Improving Cardiometabolic Health of Youth on Antipsychotic Medication
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Pediatric antipsychotic treatment is associated with significant obesity-related side
      effects, including weight gain, increased blood sugar, abnormal cholesterol, and risk of new
      onset diabetes. Antipsychotic-induced weight gain is most prominent over the first 6 months
      of treatment. In this study, youths who are started on antipsychotic medication are
      identified for a health intervention to minimize antipsychotic-induced weight gain and also
      have collateral health benefits for the child's parent. Children are identified through a
      Medicaid medication authorization program which provides a complete list of eligible youth.
      Youth-parent pairs will be enrolled. All youth and their parents enrolled in this study are
      offered healthy lifestyle education with simple targets to reduce risk of
      antipsychotic-induced weight gain (e.g. reduce sugar sweetened beverage intake, engage in 1
      hour of daily physical activity). Half of families will also receive 1) home delivery of
      bottled water, 2) provision of a child pedometer, and 3) health coaching/support from a
      telephone-delivered, parent peer program (Family Navigator). Home water delivery has been
      demonstrated to dramatically reduce sugar sweetened beverage intake in general pediatric
      studies. Child pedometers will be used to encourage parent monitoring of child physical
      activity. Parent peer support will be provided through a Family Navigator, who is a parent
      with "lived experience" raising a child with special mental health needs. Family Navigators
      address practical barriers to lifestyle changes for low income families (e.g. identify safe
      environment for physical activity, support access to food pantries) and provide emotional
      support for parents dealing with competing child health priorities (emotional stability,
      obesity health concerns). Family Navigator contact is exclusively by phone, and all study
      visits will occur in the home. The Family Navigators are supervised by a child mental health
      expert team, with an on-call licensed clinician available to address any after hours/weekend
      urgent concerns. The impact of this intervention will be studied on both child and parent
      health outcomes (weight, blood pressure, sugar sweetened beverage consumption), child
      physical activity, as well as parent behaviors associated with child healthy lifestyle
      changes (e.g. modeling healthy behaviors, monitoring child activity). Assessment of the
      impact of this healthy lifestyle intervention on other obesity related outcomes that are
      monitored through blood work (e.g. blood sugar, cholesterol). These labs are obtained by
      community prescribers as part of standard of care and submitted to Medicaid as required for
      ongoing approval. No blood work will be done in this study protocol. Child lab results will
      be requested from the Medicaid pre-authorization program.
    

Detailed description: 
      Study Procedures:

        1. Recruitment and Randomization: Eligible youths will be identified through the Maryland
           Peer Review program when individuals are approved for pediatric antipsychotic treatment.
           A complete list of all eligible youths and the head of household (parent) contact
           information will be provided through Medicaid. All parents will be mailed a letter to
           provide information on the study. The parent will be given the option to participate or
           opt out by phone (leave a message on a secure voicemail) or by mail (send in a response
           card). If parents express interest in the study or do not opt out (i.e. no response),
           the parent will contacted by phone to provide information and ask if they are interested
           in scheduling a consent visit. Consent/assent is described in consent section of this
           application. Intelligence quotient (IQ) screening will be completed using the Wechsler
           Abbreviated Scale of Intelligence and will be administered to ensure the youth has an IQ
           greater than 55 to determine eligibility.

        2. Randomization will be performed separately in strata defined by sex and age and by
           sex-adjusted BMI percentile (85th percentile of BMI or below), using the permuted block
           method. Based on current knowledge of the population of antipsychotic treated,
           Medicaid-insured youths; it is anticipated that there will be more males enrolled than
           females.

        3. Healthy Lifestyle Education (HLE) at baseline, 3 months, 6 months All participants will
           receive HLE, which is based on the American Academy of Pediatrics Institute for the
           Healthiest Childhood Weight daily guidelines which are 5 fruit/vegetable servings, 2
           hours or less screen time (TV, computer time), 1 hour or more physical activity, 0
           sugary drinks and limit fruit juice to 100% real fruit juice. Research staff (not a
           Family Navigator) will provide this teaching to all participants during home visits in
           order to standardize education across groups. HLE will be done at baseline, 3 months and
           6 months. The parent will receive a handout with this information at each of these
           visits. Additionally, the research staff will demonstrate to the parent how to read food
           labels for beverages in the home. The parent will receive a copy of calorie count per
           serving for each of the beverages in the home. This step will allow us to educate
           families on calories of sugar sweetened beverages (SSB)and also will help us to track
           child access to sugar sweetened beverages in the home. Families will be given a handout
           that lists examples of beverages and their calorie counts per serving.

