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Behavioral Intervention
Nutrition Program for Childhood Obesity
Phase 2 & 3
Recruiting
Research Sponsored by Michigan State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from week 0 (time 1) to week 15 (time 2)
Awards & highlights
Study Summary
This trial tested the effect of a nutrition program on preschoolers' eating habits and body measurements.
Who is the study for?
This trial is for preschoolers aged 3-5 years enrolled in participating daycare classrooms, with parental consent. There are no specific exclusion criteria, so all children within this age range and setting can potentially participate.Check my eligibility
What is being tested?
The 'Eat My ABCs' program is being tested to see if it helps improve the eating behaviors of Head Start preschoolers and positively affects their body measurements like BMI (Body Mass Index) and percent body fat.See study design
What are the potential side effects?
Since 'Eat My ABCs' is a nutritional program rather than a medication, there aren't typical side effects. However, changes in diet may affect each child differently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from week 0 (time 1) to week 15 (time 2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from week 0 (time 1) to week 15 (time 2)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Child's BMI
Percent body fat
Skin carotenoids
Secondary outcome measures
Home eating environment
Household food insecurity
Parent fruit/vegetable/fiber intake
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Eat My ABCsExperimental Treatment1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Behavioral modification through dietary education and structured eating plans are common treatments for childhood obesity. These interventions work by teaching children and their families about healthy eating habits, portion control, and the importance of regular meals.
Structured eating plans help to establish consistent eating patterns, reduce the intake of high-calorie, low-nutrient foods, and promote the consumption of fruits, vegetables, and whole grains. These strategies are crucial for childhood obesity patients as they address the root causes of unhealthy weight gain, promote long-term healthy behaviors, and can prevent the development of obesity-related health issues such as type 2 diabetes and cardiovascular diseases.
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Who is running the clinical trial?
Michigan State UniversityLead Sponsor
187 Previous Clinical Trials
606,872 Total Patients Enrolled
Michigan Health Endowment FundOTHER
4 Previous Clinical Trials
424 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is between 3 to 5 years old and attends a participating daycare.N/A
Research Study Groups:
This trial has the following groups:- Group 1: Eat My ABCs
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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