keywords
- Diet, Obesity, Child Preschool, Treatment Outcome, Body Mass Index, Intervention Studies, Randomized Controlled Trial, Child Day Care Centers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,266 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- University of Texas at Austin
- Study start
- Jun 2008
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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,
- 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.
- Compared to parents of children at the comparison centers, parents of children at the intervention centers on average will have greater
- 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.
- Amount of parent-child cooperation in lunch packing decisions and behaviors.
- Availability of fruit, vegetable, and whole grain in the home pantry.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lunch in the Bag Intervention | Experimental | Behavioral: Lunch is in the Bag behavioral interventionLunch 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. |
| Control | No intervention | –Parents received no specific nutrition education intervention at the ECE center, other than usual practice. |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lunch is in the Bag behavioral interventionAlso: Lunch is in the Bag, LiitBMulti-component behavior-based activities, includes: parent handouts, teacher training, age-appropriate child classroom activities, parent/child activity stations | Behavioural | Lunch in the Bag Intervention |
Primary outcome
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
Servings of fruit, vegetable, whole grain in the lunch sack
6 secondary outcomes
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
Increase in body mass index from baseline to 28 weeks
Time frame: baseline, 28 weeks
Change in parental psychosocial variables from baseline to 6 weeks, 22 weeks, and 28 weeks
Time frame: baseline, 6 weeks, 22 weeks, 28 weeks
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Background: PubMed 23243631Briley 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.
- Background: PubMed 24971674Sweitzer 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.
- Background: PubMed 25975458Sweitzer 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.
- Results publication: PubMed 26190371Sharma 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.
- Results publication: PubMed 26190228Romo-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.
- Results publication: PubMed 26746876Roberts-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.
- Derived from this study: PubMed 28080325Romo-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.
- Derived from this study: PubMed 27864471Roberts-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.
- Project WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Dietary Behavior
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna M Hoelscher, PhD principal investigator
The University of Texas Health Science Center, Houston
Margaret E. Briley, PhD principal investigator
University of Texas at Austin
Cindy R. Roberts-Gray, PhD principal investigator
Third Coast Research & Development, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lunch is in the Bag behavioral intervention in people with Dietary Behavior, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01292434, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.