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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05780008
Other study ID # STUDY00008403
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date January 1, 2023
Est. completion date May 10, 2024

Study information

Verified date June 2024
Source Michigan State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 202
Est. completion date May 10, 2024
Est. primary completion date May 7, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria: - Any preschoolers aged 3-5 years old from the participating daycare classrooms. - Having parental consent. Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Northeast Michigan Community Service Agency Alpena Michigan
United States Northwest Michigan Community Action Agency Kalkaska Michigan

Sponsors (2)

Lead Sponsor Collaborator
Michigan State University Michigan Health Endowment Fund

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary Skin carotenoids An instrument called the Veggie MeterĀ® 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 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. Change from week 0 (Time 1) to week 15 (Time 2)
Secondary 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. Change from week 0 (Time 1) to week 15 (Time 2)
Secondary 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. Change from week 0 (Time 1) to week 15 (Time 2)
Secondary 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. Change from week 0 (Time 1) to week 15 (Time 2)
Secondary 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. Change from week 0 (Time 1) to week 15 (Time 2)
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