Trial Outcomes & Findings for A Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight Loss App (NCT NCT02880254)
NCT ID: NCT02880254
Last Updated: 2019-09-25
Results Overview
A questionnaire will be handed out to each subject every month (see below) where applicable.we will utilize one-sample tests with a one-sided alpha of 0.025. One-sided tests will be used as we are only interested in whether the use of this app results in better outcomes than usual care. Compliance will utilize a binomial probability test to assess compliance against our known compliance of 50%. Questionnaire is noted here: Confidential Page 1 of 1 Kurbo Survey \[baseline\_arm\_1\]\[name\], DOB \[baseline\_arm\_1\]\[dob\] Please complete the survey below. Thank you! Group Allocation \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Who is completing this survey? Child / Patient Parent / Guardian Over the last month, abou
COMPLETED
NA
27 participants
3 months
2019-09-25
Participant Flow
difficulty recruiting participants to be in the trial in the time frame; some agreed but then never came in to consent; there were no patients who consented but did not participate
Participant milestones
| Measure |
Kurbo Only
use of app plus standard of care
Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits
|
Kurbo Plus PHC
use of app, personal health coach and standard of care
Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits
Personal Health Coach: weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Compliance and Impact on Weight of Kurbo, a Pediatric Centered Weight Loss App
Baseline characteristics by cohort
| Measure |
Kurbo Only
n=13 Participants
use of app plus standard of care
Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits
|
Kurbo Plus PHC
n=14 Participants
use of app, personal health coach and standard of care
Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits
Personal Health Coach: weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
13.1 years
STANDARD_DEVIATION 2 • n=99 Participants
|
13 years
STANDARD_DEVIATION 2.9 • n=107 Participants
|
13 years
STANDARD_DEVIATION 2.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
14 participants
n=107 Participants
|
27 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Assuming we find improved compliance and BMI-z scores, we will estimate compliance and BMI-z score differences between Kurbo and Kurbo + PHC. Estimates will be generated using direct observation as well as prediction through modeling.
A questionnaire will be handed out to each subject every month (see below) where applicable.we will utilize one-sample tests with a one-sided alpha of 0.025. One-sided tests will be used as we are only interested in whether the use of this app results in better outcomes than usual care. Compliance will utilize a binomial probability test to assess compliance against our known compliance of 50%. Questionnaire is noted here: Confidential Page 1 of 1 Kurbo Survey \[baseline\_arm\_1\]\[name\], DOB \[baseline\_arm\_1\]\[dob\] Please complete the survey below. Thank you! Group Allocation \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Who is completing this survey? Child / Patient Parent / Guardian Over the last month, abou
Outcome measures
| Measure |
Kurbo Only
n=13 Participants
use of app plus standard of care
Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits
|
Kurbo Plus PHC
n=14 Participants
use of app, personal health coach and standard of care
Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits
Personal Health Coach: weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process
|
|---|---|---|
|
3 Month Compliance With the Kurbo App as Well as the Kurbo App and PHC by a Group of Morbidly Obese Children and Adolescents in a Weight Management Program.
compliance with food tracking
|
0 percent compliant
|
14 percent compliant
|
|
3 Month Compliance With the Kurbo App as Well as the Kurbo App and PHC by a Group of Morbidly Obese Children and Adolescents in a Weight Management Program.
compliance with exercise tracking
|
0 percent compliant
|
7 percent compliant
|
SECONDARY outcome
Timeframe: 3 monthsBMI zscore will be determined from mathematical calculations derived from subject's height and weight. Z score is the number of standard deviations from the mean. A Z score of 0 is the mean. A change in z score in the positive direction reflects an increase in BMI Z score. A change in z score in the negative direction reflects a decrease in BMI Z score. A decrease in BMI z score indicates a change in BMI that favors weight loss.
Outcome measures
| Measure |
Kurbo Only
n=13 Participants
use of app plus standard of care
Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits
|
Kurbo Plus PHC
n=14 Participants
use of app, personal health coach and standard of care
Kurbo: health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits
Personal Health Coach: weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process
|
|---|---|---|
|
the Effect of the Kurbo App as Well as the Kurbo App and PHC on 3 Month Change in BMI Zscore Among Morbidly Obese Children and Adolescents Undergoing a Weight Management Program.
|
2.4 z score
Standard Deviation 0.3
|
2.2 z score
Standard Deviation 0.3
|
Adverse Events
Kurbo Only
Kurbo Plus PHC
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