- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03672227
Obesity Prevention in Head Start
Obesity Prevention in Low-Income Preschoolers: Testing the Impact of an Alternative Meal Service Approach in Head Start
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obesity disproportionately affects low-income children. Already by age 5, 20% of low-income children in the US are obese, a prevalence three times higher than among high-income children. Obesity that emerges by this young age is persistent and contributes to sustained obesity and obesity-related chronic disease in adulthood. Identifying effective approaches to prevent obesity among young, low-income children is a national priority.
Family-style dining, in which children serve themselves food and drinks from communal dishes, is advocated as a strategy to prevent childhood obesity. It is theorized that family-style dining allows children to attend to their hunger and satiety, and consume only the amount of food they need to meet their energy needs. The alternative, where adults direct children's intake, is theorized to interfere with children's ability to self-regulate their eating and cause excess weight gain. Based on this theoretical model, the USDA's Child and Adult Care Food Program (CACFP), which provides meals to 4.2 million low-income children annually, and Head Start, the federally-funded preschool program that serves 42% of all preschool-aged children in poverty nationally, strongly encourage family-style dining.
Contrary to current beliefs however, the investigators posit that many low-income children are not able to self-regulate their eating and overeat when allowed to self-serve, leading to excess weight gain. Thus, family-style dining may increase, rather than decrease, obesity among low-income children. Basic behavioral and epidemiologic research suggests that chronic stress, which many low-income children experience, contributes to obesity-promoting appetite characteristics among children. Laboratory-based experiments have demonstrated that appetite characteristics such as these lead to excessive consumption when children are allowed to self-serve. Among low-income preschoolers, one-third to one-half of children consume calories in excess of Institute of Medicine recommendations during family-style meals. This excessive energy intake is driven by intake of meat and grains, while intake of nutrient-dense, lower calorie fruits and vegetables is far below recommendations. Children's excessive and unbalanced eating during family-style dining is often noted by teachers, who are uncertain how limit these behaviors.
Changing environmental supports for eating may be particularly important for modifying the dietary intake of young children who, unlike adolescents and adults, do not yet have the cognitive capacity to inhibit intake of highly palatable foods in favor of selecting food based on healthfulness. Therefore, the objective of this Collaborative Research pilot study is to conduct T2 translational research among low-income preschool children by developing an easily-implemented curriculum to support family-style dining in Head Start called Mealtime Matters, where teachers receive focused training on preschooler nutrition, appropriate portion sizes for preschool children, responsive feeding strategies, and improvements to the classroom environment that promote children's self-regulation of eating. The feasibility and potential impact of Mealtime Matters will be examined with 72 children from up to 7 Head Start classrooms in Adrian, Michigan. The investigators hypothesize that Mealtime Matters will be feasible and acceptable to teachers. Further, by reducing prompts to over-consume and empowering teachers to direct children to serve appropriate portion sizes while using responsive feeding approaches, the investigators will: 1. Increase the proportion of children consuming within an acceptable range of the recommended kilocalories (kcal) during meals at Head Start and 2. Increase the servings of fruits and vegetables children consume during meals at Head Start. Sustained engagement in these dietary behaviors can prevent excessive weight gain and obesity.
The specific aims of this trial are:
Aim 1: Examine the effect of Mealtime Matters on children's dietary intake during meals at Head Start.
Aim 2: Examine the effect of Mealtime Matters on teacher/child mealtime interactions at Head Start.
Aim 3: Determine the feasibility and acceptability of Mealtime Matters among Head Start teachers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
TEACHERS
Inclusion Criteria:
- employed as teachers in the Adrian Public School's Head Start Program
Exclusion Criteria:
- N/A
CHILDREN
Inclusion Criteria:
- enrolled in the Adrian Public School's Head Start Program
- the specific age range for children selected of 3-4 years by September 1 of the given academic year is based on the age of eligibility for Head Start enrollment
- the custodial and legal guardian is able to provide valid consent
Exclusion Criteria:
- child has serious medical problems
- the child is a foster child
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mealtime Matters Training
This group of teachers will get a 3 hour nutrition training, followed by 2 one hour booster sessions.
|
This training will address common issues that Head Start teachers including how to deal with picky eaters, in addition to education about the nutritional needs of pre-school aged children.
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No Intervention: Family Style Dining in Head Start
This group of teachers will not get the 3 hour nutrition training until the study has concluded.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Percentage of Children Over-consuming Energy During Lunch Attributable to Mealtime Matters
Time Frame: baseline, 6 weeks post-intervention
|
Dietary intake data will be collected via the Remote Food Photography Method over 2 lunches at Head Start among children in intervention and control classrooms to identify the proportion of children over-consuming energy during meals.
Over-consumption is defined as an average per meal intake > 332 kilocalories based on IOM recommendations regarding median energy intake recommended for 3 to 5 year olds' lunch in CACFP settings.
|
baseline, 6 weeks post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Teachers' Feeding Practices Attributable to Mealtime Matters
Time Frame: baseline, 6 weeks post-intervention
|
Data will be collected at baseline among teachers in intervention and control classrooms.
Two lunch periods will be video and audio recorded to identify teachers' feeding practices.
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baseline, 6 weeks post-intervention
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Number of Teachers Satisfied With Mealtime Matters [ Time Frame: Post-training ]
Time Frame: 3 hours
|
Data on teacher satisfaction will be collected via teacher questionnaires immediately post training to better understand whether the teachers found the training interesting, relevant, easy to implement, and useful.
|
3 hours
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Number of Teachers Satisfied With Mealtime Matters
Time Frame: 6 weeks post-intervention
|
Data on teacher satisfaction will be collected via teacher questionnaires post-intervention to better understand whether the teachers found the training interesting, relevant, easy to implement, and useful.
|
6 weeks post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katherine W Bauer, PhD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00138002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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