Overweight and Obesity Clinical Trial
— WaznAppOfficial 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
NCT number | NCT03321331 |
Other study ID # | URB103369 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 5, 2018 |
Est. completion date | July 30, 2018 |
Verified date | January 2019 |
Source | American University of Beirut Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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). |
Country | Name | City | State |
---|---|---|---|
Lebanon | AUB Health & Wellness Center | Beirut |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center |
Lebanon,
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 |
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