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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04026971
Other study ID # 17-SBE-004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date December 31, 2018

Study information

Verified date July 2019
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.
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.

Locations

Country Name City State
Turkey Ege University Izmir TR

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight Loss Body weight (kg) was measured at the beginning and end of the study by researcher 3 months
Secondary 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. 3 months
Secondary 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 . 3 months
Secondary 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. 3 months
Secondary Neck circumference (cm) It was measured from just under the larynx at the beginning and end of the study by researcher. 3 months
Secondary 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. 3 months
Secondary 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. 3 months
Secondary 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. 3 months
Secondary 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. 3 months
Secondary 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. 3 months
Secondary 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. 3 months
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