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The Effect of Phone Application Supported Nutrition Education on Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
This study is a randomized controlled study aiming to evaluate the effect of phone application supported nutrition education on weight loss according to standard education.
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, phone application, nutrition education

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body mass index is 25 or more.
  • Capable of filling the data collection form
  • No visual-hearing problems
  • Having a smart phone
  • Having a internet connection
  • Individuals who agreed to participate in the study and whose written consent was obtained

Exclusion Criteria:

  • Not having smart phone
  • Not having a internet connection
  • Those who have undergone bariatric surgery
  • Pregnancy
  • Thyroid patients that using drugs
  • Individuals who require a special diet other than obesity treatment (celiac, gout, diabetes, kidney diseases, coumadin users, etc., diagnosed by a doctor)

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Phone Application Supported Nutrition Education

Classical Nutrition Education

Arm Description

Classic nutrition training and diet list is provided. Then notification was sent to obese patients for 3 months by phone application named 'MotiVe'

Classic nutrition training and diet list is provided.

Outcomes

Primary Outcome Measures

Weight Loss
Body weight (kg) was measured at the beginning and end of the study by researcher

Secondary Outcome Measures

Body Mass Index (BMI)
BMI is calculated by dividing the body weight to the height 2 times. Weight was measured with TANITA BC 418 in the clinic. Height was measured with height meter in the clinic. BMI was calculated by researcher at the beginning and end of the study.
Body fat percentage (%)
Body fat percentage was measured with TANITA BC 418, which is available in the clinic by the researcher at the beginning and end of the study .
Waist circumference (cm)
It was measured from the midway of top of hip bone and the bottom of ribs by inelastic tape measure at the beginning and end of the study by researcher.
Neck circumference (cm)
It was measured from just under the larynx at the beginning and end of the study by researcher.
Weight Efficacy Lifestyle (WEL test)
The reliability and validity of the scale has been studied in Turkey. Index was questioned and calculated at the beginning and end of the study by researcher. The increase in the score shows a positive development.
Quality of Life SF-36
The reliability and validity of the scale has been studied in Turkey. Index was questioned and calculated at the beginning and end of the study by researcher. The increase in the score shows a positive development.
Rosenberg Self-Esteem
The reliability and validity of the scale has been studied in Turkey. Index was questionedand calculated at the beginning and end of the study by researcher. Decreased Rosenberg self-esteem score indicates an increase in self-esteem.
Obese Individuals Specific Quality of Life
The reliability and validity of the scale has been studied in Turkey. Index was questioned and calculated at the beginning and end of the study by researcher. The increase in the score shows a positive development.
Healthy Life Style Behaviour Scale-II
The reliability and validity of the scale has been studied in Turkey. Index was questioned and calculated at the beginning and end of the study by researcher. The increase in the score shows a positive development.
Healthy Eating Index (HEI)
The reliability and validity of the scale has been studied in Turkey. Index was questioned and calculated at the beginning and end of the study by researcher. The increase in the score shows a positive development.

