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

Primary Purpose

Body Weight Changes, Overweight and Obesity, Sedentary Lifestyle

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Lark (JITAI)
MyFitnessPal (no JITAI)
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight Changes focused on measuring Mobile Health, mobile apps, weight control, weight management, self-directed intervention, behavioral intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • AUB Health & Wellness Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lark (JITAI)

MyFitnessPal (no JITAI)

Arm Description

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).

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".

Outcomes

Primary Outcome Measures

Weight change (kg)
Absolute change in weight (kg)
Waist circumference change (cm)
Absolute change in waist circumference (cm)
BMI change (kg/m^2)
Absolute change in BMI (kg/m^2)
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.
Physical activity change (automatically tracked - steps/week)
Through mobile phone accelerometer.
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.

Secondary Outcome Measures

Adherence
Number of missing data within each of the surveys.
Rate of Recruitment and Retention
Number of participants who were recruited, enrolled, successfully completed the study, and/or dropped out.
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")
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.
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?
Motivation to lose weight change (S-weight scale)
Stages of change (S-Weight) scale.
Motivation to lose weight change (P-weight scales)
Processes of change (P-Weight) scale.
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.

Full Information

First Posted
October 11, 2017
Last Updated
January 10, 2019
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03321331
Brief Title
A Self-directed Mobile Intervention to Promote Weight Control Among Employees of a Lebanese University
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes, Overweight and Obesity, Sedentary Lifestyle, Health Behavior
Keywords
Mobile Health, mobile apps, weight control, weight management, self-directed intervention, behavioral intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lark (JITAI)
Arm Type
Experimental
Arm Description
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).
Arm Title
MyFitnessPal (no JITAI)
Arm Type
Active Comparator
Arm Description
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".
Intervention Type
Combination Product
Intervention Name(s)
Lark (JITAI)
Other Intervention Name(s)
Lark
Intervention Description
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
Intervention Name(s)
MyFitnessPal (no JITAI)
Other Intervention Name(s)
MyFitnessPal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight change (kg)
Description
Absolute change in weight (kg)
Time Frame
Baseline, 4, 8, 12 weeks
Title
Waist circumference change (cm)
Description
Absolute change in waist circumference (cm)
Time Frame
Baseline, 12 weeks
Title
BMI change (kg/m^2)
Description
Absolute change in BMI (kg/m^2)
Time Frame
Baseline, 4, 8, 12 weeks
Title
Physical activity change (self-reported - IPAQ-SF, MET-hours/week)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Physical activity change (automatically tracked - steps/week)
Description
Through mobile phone accelerometer.
Time Frame
Baseline, 4, 8, 12 weeks
Title
Dietary caloric intake change
Description
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.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Adherence
Description
Number of missing data within each of the surveys.
Time Frame
4, 8, 12 weeks
Title
Rate of Recruitment and Retention
Description
Number of participants who were recruited, enrolled, successfully completed the study, and/or dropped out.
Time Frame
4, 8, 12 weeks
Title
Program acceptability
Description
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")
Time Frame
4, 8, 12 weeks
Title
Satisfaction with the program
Description
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.
Time Frame
12 weeks
Title
Perceived app quality change (uMARS scale)
Description
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?
Time Frame
4, 12 weeks
Title
Motivation to lose weight change (S-weight scale)
Description
Stages of change (S-Weight) scale.
Time Frame
Baseline, 12 weeks
Title
Motivation to lose weight change (P-weight scales)
Description
Processes of change (P-Weight) scale.
Time Frame
Baseline, 12 weeks
Title
Treatment Self-Regulation Questionnaire change (TSRQ scale)
Description
TSRQ measures the motivation to participate in the program. The TSRQ scale includes autonomous and controlled regulation subscales.
Time Frame
Baseline, 4, 8, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Bardus, PhD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
AUB Health & Wellness Center
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29769174
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.
Results Reference
derived

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

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