Evaluating the EVO Treatment Optimized for Resource Constraints: Elements Vital to Treat Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 524
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
The overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. The investigators will be comparing the previously developed and optimized behavioral weight loss intervention (APP) to the Diabetes Prevention Program (DPP), to evaluate program weight-loss success and cost-effectiveness.
详细描述
The proposed study seeks to determine if the APP program is an effective, resource-sensitive strategy to manage weight for obesity, as compared to the DPP program. During the 24-week active intervention phase, participants will be randomized to one of two treatments: 1) APP, wherein participants receive calorie, fat, and physical activity goals via a Smartphone application for self-monitoring, online educational readings, and biweekly sessions with a Health Promotionist; or 2) DPP, wherein participants are guided to self-monitor their physical activity, food intake, and weight via a participant log, and are guided through 16 sessions by a Health Promotionist. Assessments to track progress will occur remotely at the 3-month, 6-month, and 12-month time points of the program.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 30-45
- •Weight stable
- •Own a Smartphone and be willing to install our Smartphone app
- •Willing to conduct video conference calls with study staff
排除标准
- •Enrolled in any formal weight loss program
- •Taking anti-obesity medications
- •Not taking medications that may cause weight gain
- •Unstable medical conditions
- •Diabetes requiring insulin supplementation
- •Crohn's Disease
- •Diagnosis of obstructive sleep apnea requiring intervention (i.e., CPAP)
- •Assistive devices for mobility
- •Hospitalizations for a psychiatric disorder within the past 5 years
- •Cardiovascular disease symptoms while performing moderate intensity exercise
- •Pregnancy, trying to get pregnant, or lactating.
- •Bulimia or binge eating disorder
- •Reports of active suicidal ideation
- •Current substance abuse or dependence besides nicotine dependence
研究组 & 干预措施
Smartphone App Participants (APP)
Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist
干预措施: Smartphone App Participants (APP) (Behavioral)
Diabetes Prevention Program Participants (DPP)
Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist
干预措施: Diabetes Prevention Program Participants (DPP) (Behavioral)
结局指标
主要结局
Weight
时间窗: Baseline to 6-Months
Participant change in weight, in kilograms, from baseline to 6-months.
次要结局
- Costs of treatment(12 Months)
研究者
Angela Fidler Pfammatter, PhD
Assistant Professor
Northwestern University