NCT04945291

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 17, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 17, 2021

Last Update Submit

June 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (3)

  • UMARs satisfaction scores

    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

Study Arms (3)

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

EXPERIMENTAL

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 handsBehavioral: Mobile applications

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

ACTIVE COMPARATOR

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 handsBehavioral: Mobile applications

Fitness Pal Mobile Application (or Arabi alternative)

ACTIVE COMPARATOR

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

Interventions

The participants will learn how to estimate the portions and calories content of food using their hands as a measurement tool;

FitnessPal mobile application (or Arabic alternative) + Counting method using the handsresearch built JA Method mobile application + Counting method using the hands

the participant will use a mobile application to log their calories

Fitness Pal Mobile Application (or Arabi alternative)FitnessPal mobile application (or Arabic alternative) + Counting method using the handsresearch built JA Method mobile application + Counting method using the hands

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jumana Antoun

Hamra, Beyrouth, 110236, Lebanon

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Jumana Antoun

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: three- armed randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Family Medicine

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 30, 2021

Study Start

June 16, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations