UH3AT012521

Food-body-mind intervention: Promote whole child health - Abstract

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 [16 classrooms] and 17 rural [17 classrooms] 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 330 dyads: 160 urban dyads and 170 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’ primary outcomes including mental (chronic stress), emotional (sadness, fear, anger, positive affect), and behavioral (problem behaviors, social skills) health as well as physical health (BMI z-score, % body fat; secondary outcomes) from baseline (0 month) to 4 months (immediate post-intervention) and to 12-month follow-up compared to control;

2) Examine the effects of the intervention on improving caregivers’ physical (BMI, % body fat, blood pressure) and mental (stress, anxiety, depression) health from 0 to 4 months and to 12-month follow-up compared to control; and

3) Explore how the intervention will modify both preschoolers’ and caregivers’ MEB and physical health via the mediating mechanisms of mindfulness, emotional eating, fruit/vegetable intake, physical activity, caregiver-preschooler relationship, and caregiver coping from 0 to 4 months and to 12-month follow-up.

Results from this study will improve the evidence base of complementary and integrative health approaches that can be delivered in geographically diverse daycare settings.

Michigan State University

TO EVALUATE COMPLEMENTARY AND INTEGRATIVE HEALTH APPROACHES. THE FOLLOWING OBJECTIVES SUPPORT THIS GOAL: (1) COORDINATE AND FACILITATE THE INVESTIGATION OF COMPLEMENTARY AND INTEGRATIVE HEALTH APPROACHES THROUGH PEER-REVIEWED GRANT SOLICITATIONS, (2) INTERFACE WITH THE NCCIH NATIONAL ADVISORY COUNCIL, (3) CONDUCT TECHNOLOGY ASSESSMENT CONFERENCES FOR THE PURPOSE OF ESTABLISHING AREAS OF CLINICAL AND PRE-CLINICAL RESEARCH THAT NEED TO BE FURTHER DEVELOPED WITHIN COMPLEMENTARY HEALTH APPROACHES, AND (4) MAINTAIN A COMPREHENSIVE BIBLIOGRAPHIC DATA BASE IN CONJUNCTION WITH THE NATIONAL LIBRARY OF MEDICINE. THE NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH (NCCIH) REGULARLY EXAMINES AND REDEFINES ITS RESEARCH PRIORITIES. IN SETTING RESEARCH PRIORITIES, NCCIH CONSIDERS ITS EXISTING RESEARCH PORTFOLIO, ITS 5-YEAR STRATEGIC PLAN, THE RECOMMENDATIONS OF THE NATIONAL ADVISORY COUNCIL FOR COMPLEMENTARY AND INTEGRATIVE HEALTH, CURRENT SCIENTIFIC ADVANCES, THE PLANS OF OTHER NIH INSTITUTES AND CENTERS, AND INPUT FROM EXPERT PANELS AND STAKEHOLDERS. RESEARCH CONSTITUTING A RIGOROUS EVIDENCE BASE FOR COMPLEMENTARY HEALTH APPROACHES WILL BE DEVELOPED THROUGH A RANGE OF RESEARCH STRATEGIES INCLUDING BASIC AND TRANSLATIONAL RESEARCH, AND CLINICAL INVESTIGATION. PRIORITY SETTING ALSO TAKES INTO ACCOUNT: 1)SCIENTIFIC PROMISE, 2)AMENABILITY TO RIGOROUS SCIENTIFIC INQUIRY,3) POTENTIAL TO CHANGE HEALTH PRACTICES, AND 4) RELATIONSHIP TO USE AND PRACTICE. RESEARCH APPROACHES BASIC, TRANSLATIONAL, EFFICACY/EFFECTIVENESS, AND