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

NCT ID: NCT03321331

Last Updated: 2019-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2018-07-30

Brief Summary

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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

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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.

Conditions

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Body Weight Changes Overweight and Obesity Sedentary Lifestyle Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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).

Group Type EXPERIMENTAL

Lark (JITAI)

Intervention Type COMBINATION_PRODUCT

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)

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".

Group Type ACTIVE_COMPARATOR

MyFitnessPal (no JITAI)

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Lark MyFitnessPal

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American University of Beirut Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Marco Bardus

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco Bardus, PhD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

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AUB Health & Wellness Center

Beirut, , Lebanon

Site Status

Countries

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Lebanon

References

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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.

Reference Type DERIVED
PMID: 38375882 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29769174 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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URB103369

Identifier Type: -

Identifier Source: org_study_id

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