Clinical trial NCT03321331: A Self-directed Mobile Intervention to Promote Weight Control Among Employees of a Lebanese University
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight Changes
Overweight and Obesity
Sedentary Lifestyle
Health Behavior
Keywords: Mobile Health
mobile apps
weight control
weight management
self-directed intervention
behavioral intervention
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Be an employee of the American University of Beirut (AUB) or its Medical Center (AUBMC).
2. To be able to read, write, and understand English.
3. To own a mobile phone with either Android (v4.4 or above) with or iOS (v8 or later).
4. To be interested in better controlling their weight.

Exclusion Criteria:

1. Students, who cannot prove their status as full-time or part-time employees at AUB or AUBMC.
2. Employees who are not able to read, write, and understand English.
3. Employees who do not own a mobile phone with either Android (v4.4 or above) or iOS (v8 or later).
4. Employees who have physical disabilities preventing them from exercising or walking.
5. Employees who are on a special diet for treatment of chronic conditions (e.g., Diabetes).

Primary outcomes:
measure: Weight change (kg)
timeFrame: Baseline, 4, 8, 12 weeks
measure: Waist circumference change (cm)
timeFrame: Baseline, 12 weeks
measure: BMI change (kg/m^2)
timeFrame: Baseline, 4, 8, 12 weeks
measure: Physical activity change (self-reported - IPAQ-SF, MET-hours/week)
timeFrame: Baseline, 12 weeks
measure: Physical activity change (automatically tracked - steps/week)
timeFrame: Baseline, 4, 8, 12 weeks
measure: Dietary caloric intake change
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Adherence
timeFrame: 4, 8, 12 weeks
measure: Rate of Recruitment and Retention
timeFrame: 4, 8, 12 weeks
measure: Program acceptability
timeFrame: 4, 8, 12 weeks
measure: Satisfaction with the program
timeFrame: 12 weeks
measure: Perceived app quality change (uMARS scale)
timeFrame: 4, 12 weeks
measure: Motivation to lose weight change (S-weight scale)
timeFrame: Baseline, 12 weeks
measure: Motivation to lose weight change (P-weight scales)
timeFrame: Baseline, 12 weeks
measure: Treatment Self-Regulation Questionnaire change (TSRQ scale)
timeFrame: Baseline, 4, 8, 12 weeks
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: AUB Health & Wellness Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Marco Bardus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bardus M, Hamadeh G, Hayek B, Al Kherfan R. A Self-Directed Mobile Intervention (WaznApp) to Promote Weight Control Among Employees at a Lebanese University: Protocol for a Feasibility Pilot Randomized Controlled Trial. JMIR Res Protoc. 2018 May 16;7(5):e133. doi: 10.2196/resprot.9793.