Improving Cardiometabolic Health of Youth on Antipsychotic Medication

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.

Conditions

• Childhood Obesity

Interventions

BEHAVIORAL

Treatment

Healthy Lifestyle Education, bottled water, pedometer, family navigator service

BEHAVIORAL

Control

Healthy Lifestyle Education

Sponsors & Collaborators

• University of Maryland, Baltimore

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2021-12-31

Completion

2021-12-31