Improving Cardiometabolic Health of Youth on Antipsychotic Medication

NCT02877823 | Completed DMC

• 1 other identifier: 69387
• Study Type: interventional
• Target: 302
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Pediatric Antipsychotic Treatment; Pediatric healthy lifestyle intervention; Parent peer support

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Change in youth physical activity level

  Measured by accelerometry for 1 week at baseline, 3 months, 6 months

  baseline, 3 months, 6 months

Secondary Outcomes (4)

• Change in parent BMI

  baseline, 3 months,6 months

• Change in parent activity level

  baseline, 3 months,6 months

• Change in parent consumption of sugar sweetened beverages (SSB)

  baseline, 3 months, 6 months

• Change in parent blood pressure (BP)

  baseline, 3 months, 6 months

Other Outcomes (3)

• Change in youth blood pressure

  baseline, 3 months,6 months

• Change in youth fasting glucose from baseline to 6 months

  baseline, 3 months,6 months

• Change in youth fasting triglycerides from baseline to 6 months

  baseline, 3 months, 6 months

Study Arms (2)

Treatment

EXPERIMENTAL

1. Home delivery of bottled water supplying 48 oz. /day for the child and 24 oz. /day per other household members (up to 6 family members). 2. Child pedometer use and activity tracking to encourage child physical activity/goal setting and engage parents in monitoring their child's health behavior. 3. Family Navigator Services by telephone with the parent to help 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). 4. Healthy Lifestyle Education based on the American Academy of Pediatrics Institute for the Healthiest Childhood Weight daily guidelines which are 5 fruit and vegetable servings, two hours or less screen time, one hour or more physical activity, no sugary drinks daily and limit fruit juice to one hundred percent real fruit juice.

Behavioral: Treatment

Control

ACTIVE COMPARATOR

Healthy Lifestyle Education based on the American Academy of Pediatrics Institute for the Healthiest Childhood Weight daily guidelines which are 5 fruit and vegetable servings, two hours or less screen time, one hour or more physical activity, no sugary drinks and limit fruit juice to one hundred percent real fruit juice.

Behavioral: Control

Interventions

Treatment BEHAVIORAL

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

Also known as: HLE Home

Treatment

Control BEHAVIORAL

Healthy Lifestyle Education

Control

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Youth between the ages of 8-16 (inclusive) at time of enrollment
• New antipsychotic prescription preauthorization approval in the Maryland Medicaid Peer Review program (youth)
• Parent/legal guardian of the eligible youth

You may not qualify if:

• One or both of dyad pair is non-English speaking
• Youth lacking parent/ guardian with authority to consent for treatment (foster care youth)
• Youth residing in residential, group home, or juvenile justice detention facilities (parent participation is required to support daily activity goals)
• Youth currently treated in an inpatient hospital treatment program
• Youth unable to communicate verbally (to participate in dietary recall)
• Youth IQ \<55 by WASI
• Youth who are wheelchair bound (due to accelerometer placement)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Related Publications (33)

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MeSH Terms

Conditions

Pediatric Obesity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Child Psychiatrist

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: August 24, 2016
• Study Start: August 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share