Evaluation of App-only Users Compared With Wearable Band + App Users With Regard to Weight Management and Program Engagement on the BetterMe Platform
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Weight Change
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of a mobile wellness application, both alone and in combination with a wearable fitness tracker, for supporting weight management, physical activity, and mental well-being. Adults with a body mass index (BMI) ≥25 will be randomized to one of three groups: (1) mobile wellness application + wearable tracker, (2) mobile wellness application only, or (3) control receiving standard health information. Participants will use the interventions over a 12-week period, and outcomes including weight change, activity levels, and self-reported mental health will be assessed.
详细描述
Obesity is a growing public health concern worldwide, contributing to chronic conditions such as type 2 diabetes, cardiovascular disease, and mental health challenges. Digital wellness interventions, including mobile apps and wearable devices, have the potential to support behavior change, physical activity, and weight management.
This study will examine whether adding a wearable fitness tracker to a mobile wellness application enhances health outcomes compared with app-only use or standard health information. The trial is decentralized, conducted remotely, and does not require in-person visits.
Participants will complete baseline assessments, be randomized into one of three study arms, and follow a structured program for 12 weeks. Self-reported surveys, weight measurements (with optional video verification), app usage data, and wearable-collected data (for the tracker group) will be used to evaluate outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Age: 18+ years
- •A baseline BMI ≥ 25
- •Willing to use the BetterMe mobile wellness app and fitness tracker for the entirety of the study
- •Ownership of a smartphone
- •Currently inactive, as defined by acknowledging "several times a month" or "never" to the exercise frequency question in the screener
- •Acknowledging "I believe I can do it" or "I'm uncertain, but willing to try" to the confidence to succeed question in the screener
- •Willingness to use scales for body weighing and submit video recording
排除标准
- •A baseline BMI < 25
- •Pregnant or planning to become pregnant
- •Breast-feeding or less than 6 months postpartum
- •Currently diagnosed with insomnia, sleep apnea, or other clinical sleep disorder
- •Diagnosed thyroid, liver, kidney, cardiovascular, moderate-severe depression or anxiety, bipolar disorder, schizophrenia, or cancer-related disease
- •Recent significant weight loss (e.g., >5-10% in the last 6 months)
- •Extreme life circumstances (e.g. family illness, recently lost job, going through a divorce)
- •Cannot participate in a regular exercise routine for any reason during the course of the study (i.e. contraindications to exercise)
- •Used the same mobile wellness app and/or fitness tracker in the last year
- •Currently enrolled in an additional weight loss program (e.g. Noom, WW, health coaching) and/or working with a dietician
- •Current, previous (in the last 6 months), or planned use of weight loss medications (e.g., Ozempic, Wegovy, etc.) (in the next 6 months)
研究组 & 干预措施
App + Fitness Tracker
Participants using both a mobile wellness app and a wearable fitness tracker.
干预措施: App + Fitness Tracker (Behavioral)
App Only
participants using only the mobile wellness app.
干预措施: App Only (Behavioral)
Control Group
Participants who follow their normal health/ exercise routines, and will receive access to the BetterMe wellness blog and weekly email content to provide general wellness information.
干预措施: Control Group (Behavioral)
结局指标
主要结局
Weight Change
时间窗: 3 months
Change in % body weight
次要结局
- Physical Activity(3 months)
- Mental Health: Total Anxiety Score(3 months)
- Mental Health: Depression Total Score(3 months)
- Health-Related Quality of Life(3 months)
- App usage metrics: Time(3 months)
- App usage metrics: Exercise Count(3 months)
- App usage metrics: Frequency(3 months)