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Behavioral Intervention

Food-Body-Mind Intervention for Child Wellbeing

Phase 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 month 0 (time 1) to month 4 (time 2), and change from month 4 (time 2) to month 16 (time 3)

Awards & highlights

Study Summary

This trial aims to reduce mental health disparities for children from low-income backgrounds. If successful, it'll benefit many kids and help promote health equity nationally.

Who is the study for?

This trial is for English-speaking preschoolers aged 3-5 attending Head Start programs, with their primary caregivers participating via Facebook or a private website. Children must be able to engage in physical activity and not require a special diet due to medical conditions. Caregivers need weekly internet access.Check my eligibility

What is being tested?

The Food-Body-Mind intervention aims to improve mental health among diverse, low-income preschoolers by incorporating strategies that address nutrition, physical well-being, and psychological support. It's designed for scalability across various settings if successful.See study design

What are the potential side effects?

Since this is a non-medical intervention focusing on lifestyle changes involving diet and activities, no direct side effects are expected as typically seen with medications or clinical treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from month 0 (time 1) to month 4 (time 2), and change from month 4 (time 2) to month 16 (time 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from month 0 (time 1) to month 4 (time 2), and change from month 4 (time 2) to month 16 (time 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from month 0 (time 1) to month 4 (time 2), and change from month 4 (time 2) to month 16 (time 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Caregiver coping

Caregiver mindfulness

Caregiver-preschooler relationship

+20 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Food-Body-Mind InterventionExperimental Treatment1 Intervention

Guided by the Actor-Partner Interdependence Model, the Allostatic Load Model, and the Transactional Theory of Stress and Coping, the proposed 16-week Food-Body-Mind intervention includes: 1) a school-based mindfulness component delivered to equip preschoolers with knowledge and skills in mindful eating and movement (e.g., yoga, deep breathing exercises); 2) a home-based mindfulness component to increase caregivers' skills in practicing mindful eating, movement, and parenting behaviors at home to foster a more positive, mindful, and healthy home environment; and 3) a school learning and home practice connection component to improve caregiver-preschooler relationships.

Group II: Usual Care ControlActive Control1 Intervention

Like those in the intervention group, preschoolers assigned to the control group will receive usual Head Start activities during the intervention period. After the 12-month follow-up data collection from both intervention and control participants in each year, each control family will receive all intervention supplies including the "Tasty Healthy Cookbook," "MyPlate" plates, and a breathing ball, as well as the program manual on how to use the intervention supplies. These intervention supplies will be distributed to control families at the end of in-person data collection appointments. Moreover, a virtual caregiver meeting on mindful eating, movement, and parenting will be provided to all caregivers who are interested.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Michigan State UniversityLead Sponsor

185 Previous Clinical Trials

601,627 Total Patients Enrolled

National Center for Complementary and Integrative Health (NCCIH)NIH

833 Previous Clinical Trials

669,053 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant eligibility for this experiment restricted to those who are twenty or younger?

"This clinical trial stipulates that the lower limit of age eligibility is 3 years old, and the upper boundary for participants is 5."

Answered by AI

Has the Food-Body-Mind Intervention been approved by the United States Federal Drug Administration?

"There is existing clinical evidence that supports the safety of Food-Body-Mind Intervention, so it received a rating of 3."

Answered by AI

Am I eligible to enroll in this investigation?

"To be eligible to particpate, children must possess a satisfactory level of health and fall between 3-5 years of age. This clinical trial seeks 400 participants in total."

Answered by AI

Are there still opportunities to become involved in this research project?

"Clinicaltrials.gov states that this study is not currently enrolling individuals, as it was first posted on August 21st 2023 and last modified on September 20th of the same year. Nevertheless, there are still 1 other clinical trials actively seeking out candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Food-Body-Mind Intervention

Jiying Ling 2023. "Food-Body-Mind Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05964218.