GLOW (GLP-1 Plus Lifestyle for Overall Wellness)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 1,020
- 试验地点
- 1
- 主要终点
- Body Mass Index (BMI) Reduction
研究概览
简要总结
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.
详细描述
The premise underpinning our proposed project stems from the conceptual framework that obesity medications beneficially alter the underlying pathophysiology that largely drives eating behaviors (appetite, satiety, cravings, and "food noise"), thereby lessening the need for high doses of HBLT. In this way, medications can unburden adolescents living with obesity, their caregivers, healthcare providers, health systems, and payors from the need to engage in and provide intensive HBLT. This framework has directly informed our research strategy and methodological approach, including the design of our trial and the variables we have chosen to assess. Indeed, we plan to compare three different doses of HBLT in terms of their ability to improve health-related outcomes while having a keen eye on nutritional safety and eating disorders. The design and patient-centered outcomes for our trial have been carefully and thoughtfully crafted to provide evidence-based clarity on critical decisional dilemmas regarding how much HBLT is needed to get the most out of obesity pharmacotherapy and how social determinants of health (SDOH) factors can help guide treatment strategies to maximize effectiveness and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The investigator, participant and the study coordinator will be blinded to the HBLT treatment. Only the dietitians and study monitor will know the HBLT treatment assignments of the participants.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Low Dose HBLT
Individuals in this group will be randomized to receive low dose HBLT during the first 52 weeks of the study. The HBLT will consist of group classes with a brief overview of topics in addition to individual goal setting sessions.
干预措施: Semaglutide (Drug)
High Dose HBLT
Individuals in this group will be randomized to receive high dose HBLT during the first 52 weeks of the study. The HBLT will consist of group classes with detailed education, skill building and strategies on specific topics in addition to individual goal setting sessions.
干预措施: Semaglutide (Drug)
Medium Dose HBLT
Individuals in this group will be randomized to receive medium dose HBLT during the first 52 weeks of the study. The HBLT will consist of group classes with condensed information, skill building and strategies in addition to individual goal setting sessions.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Body Mass Index (BMI) Reduction
时间窗: 24 months
Change in body mass index
次要结局
未报告次要终点