Obesity
Conditions
Brief summary
POWER is uniquely positioned to evaluate characteristics of multi-component PWM programs that are associated with favorable health outcomes for treatment-seeking youth with obesity. The POWER Data Coordinating Center developed ranking reports of the 33 participating sites based on weight status change at 6 months. An in-depth review of program design of 4 top-performing sites was conducted. A unique feature identified was offering an individual program orientation session to patient-families prior to the start of the multi-component PWM program. This orientation helped patient-families better understand the program's expectations, and offered an opportunity to evaluate readiness to change, barriers for making lifestyle changes, and mental health problems. This information was used to tailor the intervention to better meet the needs of participating patient-families. When a survey of program characteristics was conducted of the 33 participating sites, this top-performing site was the only one to offer such a program orientation session prior to patient-families starting the PWM program. Therefore this program feature was included as part of the bundle of program enhancements (BPE) for this proposed pragmatic pilot study.
Interventions
BEHAVIORALTelehealth Encounter
Contact will be made with participants via Face Time or Skype.
Sponsors
Helen DeVos Children's Hospital
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 12 years of age and \< 18 * Scheduled for a new patient clinic visit at the multi-component PWM program at CCHMC or HDVCH * Severe obesity (≥ 120% of the 95th percentile for BMI based on age and gender at time of screening visit) * Able to understand and complete the consent process * Have access to a smart phone, device, or computer with a web camera * Have access to the internet
Exclusion criteria
* Lacking capacity to provide informed consent * Non-English speaking * Participating in any other weight management program or research study related to weight management * Have a sibling participating in any other weight management program or research study related to weight management * Taking anti-obesity medication (Phentermine, Orlistat, Qsymia, Naltrxone-Bupropion, Lorcaserin, others at the discretion of the PI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs | 6 months | 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. |
| Number of Participants Completing Six Month Treatment Period | 6 months | Completion of the 6 month treatment period will be tracked. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of Body Fat | 6 months | The health outcome to be evaluated is change in percent body fat (%). |
| Skeletal Muscle Mass Improvement Over Time | 6 months | 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. |
| Improvement in Systolic and Diastolic Blood Pressure | 6 months | The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg). |
| Improvement in Lab Values for Serum ALT | 6 months | The health outcome to be evaluated is the change in the lab value of ALT |
| Participation Rates in Clinic Visits and Group Sessions | Baseline to 6 months | Attendance of participants in each group throughout study period; from baseline visit through 6 month follow up period. |
| Change in Hba1C Levels | 6 months | Change in Hba1C from baseline to 6 month visit in intervention vs control group |
| Change in Non-HDL Cholesterol | 6 months | Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants |
| Change in Fasting Glucose | 6 months | Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants |
| 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. | 3 months | Attendance of participants in each group at 3 month follow up visit |
| Change in Triglyceride | 6 months | Change in triglyceride levels from baseline to 6 months in intervention vs control group participants |
| Change in Percent of the 95th Percentile for Body Mass Index | 6 months | The health outcome to be evaluated is change in percent of the 95th percentile for body mass index. |
Countries
United States
Participant flow
Pre-assignment details
One additional participant enrolled to make up for a lost to follow-up.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| Standard of Care Control This arm will participate in their normal clinic/program routine. | 22 |
| Total | 61 |
Baseline characteristics
| Characteristic | Telehealth Intervention | Standard of Care Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 39 Participants | 22 Participants | 61 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.9 years | 14.8 years | 14.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 22 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 16 Participants | 47 Participants |
| Region of Enrollment United States | 39 participants | 22 participants | 61 participants |
| Sex: Female, Male Female | 19 Participants | 9 Participants | 28 Participants |
| Sex: Female, Male Male | 20 Participants | 13 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 22 |
| other Total, other adverse events | 2 / 39 | 3 / 22 |
| serious Total, serious adverse events | 0 / 39 | 0 / 22 |
Outcome results
Primary
Number of Participants Completing Six Month Treatment Period
Completion of the 6 month treatment period will be tracked.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Intervention | Number of Participants Completing Six Month Treatment Period | 20 Participants |
| Standard of Care Control | Number of Participants Completing Six Month Treatment Period | 12 Participants |
Primary
Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Intervention | Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs | 20 Participants |
| Standard of Care Control | Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs | 12 Participants |
Secondary
Change in Fasting Glucose
Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants
Time frame: 6 months
Population: Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telehealth Intervention | Change in Fasting Glucose | -3.00 mg/dL |
| Standard of Care Control | Change in Fasting Glucose | 7.00 mg/dL |
Secondary
Change in Hba1C Levels
Change in Hba1C from baseline to 6 month visit in intervention vs control group
Time frame: 6 months
Population: Change in Hba1C from baseline to 6 month visit in intervention vs control group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telehealth Intervention | Change in Hba1C Levels | -0.05 percent |
| Standard of Care Control | Change in Hba1C Levels | 0.15 percent |
Secondary
Change in Non-HDL Cholesterol
Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants
Time frame: 6 months
Population: Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telehealth Intervention | Change in Non-HDL Cholesterol | 0.00 mg/dL |
| Standard of Care Control | Change in Non-HDL Cholesterol | 9.00 mg/dL |
Secondary
Change in Percentage of Body Fat
The health outcome to be evaluated is change in percent body fat (%).
