Trial Outcomes & Findings for Primary Care Pediatrics Learning Activity and Nutrition With Families (NCT NCT02873715)
NCT ID: NCT02873715
Last Updated: 2024-07-26
Results Overview
Height and weight will be taken to calculate changes in over weight status for children in FBT versus UC. Change in percent over median BMI from baseline to 24-month. Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents. Results are pooled across 10 multiple imputations and reported as mean (standard error)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1010 participants
Primary outcome timeframe
0 - 24 months
Results posted on
2024-07-26
Participant Flow
Each sites local pediatric practices participated in warm hand offs to embeded coaches in the practices to recruit interested families. Families included a targeted child, targeted parent and could include one or multiple siblings but was not required. Recruitment started in November 2017 through August 2019.
Eligible families were randomized through REDCap directly after completing the screening visit before starting the treatment phase.
Unit of analysis: families
Participant milestones
| Measure |
Usual Care (UC)
Usual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management.
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
Family-based Treatment (FBT)
Family- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Family-based treatment: Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
|---|---|---|
|
Overall Study
STARTED
|
504 226
|
506 226
|
|
Overall Study
6-month Follow-up
|
403 199
|
405 201
|
|
Overall Study
12-month Follow-up
|
380 195
|
386 199
|
|
Overall Study
18-month Follow-up
|
380 189
|
364 189
|
|
Overall Study
24-month Follow-up
|
413 205
|
386 198
|
|
Overall Study
COMPLETED
|
413 205
|
386 198
|
|
Overall Study
NOT COMPLETED
|
91 21
|
120 28
|
Reasons for withdrawal
| Measure |
Usual Care (UC)
Usual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management.
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
Family-based Treatment (FBT)
Family- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Family-based treatment: Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
84
|
94
|
|
Overall Study
Withdrawal by Subject
|
7
|
26
|
Baseline Characteristics
The population includes parents, children and siblings which differs between groups and families enrolled.
Baseline characteristics by cohort
| Measure |
Usual Care (UC)
n=504 Participants
Usual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management.
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
Family-based Treatment (FBT)
n=506 Participants
Family- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two yeart study
Family-based treatment: Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
Total
n=1010 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Index children
|
9.7 years
STANDARD_DEVIATION 1.9 • n=226 Participants • The population includes parents, children and siblings which differs between groups and families enrolled.
|
9.8 years
STANDARD_DEVIATION 1.9 • n=226 Participants • The population includes parents, children and siblings which differs between groups and families enrolled.
|
9.7 years
STANDARD_DEVIATION 1.9 • n=452 Participants • The population includes parents, children and siblings which differs between groups and families enrolled.
|
|
Age, Continuous
Parents
|
41.4 years
STANDARD_DEVIATION 7.0 • n=226 Participants • The population includes parents, children and siblings which differs between groups and families enrolled.
|
41.2 years
STANDARD_DEVIATION 7.8 • n=226 Participants • The population includes parents, children and siblings which differs between groups and families enrolled.
|
41.3 years
STANDARD_DEVIATION 7.5 • n=452 Participants • The population includes parents, children and siblings which differs between groups and families enrolled.
|
|
Age, Continuous
Siblings
|
10.4 years
STANDARD_DEVIATION 3.8 • n=52 Participants • The population includes parents, children and siblings which differs between groups and families enrolled.
|
9.7 years
STANDARD_DEVIATION 3.6 • n=54 Participants • The population includes parents, children and siblings which differs between groups and families enrolled.
|
10.0 years
STANDARD_DEVIATION 3.7 • n=106 Participants • The population includes parents, children and siblings which differs between groups and families enrolled.
|
|
Sex: Female, Male
Targeted Children · Female
|
122 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
120 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
242 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Sex: Female, Male
Targeted Children · Male
|
104 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
106 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
210 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Sex: Female, Male
Parents · Female
|
192 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
196 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
388 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Sex: Female, Male
Parents · Male
|
34 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
30 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
64 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Sex: Female, Male
Siblings · Female
|
30 Participants
n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
30 Participants
n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
60 Participants
n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Child percent over median body mass index
Targeted Children
|
53.8 percent
n=226 Participants • Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents.
|
56.1 percent
n=226 Participants • Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents.
