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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.
Study Procedures:
All parent/child participants:
Child-only measures
INTERVENTION GROUP only
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment | Behavioral | Healthy Lifestyle Education, bottled water, pedometer, family navigator service |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in parent BMI | Measurement of height/weight at baseline, 3 months, 6 months | baseline, 3 months,6 months |
| Change in parent activity level | Measured by the ENERGY-Parent Questionnaire at baseline, 3 month, 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in youth blood pressure | Measure blood pressure at baseline, 3 and 6 months. | baseline, 3 months,6 months |
| Change in youth fasting glucose from baseline to 6 months | fasting glucose at baseline, 3 months, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25603449 | Result | Christian RB, Gaynes BN, Saavedra LM, Sheitman B, Wines R, Jonas DE, Viswanathan M, Ellis AR, Woodell C, Carey TS. Use of antipsychotic medications in pediatric and young adult populations: future research needs. J Psychiatr Pract. 2015 Jan;21(1):26-36. doi: 10.1097/01.pra.0000460619.10429.4c. | |
| 24570244 | Result |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Control | Behavioral | Healthy Lifestyle Education |
|
| baseline, 3 months,6 months |
| 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 |
| Change in parent blood pressure (BP) | BP at baseline, 3 months, 6 months | baseline, 3 months, 6 months |
| baseline, 3 months,6 months |
| Change in youth fasting triglycerides from baseline to 6 months | fasting triglycerides at baseline, 3 months, 6 months | baseline, 3 months, 6 months |
| Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732. |
| 22087679 | Result | Juonala M, Magnussen CG, Berenson GS, Venn A, Burns TL, Sabin MA, Srinivasan SR, Daniels SR, Davis PH, Chen W, Sun C, Cheung M, Viikari JS, Dwyer T, Raitakari OT. Childhood adiposity, adult adiposity, and cardiovascular risk factors. N Engl J Med. 2011 Nov 17;365(20):1876-85. doi: 10.1056/NEJMoa1010112. |
| 22868273 | Result | Olfson M, Blanco C, Liu SM, Wang S, Correll CU. National trends in the office-based treatment of children, adolescents, and adults with antipsychotics. Arch Gen Psychiatry. 2012 Dec;69(12):1247-56. doi: 10.1001/archgenpsychiatry.2012.647. |
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| 19861668 | Result | Correll CU, Manu P, Olshanskiy V, Napolitano B, Kane JM, Malhotra AK. Cardiometabolic risk of second-generation antipsychotic medications during first-time use in children and adolescents. JAMA. 2009 Oct 28;302(16):1765-73. doi: 10.1001/jama.2009.1549. |
| 22795214 | Result | Bushe CJ, Slooff CJ, Haddad PM, Karagianis JL. Weight change from 3-year observational data: findings from the worldwide schizophrenia outpatient health outcomes database. J Clin Psychiatry. 2012 Jun;73(6):e749-55. doi: 10.4088/JCP.11m07246. |
| 25190097 | Result | Ballon JS, Pajvani U, Freyberg Z, Leibel RL, Lieberman JA. Molecular pathophysiology of metabolic effects of antipsychotic medications. Trends Endocrinol Metab. 2014 Nov;25(11):593-600. doi: 10.1016/j.tem.2014.07.004. Epub 2014 Sep 2. |
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| 24889953 | Result | Basu S, Seligman HK, Gardner C, Bhattacharya J. Ending SNAP subsidies for sugar-sweetened beverages could reduce obesity and type 2 diabetes. Health Aff (Millwood). 2014 Jun;33(6):1032-9. doi: 10.1377/hlthaff.2013.1246. |
| 18519465 | Result | Wang YC, Bleich SN, Gortmaker SL. Increasing caloric contribution from sugar-sweetened beverages and 100% fruit juices among US children and adolescents, 1988-2004. Pediatrics. 2008 Jun;121(6):e1604-14. doi: 10.1542/peds.2007-2834. |
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| 26524515 | Result | Reeves GM, Wehring HJ, Connors KM, Bussell K, Schiffman J, Medoff DR, Tsuji T, Walker J, Brown A, Strobeck D, Clough T, Rush CB, Riddle MA, Love RC, Zachik A, Hoagwood K, Olin SS, Stephan S, Okuzawa N, Edwards S, Baquet C, dosReis S. The Family Value of Information, Community Support, and Experience Study: Rationale, Design, and Methods of a "Family-Centered" Research Study. J Nerv Ment Dis. 2015 Dec;203(12):896-900. doi: 10.1097/NMD.0000000000000393. |
| 34143682 | Derived | Bussell K, Reeves G, Hager E, Zhu S, Correll CU, Riddle MA, Sikich L. Dietary Consumption Among Youth with Antipsychotic-Induced Weight Gain and Changes Following Healthy Lifestyle Education. J Child Adolesc Psychopharmacol. 2021 Jun;31(5):364-375. doi: 10.1089/cap.2020.0173. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |