Nutrition, HealthyPhase 2/3NCT05780008
Eat My ABCs Project
A Phase 2/3 study testing Eat My ABCs in people with Nutrition, Healthy and Obesity, Childhood, run by Michigan State University at 2 sites in United States.
Trial summary
Evaluate the effects of the "Eat My ABCs" program on improving Head Start preschoolers' eating behavior and anthropometric properties (BMI, percent body fat). Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Obesity, Childhood
- What is being tested?
- Eat My ABCs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2023to 10 May 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any preschoolers aged 3-5 years old from the participating daycare classrooms.
- Having parental consent.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northeast Michigan Community Service Agency
Alpena, Michigan, 49707
Northwest Michigan Community Action Agency
Kalkaska, Michigan, 49646
About this study
Official title: 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).
Read the 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.
- Conditions
- Nutrition, Healthy, Obesity, Childhood
- Being tested
- Eat My ABCs
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eat My ABCsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Eat My ABCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from week 0 (Time 1) to week 15 (Time 2)
Secondary outcomes (5)
Parent fruit/vegetable/fiber intake
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.
Measured: Change from week 0 (Time 1) to week 15 (Time 2)
Household food insecurity
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.
Measured: Change from week 0 (Time 1) to week 15 (Time 2)
Parental feeding skills
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.
Measured: Change from week 0 (Time 1) to week 15 (Time 2)
Parental food resource management behavior
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.
Measured: Change from week 0 (Time 1) to week 15 (Time 2)
Home eating environment
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.
Measured: Change from week 0 (Time 1) to week 15 (Time 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Jan 2023
- Primary completion7 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a one-group quasi-experimental design.
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Health Endowment Fund
- Responsible party
- Principal investigator, Jiying Ling, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780008
- Sponsor's protocol ID
- STUDY00008403
- Status last verified
- Jun 2024
- First submitted
- 27 Feb 2023
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data can be shared with request.
Publications
Lalonde H, Sawalmeh E, Buhlman R, Tadavich S, Xie Y, Ling J. Acceptability and Satisfaction of Eat My ABCs: A Mindful Eating Program for Preschoolers in Low-Income Families. Nutrients. 2026 Mar 30;18(7):1103. doi: 10.3390/nu18071103.
PubMed 41978152Ling 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.
PubMed 41475815
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eat My ABCs: Integrate Healthy Eating Into School Readiness
- ClinicalTrials.gov ID
- NCT05780008
- Acronym / sponsor ID
- STUDY00008403
- Conditions
- Nutrition, Healthy, Obesity, Childhood
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Michigan Health Endowment Fund
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the effects of the "Eat My ABCs" program on improving Head Start preschoolers' eating behavior and anthropometric properties (BMI, percent body fat).
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a one-group quasi-experimental design.
| Arm | Type | Receives |
|---|---|---|
| Eat My ABCs | Experimental | Behavioral: Eat My ABCsThe 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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Any preschoolers aged 3-5 years old from the participating daycare classrooms.
- Having parental consent.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eat My ABCsThe "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. | Behavioural | Eat My ABCs |
Primary outcome
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.
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.
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.
5 secondary outcomes
Parent fruit/vegetable/fiber intake
Time frame: 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)
Parental feeding skills
Time frame: 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)
Home eating environment
Time frame: Change from week 0 (Time 1) to week 15 (Time 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 41978152Lalonde H, Sawalmeh E, Buhlman R, Tadavich S, Xie Y, Ling J. Acceptability and Satisfaction of Eat My ABCs: A Mindful Eating Program for Preschoolers in Low-Income Families. Nutrients. 2026 Mar 30;18(7):1103. doi: 10.3390/nu18071103.
- Derived from this study: PubMed 41475815Ling 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.
- Individual participant dataSharing planned: Undecided. De-identified data can be shared with request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Eat My ABCs in people with Nutrition, Healthy and Obesity, Childhood, run by Michigan State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's BMI (time frame: Change from week 0 (Time 1) to week 15 (Time 2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05780008, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.