Food-Body-Mind Intervention for Children's Mental Health

Overseen By Codi Benjamin

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Michigan State University

Disqualifiers: Motor disability, Restrictive diet, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve mental health in young children through the Food-Body-Mind Intervention, a unique program combining mindful eating, movement, and parenting skills. It targets preschoolers from diverse, low-income backgrounds in Head Start programs. The study will compare children in this new program to those receiving usual care at Head Start. Children aged 3-5 in Head Start and their caregivers with regular internet access might be suitable participants. The goal is to determine if this program can expand to other Head Start locations nationwide. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to groundbreaking mental health solutions for children.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that the Food-Body-Mind Intervention is likely to be safe for children?

Research has shown that mindfulness programs, such as the Food-Body-Mind intervention, are generally safe for children. Increasing evidence indicates that these programs can enhance children's physical, mental, and emotional health without causing major side effects. The program includes mindfulness activities at school and home, such as mindful eating and movement, which are safe for kids.

The trial's progression to later stages suggests that earlier studies found the treatment safe enough for wider testing with children. Similar mindfulness and lifestyle programs have reported no major problems, supporting the safety of this approach for preschoolers. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the Food-Body-Mind intervention for children's mental health because it takes a holistic approach to well-being by combining mindfulness, nutrition, and movement. Unlike standard treatments that might focus on medication or therapy alone, this intervention equips preschoolers with skills in mindful eating and movement through activities like yoga and deep breathing exercises. Additionally, it includes a home-based component to improve caregiver skills in creating a mindful and healthy home environment, enhancing the caregiver-preschooler relationship. This comprehensive method aims to address mental health from multiple angles, potentially offering a more sustainable and positive impact on children's mental health.

What evidence suggests that the Food-Body-Mind Intervention might be an effective treatment for children's mental health?

Research shows that the Food-Body-Mind program, which participants in this trial may receive, aims to boost mental health in young children by focusing on mindful eating, activities like yoga, and stress-reduction techniques. Although specific data on this program is limited, similar methods have demonstrated that mindfulness and improved nutrition positively impact children's mental health. Studies have found that mindfulness in schools can reduce anxiety and enhance emotional regulation in children. Good nutrition is also crucial, as a balanced diet links to better mental and physical health. By combining these elements, the program seeks to create a healthier environment for children, potentially leading to improved mental well-being. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for racially and ethnically diverse preschoolers from low-income families, both in urban and rural areas. It aims to help children enrolled in Head Start programs who are facing mental health challenges, including problematic behavior, obesity, emotional distress, and social skills issues.

Inclusion Criteria

Parental consent and child (if the child is 5 years) verbal assent received

I am willing to use Facebook or a private website for the study.

Participants have at least weekly internet access using a smartphone, a tablet, or a computer

Exclusion Criteria

My child has a motor disability that stops them from being active.

My child has a medical condition that requires a strict diet and cannot change their fruit/vegetable intake.

My child has a diagnosed disorder that severely affects their ability to communicate and interact.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

The 16-week Food-Body-Mind intervention includes school-based and home-based mindfulness components to improve mental, emotional, and physical health of preschoolers and caregivers.

16 weeks

Regular school and home sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 4 months and 16 months post-baseline.

12 months

Data collection at 4 months and 16 months

What Are the Treatments Tested in This Trial?

Interventions

• Food-Body-Mind Intervention

Trial Overview

The Food-Body-Mind intervention being tested is a novel approach that combines dietary guidance with physical activity and mindfulness practices designed to improve the mental health of young children. The study will last for 16 weeks.

How Is the Trial Designed?

Group I: Food-Body-Mind intervention Experimental Treatment 1 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 control Active Control 1 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.

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Published Research Related to This Trial

A study of 3480 adolescents aged 11 to 15 found that better breakfast quality and overall diet are significantly linked to improved mental health indicators, such as self-rated health and life satisfaction.

