Evaluation of a Mobile Wellness Application and Wearable Fitness Tracker on Weight Management and Health Outcomes

Официальное название

Evaluation of App-only Users Compared With Wearable Band + App Users With Regard to Weight Management and Program Engagement on the BetterMe Platform

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое App + Fitness Tracker
  Participants will use a commercially available mobile wellness app alongside a wearable fitness tracker. The app provides personalized exercise programs, habit tracking, progress monitoring, and motivational support. The wearable collects daily steps, heart rate, heart rate variability, and sleep metrics to enhance personalized feedback. Participants are encouraged to engage with both tools daily over a 12-week period to support weight management, physical activity, and overall well-being.
• Поведенческое App Only
  Participants will use the same mobile wellness app without the wearable fitness tracker. The app delivers personalized exercise programs, habit tracking, progress monitoring, and motivational support. Participants are encouraged to use the app daily over 12 weeks to support weight management, physical activity, and overall well-being.
• Поведенческое Control Group
  Participants will continue their usual health and exercise routines without access to the app or wearable tracker. They will receive standard wellness information via email or blog posts over the 12-week study period. This group serves as a comparison to evaluate the effects of the interventions on weight management, physical activity, and well-being.

Первичные конечные точки

• Weight Change [Срок оценки: 3 months]

Вторичные конечные точки (7)

• Physical Activity [Срок оценки: 3 months]
• Mental Health: Total Anxiety Score [Срок оценки: 3 months]
• Mental Health: Depression Total Score [Срок оценки: 3 months]
• Health-Related Quality of Life [Срок оценки: 3 months]
• App usage metrics: Time [Срок оценки: 3 months]
• App usage metrics: Exercise Count [Срок оценки: 3 months]
• App usage metrics: Frequency [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Sterling Institutional Review Board - Remote/Virtual Participation Only — Atlanta

Идентификаторы

NCT: NCT07463144 · 12192

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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