The present study were conducted with patients who presented to the _____ University Hospital Endocrine&Metabolic Diseases Outpatient Clinic between March-September 2018 to consult a dietitian and to receive routine nutrition therapy, aged between 18-64 years and Body Mass Index (BMI)≥25. The participants were first given the standard nutrition training by the dietitian in the outpatient clinic, and then person-specific diet program. After this, the patients who gave their consent to participate in the study were randomly assigned to the case and control groups. Then, anthropometric measurements of all the participants were performed and the data collection forms were filled in. The “MOtiVE” mobile application for smart phones designed specifically for this study was installed on the smart phones of the cases, and text, visual or video messages were sent to them via this application for three months. The participants in the control group underwent the routine procedure. In line with the routine practice of the outpatient clinic, all the participants were told to present three months later for control appointments. At the end of December 2018, at the end of the three-month follow-up period, the data collection process ended. In a systematic review conducted by Aguilar-Martınez et al, showed that most of the trials last for 2-4 months(8).
Participants and Recruitment Of the patients, those who did not have a smart phone with internet connection, underwent bariatric surgery, took medication or practice a special diet for thyroid problems, diabetes, celiac, gout and kidney diseases and whose body fat analysis was not fulfilled due to the presence of a pacemaker, prosthesis etc. were not included in the study.
According to the results of a study conducted by Allen et al, 25 participants in each group was enough to reach 80% power(9). In a meta-analysis conducted by Mateo, revealed that many studies had 40-45 participants in each group, some of them being less(4). When we consider 80% power with a %5 error and medium effect size (d:0.5) we had to have 51 participants in each group calculated via G-power. When we evaluate admissions to the outpatient clinic, we saw that each week we can have 4 or 5 new participants. Thus, considering this data, we decided to take 40 participants in each group. The flowchart of the study is given in Figure 1.
In the present study, randomization was carried out in the following block allocation sequence: AABB, ABAB, BABA, BBAA, ABBA, BAAB.
Change in the BMI and other anthropometic indices and the scores obtained from the Weight Efficacy Lifestyle (WEL) test, Quality of Life Scale SF-36 (QoLSSF-36), Rosenberg Self-Esteem Scale (RSES), Obesity and Weight-Loss Quality of Life Instrument (OWLQoL), Healthy Lifestyle Behavior-II Scale (HLSB-II) and Healthy Eating Index (HEI) were the dependent variables.
The body height was measured with a stadiometer whereas the body weight, body fat percentage and BMI were measured with the Tanita BC-418 Segmental Body Composition Analyzer. Waist circumference was measured with a non-elastic standard measuring tape, with the individual wearing light clothes, standing still, in an upright position and with arms open sideward. WC was measured from the midpoint between the distal border of the lowest rib and the superior border of the iliac crest(10). Neck circumference was measured by placing the inelastic measuring tape around the neck from the point just below the laryngeal prominence.
QLSSF-36: The scale consists of social functioning, physical functioning, role limitations due to physical problems, mental health, role limitations due to emotional problems, energy/vitality, and perception of general health and pain subscales. The higher the score is the better the quality of life is(11, 12).
WEL Test: It was consisted of 20 questions about negative feelings, food accesibility, social pressure, physical disturbance and positive activity. The higher the score is the better the weight efficacy lifestyle is(13, 14).
HEI: It was developed by the United States Department of Agriculture to investigate the quality of diet in Americans(15). The new HEI-2015, which was published in 2018, consists of 13 components related to diet. The increase in scores indicates a positive development(16). Nutritional values for individuals based on their 24-hour food consumption records were calculated using the _________ (______ dietary data system) and measurements were calculated based on Dietary Guidelines for _______, 2015(17).
RSES: The first 10 items of the scale are used to measure self-esteem. Self-esteem increases as the score obtained from the RSES decreases(18, 19).
HLSB-II: The scale includes health responsibility, exercise, nutrition, self-actualization, interpersonal support, and stress management subscales(20, 21).
OWLQOL: The higher the score obtained from the scale is, the higher the quality of life of the person is(22, 23).
All of the scales were validated in ___________and found to be reliable to use in ________.
MOtiVE Application for Mobile Phones: The program was developed by the researchers with taking technical support from a software engineer, specifically for this study and it is compatible with both Android and IOS. The messages were sent to the participants in the case group once a day for three months. Messages sent to the phone screen every morning at 9:00 AM were either text, visual or video messages. The visual messages designed to draw the attention of the reader included both a text and an illustration (Figure 2).
By sending text messages like “Sunday is the only day when most of us do not work. You will be more comfortable during the weekdays if you do your shopping and prepare meals on the weekend. Prepare your meatballs this Sunday and freeze them….”, practical solutions were offered to the participants. By sending text messages like “Lifestyle changes improve your quality of life and enable you to lead a better quality of life. Improve your quality of life with diet and regular exercise. Thus, do not give up...” the participants were motivated.
Video messages were uploaded to YouTube and a link address (e.g.What is an antioxidant? https://www.youtube.com/watch?v=TIaQq1CbNBM) was sent to the cases, which enabled them to access. The videos were also subtitled so that the watcher could get the message in noisy environments. The registration screen of the MOtiVE, home screen layout, samples of messages sent for 90 days are given in Additional files.
One of the features of the MOtiVE is to calculate for how many days the participant was following the program and to send the message specific to that day to the person's phone. Thanks to this feature of the MOtiVE, it was possible to send a message like “Congratulations, you have been on a diet for a full month…” to the person who participated in the program for a month. So the program was made person-specific. Another feature of the MOtiVE is that only one-way communication was possible in order to avoid bias. The application enabled only the researchers to send messages to the participants but did not allow the participants to communicate with the researchers. In this way, standardization was established between the participants in terms of determining their knowledge and interest. Another feature of the MOtiVE is to report whether the participants see the message of that day, which enabled the researchers to find out whether the participant has read the messages.
In the analysis of the study data, IBM SPSS Statistics (version 25; IBM, New York, NY, USA) was used. Continuous variables were presented with mean±standard deviation. At the baseline, the homogenously randomization of the participants to the case and control groups was investigated using the independent samples t-test (Mann Whitney-U test if parametric condition could not be met) and chi-square tests. The efficacy of the intervention was assessed using Wilcoxon signed rank test separately in the case and control groups. p<0.05 considered significant.
Study was conducted in accordance with the Declaration of Helsinki and ethical approval was obtained from ______ University Medical Research Ethics Committee (no:17-7.1/14, 08.08.2017) and the written consent was obtained from the patients. The study was recorded in clinical trials (no: ClinicalTrials.gov NCT04026971).