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Effectiveness of Smartphone Application for Weight Loss

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
MyNetDiary app group
Paper diary group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Loss focused on measuring Adult Females, Exercise Adherence, Obesity, Physical Activity, VO2 Max, Weight Loss

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Adult females Age between 18-40 years. Individuals with BMI ≥ 25 Exclusion Criteria: Pathological conditions affecting any system Suffering from recent unhealed MSK injury/Trauma

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MyNetDiary app group

Paper diary group

Arm Description

Smart phone application MyNetDiary will be used to track calories and exercise log. The intervention period would last for 3 months.

This group will follow paper diary to track calories and exercise log for 3 months.

Outcomes

Primary Outcome Measures

Weight
It is the estimation of weight without wearing extra things by the individual. Excess or reduced weight is viewed as a sign of deciding an individual's health, with body volume estimation giving an additional aspect by calculating the distribution of body weight. A weight machine is usually used for this purpose. Weight machine is a gadget used to measure weight or mass, which is also called weight scale and weight balance system. The conventional scale comprises of two plates suspended at equal distances from a fulcrum. However, in this study, a digital weight machine will be used. The hardware comprises of a load cell or a weighing scale. The load cell calculates the person's weight and turns the mechanical force into electrical signals that can be easily obtained after microcontroller processing. Excess or reduced weight is viewed as a sign of deciding an individual's health, with body volume estimation giving an additional aspect by calculating the distribution of body
BMI
BMI stands for Body Mass Index. Mathematically it is calculated as, an individual's weight in kilograms (or pounds) divided by the square of level in meters (or feet). The categories of BMI are as follows: < 18.5 as underweight, 18.5 < 25 as normal weight, BMI 25 < 30 as overweight, BMI 30 < 35 as low obesity, BMI 35 < 40 as medium obesity and BMI ≥ 40 as extreme obesity

Secondary Outcome Measures

MyNetDairy App
The app usage data will be collected from the phone with the help of phone's app usage record and daily usage of app, its exercise log and diet log would be recorded to maintain app usage data.
Level of physical activity
The physical activity level is a method for communicating an individual's day to day activity as a number and is utilized to gauge an individual's energy consumption
Exercise adherence
Exercise adherence is a term used to define how well a patient or client is following their home exercise program or gym program and the suggestions made to them by their health expert or fitness coach. This would be recorded with the help of daily exercise and diet log by using diary or app usage.
Blood Pressure
Blood pressure is the force of blood pushing against the walls of arteries. Each time heart beats, it siphons blood into the supply routes. Blood pressure is highest when heart beats, pumping the blood. This is called systolic pressure. At the point when heart is very still, between beats, blood pressure falls. This is called diastolic pressure. Sphygmomanometer is used to measure blood pressure. It typically consists of an inflatable rubber cuff which is applied to the arm and connected to a column of mercury next to a graduated scale, enabling the determination of systolic and diastolic blood pressure by increasing and gradually releasing the pressure in the cuff. Normal blood pressure is considered as 120/80 mmHg as systolic/diastolic pressure.
VO2 max
It is the highest rate of oxygen consumption attainable during maximal exercise

Full Information

First Posted
June 26, 2023
Last Updated
October 4, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05931146
Brief Title
Effectiveness of Smartphone Application for Weight Loss
Official Title
Effectiveness of Smartphone Application for Weight Loss in Healthy Female Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
August 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is To determine the effectiveness of smartphone application for weight loss in healthy female adults. To determine the association between fitness application usage and physical activity behavior of the healthy female adults.
Detailed Description
Obesity has turned into a significant, rising well-being epidemic around the world. Doing almost no physical work has been connected with chronic weakness results and diminished personal satisfaction in adulthood. It has been perceived that innovation can uphold wellbeing upgrades around the world. The applications that target wellbeing advancement have turned into a focal piece of individuals' lives and have exhibited enormous expansions being used. Proper evidence behind usage of smart phone application for weight loss is sparse and is based on different clinical experiences and a smaller number of studies with limited methodological design. This study will contribute to describing the effectiveness of smartphone application for weight loss in female adults as well as to determine the association between fitness application usage and physical activity behavior.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Adult Females, Exercise Adherence, Obesity, Physical Activity, VO2 Max, Weight Loss