Full Information

First Posted
April 8, 2019
Last Updated
July 18, 2019
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT04026971
Brief Title
The Effect of Phone Application Supported Nutrition Education on Weight Loss
Official Title
The Effect of Phone Application Supported Nutrition Education on Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege 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
Internet-based applications are potential supporters for individuals in weight loss programs due to their accessibility and wide access. These applications are aimed at changing the lifestyle of individuals. This study is a randomized controlled study aiming to evaluate the effect of phone application supported nutrition education on weight loss according to standard education. It has been assumed that the telephone application would increase the adaptation and motivation of the people on diet. Anthropometric measurements and nutritional features of individuals, Weight Efficacy Lifestyle (WEL test), Quality of Life SF-36, Rosenberg Self-Esteem, Obese Individuals Specific Quality of Life, Healthy Life Style Behaviour Scale-II and Healthy Eating Index score changes questioned as intermediate variables. Between March and September 2018, 79 people aged between 18-64 years, whose BMI was 25 and more, who were admitted to the dietitian at Ege University Faculty of Medicine Hospital Endocrine and Metabolic Diseases Clinic and received routine nutrition education were included in the study. In the first interview, the data collection form of all individuals was filled out and anthropometric measurements of all individuals were made by the researcher. All individuals received a classic nutrition education by the clinical dietician and then written personal weight loss diets. Afterwards, only a control appointment for 3 months later was given to the control group. Phone application named Motive designed by the researcher uploaded to only case group's phone. With the telephone application text, visual and video notifications were sent to case group for 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, phone application, nutrition education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phone Application Supported Nutrition Education
Arm Type
Experimental
Arm Description
Classic nutrition training and diet list is provided. Then notification was sent to obese patients for 3 months by phone application named 'MotiVe'
Arm Title
Classical Nutrition Education
Arm Type
Other
Arm Description
Classic nutrition training and diet list is provided.
Intervention Type
Procedure
Intervention Name(s)
This study is a randomized controlled study aiming to evaluate the effect of phone application supported nutrition education on weight loss according to standard education.
Intervention Description
This study is a randomized controlled study aiming to evaluate the effect of phone application supported nutrition education on weight loss according to standard education.
Primary Outcome Measure Information:
Title
Weight Loss
Description
Body weight (kg) was measured at the beginning and end of the study by researcher
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
BMI is calculated by dividing the body weight to the height 2 times. Weight was measured with TANITA BC 418 in the clinic. Height was measured with height meter in the clinic. BMI was calculated by researcher at the beginning and end of the study.
Time Frame
3 months
Title
Body fat percentage (%)
Description
Body fat percentage was measured with TANITA BC 418, which is available in the clinic by the researcher at the beginning and end of the study .
Time Frame
3 months
Title
Waist circumference (cm)
Description
It was measured from the midway of top of hip bone and the bottom of ribs by inelastic tape measure at the beginning and end of the study by researcher.
Time Frame
3 months
Title
Neck circumference (cm)
Description
It was measured from just under the larynx at the beginning and end of the study by researcher.
Time Frame
3 months
Title
Weight Efficacy Lifestyle (WEL test)
Description
The reliability and validity of the scale has been studied in Turkey. Index was questioned and calculated at the beginning and end of the study by researcher. The increase in the score shows a positive development.
Time Frame
3 months
Title
Quality of Life SF-36
Description
The reliability and validity of the scale has been studied in Turkey. Index was questioned and calculated at the beginning and end of the study by researcher. The increase in the score shows a positive development.
Time Frame
3 months
Title
Rosenberg Self-Esteem
Description
The reliability and validity of the scale has been studied in Turkey. Index was questionedand calculated at the beginning and end of the study by researcher. Decreased Rosenberg self-esteem score indicates an increase in self-esteem.
Time Frame
3 months
Title
Obese Individuals Specific Quality of Life
Description
The reliability and validity of the scale has been studied in Turkey. Index was questioned and calculated at the beginning and end of the study by researcher. The increase in the score shows a positive development.
Time Frame
3 months
Title
Healthy Life Style Behaviour Scale-II
Description
The reliability and validity of the scale has been studied in Turkey. Index was questioned and calculated at the beginning and end of the study by researcher. The increase in the score shows a positive development.
Time Frame
3 months
Title
Healthy Eating Index (HEI)
Description
The reliability and validity of the scale has been studied in Turkey. Index was questioned and calculated at the beginning and end of the study by researcher. The increase in the score shows a positive development.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index is 25 or more. Capable of filling the data collection form No visual-hearing problems Having a smart phone Having a internet connection Individuals who agreed to participate in the study and whose written consent was obtained Exclusion Criteria: Not having smart phone Not having a internet connection Those who have undergone bariatric surgery Pregnancy Thyroid patients that using drugs Individuals who require a special diet other than obesity treatment (celiac, gout, diabetes, kidney diseases, coumadin users, etc., diagnosed by a doctor)
Facility Information:
Facility Name
Ege University
City
İzmir
State/Province
TR
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Internet-based applications are potential supporters for individuals in weight loss programs due to their accessibility and wide access. These applications are aimed at changing the lifestyle of individuals. This study is a randomized controlled study aiming to evaluate the effect of phone application supported nutrition education on weight loss according to standard education. It has been assumed that the telephone application would increase the adaptation and motivation of the people on diet. Anthropometric measurements and nutritional features of individuals, Weight Efficacy Lifestyle (WEL test), Quality of Life SF-36, Rosenberg Self-Esteem, Obese Individuals Specific Quality of Life, Healthy Life Style Behaviour Scale-II and Healthy Eating Index score changes questioned as intermediate variables.
IPD Sharing Time Frame
Access can be opened for an unlimited period of time since the study is published
IPD Sharing Access Criteria
Can be examined by researchers working on obesity and applications.

Learn more about this trial

The Effect of Phone Application Supported Nutrition Education on Weight Loss

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