RightFit
Not yet recruitingPhase 4

GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward

GLOW (GLP-1 Plus Lifestyle for Overall Wellness)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares more intensive and less intensive lifestyle support for teens taking GLP-1 weight-loss medicines. It is for teens ages 12 to 17 with obesity and looks at weight, quality of life, heart health, and nutrition.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 12 to 17 years old at screening.
  • Have a BMI at or above the 95th percentile for age and sex. BMI is a measure of weight compared with height.
  • Give permission to share information with your regular primary care provider.
  • Own a device that can join online sessions with video.

Who can't join

  • Have type 1 or type 2 diabetes, an HbA1c of 6.5% or higher (a blood sugar measure), or triglycerides of 500 mg/dL or higher (a blood fat).
  • Use FDA-approved weight-loss medicine now or within the past 6 months, or have had or plan to have weight-loss surgery during the study.
  • Have a past or current eating disorder, a major mental illness, or a depression survey score of 15 or higher. Also excluded: a hospital stay for depression in the past 6 months, any suicide attempt, or suicidal thoughts or self-harm in the past 30 days.
  • Be pregnant, breastfeeding, or planning pregnancy, or be female and unwilling to use effective birth control.
  • Have obesity caused by changes in the POMC, PCSK1, or LEPR genes, or by a genetic condition such as Bardet-Biedl or Prader-Willi syndrome.
  • Have had gallstones without gallbladder removal, pancreatitis (swelling of the pancreas), or an allergy to GLP-1 medicines. Also excluded: you or a parent, sibling, or child has had medullary thyroid cancer or multiple endocrine neoplasia type 2, a condition that causes tumors.
  • Have someone else in your household taking part in this study.
  • Have any condition or difficulty that the study doctor thinks could make participation unsafe or prevent you from following study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 * Personal history of first-degree relative history of medullary thyroid carcinoma and/or multiple endocrine neoplasia type 2 * Known hypersensitivity to GLP1 agonists * Other participants from the same household who are participating in this trial * Any disorder, unwillingness, or inability, which in the investigator's opinion might jeopardize the participant's safety or compliance with the protocol

Study sites (1)

MN