Obesity Prevention in Head Start

NCT03672227 | Completed Results DMC

• 1 other identifier: HUM00138002
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Head Start; Family Style Dining

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Teachers' Feeding Practices Attributable to Mealtime Matters

  baseline, 6 weeks post-intervention

• Number of Teachers Satisfied With Mealtime Matters [ Time Frame: Post-training ]

  3 hours

• Number of Teachers Satisfied With Mealtime Matters

  6 weeks post-intervention

Study Arms (2)

Mealtime Matters Training

EXPERIMENTAL

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

Behavioral: Mealtime Matters Training

Family Style Dining in Head Start

NO INTERVENTION

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

Interventions

Mealtime Matters Training BEHAVIORAL

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.

Mealtime Matters Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- employed as teachers in the Adrian Public School's Head Start Program

You may not qualify if:

• \- N/A
• CHILDREN
• 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
• child has serious medical problems
• the child is a foster child

Sponsors & Collaborators

• University of Michigan: lead
• Pennington Biomedical Research Center: collaborator
• Michigan State University: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Katherine Bauer
• Organization: REGENTS OF THE UNIVERSITY OF MICHIGAN

kwbauer@umich.edu

(734)763-2546

Study Officials

• Katherine W Bauer, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 14, 2018
• Study Start: August 24, 2018
• Primary Completion: December 21, 2018
• Study Completion: January 18, 2019
• Last Updated: January 10, 2022
• Results First Posted: January 10, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)