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Children's Mental, Emotional, Behavioral, and Physical HealthPhase 1NCT05964218

Food-Body-Mind Intervention

A Phase 1 study testing Food-Body-Mind Intervention in people with Children's Mental, Emotional, Behavioral, and Physical Health, run by Michigan State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 3 to 5 yearsHealthy volunteers can take part
What is being tested?
Food-Body-Mind Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
3 Dec 2023to 31 Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Parental consent and child (if the child is 5 years) verbal assent received
  • Children are 3-5 years old attending a Head Start program and caregivers are the primary adult caregivers for the children
  • Caregivers are willing to use Facebook or the private program website for participation
  • Participants have at least weekly internet access using a smartphone, a tablet, or a computer

Who cannot join

  • preschoolers who have a motor disability or impairment (e.g., cerebral palsy, spinal cord injury, lost or damaged limb, motor skills disorder, muscular dystrophy, spina bifida) preventing them from participating in any physical activity;
  • preschoolers who have a diagnosed medical condition (e.g., phenylketonuria, pediatric malabsorption syndrome, pollen food allergy syndrome) requiring a restrict diet and precluding them from any dietary changes particularly fruit/vegetable intake; and
  • preschoolers who have diagnosed disorders (e.g., autism spectrum disorder level 3) causing severe difficulty (e.g., nonverbal, cannot initiate social interaction) with communication and interaction with other people.
  • There will be no exclusion criterion for primary adult caregivers, as the primary focus is preschoolers and caregivers serve as a support role.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Community Action Agency

    Jackson, Michigan, 49203

Other trials in United States

About this study

Official title: 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 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 NIH and Healthy People 2030. If effective, it can be scalable to Head Start programs across urban and rural settings nationally with long-term sustainability benefits.

Read the detailed description

Mental, emotional, and behavioral (MEB) disorders begin in early childhood, with one in six US preschoolers aged 3-5 years diagnosed with a MEB disorder. Children from low income and economically marginalized (LIEM) backgrounds have a higher risk of being diagnosed with MEB disorders than those from higher income families. To address the mental and physical health disparities based on socioeconomic status, ethnicity/race, and urban/rural residency, the proposed study will target Head Start racially/ethnically diverse preschoolers from LIEM backgrounds in both urban and rural areas. Guided by the Actor-Partner Interdependence Model, the Allostatic Load Model, and the Transactional Theory of Stress and Coping, the pilot 5-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. The three aims are:

Aim 1: Finalize forms, procedures, community partners, protocols, and train research staff for trial implementation.

Aim 2: Implement study in 1 urban \& 1 rural daycares; complete enrollment of 12 dyads, collect baseline data, begin intervention in both daycares for 5 weeks; evaluate recruitment, data collection/management, and intervention fidelity.

Aim 3: Analyze evaluative data from both caregivers and teachers to determine their satisfaction and recommendations to guide UH3.

Being tested
Food-Body-Mind Intervention
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food-Body-Mind InterventionBehavioural

    The Food-Body-Mind intervention includes 3 main components: 1) a school-based mindfulness component delivered by daycare teachers to equip preschoolers with knowledge and skills in mindful eating and movement (e.g., yoga, deep breathing exercises) to reduce emotional eating and increase F/V intake and physical activity; 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 preschooler school learning and caregiver home practice connection component to improve caregiver-preschooler relationships.

Study groups in NCT05964218
Study groupRoleWhat they receive
Food-Body-Mind InterventionExperimentalGuided by the Actor-Partner Interdependence Model, the Allostatic Load Model, and the Transactional Theory of Stress and Coping, the pilot 5-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.
Receives: Behavioral: Food-Body-Mind Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preschoolers' problem behaviors

    Problem behaviors will be assessed by the Preschool and Kindergarten Behavior Scales-Second Edition (PKBS-2). The Problem Behavior scale includes 42 items on 2 subscales: Externalizing Problems and Internalizing Problems. Total standard scores (M=100, SD=15) will be calculated, with a higher score indicating a higher level of problem behaviors.

    Measured: Month 0 (Time 1)

Secondary outcomes (18)
  1. Preschoolers' social skills

    Social skills will be assessed by the Preschool and Kindergarten Behavior Scales-Second Edition (PKBS-2). The Social Skills scale includes 34 items on 3 subscales: Social Cooperation, Social Interaction, and Social Independence. Total standard scores (M=100, SD=15) will be calculated, with a higher score indicating a higher level of social skills.

