Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000008325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
13/08/2025
Date registered
Help: Date registered
6/01/2026
Date last updated
Help: Date last updated
6/01/2026
Date data sharing statement initially provided
Help: Data sharing statement date
6/01/2026
Date results provided
Help: Date results provided
6/01/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of smartphone application in obesity management
Scientific title
Use of a smartphone application for monitoring and managing obesity in Adults
Additional trial identifiers [1] 315042 0
Erciyes University Scientific Research Project Support Unit (TTU-2019-9492)
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Obesity 338497 0
Condition category
Condition code
Diet and Nutrition 334801 334801 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The study was planned to include 30 control and 30 intervention groups. Thirty-one control and 34 intervention group participants were reached, but one person from the intervention group left the study due to a change of city. In March 2020, the study was conducted remotely by creating two separate WhatsApp groups as control and intervention due to the global pandemic in March 2020; in Türkiye, the bans on going out, the lack of outpatient services other than emergency services and the fear of patients coming to the hospital. Participants continued to be advised to continue their diets, exercises they could do at home, and behavior change suggestions. Motivational interviews were held regularly on the phone with patients who requested them. The intervention group was again asked to continue using the smartphone application and to regularly send us visuals of the foods they consumed and their weekly exercises.
In the study, the participants in the intervention group were enabled to use a smartphone application. The Samsung Health smartphone application was downloaded to their phones during the first interview, and they were told how to use it.
When the application is first downloaded, the patient's age, gender, height, and weight values are requested. When the values are entered, the number of calories that the patient can take per day close to the basal metabolic rate is determined. The main screen includes data entry for goals, sleep, food, weight, water, and exercise. At each visit, the records were evaluated together with the participant.
The intervention group could record everything they ate and drank at that meal in the breakfast, lunch, dinner, morning snack, lunch snack, and evening snack options with the add option in the food section. The carbohydrate, fat, protein, vitamin, iron, vitamin-iron ratios, and calories of each recorded food were displayed in detail. For each meal, it was possible to add, subtract, and see the content and calories of the food before recording. When entered into the goals section, the protein, fat, and carbohydrate ratios that the patient should take at the end of the day; the number of vitamins, minerals, iron, and the amount taken by the participant could be seen.
The exercise section offers many options, from walking to mountain biking, swimming to dancing, squash to jumping rope. Manage items allowed participants to choose the exercise that suited them, target duration, location, and calories burned.
The calories, protein, fat, and carbohydrate ratios of the foods consumed, the protein, fat, and carbohydrate ratios compliance with the given diet; the exercise performed, duration, and calories spent were monitored, and the participants were guided on proper nutrition and proper exercise.
In June 2020, with the relaxation of the measures, the participants were invited to be evaluated and measured at the hospital again, but. However due to the ongoing epidemic, the participants left the study since the people they lived with had chronic diseases and were worried about carrying diseases to them from the hospital. Some of them stated that they were psychologically affected by this process and did not want to come to the hospital. The study was completed with 19 intervention group and 20 control group participants.
Considering the basal metabolic rate data obtained from bioelectrical impedance analysis, diet lists were prepared in cooperation with the dietitian per the WHO (World Health Organization) and The Society of Endocrinology and Metabolism of Türkiye (TEMD) guidelines, with three main meals and three snacks. At six months, 5-10% of basal weight was planned for clinically significant weight loss.
Both groups were offered one hour of moderate-intensity walking or equivalent aerobic exercise (swimming, climbing stairs, etc.) daily for significant weight loss. To make it easier for the participants to understand, the exercise intensity was indicated as light if they could both speak and sing, moderate if they could speak but not sing, and heavy if they could neither speak nor sing.
Each visit, a half-hour motivational interview was conducted with both groups per Miller and Rollnick's guiding principles. Although measurements were interrupted due to the the global pandemic, diet, exercise, behavior change advice, and motivational interviewing continued over the phone.
Patients were advised to change their behavior using the Beck Diet Solution book (Have a flexible list, eat slowly, be conscious of what you eat, etc.) .
All motivational interviews, visual tracking of food intake and weekly exercise, and bioelectrical impedance analyses were conducted by a single, trained researcher every 15 days for the first 2 months and monthly for the next 4 months.
The patient's gender, height, age, and body structure were entered into the bioelectrical impedance analyzer, and the patient's weight, BMI, fat percentage and fat mass, muscle mass and water content, fat percentage, fat mass, and muscle mass ratios in the extremities were determined.
Intervention code [1] 331715 0
Lifestyle
Intervention code [2] 332622 0
Behaviour
Intervention code [3] 332623 0
Treatment: Devices
Description of the comparator or control
The study included 19 control and 20 intervention group participants aged 18 and over with a Body Mass Index (BMI) between 30 and 40. Both groups were advised on diet, exercise, motivational interviewing, and behavior change. Additionally, the Nutrition Behavior Exercise Scale (NBES) was applied to both groups at the beginning and at the end of the study.
Each visit, a half-hour motivational interview was conducted with both groups. Although measurements were interrupted due to the the global pandemic, diet, exercise, behavior change advice, and motivational interviewing continued over the phone. The control group only received motivational interviews.
Control group
Active

