xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05964218</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00009256</org_study_id>
      <nct_id>NCT05964218</nct_id>
    </id_info>
    <brief_title>Food-Body-Mind Intervention</brief_title>
    <official_title>Food-Body-Mind Intervention: Promote Whole Child Health</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Michigan State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Michigan State University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national&#xD;
        emergency of mental health crises in early childhood. By targeting Head Start&#xD;
        racially/ethnically diverse preschoolers from low-income backgrounds in both urban and rural&#xD;
        areas, this intervention is expected to contribute toward reducing health disparities and&#xD;
        promoting health equity, a major priority of the NIH and Healthy People 2030. If effective,&#xD;
        it can be scalable to Head Start programs across urban and rural settings nationally with&#xD;
        long-term sustainability benefits.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Mental, emotional, and behavioral (MEB) disorders begin in early childhood, with one in six&#xD;
        US preschoolers aged 3-5 years diagnosed with a MEB disorder. Children from low income and&#xD;
        economically marginalized (LIEM) backgrounds have a higher risk of being diagnosed with MEB&#xD;
        disorders than those from higher income families. To address the mental and physical health&#xD;
        disparities based on socioeconomic status, ethnicity/race, and urban/rural residency, the&#xD;
        proposed study will target Head Start racially/ethnically diverse preschoolers from LIEM&#xD;
        backgrounds in both urban and rural areas. Guided by the Actor-Partner Interdependence Model,&#xD;
        the Allostatic Load Model, and the Transactional Theory of Stress and Coping, the proposed&#xD;
        16-week Food-Body-Mind intervention includes: 1) a school-based mindfulness component&#xD;
        delivered to equip preschoolers with knowledge and skills in mindful eating and movement&#xD;
        (e.g., yoga, deep breathing exercises); 2) a home-based mindfulness component to increase&#xD;
        caregivers' skills in practicing mindful eating, movement, and parenting behaviors at home to&#xD;
        foster a more positive, mindful, and healthy home environment; and 3) a school learning and&#xD;
        home practice connection component to improve caregiver-preschooler relationships. The&#xD;
        purpose of this 5-year cluster randomized controlled trial is to evaluate the effects of the&#xD;
        16-week school- and home-based, multi-component, Food-Body-Mind intervention on improving&#xD;
        both preschoolers' and caregivers' MEB and physical health. The long-term goal is to achieve&#xD;
        optimal whole child health in early childhood to foster a healthier generation in the US.&#xD;
        Fifty Head Start daycare centers will be randomized into the intervention (n=25: 8 urban and&#xD;
        17 rural daycare centers) or usual care control group (n=25: 8 urban and 17 rural daycare&#xD;
        centers). Five caregiver-preschooler dyads will be recruited from each daycare classroom&#xD;
        (total 400 dyads from 80 daycare classrooms: 200 urban dyads and 200 rural dyads). Analyses&#xD;
        will be based on the intention-to-treat principle. The three aims are to: 1) determine&#xD;
        effects of the intervention on improving preschoolers' mental (chronic stress by hair&#xD;
        cortisol), emotional (sadness, fear, anger, positive affect), behavioral (problem behaviors,&#xD;
        social skills), and physical health (BMI z-score, % body fat) from baseline (0 month) to 4&#xD;
        months (immediate post-intervention) and to 16 months post-baseline (12-month F/U) when&#xD;
        compared to control group in geographically diverse urban and rural Head Start daycare sites;&#xD;
        2) examine intervention effects on improving caregivers' physical (BMI, % body fat, blood&#xD;
        pressure) and mental (stress, anxiety, depression) health from 0 to 4 months and to 16 months&#xD;
        (12-month F/U) compared to control; and 3) explore the potential mediators (caregiver&#xD;
        mindfulness, emotional eating, physical activity, F/V intake, caregiver-preschooler&#xD;
        relationship, and caregiver coping) of intervention effects on preschoolers' MEB and physical&#xD;
        health and caregivers' physical and mental health from 0 to 4 months and to 16 months&#xD;
        (12-month F/U). Results from this study will improve the evidence base of complementary and&#xD;
        integrative health approaches that can be delivered in geographically diverse daycare&#xD;
        settings.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2028</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Two-group cluster RCT.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
      <masking_description>Investigators will blind data collectors, participants, statistician, and all co-Is in this study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Preschoolers' problem behaviors</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Preschoolers' problem behaviors</measure>
      <time_frame>Change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preschoolers' social skills</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preschoolers' sadness</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>Sadness will be assessed by the 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preschoolers' fear</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>Fear will 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preschoolers' anger</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preschoolers' positive affect</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dyads' BMI</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dyads' percent body fat</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preschoolers' chronic stress</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dyads' physical activity</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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 &quot;superhero with a magic belt&quot; 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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dyads' fruit/vegetable intake</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregivers' blood pressure</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregivers' anxiety</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>Anxiety will be measured by the 8-item, 5-Likert Neuro-QoL Anxiety Short Form. The scale has five response choices (never, almost never, sometimes, fairly often, very often). A calculated total raw scale score will be transformed to a T-score (mean=50, SD=10). Higher T-scores indicate greater anxiety levels.