Body Weight ChangesWaznAppNCT03321331
A Self-directed Mobile Intervention to Promote Weight Control Among Employees of a Lebanese University
A study testing Lark (JITAI) and MyFitnessPal (no JITAI) in people with Body Weight Changes and Overweight and Obesity, run by American University of Beirut Medical Center at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes, Overweight and Obesity, Sedentary Lifestyle
- What is being tested?
- Lark (JITAI) and MyFitnessPal (no JITAI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteLebanon
- Study dates
- 5 Mar 2018to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- Lark (JITAI), MyFitnessPal (no JITAI)
- Keywords
- Mobile Health, mobile apps, weight control, weight management, self-directed intervention, behavioral intervention
- Medical subject headings
- Body Weight Changes, Overweight, Obesity, Sedentary Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lark (JITAI)Combination product
Also called Lark
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)Combination product
Also called MyFitnessPal
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.
| Study group | Role | What they receive |
|---|---|---|
| Lark (JITAI) | Experimental | 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). Receives: Combination Product: Lark (JITAI) |
| MyFitnessPal (no JITAI) | Active comparator | 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". Receives: Combination Product: MyFitnessPal (no JITAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change (kg)
Absolute change in weight (kg)
Measured: Baseline, 4, 8, 12 weeks
Waist circumference change (cm)
Absolute change in waist circumference (cm)
Measured: Baseline, 12 weeks
BMI change (kg/m^2)
Absolute change in BMI (kg/m^2)
Measured: 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.
Measured: Baseline, 12 weeks
Physical activity change (automatically tracked - steps/week)
Through mobile phone accelerometer.
Measured: 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.
Measured: Baseline, 12 weeks
Secondary outcomes (8)
Adherence
Number of missing data within each of the surveys.
Measured: 4, 8, 12 weeks
Rate of Recruitment and Retention
Number of participants who were recruited, enrolled, successfully completed the study, and/or dropped out.
Measured: 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")
Measured: 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.
Measured: 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?
Measured: 4, 12 weeks
Motivation to lose weight change (S-weight scale)
Stages of change (S-Weight) scale.
Measured: Baseline, 12 weeks
Motivation to lose weight change (P-weight scales)
Processes of change (P-Weight) scale.
Measured: 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.
Measured: Baseline, 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start5 Mar 2018
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Bardus, American University of Beirut Medical Center
- Investigators
- Marco Bardus, PhD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321331
- Sponsor's protocol ID
- URB103369
- Acronym
- WaznApp
- Status last verified
- Jan 2019
- First submitted
- 11 Oct 2017
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
PubMed 38375882Bardus 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.
PubMed 29769174
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03321331
- Acronym / sponsor ID
- WaznApp / URB103369
- Keywords
- Mobile Health, mobile apps, weight control, weight management, self-directed intervention, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lark (JITAI) | Experimental | Combination Product: 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). |
| MyFitnessPal (no JITAI) | Active comparator | 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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lark (JITAI)Also: LarkLark 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. | Combination product | Lark (JITAI) |
| MyFitnessPal (no JITAI)Also: MyFitnessPalMyFitnessPal (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. | Combination product | MyFitnessPal (no JITAI) |
Primary outcome
Weight change (kg)
Time frame: Baseline, 4, 8, 12 weeks
Absolute change in weight (kg)
Waist circumference change (cm)
Time frame: Baseline, 12 weeks
Absolute change in waist circumference (cm)
BMI change (kg/m^2)
Time frame: Baseline, 4, 8, 12 weeks
Absolute change in BMI (kg/m^2)
Physical activity change (self-reported - IPAQ-SF, MET-hours/week)
Time frame: 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)
Time frame: Baseline, 4, 8, 12 weeks
Through mobile phone accelerometer.
Dietary caloric intake change
Time frame: 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.
8 secondary outcomes
Adherence
Time frame: 4, 8, 12 weeks
Rate of Recruitment and Retention
Time frame: 4, 8, 12 weeks
Program acceptability
Time frame: 4, 8, 12 weeks
Satisfaction with the program
Time frame: 12 weeks
Perceived app quality change (uMARS scale)
Time frame: 4, 12 weeks
Motivation to lose weight change (S-weight scale)
Time frame: Baseline, 12 weeks
Motivation to lose weight change (P-weight scales)
Time frame: Baseline, 12 weeks
Treatment Self-Regulation Questionnaire change (TSRQ scale)
Time frame: Baseline, 4, 8, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Derived from this study: PubMed 38375882Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
- Derived from this study: PubMed 29769174Bardus 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Bardus, PhD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lark (JITAI) and MyFitnessPal (no JITAI) in people with Body Weight Changes and Overweight and Obesity, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (kg) (time frame: Baseline, 4, 8, 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03321331, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.