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Trial record 18 of 1478 for:    child psychiatry

Healthy Bodies, Healthy Kids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01222494
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Child Mental Disorders
Obesity
Metabolic Syndrome
Interventions Behavioral: Behavioral Weight Loss
Behavioral: Diet and Exercise Education
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Antipsychotic Treated Educational Control Antipsychotic Treated Weekly Behavioral Weight Loss Non-antipsychotic Treated Weekly Behavioral Weight Loss
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 7 19 21
Completed 6 15 17
Not Completed 1 4 4
Arm/Group Title Antipsychotic Treated Educational Control Antipsychotic Treated Weekly Behavioral Weight Loss Non-antipsychotic Treated Weekly Behavioral Weight Loss Total
Hide Arm/Group Description

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 7 19 21 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 19 participants 21 participants 47 participants
12.80  (2.21) 13.35  (2.57) 13.42  (2.46) 13.30  (2.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 19 participants 21 participants 47 participants
Female
1
  14.3%
5
  26.3%
15
  71.4%
21
  44.7%
Male
6
  85.7%
14
  73.7%
6
  28.6%
26
  55.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 19 participants 21 participants 47 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
   4.8%
1
   2.1%
Not Hispanic or Latino
7
 100.0%
19
 100.0%
20
  95.2%
46
  97.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 19 participants 21 participants 47 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
  15.8%
6
  28.6%
9
  19.1%
White
7
 100.0%
15
  78.9%
13
  61.9%
35
  74.5%
More than one race
0
   0.0%
1
   5.3%
2
   9.5%
3
   6.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Primary Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 19 participants 21 participants 47 participants
Autism
4
  57.1%
11
  57.9%
0
   0.0%
15
  31.9%
Pervasive Development Disorder (PDD)
1
  14.3%
0
   0.0%
0
   0.0%
1
   2.1%
Attention Deficit Hyperactivity Disorder (ADHD)
1
  14.3%
4
  21.1%
0
   0.0%
5
  10.6%
Mood Disorder
1
  14.3%
2
  10.5%
0
   0.0%
3
   6.4%
Anxiety Disorder
0
   0.0%
1
   5.3%
0
   0.0%
1
   2.1%
Psychosis
0
   0.0%
1
   5.3%
0
   0.0%
1
   2.1%
Height  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 7 participants 19 participants 21 participants 47 participants
1.58  (0.17) 1.58  (0.15) 1.63  (0.11) 1.60  (0.14)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 7 participants 19 participants 21 participants 47 participants
72.37  (16.11) 77.08  (32.60) 85.76  (23.07) 80.26  (26.62)
DEXA-Measured Body Composition  
Mean (Standard Deviation)
Unit of measure:  Percentage of body composition
Number Analyzed 7 participants 19 participants 21 participants 47 participants
DEXA Total Percent Fat 45.40  (6.76) 41.76  (8.53) 42.24  (5.38) 42.51  (6.97)
DEXA Total Percent Lean 52.12  (6.81) 55.48  (8.23) 55.01  (5.15) 54.77  (6.73)
Proton Density Fat Fraction (PDFF)  
Mean (Standard Deviation)
Unit of measure:  Percentile
Number Analyzed 7 participants 19 participants 21 participants 47 participants
12.01  (7.82) 6.52  (8.21) 4.72  (8.61) 6.58  (8.54)
Carotid Intima Media Thickness  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 7 participants 19 participants 21 participants 47 participants
0.0494  (0.0058) 0.0451  (0.0074) 0.0504  (0.0065) 0.0484  (0.0070)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilograms per meter-squared
Number Analyzed 7 participants 19 participants 21 participants 47 participants
28.72  (2.09) 29.70  (6.83) 31.86  (5.25) 30.52  (5.69)
Body Mass Index (BMI) Percentile  
Mean (Standard Deviation)
Unit of measure:  Percentile
Number Analyzed 7 participants 19 participants 21 participants 47 participants
97.77  (1.03) 96.55  (3.30) 97.69  (2.16) 97.24  (2.60)
Body Mass Index (BMI) Z-Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Z-score
Number Analyzed 7 participants 19 participants 21 participants 47 participants
2.05  (0.23) 1.99  (0.47) 2.13  (0.38) 2.06  (0.40)
[1]
Measure Description: 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.
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 7 participants 19 participants 21 participants 47 participants
99.86  (10.35) 99.45  (19.35) 102.40  (16.07) 100.83  (16.58)
Baseline Fasting Laboratory Values  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 7 participants 19 participants 21 participants 47 participants
Glucose 93.71  (10.01) 91.32  (7.42) 87.62  (4.99) 90.02  (7.13)
Total Cholesterol 170.14  (9.67) 169.47  (37.55) 157.81  (29.09) 164.36  (31.10)
Triglycerides 114.43  (44.49) 106.26  (59.11) 99.14  (61.30) 104.30  (57.35)
HDL Cholesterol 45.00  (6.16) 46.95  (10.20) 50.71  (10.74) 48.34  (10.04)
LDL Cholesterol 102.29  (10.95) 101.68  (27.32) 87.24  (23.40) 95.32  (24.49)
Aberrant Behavior Checklist (ABC)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 7 participants 19 participants 21 participants 47 participants
Total Score 53.43  (20.14) 35.61  (24.29) 6.81  (13.39) 25.17  (26.11)
Irritability 18.57  (8.75) 11.06  (8.30) 2.19  (4.81) 8.15  (9.13)
[1]
Measure Description: 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.