Time frame: 6 months
Population: After 6 months of data collection, percent body fat calculations are compared between the two groups
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telehealth Intervention | Change in Percentage of Body Fat | 0.4 percentage of body fat |
| Standard of Care Control | Change in Percentage of Body Fat | 0.10 percentage of body fat |
Secondary
Change in Percent of the 95th Percentile for Body Mass Index
The health outcome to be evaluated is change in percent of the 95th percentile for body mass index.
Time frame: 6 months
Population: Intervention of telehealth vs standard of care for change in percent of 95th percentile for body mass index.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telehealth Intervention | Change in Percent of the 95th Percentile for Body Mass Index | -1.07 percent of 95th percentile for BMI | Standard Error 1.9 |
| Standard of Care Control | Change in Percent of the 95th Percentile for Body Mass Index | -2.35 percent of 95th percentile for BMI | Standard Error 2.26 |
Secondary
Change in Triglyceride
Change in triglyceride levels from baseline to 6 months in intervention vs control group participants
Time frame: 6 months
Population: Change in triglyceride levels from baseline to 6 months in intervention vs control group participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telehealth Intervention | Change in Triglyceride | -1.00 mg/dL |
| Standard of Care Control | Change in Triglyceride | -4.00 mg/dL |
Secondary
Improvement in Lab Values for Serum ALT
The health outcome to be evaluated is the change in the lab value of ALT
Time frame: 6 months
Population: Change in ALT blood value from baseline to 6 month visit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telehealth Intervention | Improvement in Lab Values for Serum ALT | 2.00 IU/L |
| Standard of Care Control | Improvement in Lab Values for Serum ALT | 2.00 IU/L |
Secondary
Improvement in Systolic and Diastolic Blood Pressure
The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg).
Time frame: 6 months
Population: Change in systolic blood pressure and diastolic blood pressure from baseline to 6 month evaluation in intervention participants vs control group participants
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Telehealth Intervention | Improvement in Systolic and Diastolic Blood Pressure | Systolic Blood Pressure | 2.0 mmHg |
| Telehealth Intervention | Improvement in Systolic and Diastolic Blood Pressure | Diastolic Blood Pressure | 2.0 mmHg |
| Standard of Care Control | Improvement in Systolic and Diastolic Blood Pressure | Systolic Blood Pressure | 2.0 mmHg |
| Standard of Care Control | Improvement in Systolic and Diastolic Blood Pressure | Diastolic Blood Pressure | -6.0 mmHg |
Secondary
Participation Rates in Clinic Visits and Group Sessions
Attendance of participants in each group throughout study period; from baseline visit through 6 month follow up period.
Time frame: Baseline to 6 months
Population: Number of participants who have baseline data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telehealth Intervention | Participation Rates in Clinic Visits and Group Sessions | 37 participants |
| Standard of Care Control | Participation Rates in Clinic Visits and Group Sessions | 21 participants |
Secondary
Skeletal Muscle Mass Improvement Over Time
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.
Time frame: 6 months
Population: Change in skeletal muscle mass after 6 month treatment period in intervention vs control group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telehealth Intervention | Skeletal Muscle Mass Improvement Over Time | 0.8 kg |
| Standard of Care Control | Skeletal Muscle Mass Improvement Over Time | 0.80 kg |
Secondary
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.
Attendance of participants in each group at 3 month follow up visit
Time frame: 3 months
Population: Number of participants remaining in study after baseline to 3 month follow up study period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Intervention | 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 |
| Standard of Care Control | 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. | 14 Participants |
Secondary
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.
Attendance of participants in each group at 6 month follow up visit
Time frame: 6 months
Population: Number of participants remaining at study end point with some amount of data provided
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Intervention | 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 |
| Standard of Care Control | 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. | 12 Participants |