        4. Study Assessments: Assessments will be completed for both the treatment and control
           groups as part of home visits as well as telephone calls (dietary recall) at baseline, 3
           months and 6 months.

      All parent/child participants:

        -  Weight, height, and blood pressure will be measured in the home using the same portable
           equipment used for our completed NIH-funded study of pharmacologic interventions for
           antipsychotic-induced weight gain.

        -  24-hr dietary recall: Sugar sweetened beverage intake will be assessed using the United
           States Department of Agriculture Automated Multiple Pass Method (USDA AMPM) using
           National Health and Nutrition Examination Survey (NHANES) procedures. To address
           potential variability of SSB intake over the course of a typical week, we will follow
           recommended procedures to complete three 24- hour dietary recall interviews on
           non-consecutive days (2 weekdays, 1 weekend day) at baseline, 3 months, and 6 months.
           One will be completed during the home visit and the other 2 will done by telephone
           within one week of the study visit. Parent and child will be interviewed together to get
           a complete recall of the child's dietary intake over the past 24 hours.

      Child-only measures

        -  Physical activity will be measured by accelerometry. Activity outcomes will primarily be
           measured with accelerometers to obtain more accurate and comprehensive assessment of
           activity. The same accelerometer will be secured to the child's left ankle using a
           hospital band for 7 day continuous measurement. The accelerometer is light weight (0.56
           ounces), water proof, and small (29 mm x 37 mm). Physical activity measurements will
           include: 1) Estimated calorie expenditure with total accelerometer "counts"; 2) amount
           of time in light, moderate to vigorous, and sedentary activity. Of note, the amount of
           time spent in sedentary activity is an independent predictor of obesity(A pre-paid
           addressed Federal Express envelope will be provided to the parent to send the activity
           monitor back to the study team at the end of 1 week.)

        -  Lab results: Fasting glucose and triglyceride data will be obtained from the Maryland
           Peer Review Program are submitted by community providers as part of standard of care to
           the Maryland Peer Review Program to obtain ongoing authorization.This study protocol
           does not involve any phlebotomy procedures.

        -  Parent-only measure: 1) ENERGY-Parent Questionnaire on Parenting Practices ("ENERGY-PQ")
           will be used as a primary measure of parent practices/factors associated with child
           healthy lifestyle behaviors. The ENERGY-PQ (39) is a 121 item parent self-report measure
           created to assess a priori identified contributors to pediatric obesity (e.g. parent
           modeling). 2)Sugar sweetened beverages in the home. During home visits the parent will
           be asked to show any non-alcoholic beverages that are in the home so to provide teaching
           on reading food labels (e.g. is juice 100% fruit) and to keep track of access to sugar
           sweetened beverages in the home.

      INTERVENTION GROUP only

        1. Home delivery of bottled water: Methodology from two United States pediatric trials will
           be implemented by supplying 48 ounces(oz.)/day of bottled water for the child and 24
           oz./day per other household members (up to 6 family members), to avoid competition for
           this resource and encourage healthy lifestyle practices for all family members. Bottled
           water will be provided for ease of storage and to encourage drinking water outside the
           home. All youth will be provided with a doctor's note so that they are permitted to keep
           a water bottle in the classroom. All families will be provided with written material
           that also lists benefits of tap water (fluoride for dental health, low cost), However,
           Baltimore City schools do not permit tap water consumption (concern about lead
           poisoning) and the American Academy of Pediatrics recommends bottled water as an option
           for parents who have concerns about quality of home water supply. The water delivery is
           a simple environmental intervention that is appropriate for both obese/non-obese youth.

