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| Name | Class |
|---|---|
| Helen DeVos Children's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth Intervention | Experimental | This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care. |
|
| Standard of Care Control | No Intervention | This arm will participate in their normal clinic/program routine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Encounter | Behavioral | Contact will be made with participants via Face Time or Skype. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Number of Participants Completing Six Month Treatment Period | Completion of the 6 month treatment period will be tracked. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months |
| Change in Percent of the 95th Percentile for Body Mass Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Indiana | 45229 | United States |
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One additional participant enrolled to make up for a lost to follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard of Care Control | This arm will participate in their normal clinic/program routine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard of Care Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
Each patient was observed for adverse events over their 6 month enrollment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low HDL Cholesterol | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Banks | Cincinnati Children's Hospital | 513-636-2147 | mary.banks@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2019 | Feb 27, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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The health outcome to be evaluated is change in percent of the 95th percentile for body mass index. |
| 6 months |
| Change in Percentage of Body Fat | The health outcome to be evaluated is change in percent body fat (%). | 6 months |
| 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. | 6 months |
| Improvement in Systolic and Diastolic Blood Pressure | The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg). | 6 months |
| Improvement in Lab Values for Serum ALT | The health outcome to be evaluated is the change in the lab value of ALT | 6 months |
| Change in Triglyceride | Change in triglyceride levels from baseline to 6 months in intervention vs control group participants | 6 months |
| Change in Hba1C Levels | Change in Hba1C from baseline to 6 month visit in intervention vs control group | 6 months |
| Change in Non-HDL Cholesterol | Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants | 6 months |
| Change in Fasting Glucose | Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants | 6 months |
| 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 | 3 months |
| 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 | 6 months |
This arm will participate in their normal clinic/program routine. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care Control | This arm will participate in their normal clinic/program routine. |
|
|
| Primary | Number of Participants Completing Six Month Treatment Period | Completion of the 6 month treatment period will be tracked. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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. | Number of participants who have baseline data | Posted | Number | participants | Baseline to 6 months |
|
|
|
| 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. | Intervention of telehealth vs standard of care for change in percent of 95th percentile for body mass index. | Posted | Least Squares Mean | Standard Error | percent of 95th percentile for BMI | 6 months |
|
|
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| Secondary | Change in Percentage of Body Fat | The health outcome to be evaluated is change in percent body fat (%). | After 6 months of data collection, percent body fat calculations are compared between the two groups | Posted | Median | Inter-Quartile Range | percentage of body fat | 6 months |
|
|
|
| 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. | Change in skeletal muscle mass after 6 month treatment period in intervention vs control group | Posted | Median | Inter-Quartile Range | kg | 6 months |
|
|
|
| Secondary | Improvement in Systolic and Diastolic Blood Pressure | The health outcome to be evaluated is change in both systolic and diastolic blood pressure (mmHg). | Change in systolic blood pressure and diastolic blood pressure from baseline to 6 month evaluation in intervention participants vs control group participants | Posted | Median | Inter-Quartile Range | mmHg | 6 months |
|
|
|
| Secondary | Improvement in Lab Values for Serum ALT | The health outcome to be evaluated is the change in the lab value of ALT | Change in ALT blood value from baseline to 6 month visit | Posted | Median | Inter-Quartile Range | IU/L | 6 months |
|
|
|
| Secondary | Change in Triglyceride | 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 | Posted | Median | Inter-Quartile Range | mg/dL | 6 months |
|
|
|
| Secondary | Change in Hba1C Levels | 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 | Posted | Median | Inter-Quartile Range | percent | 6 months |
|
|
|
| Secondary | Change in Non-HDL Cholesterol | 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 | Posted | Median | Inter-Quartile Range | mg/dL | 6 months |
|
|
|
| Secondary | Change in Fasting Glucose | 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 | Posted | Median | Inter-Quartile Range | mg/dL | 6 months |
|
|
|
| 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 | Number of participants remaining in study after baseline to 3 month follow up study period | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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 | Number of participants remaining at study end point with some amount of data provided | Posted | Count of Participants | Participants | 6 months |
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| 0 |
| 39 |
| 0 |
| 39 |
| 2 |
| 39 |
| EG001 | Standard of Care Control | This arm will participate in their normal clinic/program routine. | 0 | 22 | 0 | 22 | 3 | 22 |
| Elevated AST | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |