NCT04026971

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

April 8, 2019

Last Update Submit

July 18, 2019

Conditions

Keywords

obesityphone applicationnutrition education

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

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

    3 months

Secondary Outcomes (10)

  • Body Mass Index (BMI)

    3 months

  • Body fat percentage (%)

    3 months

  • Waist circumference (cm)

    3 months

  • Neck circumference (cm)

    3 months

  • Weight Efficacy Lifestyle (WEL test)

    3 months

  • +5 more secondary outcomes

Study Arms (2)

Phone Application Supported Nutrition Education

EXPERIMENTAL

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

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.

Classical Nutrition Education

OTHER

Classic nutrition training and diet list is provided.

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.

Interventions

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.

Classical Nutrition EducationPhone Application Supported Nutrition Education

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, TR, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Dietitian

Study Record Dates

First Submitted

April 8, 2019

First Posted

July 19, 2019

Study Start

March 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 19, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
CSR
Time Frame
Access can be opened for an unlimited period of time since the study is published
Access Criteria
Can be examined by researchers working on obesity and applications.

Locations