Trial Outcomes & Findings for Healthy Bodies, Healthy Kids (NCT NCT01222494)
NCT ID: NCT01222494
Last Updated: 2018-10-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Baseline and 16 weeks
Results posted on
2018-10-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
19
|
21
|
|
Overall Study
COMPLETED
|
6
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Healthy Bodies, Healthy Kids
Baseline characteristics by cohort
| Measure |
Antipsychotic Treated Educational Control
n=7 Participants
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 Weekly Behavioral Weight Loss
n=19 Participants
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.
|
Non-antipsychotic Treated Weekly Behavioral Weight Loss
n=21 Participants
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
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.80 years
STANDARD_DEVIATION 2.21 • n=5 Participants
|
13.35 years
STANDARD_DEVIATION 2.57 • n=7 Participants
|
13.42 years
STANDARD_DEVIATION 2.46 • n=5 Participants
|
13.30 years
STANDARD_DEVIATION 2.43 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Primary Diagnosis
Autism
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Primary Diagnosis
Pervasive Development Disorder (PDD)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Primary Diagnosis
Attention Deficit Hyperactivity Disorder (ADHD)
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Primary Diagnosis
Mood Disorder
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Primary Diagnosis
Anxiety Disorder
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Primary Diagnosis
Psychosis
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Height
|
1.58 meters
STANDARD_DEVIATION 0.17 • n=5 Participants
|
1.58 meters
STANDARD_DEVIATION 0.15 • n=7 Participants
|
1.63 meters
STANDARD_DEVIATION 0.11 • n=5 Participants
|
1.60 meters
STANDARD_DEVIATION 0.14 • n=4 Participants
|
|
Weight
|
72.37 kilograms
STANDARD_DEVIATION 16.11 • n=5 Participants
|
77.08 kilograms
STANDARD_DEVIATION 32.60 • n=7 Participants
|
85.76 kilograms
STANDARD_DEVIATION 23.07 • n=5 Participants
|
80.26 kilograms
STANDARD_DEVIATION 26.62 • n=4 Participants
|
|
DEXA-Measured Body Composition
DEXA Total Percent Fat
|
45.40 percentage of body composition
STANDARD_DEVIATION 6.76 • n=5 Participants
|
41.76 percentage of body composition
STANDARD_DEVIATION 8.53 • n=7 Participants
|
42.24 percentage of body composition
STANDARD_DEVIATION 5.38 • n=5 Participants
|
42.51 percentage of body composition
STANDARD_DEVIATION 6.97 • n=4 Participants
|
|
DEXA-Measured Body Composition
DEXA Total Percent Lean
|
52.12 percentage of body composition
STANDARD_DEVIATION 6.81 • n=5 Participants
|
55.48 percentage of body composition
STANDARD_DEVIATION 8.23 • n=7 Participants
|
55.01 percentage of body composition
STANDARD_DEVIATION 5.15 • n=5 Participants
|
54.77 percentage of body composition
STANDARD_DEVIATION 6.73 • n=4 Participants
|
|
Proton Density Fat Fraction (PDFF)
|
12.01 percentile
STANDARD_DEVIATION 7.82 • n=5 Participants
|
6.52 percentile
STANDARD_DEVIATION 8.21 • n=7 Participants
|
4.72 percentile
STANDARD_DEVIATION 8.61 • n=5 Participants
|
6.58 percentile
STANDARD_DEVIATION 8.54 • n=4 Participants
|
|
Carotid Intima Media Thickness
|
0.0494 centimeters
STANDARD_DEVIATION 0.0058 • n=5 Participants
|
0.0451 centimeters
STANDARD_DEVIATION 0.0074 • n=7 Participants
|
0.0504 centimeters
STANDARD_DEVIATION 0.0065 • n=5 Participants
|
0.0484 centimeters