    Measured: Month 0 (Time 1)

  2. Preschoolers' sadness

    Sadness will be assessed by the 7-item National Institutes of Health (NIH) Toolbox Sadness Parent Report Fixed Form. Response choices for the 3-Likert scale include: never or not true, sometimes or somewhat true, and often or very true. A total raw score was calculated and then transformed to the uncorrected T-scores (M=50, SD=10). A higher T-score indicates a higher level of sadness reported by parents/caregivers.

    Measured: Month 0 (Time 1)

  3. Preschoolers' fear

    Fear will be assessed by the 6-item, 3-Likert (never or not true, sometimes or somewhat true, often or very true) NIH Toolbox Fear-Over Anxious Parent Report Fixed Form. A total raw score was calculated and then transformed to the uncorrected T-scores (M=50, SD=10). A high T-score indicates a higher level of fear.

    Measured: Month 0 (Time 1)

  4. Preschoolers' anger

    Anger will be assessed using the 9-item, 3-Likert (never or not true, sometimes or somewhat true, often or very true) NIH Toolbox Anger Parent Report Fixed Form. A total raw score was calculated and transformed to the uncorrected T-scores (M=50, SD=10). A higher T-score indicates a higher level of child anger.

    Measured: Month 0 (Time 1)

  5. Preschoolers' positive affect

    Positive affect will be assessed by the 9-item NIH Toolbox Positive Affect Parent Report Fixed Form. Each question has five response choices: not at all, a little bit, somewhat, quite a bit, and very much. A total raw score was calculated and then transformed to the uncorrected T-scores (M=50, SD=10). A higher T-score indicates a higher level of positive affect.

    Measured: Month 0 (Time 1) t

  6. Dyads' 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 portable InBody 270 body composition analyzer. The online SAS program for Centers for Disease Control and Prevention Growth Charts was applied to calculate preschoolers' BMI for age and sex.

    Measured: Month 0

  7. Dyads' percent body fat

    Percent body fat will be measured to the nearest 0.1% using the portable InBody 270 body composition analyzer (FDA cleared medical device). When measuring % body fat, each participant's study ID, biological sex, age, and height will be entered into the scale. After the setup, each participant will be instructed to step on the scale surface and align feet with the food electrodes. When prompted, each participant will grab the hand electrodes by placing their thumbs on the thumb electrodes and wrapping their fingers around the bottom electrodes.

    Measured: Month 0

  8. Preschoolers' chronic stress

    Preschoolers' chronic stress will be assessed by hair cortisol concentration level. A proximal 3-cm segment hair sample, weighing approximately 20 mg, will be cut from 2-3 locations at the posterior vertex of each preschooler's head with a stainless-steel styling shear. Hair samples (labeled at the root ends furthest away from the head) will be stored in an aluminum foil pouch at room temperature. The hair samples will be analyzed by the Child Study Center lab at the Yale University. Cortisol in pg/mg will be extracted from the powdered hair by incubation with methanol for 18-24 hours.

    Measured: Month 0 (Time 1)

  9. Dyads' physical activity

    Actigraph (wGT3X-BT; 7-day period) worn on hip by both preschoolers and caregivers will be used to measure physical activity. Before distributing the ActiGraph to dyads for wearing, investigators will use the ActiLife software to initialize each ActiGraph and set to begin data collection at 5 AM on the day after dyads receive the ActiGraph from data collectors. When distributing the ActiGraph to dyads, the "superhero with a magic belt" story will be shared with preschoolers to encourage them to wear the ActiGraph for 7 consecutive days, and written wear instructions will be provided to caregivers: right hip (attached to belt) from time getting out of bed in AM to going to sleep at night for 7 consecutive days (not worn bathing/swimming).

    Measured: Month 0 (Time 1)

  10. Dyads' fruit/vegetable intake

    Fruit/vegetable intake will be assessed by the skin carotenoid levels via Veggie Meter® as well as a 2-question survey. Each participant's non-dominant index finger will be used, and the average of three scans with a range of 0-850 will be recorded as the final score. A high Veggie Meter score indicates a higher level of fruit/vegetable intake. For the 2-question survey, a sum score with a range of 0-10 will be calculated, with a higher score indicating a higher level of fruit/vegetable intake.

