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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH092435 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The US prevalence of childhood-onset obesity and type 2 diabetes, both predictors of cardiovascular risk, have increased to epidemic proportions in recent decades. Children with mental illness, especially those treated with antipsychotic medications, are at additional risk for obesity (adiposity) and related risk conditions. A variety of noninvasive techniques to assess cardiometabolic risk have begun to be applied in children, including body composition measured with dual energy x-ray absorptiometry (DEXA), carotid intima media thickness (CIMT) measured by ultrasound, and hepatic triglyceride content measured using magnetic resonance (MR) imaging-estimated proton density fat fraction (PDFF). These measures allow for the early, noninvasive study of adiposity-related metabolic risk. The overall aim of this two-study research plan is to characterize the level of measurable risk using these sensitive markers in treated and untreated children with mental health disorders, and to evaluate the magnitude of change in risk that can be observed using these biomarkers in children receiving a well established behavioral weight-loss intervention.
This project will utilize sensitive, early biomarkers of disease risk, including whole body adiposity with DEXA, PDDF and CIMT, directly relevant to diabetes and cardiovascular disease risk. The primary goals of this study are to deliver an evidence-based weight loss intervention to the population of youth who are overweight or obese as a result of antipsychotic treatment, to characterize metabolic risk associated with weight using sensitive biomarkers, and to evaluate the magnitude of change observed in these biomarkers in children receiving an established behavioral weight-loss intervention.
Aim 1: To evaluate the main effect of time of 16 weeks of a Behavioral Weight Loss (BWL) intervention on DEXA-measured whole body adiposity in overweight/obese antipsychotic (AP)-treated children compared to nonpsychiatric (NP) overweight or obese healthy controls, and in AP-treated youth randomized to monthly Usual Care (UC).
Aim 2: To evaluate the main effect of time of 16 weeks of a BWL intervention on PDFF in overweight/obese AP-treated children compared to NP overweight or obese healthy controls, and in AP-treated youth randomized monthly UC.
Aim 3: To evaluate the main effect of time of 16 weeks of a weekly behavioral weight loss intervention on CIMT in overweight/obese AP-treated children compared to NP overweight or obese healthy controls, and in AP-treated youth randomized monthly UC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antipsychotic Treated Educational Cntrl | Placebo Comparator | Antipsychotic treated participants randomized to this arm will receive diet and exercise education at monthly intervals with a study clinician or coordinator. |
|
| Antipsychotic Treated Weekly BWL | Experimental | Antipsychotic treated participants randomized to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist. |
|
| Non-antipsychotic Treated Weekly BWL | Active Comparator | Participants assigned to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Weight Loss | Behavioral | This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit. |
| Measure | Description | Time Frame |
|---|---|---|
| DEXA-measured Adiposity | Dual-Energy X-Ray Absorptiometry (DEXA) will be used to assess body fat at baseline and following 16 weeks of participation in a behavioral weight loss intervention. | Baseline and 16 weeks |
| Proton Density Fat Fraction (PDFF) | 1H Magnetic Resonance Spectroscopy (MRS) of liver will be used to assess intracellular triglyceride content at baseline and following 16 weeks of participation in a behavioral weight loss intervention. | Baseline and 16 weeks |
| Carotid Artery Intima Media Thickness (CIMT) | 9-13-MHZ B-mode Carotid Ultrasound will be used to assess intima media thickness at baseline and following 16 weeks of participation in a behavioral weight loss intervention. | Baseline and 16 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Aberrant Behavior Checklist (ABC) | Change From Baseline in Aberrant Behavior Checklist - Irritability Subscale at 16 Weeks | Baseline and 16 weeks |
INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Ginger E Nicol, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30994376 | Derived | Nicol GE, Kolko R, Lenze EJ, Yingling MD, Miller JP, Ricchio AR, Schweiger JA, Findling RL, Wilfley D, Newcomer JW. Adiposity, Hepatic Triglyceride, and Carotid Intima Media Thickness During Behavioral Weight Loss Treatment in Antipsychotic-Treated Youth: A Randomized Pilot Study. J Child Adolesc Psychopharmacol. 2019 Aug;29(6):439-447. doi: 10.1089/cap.2018.0120. Epub 2019 Apr 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Antipsychotic Treated Educational Control | Antipsychotic treated participants randomized to this arm will receive diet and exercise education at monthly intervals with a study clinician or coordinator. Diet and Exercise Education: Participants assigned to this arm will receive monthly medically validated, individualized diet and exercise education by a trained research professional. |
| FG001 | Antipsychotic Treated Weekly Behavioral Weight Loss | Antipsychotic treated participants randomized to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist. Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit. |
