Improving Cardiometabolic Health of Youth on Antipsychotic Medication

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877823
• Other study ID #: 69387
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

1. Youth between the ages of 8-16 (inclusive) at time of enrollment

2. New antipsychotic prescription preauthorization approval in the Maryland Medicaid Peer Review program (youth)

3. Parent/legal guardian of the eligible youth

Exclusion Criteria:

1. One or both of dyad pair is non-English speaking

2. Youth lacking parent/ guardian with authority to consent for treatment (foster care youth)

3. Youth residing in residential, group home, or juvenile justice detention facilities (parent participation is required to support daily activity goals)

4. Youth currently treated in an inpatient hospital treatment program

5. Youth unable to communicate verbally (to participate in dietary recall)

6. Youth IQ <55 by WASI

7. Youth who are wheelchair bound (due to accelerometer placement)

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Treatment
Healthy Lifestyle Education, bottled water, pedometer, family navigator service
• Control
Healthy Lifestyle Education

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in youth blood pressure	Measure blood pressure at baseline, 3 and 6 months.	baseline, 3 months,6 months
Other	Change in youth fasting glucose from baseline to 6 months	fasting glucose at baseline, 3 months, 6 months	baseline, 3 months,6 months
Other	Change in youth fasting triglycerides from baseline to 6 months	fasting triglycerides at baseline, 3 months, 6 months	baseline, 3 months, 6 months
Primary	Change in youth BMI z-score from baseline to 6 months	Measurement of height/weight to calculate BMI and conversion to z-score at baseline, 3 months, 6 month	baseline, 3 months, 6 months
Primary	Change in youth sugar sweetened beverage consumption	USDA 24 hour dietary recall administered at baseline, 3 months and 6 months	baseline, 3 months, 6 months
Primary	Change in youth physical activity level	Measured by accelerometry for 1 week at baseline, 3 months, 6 months	baseline, 3 months, 6 months
Secondary	Change in parent BMI	Measurement of height/weight at baseline, 3 months, 6 months	baseline, 3 months,6 months
Secondary	Change in parent activity level	Measured by the ENERGY-Parent Questionnaire at baseline, 3 month, 6 month	baseline, 3 months,6 months
Secondary	Change in parent consumption of sugar sweetened beverages (SSB)	USDA 24 hour dietary recall at baseline, 3 months, 6 months	baseline, 3 months, 6 months
Secondary	Change in parent blood pressure (BP)	BP at baseline, 3 months, 6 months	baseline, 3 months, 6 months