IMPLEMENTATION RESEARCH FOR COMPLEMENTARY AND INTEGRATIVE HEALTH APPROACHES NEED TO BE STUDIED ACROSS THE RESEARCH CONTINUUM. NCCIH CONTINUES TO EMPHASIZE BASIC RESEARCH THAT DEFINES BIOLOGICAL EFFECTS AND MECHANISMS OF ACTION, THIS RESEARCH IS AIMED AT UNDERSTANDING THE NATURE OF COMPLEMENTARY HEALTH APPROACHES SUCH AS THEIR BIOLOGY, PHYSIOLOGY, AND PHYSICAL, CHEMICAL AND BEHAVIORAL PROPERTIES. NCCIH ALSO SUPPORTS THE DEVELOPMENT OF TOOLS, MODELS, AND METHODOLOGIES FOR STUDYING THESE APPROACHES. NCCIH CONTINUES TO ENCOURAGE EFFICACY STUDIES TO DETERMINE SPECIFIC CLINICAL EFFECTS OF COMPLEMENTARY HEALTH APPROACHES UNDER CAREFULLY CONTROLLED CONDITIONS THAT MINIMIZE NONSPECIFIC AND CONTEXTUAL EFFECTS. THERE IS ALSO THE NEED TO STRENGTHEN TRANSLATIONAL AND PRELIMINARY CLINICAL RESEARCH REQUIRED TO DESIGN AND IMPLEMENT DEFINITIVE CLINICAL RESEARCH AND ""REAL WORLD"" OUTCOMES AND EFFECTIVENESS RESEARCH THAT CAPITALIZES ON THE REALITY THAT MANY COMPLEMENTARY HEALTH APPROACHES ARE IN WIDESPREAD PUBLIC USE. NCCIH'S SUPPORT OF TRANSLATIONAL RESEARCH ADDRESSES THE NEED FOR VALID, RELIABLE AND RELEVANT RESEARCH TOOLS, OUTCOME MEASURES, AND INNOVATIVE METHODOLOGY TO ENHANCE THE RIGOR OF COMPLEMENTARY HEALTH APPROACHES WITHIN CLINICAL STUDIES AND TO ENSURE THAT THEY ARE MAXIMALLY INFORMATIVE. NCCIH EMPHASIZES STUDIES THAT INFORM THE DESIGN OF FUTURE TRIALS SUCH AS THOSE THAT WILL: DEVELOP AND VALIDATE OUTCOME MEASURES, STANDARDIZE TREATMENT PROTOCOLS OR ALGORITHMS, VALIDATE TREATMENT ALGORITHMS AND/OR, DEVELOP MEASURES OF QUALITY CONTROL OR TREATMENT FIDELITY, ASSESS EFFECTS OF VARIOUS DOSES OR INTERVENTION DURATIONS, DEVELOP PRELIMINARY CLINICAL EVIDENCE REGARDING EFFICACY AND SAFETY TO SUPPORT ESTIMATES OF SAMPLE SIZE, OR ESTABLISH FEASIBILITY OF INTERVENTIONS OR STUDY DESIGNS IN SPECIFIC POPULATIONS FOR FUTURE STUDIES. NCCIH'S CLINICAL RESEARCH PORTFOLIO UTILIZES CLINICAL TRIAL, CASE-CONTROL, OBSERVATIONAL, COHORT, QUALITATIVE, AND OTHER EXPERIMENTAL METHODOLOGIES TO DETERMINE SAFETY AND ESTIMATE THE EFFICACY OF COMPLEMENTARY HEALTH APPROACHES. THE CLINICAL RESEARCH PORTFOLIO INCLUDES EFFECTIVENESS STUDIES OF THE CONTRIBUTION TO IMPROVED HEALTH AND WELLNESS MADE BY COMPLEMENTARY HEALTH APPROACHES AS THEY ARE PRACTICED IN ""REAL-WORLD"" SETTINGS. IN GENERAL, PHASE III CLINICAL TRIALS WILL BE SUPPORTED UNDER THE COOPERATIVE AGREEMENT MECHANISM AFTER CAREFUL CONSIDERATION BY NCCIH STAFF. INVESTIGATORS INTERESTED IN PROPOSING PHASE III STUDIES ARE STRONGLY ENCOURAGED TO CONTACT A RELEVANT NCCIH PROGRAM OFFICER (HTTPS://NCCIH.NIH.GOV/TOOLS/EMAILPROGRAMOFFICERS). AREAS OF SPECIAL INTEREST FUNDAMENTAL SCIENTIFIC INQUIRY IS ESSENTIAL TO THE PROGRESS OF BIOMEDICINE BY ENHANCING THE UNDERSTANDING OF HOW LIVING SYSTEMS WORK. THIS UNDERSTANDING SERVES AS A FOUNDATION FOR TRANSLATIONAL AND CLINICAL STUDIES THAT CAN LEAD TO IMPROVED APPROACHES TO THE MANAGEMENT, TREATMENT, AND PREVENTION OF