|
54.7 percent
n=452 Participants • Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents.
|
|
Sex: Female, Male
Siblings · Male
|
22 Participants
n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
24 Participants
n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
46 Participants
n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Ethnicity (NIH/OMB)
Targeted Children · Hispanic or Latino
|
19 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
21 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
40 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Ethnicity (NIH/OMB)
Targeted Children · Not Hispanic or Latino
|
207 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
205 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
412 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Ethnicity (NIH/OMB)
Targeted Children · Unknown or Not Reported
|
0 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Ethnicity (NIH/OMB)
Parents · Hispanic or Latino
|
8 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
17 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
25 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Ethnicity (NIH/OMB)
Parents · Not Hispanic or Latino
|
218 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
209 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
427 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Ethnicity (NIH/OMB)
Parents · Unknown or Not Reported
|
0 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Ethnicity (NIH/OMB)
Siblings · Hispanic or Latino
|
5 Participants
n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
6 Participants
n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
11 Participants
n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Ethnicity (NIH/OMB)
Siblings · Not Hispanic or Latino
|
47 Participants
n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
48 Participants
n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
95 Participants
n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Ethnicity (NIH/OMB)
Siblings · Unknown or Not Reported
|
0 Participants
n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Targeted Children · American Indian or Alaska Native
|
1 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
1 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Targeted Children · Asian
|
3 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
5 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
8 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Targeted Children · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Targeted Children · Black or African American
|
65 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
58 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
123 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Targeted Children · White
|
127 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
131 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
258 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Targeted Children · More than one race
|
22 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
17 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
39 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Targeted Children · Unknown or Not Reported
|
8 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
15 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
23 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Parents · American Indian or Alaska Native
|
0 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Parents · Asian
|
3 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
3 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
6 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Parents · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Parents · Black or African American
|
55 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
58 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
113 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Parents · White
|
139 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
148 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
287 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Parents · More than one race
|
2 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
1 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
3 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Parents · Unknown or Not Reported
|
27 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
16 Participants
n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
43 Participants
n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Siblings · American Indian or Alaska Native
|
1 Participants
n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
1 Participants
n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Siblings · Asian
|
0 Participants
n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
1 Participants
n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
1 Participants
n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Siblings · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
0 Participants
n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Siblings · Black or African American
|
13 Participants
n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
12 Participants
n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
25 Participants
n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Siblings · White
|
21 Participants
n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
27 Participants
n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
48 Participants
n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Siblings · More than one race
|
5 Participants
n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
5 Participants
n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
10 Participants
n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Race (NIH/OMB)
Siblings · Unknown or Not Reported
|
12 Participants
n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
9 Participants
n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
21 Participants
n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Participants
Targeted children
|
226 Participants
n=504 Participants
|
226 Participants
n=506 Participants
|
452 Participants
n=1010 Participants
|
|
Participants
Parents
|
226 Participants
n=504 Participants
|
226 Participants
n=506 Participants
|
452 Participants
n=1010 Participants
|
|
Participants
Siblings
|
52 Participants
n=504 Participants
|
54 Participants
n=506 Participants
|
106 Participants
n=1010 Participants
|
|
Body mass index (BMI)
Targeted Children
|
26.9 kg/m^2
STANDARD_DEVIATION 5.2 • n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
26.7 kg/m^2
STANDARD_DEVIATION 5.0 • n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
26.8 kg/m^2
STANDARD_DEVIATION 5.1 • n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Body mass index (BMI)
Parents
|
37.5 kg/m^2
STANDARD_DEVIATION 7.9 • n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
36.5 kg/m^2
STANDARD_DEVIATION 7.6 • n=226 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
37.0 kg/m^2
STANDARD_DEVIATION 7.8 • n=452 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Body mass index (BMI)
Siblings
|
27.4 kg/m^2
STANDARD_DEVIATION 7.9 • n=52 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
24.4 kg/m^2
STANDARD_DEVIATION 5.6 • n=54 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
25.9 kg/m^2
STANDARD_DEVIATION 7.0 • n=106 Participants • The total population includes targeted children, parents and siblings. Each row seperately identifies the targeted children, parents and siblings.
|
|
Child percent over median body mass index
Sibling
|
51.8 percent
n=52 Participants • Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents.
