A Self-directed Mobile Intervention to Promote Weight Control Among Employees of a Lebanese University

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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. EXPECTED IMPACT: This project will provide preliminary evidence on the efficacy of weight management apps, promoting behavior change among employees of an academic workplace. The results will inform larger scale studies targeting this population in Lebanon, and will be used as benchmark for further investigations in other settings and with other target groups.

Official Title
-----------------
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

Conditions
-----------------
Body Weight Changes, Overweight and Obesity, Sedentary Lifestyle, Health Behavior

Intervention / Treatment
-----------------
* Combination Product: Lark (JITAI)
* Combination Product: MyFitnessPal (no JITAI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lark (JITAI)<br>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). | Combination Product: Lark (JITAI)<br>* Lark works as a just-in-time adaptive intervention (JITAI), providing interactive counseling through a chat-style interface. The app prompts users to self-monitor, set goals, review them, provides feedback, and social support.<br>* Other names: Lark;|
| Active Comparator: MyFitnessPal (no JITAI)<br>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. | Combination Product: MyFitnessPal (no JITAI)<br>* MyFitnessPal (MFP) is a calorie counting app, which relies on user input for food tracking, but automatically tracks activity through the phone or through integrations with wearable devices. This app provides allows to set weight and caloric goals, review them and to receive feedback, but it has limited social support, a feature that is generally lacking in calorie-counting apps.<br>* Other names: MyFitnessPal;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change (kg) | Absolute change in weight (kg) | Baseline, 4, 8, 12 weeks | 
| Waist circumference change (cm) | Absolute change in waist circumference (cm) | Baseline, 12 weeks | 
| BMI change (kg/m^2) | Absolute change in BMI (kg/m^2) | Baseline, 4, 8, 12 weeks | 
| Physical activity change (self-reported - IPAQ-SF, MET-hours/week) | 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. | Baseline, 12 weeks | 
| Physical activity change (automatically tracked - steps/week) | Through mobile phone accelerometer. | Baseline, 4, 8, 12 weeks | 
| Dietary caloric intake change | 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. | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Number of missing data within each of the surveys. | 4, 8, 12 weeks | 
| Rate of Recruitment and Retention | Number of participants who were recruited, enrolled, successfully completed the study, and/or dropped out. | 4, 8, 12 weeks | 
| Program acceptability | Qualitative acceptability feedback related to the program will be collected at each data point through open-ended questions (Do you have any concerns about the study procedures? Write a comment in the field below; Do you have any concerns about the app you have used? Write a comment in the field below; Do you have any concerns about the questionnaires? Write a comment in the field below) | 4, 8, 12 weeks | 
| Satisfaction with the program | 7-point rating scale (semantic differential) ranging from extremely satisfied to extremely dissatisfied. An open-ended question will give participants the option to elaborate on their response. | 12 weeks | 
| Perceived app quality change (uMARS scale) | App quality will be assessed through the user version of the Mobile App Rating Scale - uMARS. The uMARS scale provides a measure of app quality based on the average of four sub-domains: engagement, functionality, aesthetics, and information. Each of the sub-domains is based on the average value of multiple items, assessed through 5-point Likert scales (engagement: 5 items; functionality and information: 4 items; aesthetics: 3 items). The uMARS includes also 4 items that are aimed to address a subjective quality domain, which are: Would you recommend this app to people who might benefit from it? How many times do you think you would use this app in the future if it was relevant to you? Would you pay for this app? What is your overall star rating of the app? | 4, 12 weeks | 
| Motivation to lose weight change (S-weight scale) | Stages of change (S-Weight) scale. | Baseline, 12 weeks | 
| Motivation to lose weight change (P-weight scales) | Processes of change (P-Weight) scale. | Baseline, 12 weeks | 
| Treatment Self-Regulation Questionnaire change (TSRQ scale) | TSRQ measures the motivation to participate in the program. The TSRQ scale includes autonomous and controlled regulation subscales. | Baseline, 4, 8, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mobile Health, mobile apps, weight control, weight management, self-directed intervention, behavioral intervention