Can Commercial Mobile Apps for Weight Management be Used in Interventions? Bridging the Gap Between Usability, Theoretical Adherence, and User Experience - Part II - WaznApp Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Weight change (kg)
研究概览
简要总结
WaznApp study is a 12-week randomized controlled trial aimed to evaluate the feasibility and preliminary efficacy of a self-directed behavioral weight-loss intervention targeting employees of an academic institution, using two popular consumer mobile applications for weight loss. The hypothesis is that individuals assigned to the app that provides interactive feedback and proactively motivates engagement in healthy behaviors (eating healthily and being more active) will be significantly better than those who receive the comparison condition (a simple calorie tracking app).
详细描述
BACKGROUND: Recent reviews show that popular mobile apps for weight loss and weight management embed elements that are commonly associated with behavior change, such as setting goals, self-reporting and monitoring behavior, and prompting feedback on performance. These technologies show good potential for developing interventions for the prevention of noncommunicable diseases. Despite their potential, little is known about how these changes can occur and the way end-users perceive and use these apps. Few studies tested if commercial apps for weight management can be used in interventions for behavior change.
PURPOSE: To assess the feasibility and preliminary efficacy of a self-directed weight-loss intervention targeting employees of an academic institution, using consumer mobile applications for weight loss (Lark and MyFitnessPal).
SETTING: American University of Beirut campus and Medical Center, Beirut, Lebanon.
PARTICIPANTS: Employees (adults aged 18+), with criteria of being able to read, write, and understand English, being owners of a mobile phone with either Android (v4.4 or above) or iPhone operative system (v8 or later); in better controlling their weight, and provide written informed consent to participate in the trial.
RESEARCH DESIGN: The study is a single-center, parallel randomized controlled trial with two study arms (intervention and control). The intervention arm will use Lark, a mobile coach app, which provides a just-in-time adaptive intervention (JITAI) by providing motivational feedback, goal setting, and emotional social support, among other change techniques. The control group will use MyFitnessPal, a calorie-counting app, which does not include JITAI components, but allows users to keep track of their caloric intake and energy expenditure.
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
- Single (Outcomes Assessor)
盲法说明
Assessments regarding body weight and waist circumference will be conducted by nurses at the University Health Services clinics, who are blind to treatment allocation. The assessor will go through an assessment training program and will be informed about the study, but not about the allocation or treatments. Due to the nature of the intervention neither participants nor staff can be blinded to allocation, but are strongly inculcated not to disclose the allocation status of the participant at the follow up assessments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be an employee of the American University of Beirut (AUB) or its Medical Center (AUBMC).
- •To be able to read, write, and understand English.
- •To own a mobile phone with either Android (v4.4 or above) with or iOS (v8 or later).
- •To be interested in better controlling their weight.
排除标准
- •Students, who cannot prove their status as full-time or part-time employees at AUB or AUBMC.
- •Employees who are not able to read, write, and understand English.
- •Employees who do not own a mobile phone with either Android (v4.4 or above) or iOS (v8 or later).
- •Employees who have physical disabilities preventing them from exercising or walking.
- •Employees who are on a special diet for treatment of chronic conditions (e.g., Diabetes).
研究组 & 干预措施
Lark (JITAI)
Participants in the intervention arm will use for 12 weeks the pro version of a mHealth app called "Lark", developed by Lark Technologies Ltd. Lark is a coach app, which uses several variables to generate smart and empathic conversations. Variables include activity, sleep, meals, weight, and height data, weight goal set by the user/Lark coach, activity goal set by user/Lark coach, starchy food goal set by user/Lark coach. Lark uses all these variables to create a dynamic coaching system, constantly changing and adapting to the user in the moment and over time. For these features, Lark provides a just in time adaptive intervention (JITAI).
干预措施: Lark (JITAI) (Combination Product)
MyFitnessPal (no JITAI)
Participants in the control arm will be assigned to use MyFitnessPal. Similar to the intervention arm, they will be instructed to use the app for 12 weeks. MyFitnessPal does not include JITAI components, but allows users to keep track of their caloric intake and energy expenditure. MyFitnessPal has features that can be associated with effective behavior change techniques, including: self-monitoring of behavior and outcomes, goal setting and feedback (similar to Lark). In MyFitnessPal, social support is limited to comments and 'likes' from friends of its restricted user community, therefore tackling the techniques of "social comparisons" and "social reward".
干预措施: MyFitnessPal (no JITAI) (Combination Product)
结局指标
主要结局
Weight change (kg)
时间窗: Baseline, 4, 8, 12 weeks
Absolute change in weight (kg)
Waist circumference change (cm)
时间窗: Baseline, 12 weeks
Absolute change in waist circumference (cm)
BMI change (kg/m^2)
时间窗: Baseline, 4, 8, 12 weeks
Absolute change in BMI (kg/m\^2)
Physical activity change (self-reported - IPAQ-SF, MET-hours/week)
时间窗: Baseline, 12 weeks
Measured through the International Physical Activity Questionnaire, short form (IPAQ-SF). IPAQ-SF requires respondents to estimate how much time they spent while doing activities in the previous week, in four domains: vigorous or moderate physical activity, walking and sitting. A total physical activity score is calculated by summing the time spent in each domain. Total physical activity score and sub-domain scores can be expressed in hours/week, or converted to metabolic-equivalents (METs), following the IPAQ scoring protocol.
Physical activity change (automatically tracked - steps/week)
时间窗: Baseline, 4, 8, 12 weeks
Through mobile phone accelerometer.
Dietary caloric intake change
时间窗: Baseline, 12 weeks
Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, version 2016, developed by the National Cancer Institute, Bethesda, MD. The multiple pass approach in 24-hour recall consists of 8 modules: a meal based quick list, meal gap review, detail pass, final review, forgotten foods, last chance, usual intake question and supplements module. It provides a detailed assessment of dietary intake over the past 24 hours including food, drinks and supplements, as well as timing, form, portion size, the way food has been prepared, consumption of additions such as sugar, cream, dressing, etc., in addition to the source/brand of food. The 2016 version of the system includes also pictures of portions which are deemed to reduce overestimation or underestimation of food intake.
次要结局
- Motivation to lose weight change (P-weight scales)(Baseline, 12 weeks)
- Adherence(4, 8, 12 weeks)
- Rate of Recruitment and Retention(4, 8, 12 weeks)
- Program acceptability(4, 8, 12 weeks)
- Satisfaction with the program(12 weeks)
- Perceived app quality change (uMARS scale)(4, 12 weeks)
- Motivation to lose weight change (S-weight scale)(Baseline, 12 weeks)
- Treatment Self-Regulation Questionnaire change (TSRQ scale)(Baseline, 4, 8, 12 weeks)
研究者
Marco Bardus
Assistant Professor
American University of Beirut Medical Center