Child Behavior Checklist (CBCL)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 7 participants 19 participants 21 participants 47 participants
70.14  (26.34) 57.06  (28.39) 16.67  (15.20) 40.61  (31.80)
[1]
Measure Description: 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.
1.Primary Outcome
Title DEXA-measured Adiposity
Hide Description 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.
Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (ITT) sample with week 0 and week 16 data.
Arm/Group Title Antipsychotic Treated Educational Control Antipsychotic Treated Weekly Behavioral Weight Loss Non-antipsychotic Treated Weekly Behavioral Weight Loss
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 6 15 17
Mean (Standard Deviation)
Unit of Measure: kilograms
0.76  (2.05) -0.43  (3.13) -2.79  (3.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antipsychotic Treated Educational Control, Antipsychotic Treated Weekly Behavioral Weight Loss, Non-antipsychotic Treated Weekly Behavioral Weight Loss
Comments An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p < 0.05.
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Proton Density Fat Fraction (PDFF)
Hide Description 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.
Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (ITT) sample with week 0 and week 16 data.
Arm/Group Title Antipsychotic Treated Educational Control Antipsychotic Treated Weekly Behavioral Weight Loss Non-antipsychotic Treated Weekly Behavioral Weight Loss
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 6 12 16
Mean (Standard Deviation)
Unit of Measure: percent
-0.62  (1.57) -0.41  (4.95) -1.75  (4.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antipsychotic Treated Educational Control, Antipsychotic Treated Weekly Behavioral Weight Loss, Non-antipsychotic Treated Weekly Behavioral Weight Loss
Comments An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p < 0.05.
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Carotid Artery Intima Media Thickness (CIMT)
Hide Description 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.
Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (ITT) sample with week 0 and week 16 data.
Arm/Group Title Antipsychotic Treated Educational Control Antipsychotic Treated Weekly Behavioral Weight Loss Non-antipsychotic Treated Weekly Behavioral Weight Loss
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 6 10 17
Mean (Standard Deviation)
Unit of Measure: millimeters
-0.0014  (0.0045) 0.0032  (0.0098) 0.0004  (0.0064)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antipsychotic Treated Educational Control, Antipsychotic Treated Weekly Behavioral Weight Loss, Non-antipsychotic Treated Weekly Behavioral Weight Loss
Comments An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p < 0.05.
Method ANCOVA
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Aberrant Behavior Checklist (ABC)
Hide Description Change From Baseline in Aberrant Behavior Checklist - Irritability Subscale at 16 Weeks
Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (ITT) sample with week 0 and week 16 data.
Arm/Group Title Antipsychotic Treated Educational Control Antipsychotic Treated Weekly Behavioral Weight Loss Non-antipsychotic Treated Weekly Behavioral Weight Loss
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 6 15 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.00  (4.65) -1.27  (5.82) -1.38  (4.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antipsychotic Treated Educational Control, Antipsychotic Treated Weekly Behavioral Weight Loss, Non-antipsychotic Treated Weekly Behavioral Weight Loss
Comments An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p < 0.05.
Method ANCOVA
Comments [Not Specified]
Time Frame Adverse event data was collected over a period of 16 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Antipsychotic Treated Educational Control Antipsychotic Treated Weekly Behavioral Weight Loss Non-antipsychotic Treated Weekly Behavioral Weight Loss
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Antipsychotic Treated Educational Control Antipsychotic Treated Weekly Behavioral Weight Loss Non-antipsychotic Treated Weekly Behavioral Weight Loss
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/19 (0.00%)   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Antipsychotic Treated Educational Control Antipsychotic Treated Weekly Behavioral Weight Loss Non-antipsychotic Treated Weekly Behavioral Weight Loss
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/19 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Antipsychotic Treated Educational Control Antipsychotic Treated Weekly Behavioral Weight Loss Non-antipsychotic Treated Weekly Behavioral Weight Loss
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/19 (0.00%)   0/21 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Ginger Nicol
Organization: Washington University
Phone: 314-362-2461
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01222494     History of Changes
Other Study ID Numbers: 10-0425
K23MH092435 ( U.S. NIH Grant/Contract )
First Submitted: October 5, 2010
First Posted: October 18, 2010
Results First Submitted: July 25, 2018
Results First Posted: October 15, 2018
Last Update Posted: October 15, 2018