| FG002 | Non-antipsychotic Treated Weekly Behavioral Weight Loss | Participants assigned to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist. Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Antipsychotic Treated Educational Control | Antipsychotic treated participants randomized to this arm will receive diet and exercise education at monthly intervals with a study clinician or coordinator. Diet and Exercise Education: Participants assigned to this arm will receive monthly medically validated, individualized diet and exercise education by a trained research professional. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | DEXA-measured Adiposity | Dual-Energy X-Ray Absorptiometry (DEXA) will be used to assess body fat at baseline and following 16 weeks of participation in a behavioral weight loss intervention. | Modified Intent to Treat (ITT) sample with week 0 and week 16 data. | Posted | Mean | Standard Deviation | kilograms | Baseline and 16 weeks |
|
Adverse event data was collected over a period of 16 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antipsychotic Treated Educational Control | Antipsychotic treated participants randomized to this arm will receive diet and exercise education at monthly intervals with a study clinician or coordinator. Diet and Exercise Education: Participants assigned to this arm will receive monthly medically validated, individualized diet and exercise education by a trained research professional. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ginger Nicol | Washington University | 314-362-2461 | nicolg@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2018 | Sep 13, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Diet and Exercise Education | Behavioral | Participants assigned to this arm will receive monthly medically validated, individualized diet and exercise education by a trained research professional. |
|
| BG001 | Antipsychotic Treated Weekly Behavioral Weight Loss | Antipsychotic treated participants randomized to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist. Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit. |
| BG002 | Non-antipsychotic Treated Weekly Behavioral Weight Loss | Participants assigned to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist. Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Primary Diagnosis | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | meters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| DEXA-Measured Body Composition | Mean | Standard Deviation | percentage of body composition |
|
| Proton Density Fat Fraction (PDFF) | Mean | Standard Deviation | percentile |
|
| Carotid Intima Media Thickness | Mean | Standard Deviation | centimeters |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per meter-squared |
|
| Body Mass Index (BMI) Percentile | Mean | Standard Deviation | percentile |
|
| Body Mass Index (BMI) Z-Score | The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched children). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. | Mean | Standard Deviation | z-score |
|
| Waist Circumference | Mean | Standard Deviation | centimeters |
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| Baseline Fasting Laboratory Values | Mean | Standard Deviation | mg/dl |
|
| Aberrant Behavior Checklist (ABC) | This instrument is a five-factor scale comprising 58 items under the categories of (I) Irritability, Agitation, Crying; (II) Lethargy, Social Withdrawal; (III) Stereotypic Behavior; (IV) Hyperactivity, Noncompliance; and (V) Inappropriate Speech. The 15-item Irritability subscale score ranges from 0 to 45. The cut-off of ≥ 18 on this subscale will identify individuals that are 1.3 to 1.5 SD above the mean. A lower score is better.The total score can range from a minimum of 0 (no problem behaviors) to a maximum of 174, with higher scores indicating a worse outcome/more symptoms. | Mean | Standard Deviation | units on a scale |
|
| Child Behavior Checklist (CBCL) | The CBCL/ABCL is a 113 item scale that serves as a general screening measure of behavior problems, competencies, and school functioning. Each item is scored a 0, 1, or 2. A lower score is better. The eight empirically-based syndrome scales are: Aggressive Behavior, Anxious/Depressed, Attention Problems, Rule-Breaking Behavior, Somatic Complaints, Social Problems, Thought Problems and Withdrawn/Depressed. | Mean | Standard Deviation | units on a scale |
|
Antipsychotic treated participants randomized to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist. Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit. |
| OG002 | Non-antipsychotic Treated Weekly Behavioral Weight Loss | Participants assigned to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist. Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit. |
|
|
|
| Primary | Proton Density Fat Fraction (PDFF) | 1H Magnetic Resonance Spectroscopy (MRS) of liver will be used to assess intracellular triglyceride content at baseline and following 16 weeks of participation in a behavioral weight loss intervention. | Modified Intent to Treat (ITT) sample with week 0 and week 16 data. | Posted | Mean | Standard Deviation | percent | Baseline and 16 weeks |
|
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|
|
| Primary | Carotid Artery Intima Media Thickness (CIMT) | 9-13-MHZ B-mode Carotid Ultrasound will be used to assess intima media thickness at baseline and following 16 weeks of participation in a behavioral weight loss intervention. | Modified Intent to Treat (ITT) sample with week 0 and week 16 data. | Posted | Mean | Standard Deviation | millimeters | Baseline and 16 weeks |
|
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| Other Pre-specified | Aberrant Behavior Checklist (ABC) | Change From Baseline in Aberrant Behavior Checklist - Irritability Subscale at 16 Weeks | Modified Intent to Treat (ITT) sample with week 0 and week 16 data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 16 weeks |
|
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|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Antipsychotic Treated Weekly Behavioral Weight Loss | Antipsychotic treated participants randomized to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist. Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | Non-antipsychotic Treated Weekly Behavioral Weight Loss | Participants assigned to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist. Behavioral Weight Loss: This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |