ObesityNCT03939494
Healthy Weight for Teens
A study testing Telehealth Encounter in people with Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity
- What is being tested?
- Telehealth Encounter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ≥ 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Indiana, 45229
About this study
Official title: Enhancing Effectiveness Of Existing Weight Management Programs For Teens With Severe Obesity: A 6-Month Feasibility Pilot
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.
- Conditions
- Obesity
- Being tested
- Telehealth Encounter
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth EncounterBehavioural
Contact will be made with participants via Face Time or Skype.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Intervention | Experimental | This arm receives 26 hours of telehealth encounters with a registered dietitian in conjunction with their normal clinic/program care. Receives: Behavioral: Telehealth Encounter |
| Standard of Care Control | No intervention | This arm will participate in their normal clinic/program routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Number of Participants Completing Six Month Treatment Period
Completion of the 6 month treatment period will be tracked.
Measured: 6 months
Secondary outcomes (12)
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.
Measured: Baseline to 6 months
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.
Measured: 6 months
Change in Percentage of Body Fat
The health outcome to be evaluated is change in percent body fat (%).
Measured: 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.
Measured: 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).
Measured: 6 months
Improvement in Lab Values for Serum ALT
The health outcome to be evaluated is the change in the lab value of ALT
Measured: 6 months
Change in Triglyceride
Change in triglyceride levels from baseline to 6 months in intervention vs control group participants
Measured: 6 months
Change in Hba1C Levels
Change in Hba1C from baseline to 6 month visit in intervention vs control group
Measured: 6 months
Change in Non-HDL Cholesterol
Change in non-HDL cholesterol from baseline to 6 month visit in intervention vs control group participants
Measured: 6 months
Change in Fasting Glucose
Change in fasting glucose from baseline to 6 month visit in intervention vs control group participants
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start18 Jul 2018
- Primary completion1 Jun 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Helen DeVos Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939494
- Sponsor's protocol ID
- 2018-4028
- Status last verified
- Jun 2024
- First submitted
- 11 Apr 2019
- Last updated
- 12 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Effectiveness Of Existing Weight Management Programs For Teens With Severe Obesity: A 6-Month Feasibility Pilot
- ClinicalTrials.gov ID
- NCT03939494
- Acronym / sponsor ID
- 2018-4028
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Helen DeVos Children's Hospital
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Posted 12 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth Intervention | Experimental | Behavioral: Telehealth EncounterThis 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth EncounterContact will be made with participants via Face Time or Skype. | Behavioural | Telehealth Intervention |
Primary outcome
Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs
Time frame: 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
Time frame: 6 months
Completion of the 6 month treatment period will be tracked.
12 secondary outcomes
Participation Rates in Clinic Visits and Group Sessions
Time frame: Baseline to 6 months
Change in Percent of the 95th Percentile for Body Mass Index
Time frame: 6 months
Change in Percentage of Body Fat
Time frame: 6 months
Skeletal Muscle Mass Improvement Over Time
Time frame: 6 months
Improvement in Systolic and Diastolic Blood Pressure
Time frame: 6 months
Improvement in Lab Values for Serum ALT
Time frame: 6 months
Change in Triglyceride
Time frame: 6 months
Change in Hba1C Levels
Time frame: 6 months
Change in Non-HDL Cholesterol
Time frame: 6 months
Change in Fasting Glucose
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Encounter in people with Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Implemenmtation of BPE (Bundle of Program Enhancements) in Existing Multi-component PWM Programs (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.