A Community-based, Family Navigator Intervention to Improve Cardiometabolic Health of Medicaid-insured Youth Identified Through an Antipsychotic Medication Preauthorization Program

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