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

Overweight and Obesity Clinical Trial

— WaznApp  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03321331
• Other study ID #: URB103369
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: January 2019
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Health Behavior
• Overweight
• Overweight and Obesity
• Sedentary Lifestyle

Intervention

Combination Product:
• Lark (JITAI)
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.
• MyFitnessPal (no JITAI)
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.

Locations

Country	Name	City	State
Lebanon	AUB Health & Wellness Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change (kg)	Absolute change in weight (kg)	Baseline, 4, 8, 12 weeks
Primary	Waist circumference change (cm)	Absolute change in waist circumference (cm)	Baseline, 12 weeks
Primary	BMI change (kg/m^2)	Absolute change in BMI (kg/m^2)	Baseline, 4, 8, 12 weeks
Primary	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
Primary	Physical activity change (automatically tracked - steps/week)	Through mobile phone accelerometer.	Baseline, 4, 8, 12 weeks
Primary	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	Adherence	Number of missing data within each of the surveys.	4, 8, 12 weeks
Secondary	Rate of Recruitment and Retention	Number of participants who were recruited, enrolled, successfully completed the study, and/or dropped out.	4, 8, 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Motivation to lose weight change (S-weight scale)	Stages of change (S-Weight) scale.	Baseline, 12 weeks
Secondary	Motivation to lose weight change (P-weight scales)	Processes of change (P-Weight) scale.	Baseline, 12 weeks
Secondary	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