Eat My ABCs Project

June 5, 2024 updated by: Jiying Ling, Michigan State University

Eat My ABCs: Integrate Healthy Eating Into School Readiness

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The 14-week, community-led, program, aimed to establish lifelong healthy eating habits among vulnerable low-income preschoolers living in rural Michigan, includes three main components: (1) "Eat My ABCs" child curriculum, (2) child fruit/vegetable letters to parents, and (3) program cookbook.

"Eat My ABCs" Child Curriculum. Head Start teachers, along with teacher assistants/aids, will independently teach the age appropriate "Eat My ABCs" curriculum per week, for a total of 14 weeks. The "Eat My ABCs" curriculum follows the alphabet theme and incorporates the five senses into learning (hear fruit and vegetable information, see the color, feel the texture, smell the scent, and taste the flavor). Each week includes two sessions: 1) healthy eating learning on one fruit and one vegetable by incorporating school readiness knowledge on numbers, shapes, colors, and alphabets; and 2) food taste-testing activities to expose children to 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 to overcome their limited cooking skills, busy schedules, and tight family budget. The program cookbook contains all budget-friendly recipes for healthy breakfasts, family meals, quick-fixes, kid-friendly snacks, and occasional sweets; and these recipes are culturally appropriate with a variety of choices such as American, Italian, Mexican, and Asian cuisines. In the cookbook, the investigators also promote slow /pressure-cooking recipes as using a slow or pressure cooker to prepare easy but healthy meals is an effective way to overcome low-income parent barriers of lack of time and cooking skills. In addition, the cookbook contains creative ways of making fruit/vegetable healthy, tasty, and kid-friendly at home.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Alpena, Michigan, United States, 49707
        • Northeast Michigan Community Service Agency
      • Kalkaska, Michigan, United States, 49646
        • Northwest Michigan Community Action Agency

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Eat My ABCs
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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child's BMI
Time Frame: Change from week 0 (Time 1) to week 15 (Time 2)
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
Time Frame: Change from week 0 (Time 1) to week 15 (Time 2)
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
Time Frame: Change from week 0 (Time 1) to week 15 (Time 2)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent fruit/vegetable/fiber intake
Time Frame: Change from week 0 (Time 1) to week 15 (Time 2)
The 10-item Block Dietary Fruit/Vegetable/Fiber Screener will be used to assess parents' fruit/vegetable/fiber intake. A total score (range 0-50) will be calculated with a higher score indicating a higher intake of fruits and vegetables.
Change from week 0 (Time 1) to week 15 (Time 2)
Household food insecurity
Time Frame: Change from week 0 (Time 1) to week 15 (Time 2)
The U.S. Household Food Security Survey Module (19 questions) will be used. A total score (range 0-18) will be calculated with a higher score indicating a lower household food security.
Change from week 0 (Time 1) to week 15 (Time 2)
Parental feeding skills
Time Frame: Change from week 0 (Time 1) to week 15 (Time 2)
The Child Feeding Questionnaire (33 questions) will be used. Mean score (range 1-5) will be calculated for seven subscales including perceived responsibility for child feeding, perceived parent weight status, perceived child weight status, concerns about child weight, restriction of child's access to food, pressure to ask child to eat more food, and monitoring of child's eating. A higher mean score indicating a higher perceived feeding attitudes, beliefs, and practices.
Change from week 0 (Time 1) to week 15 (Time 2)
Parental food resource management behavior
Time Frame: Change from week 0 (Time 1) to week 15 (Time 2)
The 9-item Expanded Food and Nutrition Education Program Checklist will be used. A mean score (range 1-5) will be calculated with a higher mean score indicating a higher parental food resource management behavior.
Change from week 0 (Time 1) to week 15 (Time 2)
Home eating environment
Time Frame: Change from week 0 (Time 1) to week 15 (Time 2)
The 10-item Family Nutrition and Physical Activity Screening Tool will be used. A total score (range 10-40) will be calculated with a higher score indicating a healthier home eating environment.
Change from week 0 (Time 1) to week 15 (Time 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Michigan State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Michigan Health Endowment Fund

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00008403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

De-identified data can be shared with request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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