Obesity Prevention in Head Start

Childhood Obesity Clinical Trial

Official title:

Obesity Prevention in Low-Income Preschoolers: Testing the Impact of an Alternative Meal Service Approach in Head Start

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672227
• Other study ID #: HUM00138002
• Status: Completed
• Phase: N/A
• Start date: August 24, 2018
• Est. completion date: January 18, 2019

Study information

• Verified date: November 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Family style dining is a widely-advocated approach by which to feed children in early education settings. While family-style dining is hypothesized to allow children to attend to their hunger and satiety and consume only the amount of food they need to meet their energy needs, children's ability to self-regulate eating in this setting is dependent on a number of factors including early life experiences, the feeding strategies caregivers use during meals, and the eating environment. The goal of this study is to develop and implement a novel curriculum for childcare providers, Mealtime Matters, that addresses the factors that interfere with children's self-regulation of eating and offers caregivers strategies to reduce exposures that promote over-eating in the early education environment. Mealtime Matters will be pilot tested through a randomized controlled trial design with 7 Head Start classrooms, enrolling approximately 72 low-income preschool-aged children. Intervention feasibility and acceptability will be examined, as well as changes in caregiver/child mealtime interactions and children's dietary intake during meals at Head Start. Study results will inform the development of a fully-scaled efficacy trial.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: January 18, 2019
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Mealtime Matters Training
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Michigan State University, Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percentage of Children Over-consuming Energy During Lunch Attributable to Mealtime Matters	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
Secondary	Change in Teachers' Feeding Practices Attributable to Mealtime Matters	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.	baseline, 6 weeks post-intervention
Secondary	Number of Teachers Satisfied With Mealtime Matters [ Time Frame: Post-training ]	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
Secondary	Number of Teachers Satisfied With Mealtime Matters	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