NCT06470659已完成不适用
Effectiveness of a Telehealth Medical Weight Management Program Prescribing Anti-obesity Medications Paired With a Digital Behavioral Weight Management Program
Michelle Cardel, PhD, MS, RD2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2024年6月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Percent body weight lost at 12 weeks
研究概览
简要总结
The study compares the effectiveness of adults living with overweight or obesity taking weight management medications alone vs taking them with behavioral and lifestyle support. The primary outcome is percent body weight lost at 12-weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI of >30 or BMI of >27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
- •Determined eligible for Bupropion/Naltrexone or Liraglutide by WW Clinic medical provider and initiated a medication management plan
排除标准
- •Uncontrolled hypertension
- •History of seizures
- •History of glaucoma
- •History of chronic kidney disease
- •Currently taking bupropion
- •Currently taking naltrexone
- •Current or previous history of anorexia or bulimia nervosa
- •Engagement with vomiting or laxative use within the last 28 days with the aim of controlling their shape or weight
- •Currently taking opioids
- •Previous surgical obesity treatment
- •Use of other anti-obesity medication in last 90 days or a GLP1 in the last 180 days
- •Lost weight >11 lbs in the last 90 days
- •Pregnant, breastfeeding, intends to become pregnant, of child-bearing potential and not using a highly effective contraceptive method
- •Any other reason rendering a participant unsuitable for trial participation, as determined by a clinician or study investigator
结局指标
主要结局
Percent body weight lost at 12 weeks
时间窗: Baseline, 12 weeks
Measurement of weight using a bluetooth body weight scale
次要结局
- Physical Activity and Sedentary Behavior(Baseline, 12 weeks)
- Well-being(Baseline, 12 weeks)
- Impact on Quality of Life(Baseline, 12 weeks)
- Body Appreciation(Baseline, 12 weeks)
- Change in body weight (in kg or pounds) at 12 weeks(Baseline, 12 weeks)
- Habit/Automaticity(Baseline, 12 weeks)
- Self-Compassion(Baseline, 12 weeks)
- Dietary Intake(Baseline, 12 weeks)
- Hunger VAS (Visual Analogue Scale)(Baseline, 12 weeks)
- Food Cravings(Baseline, 12 weeks)
- Weight Bias(Baseline, 12 weeks)
研究者
Michelle Cardel, PhD, MS, RD
Senior Director of Global Clinical Research and Nutrition
WW International Inc
研究点 (2)
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