Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04945291 |
| Other study ID # |
SBS-2021-0041 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 16, 2021 |
| Est. completion date |
July 2022 |
Study information
| Verified date |
June 2021 |
| Source |
American University of Beirut Medical Center |
| Contact |
Jumana Antoun |
| Phone |
+9613486509 |
| Email |
ja46[@]aub.edu.lb |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This research aims to measure anew way of calories counting using a mobile app on weight loss
and adherence to the mobile app. The participants should be adults who is overweight or obese
and should have a smartphone with access to the internet. The participants will fill a
baseline survey, take the height and weight measurements, watch a video about the use of the
calories counting and app. A follow up visit will be in 4 weeks to take the height and weight
measurements and fill a questionnaire. There is an option for the participants to continue
with the research for additional 11 months with visit at 3, 6 and 12 months.
Description:
Obesity has been recognized as a disease by the American Medical Association in 2013. It has
been alarmingly on the rise over the past two decades, especially in the MENA region. In
Lebanon, 53.5% of the population is overweight and 18.16% obese. Self-monitoring, as part of
behavioral interventions, is beneficial for weight loss, especially in the context of mobile
application interventions. However, estimation of the food portions for proper food logging
remains a challenge despite the use of databases, scales and household utensils.
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
