NCT05780008

Brief Summary

Evaluate the effects of the "Eat My ABCs" program on improving Head Start preschoolers' eating behavior and anthropometric properties (BMI, percent body fat).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

February 27, 2023

Last Update Submit

June 5, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Child's BMI

    Height will be measured to the nearest 0.1cm using the Shorr board, and weight will be measured to the nearest 0.1kg using the Seca 874 scale or the BF-689 body fat/body water monitor. The online SAS program for Centers for Disease Control and Prevention Growth Charts was applied to calculate preschoolers' BMI for age and sex.

    Change from week 0 (Time 1) to week 15 (Time 2)

  • Percent body fat

    Percent body fat will be measured to the nearest 0.1% using the BF-689 body fat/body water monitor. Each participant's biological sex, age, and height in cm were entered into the monitor for measuring % body fat. Trained data collectors then instructed participants to step onto the monitor surface and align feet with the four electrodes.

    Change from week 0 (Time 1) to week 15 (Time 2)

  • Skin carotenoids

    An instrument called the Veggie Meter® will be utilized to assess skin carotenoids as an indicator for fruit/vegetable intake. To assess skin carotenoids in this study, each participant's non-dominant index finger will be used, and the average of three scans will be recorded as the final score.

    Change from week 0 (Time 1) to week 15 (Time 2)

Secondary Outcomes (5)

  • Parent fruit/vegetable/fiber intake

    Change from week 0 (Time 1) to week 15 (Time 2)

  • Household food insecurity

    Change from week 0 (Time 1) to week 15 (Time 2)

  • Parental feeding skills

    Change from week 0 (Time 1) to week 15 (Time 2)

  • Parental food resource management behavior

    Change from week 0 (Time 1) to week 15 (Time 2)

  • Home eating environment

    Change from week 0 (Time 1) to week 15 (Time 2)

Study Arms (1)

Eat My ABCs

EXPERIMENTAL

The experimental arm will receive the 14-week program including three main components: (1) "Eat My ABCs" child curriculum, (2) child fruit/vegetable letters to parents, and (3) program cookbook.

Behavioral: Eat My ABCs

Interventions

Eat My ABCsBEHAVIORAL

The "Eat My ABCs" curriculum incorporates senses into learning (hear, see, smell, taste) and includes two sessions/week: 1) healthy eating learning; and 2) mindful food taste-testing activities to expose children to the one fruit, one vegetable, and relevant food items made from the one fruit and one vegetable to teach children the creative ways to make fruit/vegetable healthy and tasty. Child Letter to Parents. Every week, each child will create one letter, using stickers, regarding the one fruit and one vegetable presented in the program that he/she tasted or wanted to try at home. Program Cookbook. The investigators have developed a targeted program cookbook for low-income families. The program cookbook contains all budget-friendly recipes for healthy breakfasts, family meals, quick-fixes, kid-friendly snacks, and occasional sweets. In addition, the cookbook contains creative ways of making fruit/vegetable healthy, tasty, and kid-friendly at home.

Eat My ABCs

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Any preschoolers aged 3-5 years old from the participating daycare classrooms.
  • Having parental consent.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northeast Michigan Community Service Agency

Alpena, Michigan, 49707, United States

Location

Northwest Michigan Community Action Agency

Kalkaska, Michigan, 49646, United States

Location

Related Publications (1)

  • Ling J, Kao TA, Yang X. Impact of food accessibility on eating and anthropometric outcomes among rural parent-child dyads: a secondary data analysis of a mindful eating intervention. BMJ Open. 2025 Dec 31;15(12):e108076. doi: 10.1136/bmjopen-2025-108076.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This will be a one-group quasi-experimental design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 22, 2023

Study Start

January 1, 2023

Primary Completion

May 7, 2024

Study Completion

May 10, 2024

Last Updated

June 7, 2024

Record last verified: 2024-06

Locations