DISEASES AND SYMPTOMS. ONE KEY GOAL IS TO ADVANCE OUR UNDERSTANDING OF BASIC BIOLOGICAL MECHANISMS OF ACTION OF NATURAL PRODUCTS, INCLUDING PREBIOTICS AND PROBIOTICS. NCCIH WILL CONTINUE TO SPONSOR RESEARCH ON COMPOUNDS ISOLATED FROM NATURAL PRODUCTS AS WELL AS COMPLEX MIXTURES FROM WHICH THEY ORIGINATE. ADDITIONALLY, NCCIH WILL CONTINUE TO SUPPORT RESEARCH TO ELUCIDATE THE EFFECTS OF PREBIOTICS AND PROBIOTICS ON THE MICROBIOTA NATURALLY PRESENT IN THE HUMAN BODY. ANOTHER KEY GOAL IS TO ADVANCE OUR UNDERSTANDING OF THE MECHANISMS OF ACTION BY WHICH MIND AND BODY APPROACHES (INCLUDING, BUT NOT LIMITED TO: MEDITATION, SPINAL MANIPULATION, MASSAGE, YOGA, TAI CHI, HYPNOSIS AND ACUPUNCTURE) AFFECT HEALTH, RESILIENCY, AND WELL-BEING. A THIRD KEY GOAL IS TO DEVELOP NEW AND IMPROVED RESEARCH METHODS AND TOOLS FOR CONDUCTING RIGOROUS STUDIES OF COMPLEMENTARY HEALTH APPROACHES AND THEIR INTEGRATION INTO HEALTH CARE. THESE NEW METHODS COULD CATALYZE ADVANCES IN NATURAL PRODUCT METHODOLOGY AND SUPPORT DEVELOPMENT OF NOVEL TECHNOLOGY AND INSTRUMENTS TO CARRY OUT RIGOROUS RESEARCH ON SYMPTOM MANAGEMENT AND FUNCTIONAL CHANGES PRIMARILY FOR MIND AND BODY APPROACHES. TO IMPROVE CARE FOR HARD -TO-MANAGE SYMPTOMS SUCH AS PAIN, ANXIETY, AND DEPRESSION, BOTH MIND AND BODY PRACTICES AND NATURAL PRODUCTS WILL BE RIGOROUSLY STUDIED USING WELL-ESTABLISHED METHODOLOGY. NCCIH WILL ALSO SUPPORT STUDIES IN ""REAL WORLD"" CLINICAL SETTINGS TO TEST THE SAFETY AND EFFICACY OF COMPLEMENTARY HEALTH APPROACHES, INCLUDING THEIR INTEGRATION INTO HEALTH CARE. INDIVIDUAL BEHAVIOR PLAYS A KEY ROLE IN HEALTH PROMOTION AND DISEASE PREVENTION. IT IS WELL ESTABLISHED THAT ADOPTING AND MAINTAINING HEALTHY BEHAVIORS (E.G., DIET AND EXERCISE) AND MODIFYING UNHEALTHY BEHAVIORS REDUCES RISKS OF MAJOR CHRONIC DISEASES. NCCIH WILL INVESTIGATE MECHANISMS OF ACTION OF COMPLEMENTARY AND INTEGRATIVE HEALTH APPROACHES IN HEALTH RESILIENCE AND PRACTICES THAT IMPROVE HEALTH AND PREVENT DISEASE. THESE APPROACHES WILL BE STUDIED ACROSS THE LIFESPAN AND IN DIVERSE POPULATIONS. NCCIH WILL ALSO EXPLORE RESEARCH OPPORTUNITIES TO STUDY AND ACCESS THE SAFETY AND EFFICACY OF COMPLEMENTARY HEALTH APPROACHES IN NONCLINICAL SETTINGS SUCH AS COMMUNITY- AND EMPLOYER-BASED WELLNESS PROGRAMS. TOP SCIENTIFIC PRIORITIES THE TOP SCIENTIFIC PRIORITIES INCLUDE THE NONPHARMACOLOGIC MANAGEMENT OF PAIN, NEUROBIOLOGICAL EFFECTS AND MECHANISMS, INNOVATIVE APPROACHES FOR ESTABLISHING BIOLOGICAL SIGNATURES OF NATURAL PRODUCTS, DISEASE PREVENTION AND HEALTH PROMOTION ACROSS THE LIFESPAN, AND CLINICAL TRIALS UTILIZING INNOVATIVE STUDY DESIGNS TO ACCESS COMPLEMENTARY HEALTH APPROACHES AND THEIR INTEGRATION INTO HEALTH CARE. PAIN IS THE CONDITION FOR WHICH ADULTS IN THE UNITED STATES MOST OFTEN USE COMPLEMENTARY AND INTEGRATIVE HEALTH APPROACHES. GROWING EVIDENCE INDICATES THAT SOME COMPLEMENTARY HEALTH APPROACHES MAY HELP IN ITS TREATMENT AND MANAGEMENT. DISCOVERING THE MECHANISMS