The Comparative Effectiveness of Commercial Weight Management Programs in Adults Living With Overweight or Obesity: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 459
- 试验地点
- 1
- 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 three commercial weight management programs. The primary outcome is absolute and percentage weight change 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •BMI ≥27 kg/m²
- •Own a bodyweight scale that they can weigh themselves with during the study
- •Willing and able to comply with study protocol
- •Capable of providing informed consent
- •Able to read and write in English
- •Willing to be randomized
- •Willing to sign a Non Disclosure Agreement
排除标准
- •Pregnant, lactating, or plans to become pregnant in the next 6 months
- •Previous bariatric surgery or planned bariatric surgery during the study period
- •Major surgery within the past 6 months or plans to have surgery during the study period
- •Participation in the previous 3 months or current participation in a structured behavioral weight loss program
- •Participation in another structured weight loss program during the study period (i.e., the next 3 months)
- •Communication needs that would render them unable to understand the study and/or intervention materials
- •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 anti-obesity medications, planning to take anti-obesity medications in the next 6 months, or previously taken anti-obesity medications in the previous 3 months
- •Weight loss of ≥ 5 kg (11 lb) in the previous 6 months
- •Self-reported diagnosis of severe depression, bipolar disorder, substance abuse, or psychosis
- •Participants who are involved in any other research studies at this time
- •Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months
- •Chronic/inflammatory gastrointestinal disorders (irritable bowel syndrome is acceptable)
- •History of heart problems (e.g., angina, bypass surgery, myocardial infarction, etc.) within previous 6 months
- •Diagnosis of type 1 or type 2 diabetes
- •Presence of implanted cardiac defibrillator or pacemaker
- •History of cancer within past 5 years or current treatment for cancer
- •Hospitalization for psychiatric disorders during the last 12 months
研究组 & 干预措施
Commercial weight management program 1
Participants in this group receive behavioral / lifestyle support from an evidence-based commercial weight management program.
干预措施: Commercial weight management program (Behavioral)
Commercial weight management program 2
Participants in this group receive behavioral / lifestyle support from an evidence-based commercial weight management program.
干预措施: Commercial weight management program (Behavioral)
Commercial weight management program 3
Participants in this group receive behavioral / lifestyle support from an evidence-based commercial weight management program.
干预措施: Commercial weight management program (Behavioral)
结局指标
主要结局
Percent body weight lost at 12 weeks
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks
Measurement of weight using a body weight scale
Change in body weight (in kg or pounds) at 12 weeks
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks
Measurement of weight using a body weight scale
次要结局
- Physical Activity and Sedentary Behavior(Baseline, 12 weeks)
- Hunger(Baseline, 12 weeks)
- Dietary intake(Baseline, 12 weeks)
- Body appreciation(Baseline, 12 weeks)
- Impact of Weight on Quality(Baseline, 12 weeks)
- Weight Bias Internalization(Baseline, 12 weeks)
- Wellbeing(Baseline, 12 weeks)
- Self-Compassion(Baseline, 12 weeks)
- Food cravings(Baseline, 12 weeks)
研究者
Kara Marlatt
Senior Director, Scientific Research
WW International Inc