Study Results
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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UNKNOWN
NA
276 participants
INTERVENTIONAL
2021-06-16
2022-07-31
Brief Summary
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Detailed Description
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Objective: To measure the efficacy of a novel 12-month self-monitoring program for weight loss and long-term adherence to the use of the application. The program entails estimation of food consumption using the hand and a mobile application (developed by the research team) that relies on evidence-based behavioral interventions.
Design: Randomized controlled trial Setting: American University of Beirut Medical Center Participants: Adults who are overweight or obese will be recruited from AUB/AUBMC staff and students and the community. Participants should be 18 years old and above and should have a smartphone with access to the internet.
Interventions: This research will be a three-armed randomized controlled trial. The first phase (I) will test three different methods of calorie counting each allocated to an arm of our trial at 4 weeks and the second phase (II) will test the long term efficacy of our method and its sustainability. One arm specific for the control group will be using a commercial mobile application called Fitness Pal (or رشاقة for Arabic preference) alone; another arm will be using the commercial mobile application Fitness Pal (or رشاقة for Arabic preference) along with the food estimation method using hands, and the third arm will be using the developed mobile application of the study along with the food estimation method using hands. Phase I constitutes a baseline and 4-weeks-visit where we will seek the participants' feedback concerning the mobile application and the hand counting method. Phase II: participants who are motivated to continue using the mobile applications and self-monitoring will be followed up to a period of one year.
Follow up visits will take place at 3 months, 6 months, and 12 months following the start of trial to assess for any change in participant's weight and adherence to the use of the mobile application and counting method.
Main Outcome Measures: The primary outcome of phase I will be the satisfaction with the counting method and mobile app mobile application rating and satisfaction with the various application features. The primary outcome of phase II will be the difference in the percentage of participants who achieved weight loss of 5% of their baseline weight among the three groups at 3 months, 6 months, and weight loss of 10% of their baseline weight at 12 months post-intervention.
Secondary outcomes include (1) a decrease in weight in Kg from baseline at 1,3,6 and 12 months; (2) a decrease in waist circumference in cm from baseline at 1, 3, 6, and 12 months, (3) frequency of logging in days, (4) adherence to the use of the application. In addition, demographics characteristics, self-regulation and internal motivation of the participants will be explored whether they affect any of the primary and secondary outcomes
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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research built JA Method mobile application + Counting method using the hands
The participant will watch a video that explains a new counting method using the hands and use the research built mobile application to log and track the calories
New way of counting calories using the hands
The participants will learn how to estimate the portions and calories content of food using their hands as a measurement tool;
Mobile applications
the participant will use a mobile application to log their calories
FitnessPal mobile application (or Arabic alternative) + Counting method using the hands
the participants will watch a video that explains a new counting method using the hands and they will be asked to use a commercial mobile app to log and track the calories
New way of counting calories using the hands
The participants will learn how to estimate the portions and calories content of food using their hands as a measurement tool;
Mobile applications
the participant will use a mobile application to log their calories
Fitness Pal Mobile Application (or Arabi alternative)
The participants will watch a generic video about the mobile app and they will be asked to use a commercial mobile app to log and track the calories
Mobile applications
the participant will use a mobile application to log their calories
Interventions
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New way of counting calories using the hands
The participants will learn how to estimate the portions and calories content of food using their hands as a measurement tool;
Mobile applications
the participant will use a mobile application to log their calories
Eligibility Criteria
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Inclusion Criteria
* BMI more than 25 (overweight or obese)
18 Years
ALL
Yes
Sponsors
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American University of Beirut Medical Center
OTHER
Responsible Party
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Jumana Antoun
Associate Professor of Family Medicine
Locations
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Jumana Antoun
Hamra, Beyrouth, Lebanon
Countries
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Central Contacts
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Facility Contacts
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Jumana Antoun
Role: primary
Other Identifiers
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SBS-2021-0041
Identifier Type: -
Identifier Source: org_study_id