|
37.3 percent
n=54 Participants • Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents.
|
41.9 percent
n=106 Participants • Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents.
|
|
Child BMI percentile
Targeted Children
|
98.46 percentile
n=226 Participants • Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents
|
98.27 percentile
n=226 Participants • Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents
|
98.40 percentile
n=452 Participants • Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents
|
|
Child BMI percentile
Siblings
|
98.04 percentile
n=52 Participants • Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents
|
96.96 percentile
n=54 Participants • Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents
|
97.43 percentile
n=106 Participants • Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents
|
PRIMARY outcome
Timeframe: 0 - 24 monthsPopulation: Targeted Children
Height and weight will be taken to calculate changes in over weight status for children in FBT versus UC. Change in percent over median BMI from baseline to 24-month. Percent over the age- and sex-specific 50th BMI percentile for kids, percent over the sex-specific 50th BMI percentile for 20-year-olds for parents. Parents are not included in this measurement. This measurement is to describe child body composition and not used for parents. Results are pooled across 10 multiple imputations and reported as mean (standard error)
Outcome measures
| Measure |
Usual Care (UC)
n=226 Participants
Usual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management.
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
Family-based Treatment (FBT)
n=226 Participants
Family- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Family-based treatment: Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
|---|---|---|
|
Body Composition Measures of Targeted Child. Percent Change Over the Median BMI
|
10.2 percent change
Standard Deviation 1.0
|
3.4 percent change
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 0-24 monthsPopulation: Participating Parents
Height and weight will be taken to calculate changes in over weight status for parents in FBT versus UC. Results are pooled across 10 multiple imputations and reported as mean (standard error)
Outcome measures
| Measure |
Usual Care (UC)
n=226 Participants
Usual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management.
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
Family-based Treatment (FBT)
n=226 Participants
Family- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Family-based treatment: Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
|---|---|---|
|
Body Composition Measures of Participating Parent. BMI (kg/m^2) Change From Baseline to 24 Month
|
-0.03 Change in kg/m^2 (BMI)
Standard Deviation 0.22
|
-0.62 Change in kg/m^2 (BMI)
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: 0-24 monthsPopulation: Siblings
Height and weight will be taken for non-targeted siblings to determine if weight loss effects of FBT extend beyond the participating parent and child.
Outcome measures
| Measure |
Usual Care (UC)
n=52 Participants
Usual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management.
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
Family-based Treatment (FBT)
n=54 Participants
Family- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Family-based treatment: Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
|---|---|---|
|
Body Composition Measures, Siblings
|
8.3 Change in % over median BMI
Standard Deviation 2.6
|
6.6 Change in % over median BMI
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 0, and 24 monthsPopulation: Parents and children are reported separately. Intent to treat was not used, number analyzed included parents and children with complete data (baseline and 24 month delay discounting measures). Siblings are not analyzed here.
Delay discounting will be measured using an adjusting amount discounting task with a delayed reward of $100. K-values will be calculated and log-versions will be used due to skewness of k-values. More negative k-values indicate more delayed choices, which is considered better decision making
Outcome measures
| Measure |
Usual Care (UC)
n=287 Participants
Usual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management.
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
Family-based Treatment (FBT)
n=271 Participants
Family- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Family-based treatment: Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
|---|---|---|
|
Delay Discounting
Parent 24-month Delay discounting log k-value
|
-6.45 natural log
Standard Deviation 2.58
|
-6.75 natural log
Standard Deviation 2.43
|
|
Delay Discounting
Parent baseline delay discounting log k-value
|
-5.98 natural log
Standard Deviation 3.21
|
-6.14 natural log
Standard Deviation 2.54
|
|
Delay Discounting
Child baseline delay discounting log k-value
|
-4.37 natural log
Standard Deviation 4.02
|
-4.22 natural log
Standard Deviation 3.48
|
|
Delay Discounting
Child 24-month Delay discounting log k-value
|
-4.76 natural log
Standard Deviation 3.23
|
-4.71 natural log
Standard Deviation 2.62
|
Adverse Events
Usual Care (UC)
Serious events: 24 serious events
Other events: 314 other events
Deaths: 0 deaths
Family-based Treatment (FBT)
Serious events: 39 serious events
Other events: 345 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care (UC)
n=504 participants at risk
Usual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management.
