ObesityNCT04026971
The Effect of Phone Application Supported Nutrition Education on Weight Loss
A study of Obesity, run by Ege University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity
- Being tested
- 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.
- Keywords
- obesity, phone application, nutrition education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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' Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Body weight (kg) was measured at the beginning and end of the study by researcher
Measured: 3 months
Secondary outcomes (10)
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.
Measured: 3 months
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 .
Measured: 3 months
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.
Measured: 3 months
Neck circumference (cm)
It was measured from just under the larynx at the beginning and end of the study by researcher.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Mar 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doğa Peksever, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026971
- Sponsor's protocol ID
- 17-SBE-004
- Status last verified
- Jul 2019
- First submitted
- 8 Apr 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Phone Application Supported Nutrition Education on Weight Loss
- ClinicalTrials.gov ID
- NCT04026971
- Acronym / sponsor ID
- 17-SBE-004
- Conditions
- Obesity
- Keywords
- obesity, phone application, nutrition education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone Application Supported Nutrition Education | Experimental | 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.Classic nutrition training and diet list is provided. Then notification was sent to obese patients for 3 months by phone application named 'MotiVe' |
| Classical Nutrition Education | Other | 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.Classic nutrition training and diet list is provided. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Not having smart phone
- Not having a internet connection
- Those who have undergone bariatric surgery
- Pregnancy
- Thyroid patients that using drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Classical Nutrition Education, Phone Application Supported Nutrition Education |
Primary outcome
Weight Loss
Time frame: 3 months
Body weight (kg) was measured at the beginning and end of the study by researcher
10 secondary outcomes
Body Mass Index (BMI)
Time frame: 3 months
Body fat percentage (%)
Time frame: 3 months
Waist circumference (cm)
Time frame: 3 months
Neck circumference (cm)
Time frame: 3 months
Weight Efficacy Lifestyle (WEL test)
Time frame: 3 months
Quality of Life SF-36
Time frame: 3 months
Rosenberg Self-Esteem
Time frame: 3 months
Obese Individuals Specific Quality of Life
Time frame: 3 months
Healthy Life Style Behaviour Scale-II
Time frame: 3 months
Healthy Eating Index (HEI)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obesity, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.