STANDARD_DEVIATION 0.0070 • n=4 Participants
|
|
Body Mass Index (BMI)
|
28.72 kilograms per meter-squared
STANDARD_DEVIATION 2.09 • n=5 Participants
|
29.70 kilograms per meter-squared
STANDARD_DEVIATION 6.83 • n=7 Participants
|
31.86 kilograms per meter-squared
STANDARD_DEVIATION 5.25 • n=5 Participants
|
30.52 kilograms per meter-squared
STANDARD_DEVIATION 5.69 • n=4 Participants
|
|
Body Mass Index (BMI) Percentile
|
97.77 percentile
STANDARD_DEVIATION 1.03 • n=5 Participants
|
96.55 percentile
STANDARD_DEVIATION 3.30 • n=7 Participants
|
97.69 percentile
STANDARD_DEVIATION 2.16 • n=5 Participants
|
97.24 percentile
STANDARD_DEVIATION 2.60 • n=4 Participants
|
|
Body Mass Index (BMI) Z-Score
|
2.05 z-score
STANDARD_DEVIATION 0.23 • n=5 Participants
|
1.99 z-score
STANDARD_DEVIATION 0.47 • n=7 Participants
|
2.13 z-score
STANDARD_DEVIATION 0.38 • n=5 Participants
|
2.06 z-score
STANDARD_DEVIATION 0.40 • n=4 Participants
|
|
Waist Circumference
|
99.86 centimeters
STANDARD_DEVIATION 10.35 • n=5 Participants
|
99.45 centimeters
STANDARD_DEVIATION 19.35 • n=7 Participants
|
102.40 centimeters
STANDARD_DEVIATION 16.07 • n=5 Participants
|
100.83 centimeters
STANDARD_DEVIATION 16.58 • n=4 Participants
|
|
Baseline Fasting Laboratory Values
Glucose
|
93.71 mg/dl
STANDARD_DEVIATION 10.01 • n=5 Participants
|
91.32 mg/dl
STANDARD_DEVIATION 7.42 • n=7 Participants
|
87.62 mg/dl
STANDARD_DEVIATION 4.99 • n=5 Participants
|
90.02 mg/dl
STANDARD_DEVIATION 7.13 • n=4 Participants
|
|
Baseline Fasting Laboratory Values
Total Cholesterol
|
170.14 mg/dl
STANDARD_DEVIATION 9.67 • n=5 Participants
|
169.47 mg/dl
STANDARD_DEVIATION 37.55 • n=7 Participants
|
157.81 mg/dl
STANDARD_DEVIATION 29.09 • n=5 Participants
|
164.36 mg/dl
STANDARD_DEVIATION 31.10 • n=4 Participants
|
|
Baseline Fasting Laboratory Values
Triglycerides
|
114.43 mg/dl
STANDARD_DEVIATION 44.49 • n=5 Participants
|
106.26 mg/dl
STANDARD_DEVIATION 59.11 • n=7 Participants
|
99.14 mg/dl
STANDARD_DEVIATION 61.30 • n=5 Participants
|
104.30 mg/dl
STANDARD_DEVIATION 57.35 • n=4 Participants
|
|
Baseline Fasting Laboratory Values
HDL Cholesterol
|
45.00 mg/dl
STANDARD_DEVIATION 6.16 • n=5 Participants
|
46.95 mg/dl
STANDARD_DEVIATION 10.20 • n=7 Participants
|
50.71 mg/dl
STANDARD_DEVIATION 10.74 • n=5 Participants
|
48.34 mg/dl
STANDARD_DEVIATION 10.04 • n=4 Participants
|
|
Baseline Fasting Laboratory Values
LDL Cholesterol
|
102.29 mg/dl
STANDARD_DEVIATION 10.95 • n=5 Participants
|
101.68 mg/dl
STANDARD_DEVIATION 27.32 • n=7 Participants
|
87.24 mg/dl
STANDARD_DEVIATION 23.40 • n=5 Participants
|
95.32 mg/dl
STANDARD_DEVIATION 24.49 • n=4 Participants
|
|
Aberrant Behavior Checklist (ABC)
Total Score
|
53.43 units on a scale
STANDARD_DEVIATION 20.14 • n=5 Participants
|
35.61 units on a scale
STANDARD_DEVIATION 24.29 • n=7 Participants
|
6.81 units on a scale
STANDARD_DEVIATION 13.39 • n=5 Participants
|
25.17 units on a scale
STANDARD_DEVIATION 26.11 • n=4 Participants
|
|
Aberrant Behavior Checklist (ABC)
Irritability
|
18.57 units on a scale
STANDARD_DEVIATION 8.75 • n=5 Participants
|
11.06 units on a scale
STANDARD_DEVIATION 8.30 • n=7 Participants
|
2.19 units on a scale
STANDARD_DEVIATION 4.81 • n=5 Participants
|
8.15 units on a scale
STANDARD_DEVIATION 9.13 • n=4 Participants
|
|
Child Behavior Checklist (CBCL)
|
70.14 units on a scale
STANDARD_DEVIATION 26.34 • n=5 Participants
|
57.06 units on a scale
STANDARD_DEVIATION 28.39 • n=7 Participants
|
16.67 units on a scale