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
Family-based Treatment (FBT)
n=506 participants at risk
Family- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two yeart study
Family-based treatment: Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
|---|---|---|
|
General disorders
Parent Doctor Visit
|
0.00%
0/226 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
0.00%
0/226 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
Psychiatric disorders
Parent Mental Health
|
0.88%
2/226 • Number of events 2 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
0.44%
1/226 • Number of events 1 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Parent Hospitalization
|
4.9%
11/226 • Number of events 16 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
9.7%
22/226 • Number of events 26 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Parent Injury
|
0.44%
1/226 • Number of events 1 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
0.00%
0/226 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
Pregnancy, puerperium and perinatal conditions
Parent Pregnancy
|
1.3%
3/226 • Number of events 3 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
0.44%
1/226 • Number of events 1 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Targeted Child Doctor Visit
|
0.00%
0/226 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
0.44%
1/226 • Number of events 1 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
Psychiatric disorders
Targeted Child Mental Health
|
2.2%
5/226 • Number of events 5 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
3.5%
8/226 • Number of events 9 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Targeted Child Hospitalizations
|
0.44%
1/226 • Number of events 2 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
0.44%
1/226 • Number of events 1 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Targeted Child Injury
|
0.00%
0/226 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
0.00%
0/226 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
Psychiatric disorders
Sibling mental health
|
0.00%
0/52 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
5.6%
3/54 • Number of events 4 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Sibling hospitalization
|
1.9%
1/52 • Number of events 1 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
3.7%
2/54 • Number of events 2 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Sibling Doctor Visit
|
0.00%
0/52 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
0.00%
0/54 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Sibling Injury
|
0.00%
0/52 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
0.00%
0/54 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
Other adverse events
| Measure |
Usual Care (UC)
n=504 participants at risk
Usual Care will consist of the care typically delivered by the family's primary care provider for children with overweight or obesity. The implementations of UC may vary between providers but typically includes and assessment of the child's weight, help remove barriers to weight loss and introductions of goals for better weight management.
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
Family-based Treatment (FBT)
n=506 participants at risk
Family- Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two yeart study
Family-based treatment: Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
Usual Care: Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
|
|---|---|---|
|
General disorders
Targeted Child Doctor appointments
|
11.9%
27/226 • Number of events 30 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
12.4%
28/226 • Number of events 30 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Parent Doctor appointments
|
20.4%
46/226 • Number of events 73 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
30.1%
68/226 • Number of events 98 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Parent Common Pediatric Event
|
16.4%
37/226 • Number of events 42 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
12.4%
28/226 • Number of events 42 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
Psychiatric disorders
Parent Mental Health
|
19.0%
43/226 • Number of events 54 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
21.7%
49/226 • Number of events 65 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Parent Injury
|
15.0%
34/226 • Number of events 40 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
15.5%
35/226 • Number of events 43 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Targeted Child Common Pediatric Events
|
22.1%
50/226 • Number of events 72 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
18.6%
42/226 • Number of events 69 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
Psychiatric disorders
Targeted Child Mental Health
|
23.0%
52/226 • Number of events 73 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
21.2%
48/226 • Number of events 72 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Targeted Child Injury
|
11.1%
25/226 • Number of events 28 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
20.8%
47/226 • Number of events 62 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Sibling Doctor Appointments
|
17.3%
9/52 • Number of events 11 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
16.7%
9/54 • Number of events 9 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Sibling Common Pediatric Events
|
32.7%
17/52 • Number of events 20 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
37.0%
20/54 • Number of events 31 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Sibling Mental Health
|
13.5%
7/52 • Number of events 9 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
18.5%
10/54 • Number of events 19 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
|
General disorders
Sibling Injury
|
15.4%
8/52 • Number of events 9 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
13.0%
7/54 • Number of events 10 • Adverse events and Serious Adverse events were collect over the full two year study, 24 month +/- 3 months.
A systematic survey was administered at each measurement time point for the family. Non-systematic adverse events were collected by the coaches if they shared during treatment session with their coaches over the two year study.
|
Additional Information
Leonard H. Epstein, PhD, SUNY Distinguished Professor
University at Buffalo
Phone: 716-829-3400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place