GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward (NCT06977438) | Clinical Trial Compass
Not Yet RecruitingPhase 4
GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward
United States1,020 participantsStarted 2026-10-01
Plain-language summary
The rapid emergence of new and highly effective obesity medications has turned the field of pediatric weight management on its head. Adolescents living with obesity, their caregivers, healthcare providers, healthcare systems, policymakers, and payors are now wondering what role health behavior and lifestyle treatment (HBLT) has in terms of body mass index (BMI) reduction, improvements in quality of life and cardiometabolic health, and mitigating nutritional concerns when medications are used. Is intensive HBLT needed or could low intensity HBLT be an equally effective alternative; and if so, for whom? Our proposed project will answer these important questions that arise daily in the clinical setting and will generate critical new insights to guide decision-making for teens with obesity and the stakeholders who care deeply about them.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 12 to \< 18 years at screening
* BMI \>/= 95th percentile based on age and sex at screening
* Provide release of information for established primary health provider
* Own a device capable of connecting to the virtual platform sessions with video
Exclusion Criteria:
* Diabetes (type 1 or 2) due to safety concerns about proper surveillance of glycemic control virtually
* HbA1c \>/= 6.5%
* Current or recent (\< 6 months prior to screening) use of FDA-approved obesity medications
* Previous metabolic/bariatric surgery or metabolic/bariatric surgery planned during the study period
* Hypertriglyceridemia (TG \>/= 500 mg/dL)
* Any past or current diagnosis of an eating disorder (i.e. anorexia nervosa, atypical anorexia nervosa, bulimia nervosa)
* Major psychiatric disorder (e.g. schizophrenia, bipolar disorder)
* Unstable clinically-diagnosed depression, defined as requiring psychiatric hospitalization in the last six months)
* History of suicide attempt
* History of suicidal ideation or self-harm within 30 days of screening
* Patient Health Questionnaire (PHQ-9) score \>/= 15 at screening
* Current pregnancy, breast feeding, or plans to become pregnant
* Females refusing to use effective contraception
* Diagnosis of monogenic obesity due to mutations in POMC, PCSK1, or LEPR
* Diagnosis of syndromic obesity including, but not limited to, Bardet Biedl or Prader-Willi Syndrome
* History of cholelithiasis without cholecystectomy
* History of pancreatitis
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.