Obesity was identified as a major factor that weakens the positive relationship between diet quality and mental health, while physical activity may enhance this relationship, highlighting the importance of nutrition in adolescent mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of breakfast, total diet quality, and mental health in adolescents: a cross-sectional study of HBSC in Greece. Liu, L., Guo, C., Lang, F., et al.[2023]

Experiential nutrition interventions, such as cooking classes and school gardens, significantly improve primary schoolchildren's willingness to try new foods and enhance their cooking skills and nutritional knowledge, based on a review of 67 successful studies.

Successful programs often involve multiple strategies, parental involvement, and a specific focus on increasing vegetable intake, highlighting the importance of a comprehensive approach to nutrition education in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of successful primary school-based experiential nutrition programmes: a systematic literature review. Charlton, K., Comerford, T., Deavin, N., et al.[2023]

A review of 18 studies on school food environment interventions found that 17 reported positive effects on either body mass index (BMI) or healthier food choices, highlighting the potential of these interventions to improve student eating behaviors.

Despite the positive outcomes, most studies were of weak quality and only a few included control groups, indicating a need for more rigorous research to better understand the effectiveness of food environment changes in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of changes to the school food environment on eating behaviours and/or body weight in children: a systematic review. Driessen, CE., Cameron, AJ., Thornton, LE., et al.[2022]

Certain dietary factors, such as fatty acids and food additives, may influence hyperactivity and behavior in children, with some evidence suggesting that specific food additives can exacerbate hyperactivity in those with behavioral issues.

Dietary manipulation is often viewed as a more acceptable treatment for hyperactivity in children compared to medication, but caution is needed to avoid unsupervised dietary restrictions, as they may not be sufficient alone for managing conditions like ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary influences on cognitive development and behaviour in children. Stevenson, J.[2019]

Multi-component psychological interventions, particularly those using motivational interviewing and cognitive behavioral therapy, significantly reduce BMI z-scores and waist circumference in school-aged children with overweight or obesity, based on a review of 30 studies involving various group-based interventions.

The weight loss achieved through these interventions appears to be maintainable over time, as no significant differences were found between post-treatment and last follow-up measurements, suggesting the effectiveness of these approaches in promoting long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of psychological interventions targeting overweight and obesity in school-aged children: a systematic review and meta-analysis. Baygi, F., Djalalinia, S., Qorbani, M., et al.[2023]

A comprehensive school-based program is essential for preventing eating disturbances, addressing issues like obesity, anorexia, and unhealthy dieting through staff training, classroom interventions, and counseling for at-risk students.

The program should focus on modifying both individual behaviors and environmental factors, integrating health promotion into existing curricula, and providing opportunities for healthy eating and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based programs for preventing eating disturbances. Neumark-Sztainer, D.[2019]

The 'My Feelings Form' (MFF) was developed and validated as an age-appropriate patient-reported outcome measure for children's mental health, involving 317 children from a primary school and 25 from Child and Adolescent Mental Health Services (CAMHS).

The MFF demonstrated good test-retest reliability (correlation of 0.74) and effectively distinguished between children in CAMHS and those in school, indicating its potential as a useful tool for assessing children's mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development, preliminary validation and reliability of the colourful 'My Feelings Form' self-report for young children. Mulligan, A., Sresthaporn, N., Mulroy, S., et al.[2023]

Mental health issues affect 10-20% of children and adolescents globally, highlighting the urgent need for early intervention to mitigate long-term consequences.

Screening for emotional and behavioral problems is crucial as the first step in early intervention, allowing for timely support and treatment to improve mental health outcomes in young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The promotion of mental health and the prevention of mental health problems in child and adolescent. Cho, SM., Shin, YM.[2021]

The study evaluated nursing and multidisciplinary interventions in a Youth Inpatient Unit in Christchurch, New Zealand, focusing on their effectiveness in improving outcomes for adolescents, as measured by the Health of the Nation Outcome Scales for Children and Adolescents.

