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Obesity Prevention in Head Start

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mealtime Matters Training
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Head Start, Family Style Dining

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mealtime Matters Training

Family Style Dining in Head Start

Arm Description

This group of teachers will get a 3 hour nutrition training, followed by 2 one hour booster sessions.

This group of teachers will not get the 3 hour nutrition training until the study has concluded.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 7, 2018
Last Updated
November 13, 2021
Sponsor
University of Michigan
Collaborators
Pennington Biomedical Research Center, Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT03672227
Brief Title
Obesity Prevention in Head Start
Official Title
Obesity Prevention in Low-Income Preschoolers: Testing the Impact of an Alternative Meal Service Approach in Head Start
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 24, 2018 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
January 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Pennington Biomedical Research Center, Michigan State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Head Start, Family Style Dining

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two arms in this study. In the intervention arm, teachers will receive the Mealtime Matters training about child nutrition. In the control arm, the teachers do not receive the Mealtime Matters until the completion of the study.
Masking
Investigator
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mealtime Matters Training
Arm Type
Experimental
Arm Description
This group of teachers will get a 3 hour nutrition training, followed by 2 one hour booster sessions.
Arm Title
Family Style Dining in Head Start
Arm Type
No Intervention
Arm Description
This group of teachers will not get the 3 hour nutrition training until the study has concluded.
Intervention Type
Behavioral
Intervention Name(s)
Mealtime Matters Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Percentage of Children Over-consuming Energy During Lunch Attributable to Mealtime Matters
Description
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.
Time Frame
baseline, 6 weeks post-intervention
Secondary Outcome Measure Information:
Title
Change in Teachers' Feeding Practices Attributable to Mealtime Matters
Description
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.
Time Frame
baseline, 6 weeks post-intervention
Title
Number of Teachers Satisfied With Mealtime Matters [ Time Frame: Post-training ]
Description
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.
Time Frame
3 hours
Title
Number of Teachers Satisfied With Mealtime Matters
Description
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.
Time Frame
6 weeks post-intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine W Bauer, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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