Calories Counting Using an App for Weight Loss

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

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.

Study Overview

• Status: Recruiting
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: New way of counting calories using the hands; Behavioral: Mobile applications

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

• Study Type: Interventional
• Enrollment (Anticipated): 276
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jumana Antoun; Phone Number: +9613486509; Email: ja46@aub.edu.lb

Study Locations

• Lebanon
  • Beyrouth
    • Hamra, Beyrouth, Lebanon, 110236
      • Recruiting
      • Jumana Antoun
      • Contact: Jumana Antoun; Phone Number: 03486509; Email: ja46@aub.edu.lb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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; Behavioral: Mobile applications; the participant will use a mobile application to log their calories
Active Comparator: 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	Behavioral: 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; Behavioral: Mobile applications; the participant will use a mobile application to log their calories
Active Comparator: 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	Behavioral: Mobile applications; the participant will use a mobile application to log their calories

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants who achieved weight loss of 5% of the baseline weight	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UMARs satisfaction scores	Satisfaction with the mobile application features	1 month
Percentage of participants who achieved weight loss of 5% of their baseline weight		6 months
Percentage of participants who achieved weight loss of 10% of their baseline weight		12 months

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: SBS-2021-0041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No