    Measured: Month 0 (Time 1)

  11. Caregivers' blood pressure

    Systolic and diastolic blood pressure will be assessed by the SunTech CT40 device. Investigators will follow the procedures in the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: 1) Caffeine, exercise, and smoking will be avoided for at least 30 minutes before measurement; 2) The caregiver will be seated quietly for at least 5 minutes in a chair, with feet on the floor and arms supported at heart level; 3) An appropriate sized cuff (cuff bladder encircling at least 80% of the arm) will be used on the left arm unless having a surgery or injury; 4) Two measurements will be taken at 1 minute interval and averaged for recording; and 5) The caregiver will receive their blood pressure reading in writing as well as the American Heart Association Blood Pressure Fact Sheet demonstrating the blood pressure categories, strategies for controlling blood pressure, and blood pressure resources.

    Measured: Month 0 (Time 1)

  12. Caregiver-preschooler relationship

    Caregiver-preschooler relationship will be measured by the 15-item Child-Parent Relationship Scale - Short Form (CPRS-SF), which is a 5-point Likert scale with 2 subscales: conflict and closeness. Sum scores (range for conflict subscale is 8-40, range for closeness subscale is 8-35) will be calculated, with a higher sum score indicating a higher level of relationship.

    Measured: Month 0 (Time 1)

  13. Caregiver mindfulness

    Caregiver mindfulness will be assessed by the 15-item Mindful Attention Awareness Scale, which is a 6-point Likert scale to assess trait mindfulness. A mean score (min-max: 1-6) will be calculated, with a higher mean score indicating a higher level of mindfulness.

    Measured: Month 0 (Time 1)

  14. Caregiver coping

    Parental coping strategies (problem-focused, emotion-focused, and avoidant coping) will be measured by the 28-item Coping Orientation to Problems Experienced Inventory (Brief-COPE). It is a 4-point Likert scale. Mean scores (min-max: 1-4) will be calculated for each coping category, with a higher mean score indicating a higher level of coping.

    Measured: Month 0 (Time 1)

  15. Household food insecurity

    The U.S. Household Food Security Survey Module will be used to assess household, parent, and preschooler food insecurity status. Raw sum score will be calculated for each outcome (household food insecurity raw score range is 0-18, raw score range for adult food insecurity is 0-10, raw score range for child food insecurity is 0-8) and then divided into food insecure and food secure categories. A higher raw score indicates a higher level of food insecurity.

    Measured: Month 0 (Time 1)

  16. Home environment

    Home environment will be assessed by the 20-item Family Nutrition and Physical Activity Screening Tool.t has two subscales: eating and physical activity home environment. A sum score, with a range of 10-80 will be calculated, with a higher sum score indicating a healthier home environment.

    Measured: Month 0 (Time 1)

  17. Caregivers' anxiety and depression

    Caregivers' anxiety and depression will be measured by the Patient Health Questionnaire (PHQ)-4. The PHQ-4 is a questionnaire answered on a four point Likert-type scale. It has the two-item measure for depression (PHQ-2) and a two-item measure for anxiety (Generalized Anxiety Disorder, GAD-2). The total PHQ-4 score (range 0-12) will be calculated, with a higher score indicating a higher level of anxiety and depression.

    Measured: Month 0 (Time 1)

  18. Caregivers' stress

    Caregivers' stress will be assessed by the 10-item Perceived Stress Scale. It is a 5-point Likert scale, with response choices of never to very often. A sum score (range: 0-40) will be calculated, with a higher sum score indicating a higher level of perceived stress.

    Measured: Month 0 (Time 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start3 Dec 2023
  3. Primary completion30 Apr 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
One-group pilot study with baseline assessment (T1) only.
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05964218
Sponsor's protocol ID
STUDY00009256
Other IDs
UG3AT012521
Status last verified
Sep 2024
First submitted
18 Jul 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified electronic data and associated documentations will be archived for future use. Data will only be made available under the terms and conditions consistent with the informed consent and as approved by the university IRB and any laws and regulations. All personal identifiers (e.g., name, contact data) will be deleted from datasets. Investigators will replace original ID numbers with new, randomized ID numbers to serve linkage with existing data both in terms of the ID number and order within the data. Key study documents (e.g., protocols, procedures, and instruments) that will enable the use of prepared datasets by outside investigators will be provided. Study documentations will include descriptive information regarding study protocols, data collection instruments, codebooks, algorithms for calculated or derived data elements, descriptions of data derived from objective measurements or procedures, and descriptions of all variable recoding performed.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Food-Body-Mind Intervention in people with Children's Mental, Emotional, Behavioral, and Physical Health, run by Michigan State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preschoolers' problem behaviors (time frame: Month 0 (Time 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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