Charge: Optimizing a Standalone Text Messaging-Based Weight Loss Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 534
- 试验地点
- 2
- 主要终点
- Average Weight Change
研究概览
简要总结
This study evaluates different versions of a text messaging-based app for weight loss. This study will place participants to 1 of 32 experimental conditions that reflect different texting components and levels. Participants will be randomized to a condition. The investigators will recruit 448 adults into a 6-month weight loss program, with an additional follow-up 6-months after the intervention ends.
详细描述
Standalone text messaging-based weight loss treatments are scalable and can achieve population reach. However, these interventions are also modular; they can be delivered independently to maximize cost-effectiveness or combined with other approaches (e.g. provider counseling) to maximize outcomes. This study is a 12-month experimental trial among 448 adults with obesity. All participants will receive a core 6-month weight loss texting intervention that includes tailored behavior change goals, interactive self-monitoring, automated feedback, and skills training. Participants will be randomly assigned to 1 of 32 different experimental conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- 是
入选标准
- •males and females aged 18-65 years
- •participants have English language proficiency
- •participants have a BMI between 25-40 kg/m2
- •Participants will own a smartphone
- •Participants will be willing to receive multiple text messages daily.
排除标准
- •prior or planned bariatric surgery
- •psychiatric hospitalization in past 12 months
- •pregnancy, nursing, or planned pregnancy
- •history of a cardiovascular event
- •history of an eating disorder
- •history of a condition (e.g., end stage renal disease, cancer, schizophrenia) or use of medications (e.g., lithium, steroids, anti-psychotics) that would affect weight measurement, for which weight loss is contraindicated, or might promote weight change
- •current participation in a weight loss trial and/or recent weight loss > 10%
- •investigator discretion for safety reasons
结局指标
主要结局
Average Weight Change
时间窗: baseline, 6 months
Mean change in weight in kg (6 months post-randomization- baseline weight)
次要结局
- Change in Diet(baseline, 6 months)
- Average Change in Physical Activity(baseline, 6 months)