Food-Body-Mind Intervention (16 Weeks)
Recruiting
Phase 2
Phase 3
Interventional Study
Mental Health Wellness
Emotional Problem
Behavioral Problem of Child
Social Skills
Obesity, Childhood
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 3 – 5
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 800 (estimated)
- Sponsor
- Michigan State University · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood. By targeting Head Start racially/ethnically diverse preschoolers from low-income backgrounds in both urban and rural areas, this intervention is expected to contribute toward reducing health disparities and promoting health equity, a major priority of the N…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
1. Parental consent and child (if the child is 5 years) verbal assent received
2. Children are 3-5 years old attending a Head Start program and caregivers are the primary adult caregivers for the children
3. Caregivers are willing to use Facebook or the private program website f…
Contacts