Trial Outcomes & Findings for Healthy Weight for Teens (NCT NCT03939494)
NCT ID: NCT03939494
Last Updated: 2024-06-12
Results Overview
Successful implementation of a "bundle of program enhancements" by existing clinical staff within existing pediatric weight management programs. This success will be defined by ≥80% of randomized intervention group participants and their parent/guardian attending the individual program orientation prior to their initial medical assessment as part of the pediatric weight management program and completing the interactive remote follow-up encounters to achieve the 26 provider contact hours in combination with time spent at clinic visits over the 6 month treatment period.
COMPLETED
NA
61 participants
6 months
2024-06-12
Participant Flow
One additional participant enrolled to make up for a lost to follow-up.
Participant milestones
| Measure |
Telehealth Intervention
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
22
|
|
Overall Study
COMPLETED
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
25
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Healthy Weight for Teens
Baseline characteristics by cohort
| Measure |
Telehealth Intervention
n=39 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=22 Participants
This arm will participate in their normal clinic/program routine.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
39 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
61 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
|
14.9 years
n=99 Participants
|
14.8 years
n=107 Participants
|
14.8 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=99 Participants
|
22 participants
n=107 Participants
|
61 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsSuccessful implementation of a "bundle of program enhancements" by existing clinical staff within existing pediatric weight management programs. This success will be defined by ≥80% of randomized intervention group participants and their parent/guardian attending the individual program orientation prior to their initial medical assessment as part of the pediatric weight management program and completing the interactive remote follow-up encounters to achieve the 26 provider contact hours in combination with time spent at clinic visits over the 6 month treatment period.
Outcome measures
| Measure |
Telehealth Intervention
n=39 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=22 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs
|
20 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 6 monthsCompletion of the 6 month treatment period will be tracked.
Outcome measures
| Measure |
Telehealth Intervention
n=39 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=22 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Number of Participants Completing Six Month Treatment Period
|
20 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Number of participants who have baseline data
Attendance of participants in each group throughout study period; from baseline visit through 6 month follow up period.
Outcome measures
| Measure |
Telehealth Intervention
n=37 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=21 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Participation Rates in Clinic Visits and Group Sessions
|
37 participants
|
21 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intervention of telehealth vs standard of care for change in percent of 95th percentile for body mass index.
The health outcome to be evaluated is change in percent of the 95th percentile for body mass index.
Outcome measures
| Measure |
Telehealth Intervention
n=15 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=10 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Change in Percent of the 95th Percentile for Body Mass Index
|
-1.07 percent of 95th percentile for BMI
Standard Error 1.90
|
-2.35 percent of 95th percentile for BMI
Standard Error 2.26
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: After 6 months of data collection, percent body fat calculations are compared between the two groups
The health outcome to be evaluated is change in percent body fat (%).
Outcome measures
| Measure |
Telehealth Intervention
n=15 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=8 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Change in Percentage of Body Fat
|
0.4 percentage of body fat
Interval -0.8 to 1.6
|
0.10 percentage of body fat
Interval -1.7 to 0.85
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Change in skeletal muscle mass after 6 month treatment period in intervention vs control group
The health outcome to be evaluated is change in skeletal muscle mass (kg). An improvement will be indicated by an increase in skeletal muscle mass.
Outcome measures
| Measure |
Telehealth Intervention
n=15 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=8 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Skeletal Muscle Mass Improvement Over Time
|
0.8 kg
Interval -0.1 to 2.0
|
0.80 kg
Interval -0.45 to 1.85
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Change in systolic blood pressure and diastolic blood pressure from baseline to 6 month evaluation in intervention participants vs control group participants
The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg).
Outcome measures
| Measure |
Telehealth Intervention
n=13 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=6 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Improvement in Systolic and Diastolic Blood Pressure
Systolic Blood Pressure
|
2.0 mmHg
Interval -3.0 to 8.0
|
2.0 mmHg
Interval -8.0 to 8.0
|
|
Improvement in Systolic and Diastolic Blood Pressure
Diastolic Blood Pressure
|
2.0 mmHg
Interval -4.0 to 8.0
|
-6.0 mmHg
Interval -16.0 to 0.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Change in ALT blood value from baseline to 6 month visit
The health outcome to be evaluated is the change in the lab value of ALT
Outcome measures
| Measure |
Telehealth Intervention
n=8 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=6 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Improvement in Lab Values for Serum ALT
|
2.00 IU/L
Interval -8.0 to 4.5
|
2.00 IU/L
Interval -5.0 to 4.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Change in triglyceride levels from baseline to 6 months in intervention vs control group participants
Change in triglyceride levels from baseline to 6 months in intervention vs control group participants
Outcome measures
| Measure |
Telehealth Intervention
n=9 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=6 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Change in Triglyceride
|
-1.00 mg/dL
Interval -21.0 to 16.0
|
-4.00 mg/dL
Interval -6.0 to 3.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Change in Hba1C from baseline to 6 month visit in intervention vs control group
Change in Hba1C from baseline to 6 month visit in intervention vs control group
Outcome measures
| Measure |
Telehealth Intervention
n=8 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=6 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Change in Hba1C Levels
|
-0.05 percent
Interval -0.15 to 0.15
|
0.15 percent
Interval 0.0 to 0.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants
Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants
Outcome measures
| Measure |
Telehealth Intervention
n=9 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=5 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Change in Non-HDL Cholesterol
|
0.00 mg/dL
Interval -12.0 to 5.0
|
9.00 mg/dL
Interval 5.0 to 14.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants
Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants
Outcome measures
| Measure |
Telehealth Intervention
n=9 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=6 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Change in Fasting Glucose
|
-3.00 mg/dL
Interval -4.0 to 1.0
|
7.00 mg/dL
Interval 1.0 to 15.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Number of participants remaining in study after baseline to 3 month follow up study period
Attendance of participants in each group at 3 month follow up visit
Outcome measures
| Measure |
Telehealth Intervention
n=27 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=14 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Test Whether the Intervention Group Has Greater Rates of Participation and Retention in Standard-of-care Clinic Visits and Group Sessions (if Offered) Compared to the Control Group.
|
27 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Number of participants remaining at study end point with some amount of data provided
Attendance of participants in each group at 6 month follow up visit
Outcome measures
| Measure |
Telehealth Intervention
n=16 Participants
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=12 Participants
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Test Whether the Intervention Group Has Greater Rates of Participation and Retention in Standard-of-care Clinic Visits and Group Sessions (if Offered) Compared to the Control Group.
|
16 Participants
|
12 Participants
|
Adverse Events
Telehealth Intervention
Standard of Care Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Telehealth Intervention
n=39 participants at risk
This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care.
Telehealth Encounter: Contact will be made with participants via Face Time or Skype.
|
Standard of Care Control
n=22 participants at risk
This arm will participate in their normal clinic/program routine.
|
|---|---|---|
|
Blood and lymphatic system disorders
Low HDL Cholesterol
|
5.1%
2/39 • Number of events 2 • Each patient was observed for adverse events over their 6 month enrollment period.
|
9.1%
2/22 • Number of events 2 • Each patient was observed for adverse events over their 6 month enrollment period.
|
|
Blood and lymphatic system disorders
Elevated AST
|
5.1%
2/39 • Number of events 2 • Each patient was observed for adverse events over their 6 month enrollment period.
|
9.1%
2/22 • Number of events 2 • Each patient was observed for adverse events over their 6 month enrollment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place