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preschoolers' emotional eating</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>Emotional eating among preschoolers will be measured by the 35-item Child Eating Behaviour Questionnaire. The Child Eating Behaviour Questionnaire has 8 subscales including food responsiveness, emotional over-eating, enjoyment of food, desire to drink, satiety responsiveness, slowness in eating, emotional under-eating, and food fussiness. Mean scores (range: 1-5) will be calculated for each subscale, and a higher mean score indicates a higher level of that eating behavior.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregiver-preschooler relationship</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregiver mindfulness</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregiver coping</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Household food insecurity</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Home environment</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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. I</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregivers' depression</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>Depression will be measured by the Neuro-QoL Depression Short Form. The 8-item Neuro-QoL Depression Short Form has five response choices (never, almost never, sometimes, fairly often, very often). A calculated total raw score will be transformed to a T-score (mean=50, SD=10). Higher T-scores indicate greater depression levels.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregivers' anxiety and depression</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>Caregivers' anxiety and depression will be measured by the Patient Health Questionnaire (PHQ)-4. The PHQ-4 is a four 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregivers' emotional eating</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>Emotional eating among caregivers will be measured by the 18-item Three-Factor Eating Questionnaire. The 18-item Three-Factor Eating Questionnaire has three subscales including uncontrolled eating, cognitive restraint, and emotional eating. Mean scores (range 1-4) will be calculated, with a higher score indicating a higher level of emotional eating.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregivers' stress</measure>
      <time_frame>Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Children's Mental, Emotional, Behavioral, and Physical Health</condition>
    <arm_group>
      <arm_group_label>Food-Body-Mind Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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 &quot;Tasty Healthy Cookbook,&quot; &quot;MyPlate&quot; 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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Food-Body-Mind Intervention</intervention_name>
      <description>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.</description>
      <arm_group_label>Food-Body-Mind Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Parental consent and child (if the child is 5 years) verbal assent received&#xD;
  &#xD;
            2. Participants understand and speak English&#xD;
  &#xD;
            3. Children are 3-5 years old attending a Head Start program and caregivers are the&#xD;
               primary adult caregivers for the children&#xD;
  &#xD;
            4. Caregivers are willing to use Facebook or the private program website for&#xD;
               participation&#xD;
  &#xD;
            5. Participants have at least weekly internet access using a smartphone, a tablet, or a&#xD;
               computer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. preschoolers who have a motor disability or impairment (e.g., cerebral palsy, spinal&#xD;
               cord injury, lost or damaged limb, motor skills disorder, muscular dystrophy, spina&#xD;
               bifida) preventing them from participating in any physical activity;&#xD;
  &#xD;
            2. preschoolers who have a diagnosed medical condition (e.g., phenylketonuria, pediatric&#xD;
               malabsorption syndrome, pollen food allergy syndrome) requiring a restrict diet and&#xD;
               precluding them from any dietary changes particularly fruit/vegetable intake; and&#xD;
  &#xD;
            3. preschoolers who have diagnosed disorders (e.g., autism spectrum disorder) causing&#xD;
               difficulty with communication and interaction with other people. Investigators expect&#xD;
               these three criteria will exclude very few preschoolers based on investigators' prior&#xD;
               clinical trial experiences working with Head Start daycare centers.&#xD;
  &#xD;
          There will be no exclusion criterion for primary adult caregivers, as the primary focus is&#xD;
          preschoolers and caregivers serve as a support role.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>5 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jiying Ling, PhD</last_name>
      <phone>5173538591</phone>
      <email>lingjiyi@msu.edu</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Michigan State University</investigator_affiliation>
      <investigator_full_name>Jiying Ling</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>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.&#xD;
  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.&#xD;
  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.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will become available within 24 months after the study ends, and last for a minimum of 10 years.</ipd_time_frame>
      <ipd_access_criteria>De-identified data can be shared with request.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05964218
  org study id: STUDY00009256
  nct id: NCT05964218
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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 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. The
        purpose of this 5-year cluster randomized controlled trial is to evaluate the effects of the
        16-week school- and home-based, multi-component, Food-Body-Mind intervention on improving
        both preschoolers' and caregivers' MEB and physical health. The long-term goal is to achieve
        optimal whole child health in early childhood to foster a healthier generation in the US.
