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Calories Counting Using an App for Weight Loss

Primary Purpose

Weight Loss

Status
Unknown status
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
New way of counting calories using the hands
Mobile applications
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

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

Inclusion Criteria:

  • Should have a smartphone with access to the internet
  • BMI more than 25 (overweight or obese)

Sites / Locations

  • Jumana AntounRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

research built JA Method mobile application + Counting method using the hands

FitnessPal mobile application (or Arabic alternative) + Counting method using the hands

Fitness Pal Mobile Application (or Arabi alternative)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Percentage of participants who achieved weight loss of 5% of the baseline weight

Secondary Outcome Measures

UMARs satisfaction scores
Satisfaction with the mobile application features
Percentage of participants who achieved weight loss of 5% of their baseline weight
Percentage of participants who achieved weight loss of 10% of their baseline weight

Full Information

First Posted
June 17, 2021
Last Updated
June 29, 2021
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04945291
Brief Title
Calories Counting Using an App for Weight Loss
Official Title
Evaluation of a Food Estimation Method Using the Hands and a Mobile App for Self-monitoring of Calories and Weight Loss: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

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

5. Study Description

Brief 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
three- armed randomized controlled trial
Masking
Outcomes Assessor
Masking Description
The participants will know the application they are using; the outcome assessor will be blinded to the user app when they fill the questionnaire and take the height and weight measurements
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
research built JA Method mobile application + Counting method using the hands
Arm Type
Experimental
Arm Description
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
Arm Title
FitnessPal mobile application (or Arabic alternative) + Counting method using the hands
Arm Type
Active Comparator
Arm Description
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
Arm Title
Fitness Pal Mobile Application (or Arabi alternative)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
New way of counting calories using the hands
Intervention Description
The participants will learn how to estimate the portions and calories content of food using their hands as a measurement tool;
Intervention Type
Behavioral
Intervention Name(s)
Mobile applications
Intervention Description
the participant will use a mobile application to log their calories
Primary Outcome Measure Information:
Title
Percentage of participants who achieved weight loss of 5% of the baseline weight
Time Frame
3 months
Secondary Outcome Measure Information:
Title
UMARs satisfaction scores
Description
Satisfaction with the mobile application features
Time Frame
1 month
Title
Percentage of participants who achieved weight loss of 5% of their baseline weight
Time Frame
6 months
Title
Percentage of participants who achieved weight loss of 10% of their baseline weight
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Should have a smartphone with access to the internet BMI more than 25 (overweight or obese)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jumana Antoun
Phone
+9613486509
Email
ja46@aub.edu.lb
Facility Information:
Facility Name
Jumana Antoun
City
Hamra
State/Province
Beyrouth
ZIP/Postal Code
110236
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jumana Antoun
Phone
03486509
Email
ja46@aub.edu.lb

12. IPD Sharing Statement

Plan to Share IPD
No

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Calories Counting Using an App for Weight Loss

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