NCT06977438Not yet recruitingPhase 4
GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward
GLOW (GLP-1 Plus Lifestyle for Overall Wellness)
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1020 (estimated)
- First submitted
- 9 May 2025
- Start date
- 15 Nov 2026
- Primary completion date
- 31 Jan 2031
- Lead sponsor
- University of Minnesota
- Diseases
- Obesity
- NCT number
- NCT06977438
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1020
- From 15 Nov 2026 to the primary completion date, 31 Jan 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Diabetes (type 1 or 2) due to safety concerns about proper surveillance of glycemic control virtually
- 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
- Diagnosis of syndromic obesity including, but not limited to, Bardet Biedl or Prader-Willi Syndrome
- History of cholelithiasis without cholecystectomy
- History of pancreatitis
- Personal history of first-degree relative history of medullary thyroid carcinoma and/or multiple endocrine neoplasia type 2
- Known hypersensitivity to GLP1 agonists
- Any disorder, unwillingness, or inability, which in the investigator's opinion might jeopardize the participant's safety or compliance with the protocol
Lab values
- HbA1c \>/= 6.5%
- Hypertriglyceridemia (TG \>/= 500 mg/dL)
Other
- 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
- Other participants from the same household who are participating in this trial
Who the study is looking for
- 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
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota, Center for Pediatric Obesity Medicine Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.