STANDARD_DEVIATION 15.20 • n=5 Participants
|
40.61 units on a scale
STANDARD_DEVIATION 31.80 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksPopulation: Modified Intent to Treat (ITT) sample with week 0 and week 16 data.
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.
Outcome measures
| Measure |
Antipsychotic Treated Educational Control
n=6 Participants
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 Weekly Behavioral Weight Loss
n=15 Participants
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.
|
Non-antipsychotic Treated Weekly Behavioral Weight Loss
n=17 Participants
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.
|
|---|---|---|---|
|
DEXA-measured Adiposity
|
0.76 kilograms
Standard Deviation 2.05
|
-0.43 kilograms
Standard Deviation 3.13
|
-2.79 kilograms
Standard Deviation 3.35
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksPopulation: Modified Intent to Treat (ITT) sample with week 0 and week 16 data.
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.
Outcome measures
| Measure |
Antipsychotic Treated Educational Control
n=6 Participants
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 Weekly Behavioral Weight Loss
n=12 Participants
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.
|
Non-antipsychotic Treated Weekly Behavioral Weight Loss
n=16 Participants
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.
|
|---|---|---|---|
|
Proton Density Fat Fraction (PDFF)
|
-0.62 percent
Standard Deviation 1.57
|
-0.41 percent
Standard Deviation 4.95
|
-1.75 percent
Standard Deviation 4.93
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksPopulation: Modified Intent to Treat (ITT) sample with week 0 and week 16 data.
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.
Outcome measures
| Measure |
Antipsychotic Treated Educational Control
n=6 Participants
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 Weekly Behavioral Weight Loss
n=10 Participants
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.
|
Non-antipsychotic Treated Weekly Behavioral Weight Loss
n=17 Participants
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.
|
|---|---|---|---|
|
Carotid Artery Intima Media Thickness (CIMT)
|
-0.0014 millimeters
Standard Deviation 0.0045
|
0.0032 millimeters
Standard Deviation 0.0098
|
0.0004 millimeters
Standard Deviation 0.0064
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 16 weeksPopulation: Modified Intent to Treat (ITT) sample with week 0 and week 16 data.
Change From Baseline in Aberrant Behavior Checklist - Irritability Subscale at 16 Weeks
Outcome measures
| Measure |
Antipsychotic Treated Educational Control
n=6 Participants
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 Weekly Behavioral Weight Loss
n=15 Participants
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.
|
Non-antipsychotic Treated Weekly Behavioral Weight Loss
n=16 Participants
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.
|
|---|---|---|---|
|
Aberrant Behavior Checklist (ABC)
|
3.00 units on a scale
Standard Deviation 4.65
|
-1.27 units on a scale
Standard Deviation 5.82
|
-1.38 units on a scale
Standard Deviation 4.32
|
Adverse Events
Antipsychotic Treated Educational Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Antipsychotic Treated Weekly Behavioral Weight Loss
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-antipsychotic Treated Weekly Behavioral Weight Loss
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place