Trial Outcomes & Findings for Mobile Integrated Care for Childhood Obesity (NCT NCT05936385)
NCT ID: NCT05936385
Last Updated: 2025-07-24
Results Overview
Change in BMI percentile (above the 95th percentile) for age and sex. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
6 months
Results posted on
2025-07-24
Participant Flow
Participant milestones
| Measure |
Healthy Lifestyle
Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.
|
Standard of Care
Weight checks and lifestyle counseling with primary care provider every other month.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Integrated Care for Childhood Obesity
Baseline characteristics by cohort
| Measure |
Healthy Lifestyle
n=29 Participants
Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.
|
Standard of Care
n=30 Participants
Weight checks and lifestyle counseling with primary care provider every other month.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.1 Years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
8.2 Years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
8.6 Years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
BMI percentile above the 95th percentile
|
119.4 BMI percentile above the 95th percentile
STANDARD_DEVIATION 14.2 • n=5 Participants
|
123.9 BMI percentile above the 95th percentile
STANDARD_DEVIATION 19.8 • n=7 Participants
|
121.8 BMI percentile above the 95th percentile
STANDARD_DEVIATION 17.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 7 participants did not have anthropometric measurements collected in the EHR at the end of study
Change in BMI percentile (above the 95th percentile) for age and sex. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms.
Outcome measures
| Measure |
Healthy Lifestyle
n=25 Participants
Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.
|
Standard of Care
n=27 Participants
Weight checks and lifestyle counseling with primary care provider every other month.
|
|---|---|---|
|
Change in Child Adiposity
|
-0.55 Change in BMI percentile
Standard Deviation 7.18
|
0.64 Change in BMI percentile
Standard Deviation 5.30
|
PRIMARY outcome
Timeframe: 6 monthsLost to follow-up (attrition) from study as documented in the electronic health record.
Outcome measures
| Measure |
Healthy Lifestyle
n=29 Participants
Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.
|
Standard of Care
n=30 Participants
Weight checks and lifestyle counseling with primary care provider every other month.
|
|---|---|---|
|
Visit Adherence
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 7 participants did not have anthropometric measures recorded in the EHR at baseline and study end due to lost to follow-up
Differences in change in BMI percentile (above the 95th percentile) for age and sex between subgroups based on race, ethnicity, and insurance status. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment.
Outcome measures
| Measure |
Healthy Lifestyle
n=25 Participants
Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.
|
Standard of Care
n=27 Participants
Weight checks and lifestyle counseling with primary care provider every other month.
|
|---|---|---|
|
Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics
Hispanic or Latino
|
-1.90 Change in BMI percentile
Standard Deviation 9.68
|
-0.04 Change in BMI percentile
Standard Deviation 4.43
|
|
Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics
Non-Hispanic White
|
-0.56 Change in BMI percentile
Standard Deviation 7.11
|
-0.09 Change in BMI percentile
Standard Deviation 6.83
|
|
Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics
Non-Hispanic Black
|
0.81 Change in BMI percentile
Standard Deviation 4.61
|
1.67 Change in BMI percentile
Standard Deviation 4.38
|
|
Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics
Private Insurance
|
-1.64 Change in BMI percentile
Standard Deviation 2.16
|
0.04 Change in BMI percentile
Standard Deviation 6.24
|
|
Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics
Public Insurance
|
-0.28 Change in BMI percentile
Standard Deviation 7.99
|
0.89 Change in BMI percentile
Standard Deviation 5.02
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Number analyzed in rows below are only those who were lost to follow-up (attrition) for each race, ethnicity, or insurance category
Differences in lost to follow-up (attrition) from study as documented in the electronic health record between subgroups based on race, ethnicity, and insurance status. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment.
Outcome measures
| Measure |
Healthy Lifestyle
n=29 Participants
Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.
|
Standard of Care
n=30 Participants
Weight checks and lifestyle counseling with primary care provider every other month.
|
|---|---|---|
|
Differences in Visit Adherence Based on Child Sociodemographic Characteristics
Non-Hispanic Black · Attrition
|
5 Participants
|
4 Participants
|
|
Differences in Visit Adherence Based on Child Sociodemographic Characteristics
Non-Hispanic Black · Non-Attrition
|
5 Participants
|
7 Participants
|
|
Differences in Visit Adherence Based on Child Sociodemographic Characteristics
Non-Hispanic White · Attrition
|
3 Participants
|
1 Participants
|
|
Differences in Visit Adherence Based on Child Sociodemographic Characteristics
Non-Hispanic White · Non-Attrition
|
8 Participants
|
10 Participants
|
|
Differences in Visit Adherence Based on Child Sociodemographic Characteristics
Hispanic or Latino · Attrition
|
0 Participants
|
3 Participants
|
|
Differences in Visit Adherence Based on Child Sociodemographic Characteristics
Hispanic or Latino · Non-Attrition
|
8 Participants
|
5 Participants
|
Adverse Events
Healthy Lifestyle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
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
Thao-Ly Phan, Associate Professor of Pediatrics
Nemours Children's Health
Phone: 302-331-7342
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place