        2. Child pedometer use and activity tracking: The pedometer intervention is structured to
           1) encourage child physical activity/goal setting and 2) engage parents in monitoring
           their child's health behavior. Youth will be given a pedometer and up to two additional
           replacements over the course of the study if the pedometer is lost or broken. Prior
           studies have raised concerns that pedometers are less accurate for overweight/obese
           individuals because the spring mechanism is affected by positioning (e.g. tilting at
           waist for individuals with large abdominal girth). However, newer design pedometers
           (piezo-electric internal mechanism) have improved measurements. It will be recommended
           to the parent that youth wear the pedometer daily and the parent will be instructed on
           activity monitoring and goal setting. Physical activity goals will be structured based
           on the "small change" approach developed by Rodearmel et al. (2007). The first two weeks
           the parent tracks the child's daily activity. A goal is set to increase the daily number
           of steps by 2000 steps over the 6-month intervention. The goal begins after the baseline
           steps are reviewed. The Family Navigator will assist the parent in goal setting,
           addressing barriers to physical activity (e.g. safe environment for play), role play how
           to encourage child activity, and provide emotional support to the parent in making
           changes. The parents will be asked to check daily child activity and record this
           information on a password protected, secure website (just study ID number and number of
           steps recorded) or call in the information on a secure voicemail and we will provide
           feedback on the activity at the 3- and 6- month visits (a certificate for the child with
           their average number of steps and a graph of mean weekly steps). Tracking steps this way
           rather than using a paper log will allow time stamp when the pedometer data is checked
           and the date and time of entries will be tracked. A secure telephone voicemail option
           for parents who find it difficult or cumbersome to log on to a website daily will be
           provided and parents receive instructions and practice of the procedure at the home
           visits (baseline, 3 months).

        3. Family Navigator Services: Family engagement is viewed as critical to promoting youth
           healthy lifestyle changes. Family Navigators are viewed as "highly credible" sources of
           information because of their own experiences of raising a child with serious mental
           illness. In this study, parents will receive contact from a Family Navigator (FN) over
           the course of the study through both scheduled phone calls (weekly calls the first month
           followed by calls every 2 weeks) and ad-hoc flexible telephone delivered service
           (including weekend and evening call time availability). Utilization of FN services will
           be tracked by time, day of week, and duration of all calls. Family Navigator contact
           will serve to engage and empower parents in child healthy lifestyle changes. They will
           also be able to assist with resource needs for the household (food/housing services).

      Procedures to monitor safety and minimize risks:

      This study focuses on simple, behavioral targets (reduce sugar sweetened beverages, engage in
      daily activity) to reduce antipsychotic-induced weight gain that commonly occurs after
      medication treatment is initiated. Minimal risks are anticipated. A licensed child mental
      health clinician will be available on call (including weekends and after hours) to assess any
      urgent concerns reported by a participant, a Family Navigator, or a research staff member
      conducting a home visit. The Safety Screen will be administered with the parent and youth
      separately at the beginning of the visit. All staff will follow Maryland guidelines for
      reporting of suspected abuse/neglect, and the parents will be informed of this potential risk
      in confidentiality as part of the informed consent procedures. Any study charts that are
      needed for home visits will be transferred in a locked brief case to also protect
      confidentiality. Family Navigators will only have telephone contact on health coaching with a
      parent-guardian. Other adult family members who have a caregiver role (e.g. grandparent) can
      participate in a call only if invited by the parent and only when the parent is on the call
      (e.g. a parent can opt to include someone else by speaker phone). If the parent requests to
      have another caregiver join the visit or call no assessments or procedures will be conducted
      with that person and they will not be consented. The only purpose for allowing them to join a
      call or visit is to support the parent/child participants. Prior to signing consent, the
      Confirmation of Participant Understanding of Consent form will be administered. If the parent
      does not verbalize an adequate understanding of the study the research assistant (RA) will
      review the consent again with the parent, answer questions and then re-administer the
      Confirmation of Participant Understanding of Consent Form. If the parent is still unable to
      verbalize an adequate understanding of the study the Principal Investigator will meet with
      the parent to determine if they have an adequate understanding to be eligible to participate.
      If the parent does not verbalize an adequate understanding of the study they will not be
      eligible to participate.

      The Safety monitor will be notified within 48 hours of 1) any adverse events, including
      patient use of emergency services (Emergency room visits, hospitalizations) 2) any Child
      Protective Services reports; or 3) any clinically urgent concerns assessed by the on-call
      clinician (e.g. clinician called because parent's blood pressure met flag for review by a
      medical provider on our team).
    

Intervention name(s): Treatment; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Healthy Lifestyle Education, bottled water, pedometer, family navigator service; Healthy Lifestyle Education
Other intervention name(s): HLE Home
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Antipsychotic Treatment; Pediatric healthy lifestyle intervention; Parent peer support