BY WHICH A COMPLEMENTARY APPROACH EXERTS ITS EFFECTS COULD HELP IN THE DESIGN OF BETTER TREATMENTS AND PREDICT WHICH PEOPLE ARE MOST LIKELY TO RESPOND. WHETHER AND HOW COMPLEMENTARY HEALTH APPROACHES DIRECTLY MODULATE OR MODIFY THE STRUCTURE AND/OR THE FUNCTION OF THE ENTIRE OR PART OF THE NERVOUS SYSTEM REMAINS UNDERSTUDIED. ADVANCES IN GENOMICS, NEUROSCIENCE, STEM CELLS, SYSTEMS BIOLOGY, AND NEUROIMAGING OFFER EXCELLENT CONCEPTUAL RESOURCES AND OPPORTUNITIES FOR INNOVATIVE AND IMPACTFUL MECHANISTIC STUDIES OF COMPLEMENTARY HEALTH APPROACHES. THE PURPOSE OF INNOVATIVE APPROACHES FOR ESTABLISHING BIOLOGICAL SIGNATURES OF NATURAL PRODUCTS IS TO ADVANCE THE CHARACTERIZATION OF THE BIOLOGIC ACTIVITY OF COMPLEX NATURAL PRODUCTS BROADLY WITH AN EMPHASIS ON DETERMINING METABOLIC PROFILES. THERE HAS BEEN A GROWING INTEREST IN THE USE OF COMPLEMENTARY HEALTH APPROACHES FOR THE PREVENTION OF MENTAL, EMOTIONAL, AND BEHAVIORAL DISORDERS AND FOR THE PROMOTION OF PSYCHOLOGICAL AND PHYSICAL HEALTH, WELL-BEING, AND RESILIENCE. HOWEVER, THE EVIDENCE FOR THE USE OF COMPLEMENTARY MODALITIES IN THE CONTEXT OF PREVENTION AND HEALTH PROMOTION IS MODEST. RIGOROUSLY DESIGNED, DEVELOPMENTALLY APPROPRIATE STUDIES ARE NEEDED TO DETERMINE THE EFFICACY AND EFFECTIVENESS OF COMPLEMENTARY HEALTH APPROACHES FOR HEALTH PROMOTION AND DISEASE PREVENTION ACROSS THE LIFESPAN. EARLY STAGE AND NEW INVESTIGATORS NCCIH IS STRONGLY COMMITTED TO ASSISTING NEW AND EARLY STAGE INVESTIGATORS IN ESTABLISHING A RESEARCH CAREER. EARLY STAGE INVESTIGATORS ARE THOSE WITHIN 10 YEARS OF COMPLETING THEIR TERMINAL RESEARCH DEGREE, OR THEIR MEDICAL RESIDENCY, OR ITS EQUIVALENT. NEW INVESTIGATORS ARE THOSE WHO HAVE YET TO COMPETE SUCCESSFULLY FOR A SUBSTANTIAL (E.G., R01) NIH RESEARCH GRANT. EACH ADVISORY COUNCIL ROUND, BASED ON AVAILABLE FUNDS, NCCIH: 1) WILL CONSIDER EARLY STAGE OR NEW INVESTIGATOR STATUS AS ONE OF THE CRITERIA FOR DESIGNATING GRANT APPLICATIONS AS BEING OF HIGH PROGRAM PRIORITY AND 2) MAY MAKE ADDITIONAL R01 GRANT AWARDS TO NEW AND EARLY STAGE INVESTIGATORS WITH PERCENTILES OR SCORES OUT OF PAYLINE ORDER. NCCIH CONTINUES TO ACCEPT APPLICATIONS IN AREAS NOT LISTED AS A SPECIFIC PRIORITY AREA VIA THE INVESTIGATOR INITIATED FUNDING OPPORTUNITIES. ALL INVESTIGATORS ARE URGED TO DISCUSS POTENTIAL APPLICATIONS WITH THE RELEVANT NCCIH PROGRAM OFFICER (HTTPS://NCCIH.NIH.GOV/TOOLS/EMAILPROGRAMOFFICERS)

93.310 - Trans-NIH Research Support

National Center for Complementary and Integrative Health (NCCIH) [HHS - NIH]

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Michigan United States

State-Wide

Fostering Mental, Emotional, and Behavioral (MEB) Health Among Children in School Settings: Opportunities for Multisite Trials of Complementary and Integrative Health Interventions (Clinical Trial Optional) (RFA-AT-23-003)

Amendment Since initial award the total obligations have increased 129% from $1,457,654 to $3,344,044.