Findings suggest that while most interventions were used similarly across different diagnoses, stress management and problem-solving education were particularly beneficial for patients with mixed affective disorders, highlighting the importance of targeted interventions in adolescent psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An examination of frequent nursing interventions and outcomes in an adolescent psychiatric inpatient unit. Bobier, C., Dowell, J., Swadi, H.[2019]

Research shows that matching specific therapies to mental health diagnoses has little effect on treatment outcomes, indicating a need for new approaches in mental health care.

The Outcome Orientated Child and Adolescent Mental Health Services (OO-CAMHS) model, developed by a community mental health team, incorporates evidence-based practices that focus on feedback and patient alliance, showing promise in improving outcomes for young mental health service users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome Orientated Child and Adolescent Mental Health Services (OO-CAMHS): a whole service model. Timimi, S., Tetley, D., Burgoine, W., et al.[2019]

A review of 200 experimental studies on child and adolescent mental health treatment from 1996 to 2011 showed a significant increase in research focus, particularly on consumer-oriented outcomes, which rose from 8 to 47 studies, indicating a shift towards outcomes that matter to families and caregivers.

The majority of studies still concentrated on symptoms and diagnoses, but the introduction of new outcome domains like parent symptoms and health-related outcomes reflects a growing recognition of the importance of broader impacts, aligning with current health care priorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome domains in child mental health research since 1996: have they changed and why does it matter? Hoagwood, KE., Jensen, PS., Acri, MC., et al.[2022]

The study, involving 693 Danish children aged 8 to 11, found that healthy school meals did not significantly improve concentration or processing speed, but did enhance reading performance, with increases in reading speed and the number of correct sentences.

While the intervention did not affect overall math performance, it did lead to a reduction in errors during reading tasks, suggesting that healthy meals may help with complex cognitive activities like reading, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Nordic school meals on concentration and school performance in 8- to 11-year-old children in the OPUS School Meal Study: a cluster-randomised, controlled, cross-over trial. Sørensen, LB., Dyssegaard, CB., Damsgaard, CT., et al.[2015]

In a study of 787 children aged eight and nine, better overall diet quality was significantly associated with fewer mental health problems, suggesting that what children eat can impact their mental well-being.

The study utilized a brief six-item questionnaire to assess diet quality, demonstrating its effectiveness as a simple tool for parents to evaluate their child's nutrition in relation to mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet quality and mental health problems in late childhood. Dimov, S., Mundy, LK., Bayer, JK., et al.[2021]

The Healthy, Hunger-Free Kids Act of 2010 improved school lunch standards for K-12 students by increasing the availability of whole grains, fruits, and vegetables, which has led to children consuming more healthful foods.

There is no evidence of increased plate waste from the revised lunch standards, and the Society of Behavioral Medicine supports maintaining these standards while also advocating for further evaluation of their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Society of Behavioral Medicine (SBM) position statement: SBM supports retaining healthy school lunch policies. Buscemi, J., Odoms-Young, A., Yaroch, AL., et al.[2019]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06597474

NCT06597474 | Food-Body-Mind Intervention (16 Weeks)

This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood.

2.

reporter.nih.gov

reporter.nih.gov/project-details/11195725

Food-Body-Mind Intervention: Promote whole child health

This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood. By targeting ...

3.

withpower.com

withpower.com/trial/phase-2-and-3-problematic-behavior-in-children-7-2024-3a1e7

Food-Body-Mind Intervention for Children's Mental Health

This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood.

4.

peearz.com

peearz.com/trialsindex?nctid=NCT05964218

Food-Body-Mind Intervention | Peearz Health

This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9441951/

Nutrition and mental health: A review of current knowledge ...

This review aims to answer whether and to what extent lifestyle and related nutrition affect mental health and whether there is scientific evidence supporting ...

6.

trialx.com

trialx.com/clinical-trials/listings/286130/food-body-mind-intervention/?&radius=50

Food-Body-Mind Intervention | Clinical Research Trial ...

This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12241280/

A Mindfulness-Based Lifestyle Intervention Among ...

Mindfulness-based interventions are increasingly recognized for their positive impact on children's physical, mental, emotional, ...