        Fifty Head Start daycare centers will be randomized into the intervention (n=25: 8 urban and
        17 rural daycare centers) or usual care control group (n=25: 8 urban and 17 rural daycare
        centers). Five caregiver-preschooler dyads will be recruited from each daycare classroom
        (total 400 dyads from 80 daycare classrooms: 200 urban dyads and 200 rural dyads). Analyses
        will be based on the intention-to-treat principle. The three aims are to: 1) determine
        effects of the intervention on improving preschoolers' mental (chronic stress by hair
        cortisol), emotional (sadness, fear, anger, positive affect), behavioral (problem behaviors,
        social skills), and physical health (BMI z-score, % body fat) from baseline (0 month) to 4
        months (immediate post-intervention) and to 16 months post-baseline (12-month F/U) when
        compared to control group in geographically diverse urban and rural Head Start daycare sites;
        2) examine intervention effects on improving caregivers' physical (BMI, % body fat, blood
        pressure) and mental (stress, anxiety, depression) health from 0 to 4 months and to 16 months
        (12-month F/U) compared to control; and 3) explore the potential mediators (caregiver
        mindfulness, emotional eating, physical activity, F/V intake, caregiver-preschooler
        relationship, and caregiver coping) of intervention effects on preschoolers' MEB and physical
        health and caregivers' physical and mental health from 0 to 4 months and to 16 months
        (12-month F/U). Results from this study will improve the evidence base of complementary and
        integrative health approaches that can be delivered in geographically diverse daycare
        settings.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two-group cluster RCT.
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  masking description: Investigators will blind data collectors, participants, statistician, and all co-Is in this study.
  measure: Preschoolers' problem behaviors
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2)
  description: 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.
  measure: Preschoolers' problem behaviors
  time frame: Change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  measure: Preschoolers' social skills
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  measure: Preschoolers' sadness
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: Sadness will be assessed by the 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.
  measure: Preschoolers' fear
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: Fear will 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.
  measure: Preschoolers' anger
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  measure: Preschoolers' positive affect
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  measure: Dyads' BMI
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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 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.
  measure: Dyads' percent body fat
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  measure: Preschoolers' chronic stress
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  measure: Dyads' physical activity
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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).
  measure: Dyads' fruit/vegetable intake
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  measure: Caregivers' blood pressure
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  measure: Caregivers' anxiety
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: Anxiety will be measured by the 8-item, 5-Likert Neuro-QoL Anxiety Short Form. The scale has five response choices (never, almost never, sometimes, fairly often, very often). A calculated total raw scale score will be transformed to a T-score (mean=50, SD=10). Higher T-scores indicate greater anxiety levels.
  measure: Preschoolers' emotional eating
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: Emotional eating among preschoolers will be measured by the 35-item Child Eating Behaviour Questionnaire. The Child Eating Behaviour Questionnaire has 8 subscales including food responsiveness, emotional over-eating, enjoyment of food, desire to drink, satiety responsiveness, slowness in eating, emotional under-eating, and food fussiness. Mean scores (range: 1-5) will be calculated for each subscale, and a higher mean score indicates a higher level of that eating behavior.
  measure: Caregiver-preschooler relationship
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  measure: Caregiver mindfulness
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  measure: Caregiver coping
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  measure: Household food insecurity
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  measure: Home environment
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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. I
  measure: Caregivers' depression
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: Depression will be measured by the Neuro-QoL Depression Short Form. The 8-item Neuro-QoL Depression Short Form has five response choices (never, almost never, sometimes, fairly often, very often). A calculated total raw score will be transformed to a T-score (mean=50, SD=10). Higher T-scores indicate greater depression levels.
  measure: Caregivers' anxiety and depression
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: Caregivers' anxiety and depression will be measured by the Patient Health Questionnaire (PHQ)-4. The PHQ-4 is a four 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.
  measure: Caregivers' emotional eating
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: Emotional eating among caregivers will be measured by the 18-item Three-Factor Eating Questionnaire. The 18-item Three-Factor Eating Questionnaire has three subscales including uncontrolled eating, cognitive restraint, and emotional eating. Mean scores (range 1-4) will be calculated, with a higher score indicating a higher level of emotional eating.
  measure: Caregivers' stress
  time frame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
  description: 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.
  arm group label: Food-Body-Mind Intervention
  arm group type: Experimental
  description: 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.
  arm group label: Usual Care Control
  arm group type: No Intervention
  description: 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.
  intervention type: Behavioral
  intervention name: Food-Body-Mind Intervention
  description: 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.
  arm group label: Food-Body-Mind Intervention
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 5 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jiying Ling, PhD
  phone: 5173538591
  email: lingjiyi@msu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Michigan State University
  investigator full name: Jiying Ling
  investigator title: Associate Professor
  sharing ipd: Yes
  ipd description: 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.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Data will become available within 24 months after the study ends, and last for a minimum of 10 years.
  ipd access criteria: De-identified data can be shared with request.