Outcomes
Primary outcome [1] 343629 0
In the bioelectrical impedance measurements at six months follow-up, weight, mean of 5.46 kg in the control group, mean of 4.30 kg in the intervention group decreased. Clinically significant weight loss of 5% or more was 55% in the control group and 36.84% in the intervention group.
Timepoint [1] 343629 0
Baseline and at the end of the sixth month, total weight loss and weight loss from fat were evaluated.
Secondary outcome [1] 450824 0
Lifestyle change
Timepoint [1] 450824 0
Nutrition Behavior Exercise Scale was used to assess the outcome of the study at baseline and after completion.
Secondary outcome [2] 450825 0
Behavior change
Timepoint [2] 450825 0
Nutrition Behavior Exercise Scale was used to assess the outcome of the study at baseline and after completion.

Eligibility
Key inclusion criteria
Obese individuals over the age of 18 with a body mass index between 30 and 40 were included in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Those with psychiatric illnesses, those with illnesses that may affect weight gain, those using medication, and pregnant women were not included.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study ended with the completion of the planned follow-up of 39 patients. Data were analyzed using TURCOSA statistical software (Turcosa Analytics Ltd Co, Türkiye, www.turcosa.com.tr). The distribution of the study data was evaluated by Shapiro-Wilk's test statistic, histogram, and q-q graph. Intergroup comparisons were made using an independent two-sample t-test, a dependent two-sample t-test for quantitative variables, and a one-way analysis of variance for repeated measures. Levene's test evaluated the homogeneity of variance. Statistical significance level p<0.05 was considered significant.
In the evaluation of the NBES data, Cronbach's alpha internal consistency coefficient was 0.850 in the Psychological/Dependent Eating Behavior dimension; Cronbach's alpha internal consistency coefficient was 0.713 in the Healthy Eating-Exercise Behavior dimension; Cronbach's alpha internal consistency coefficient was 0.487 in the Unhealthy Eating-Exercise Behavior dimension; Cronbach's alpha internal consistency coefficient was 0.460 in the Meal Pattern dimension; and Cronbach's alpha internal consistency coefficient was 0.754 in the total dimension for all of these four subscales.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2019
Date of last participant enrolment
Anticipated
Actual
30/04/2021
Date of last data collection
Anticipated
Actual
29/10/2021
Sample size
Target
65
Accrual to date
Final
39
Recruitment outside Australia
Country [1] 27277 0
Turkey
State/province [1] 27277 0
Kayseri

Funding & Sponsors
Funding source category [1] 319604 0
University
Name [1] 319604 0
Erciyes University Scientific Research Project Unit
Country [1] 319604 0
Turkey
Primary sponsor type
University
Name
Erciyes University Scientific Research Project Unit
Address
Country
Turkey
Secondary sponsor category [1] 322207 0
None
Name [1] 322207 0
Address [1] 322207 0
Country [1] 322207 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318169 0
Erciyes University Faculty of Medicine Clinical Research Ethics Committee
Ethics committee address [1] 318169 0
Ethics committee country [1] 318169 0
Turkey
Date submitted for ethics approval [1] 318169 0
07/08/2019
Approval date [1] 318169 0
25/09/2019
Ethics approval number [1] 318169 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143338 0
Dr Elif Deniz Safak
Address 143338 0
Erciyes School of Medicine Department of Family Medicine Talas Road 38039 Kayseri/Türkiye
Country 143338 0
Turkey
Phone 143338 0
+90 5333870919
Fax 143338 0
Email 143338 0
[email protected]
Contact person for public queries
Name 143339 0
Elif Deniz Safak
Address 143339 0
Erciyes School of Medicine Department of Family Medicine Talas Road 38039 Kayseri/Türkiye
Country 143339 0
Turkey
Phone 143339 0
+90 5333870919
Fax 143339 0
Email 143339 0
[email protected]
Contact person for scientific queries
Name 143340 0
Elif Deniz Safak
Address 143340 0
Erciyes School of Medicine Department of Family Medicine Talas Road 38039 Kayseri/Türkiye
Country 143340 0
Turkey
Phone 143340 0
+90 5333870919
Fax 143340 0
Email 143340 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  [email protected] Ethical approval -1.pdf


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ThesisYes Betul_Goncagul_Kecebas_tez.pdf
Conference abstractNo congress_proceedings2021-DAAHK-20.pdf

Documents added automatically
No additional documents have been identified.