- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04026971
The Effect of Phone Application Supported Nutrition Education on Weight Loss
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
TR
-
İzmir, TR, Turkey, 35100
- Ege University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phone Application Supported Nutrition Education
Classic nutrition training and diet list is provided.
Then notification was sent to obese patients for 3 months by phone application named 'MotiVe'
|
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.
|
Other: Classical Nutrition Education
Classic nutrition training and diet list is provided.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Loss
Time Frame: 3 months
|
Body weight (kg) was measured at the beginning and end of the study by researcher
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index (BMI)
Time Frame: 3 months
|
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.
|
3 months
|
Body fat percentage (%)
Time Frame: 3 months
|
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 .
|
3 months
|
Waist circumference (cm)
Time Frame: 3 months
|
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.
|
3 months
|
Neck circumference (cm)
Time Frame: 3 months
|
It was measured from just under the larynx at the beginning and end of the study by researcher.
|
3 months
|
Weight Efficacy Lifestyle (WEL test)
Time Frame: 3 months
|
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.
|
3 months
|
Quality of Life SF-36
Time Frame: 3 months
|
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.
|
3 months
|
Rosenberg Self-Esteem
Time Frame: 3 months
|
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.
|
3 months
|
Obese Individuals Specific Quality of Life
Time Frame: 3 months
|
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.
|
3 months
|
Healthy Life Style Behaviour Scale-II
Time Frame: 3 months
|
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.
|
3 months
|
Healthy Eating Index (HEI)
Time Frame: 3 months
|
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.
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-SBE-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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