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MyNetDiary app group
Arm Type
Experimental
Arm Description
Smart phone application MyNetDiary will be used to track calories and exercise log. The intervention period would last for 3 months.
Arm Title
Paper diary group
Arm Type
Experimental
Arm Description
This group will follow paper diary to track calories and exercise log for 3 months.
Intervention Type
Other
Intervention Name(s)
MyNetDiary app group
Intervention Description
MyNetDiary will be used to track calories, and exercise while motivating for living a healthier life each day.The intervention period would last for three months. Total energy expenditure (TEE) of every participant enrolled into the study would be calculated at the start of the study and an exercise and diet plan with a calorie deficit of around 1000 kcal per week would be provided to the participant. The diet and exercise plan would be modified according to the new TEE of the participant. MyNetDiary app has built-in food and exercise activities with their respective calories' count. Moreover, customized foods and exercises can also be added into the application
Intervention Type
Other
Intervention Name(s)
Paper diary group
Intervention Description
Paper Diary will be used to track calories and exercise. The nutritional intake and exercise would be recorded for three months. The diet and exercise plans would be modified according to the new Total Energy Expenditure of the participants.
Primary Outcome Measure Information:
Title
Weight
Description
It is the estimation of weight without wearing extra things by the individual. Excess or reduced weight is viewed as a sign of deciding an individual's health, with body volume estimation giving an additional aspect by calculating the distribution of body weight. A weight machine is usually used for this purpose. Weight machine is a gadget used to measure weight or mass, which is also called weight scale and weight balance system. The conventional scale comprises of two plates suspended at equal distances from a fulcrum. However, in this study, a digital weight machine will be used. The hardware comprises of a load cell or a weighing scale. The load cell calculates the person's weight and turns the mechanical force into electrical signals that can be easily obtained after microcontroller processing. Excess or reduced weight is viewed as a sign of deciding an individual's health, with body volume estimation giving an additional aspect by calculating the distribution of body
Time Frame
3 months
Title
BMI
Description
BMI stands for Body Mass Index. Mathematically it is calculated as, an individual's weight in kilograms (or pounds) divided by the square of level in meters (or feet). The categories of BMI are as follows: < 18.5 as underweight, 18.5 < 25 as normal weight, BMI 25 < 30 as overweight, BMI 30 < 35 as low obesity, BMI 35 < 40 as medium obesity and BMI ≥ 40 as extreme obesity
Time Frame
3 months
Secondary Outcome Measure Information:
Title
MyNetDairy App
Description
The app usage data will be collected from the phone with the help of phone's app usage record and daily usage of app, its exercise log and diet log would be recorded to maintain app usage data.
Time Frame
3 months
Title
Level of physical activity
Description
The physical activity level is a method for communicating an individual's day to day activity as a number and is utilized to gauge an individual's energy consumption
Time Frame
3 months
Title
Exercise adherence
Description
Exercise adherence is a term used to define how well a patient or client is following their home exercise program or gym program and the suggestions made to them by their health expert or fitness coach. This would be recorded with the help of daily exercise and diet log by using diary or app usage.
Time Frame
3 months
Title
Blood Pressure
Description
Blood pressure is the force of blood pushing against the walls of arteries. Each time heart beats, it siphons blood into the supply routes. Blood pressure is highest when heart beats, pumping the blood. This is called systolic pressure. At the point when heart is very still, between beats, blood pressure falls. This is called diastolic pressure. Sphygmomanometer is used to measure blood pressure. It typically consists of an inflatable rubber cuff which is applied to the arm and connected to a column of mercury next to a graduated scale, enabling the determination of systolic and diastolic blood pressure by increasing and gradually releasing the pressure in the cuff. Normal blood pressure is considered as 120/80 mmHg as systolic/diastolic pressure.
Time Frame
3 months
Title
VO2 max
Description
It is the highest rate of oxygen consumption attainable during maximal exercise
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult females Age between 18-40 years. Individuals with BMI ≥ 25 Exclusion Criteria: Pathological conditions affecting any system Suffering from recent unhealed MSK injury/Trauma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noman Sadiq, MS-SPT
Organizational Affiliation
Riphah International University, Islamabad.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Smartphone Application for Weight Loss

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