scholarly journals Feasibility and Subjective Effectiveness Assessment Using a Mobile Health Application for a Health Management Applied Traditional Medicine Perspective: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Younghwa Baek ◽  
Kyungsik Jeong ◽  
Siwoo Lee ◽  
Hoseok Kim ◽  
Bok-Nam Seo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mobile Health ◽  
Primary Outcome ◽  
Health Management ◽  
Controlled Trial ◽  
Control Group ◽  
Health Promoting Behaviors ◽  
Randomized Controlled ◽  
Health Promoting ◽  
Secondary Outcomes

BACKGROUND Mobile health (mHealth) is a major source of health management systems such as health promotion behavior, chronic disease, and mental illness. Moreover, mHealth, a new model of digital healthcare in need of change due to the COVID-19 pandemic, will increase and demand for use worldwide. Accordingly, interest in health care in everyday life and the importance of mobile health are growing. OBJECTIVE We developed a MibyeongBogam (MBBG) application that evaluates the user’s subhealth status by use of a smartphone and provides a health management method based on that user’s subhealth status for use in everyday life. The primary objective of this study was to compare health status awareness after the use of the MBBG application between the intervention and control groups, and to evaluate the application’s practicality. METHODS This study was a prospective, open-label, parallel group, randomized controlled trial as an intervention for MBBG. The study was conducted at two hospitals in Korea with 150 healthy people in their 30s and 40s, at a 1:1 allocation ratio. Participants visited the hospital three times: pre-intervention, intermediate visit six weeks after intervention, and final visit 12 weeks after intervention. Key endpoints were measured at the first visit before intervention and at 12 weeks after intervention. The primary outcome was the awareness of subhealth status and secondary outcomes were health status, health-promoting behaviors, and motivation for healthy behaviors. RESULTS The primary outcome, subhealth awareness, tended to slightly increase in both groups after the uncompensated intervention, but there was no significant difference between groups (MBBG group = 23.69±0.25, control group = 23.1±0.25, p=0.088). In the case of secondary outcomes, only some variables of subhealth status showed significant differences between the two groups after intervention, and the intervention group showed an improvement in the total score of subhealth (p = 0.025), sleep disturbance (p = 0.024), depression (p = 0.003), anger (p = 0.01), and anxiety symptoms (p = 0.009) compared to the control group. CONCLUSIONS In this study, the MBBG application showed positive potential for improving the health, especially the mental health, of individuals without particular health problems. However, the effects of the application on health-promoting behaviors were not clearly evaluated. Therefore, further studies to assess improvements in health after the use of personalized health management programs provided by the MBBG application would need to be performed. It is thought that the MBBG application would be useful for the general public, who are not diagnosed with a disease but cannot enjoy an optimal daily life due to discomfort, to seek strategies that can improve their health. CLINICALTRIAL Clinical Research Information Service, KCT0003488. (https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=14379)

scholarly journals A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lara Bücker ◽  
Josefine Gehlenborg ◽  
Steffen Moritz ◽  
Stefan Westermann
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Group Differences ◽  
Control Group ◽  
Gambling Problems ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

scholarly journals An Internet-Based Cognitive Behavioral Therapy Program Adapted to Patients With Cardiovascular Disease and Depression: Randomized Controlled Trial

10.2196/14648 ◽  
2019 ◽  
Vol 6 (10) ◽  
pp. e14648 ◽  
Author(s):  
Peter Johansson ◽  
Mats Westas ◽  
Gerhard Andersson ◽  
Urban Alehagen ◽  
Anders Broström ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Primary Outcome ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Eq Vas

Background Depression is a common cause of reduced well-being and prognosis in patients with cardiovascular disease (CVD). However, there is a lack of effective intervention strategies targeting depression. Objective The study aimed to evaluate the effects of a nurse-delivered and adapted internet-based cognitive behavioral therapy (iCBT) program aimed at reducing depression in patients with CVD. Methods A randomized controlled trial was conducted. A total of 144 patients with CVD with at least mild depression (Patient Health Questionnaire–9 [PHQ-9] score ≥5) were randomized 1:1 to a 9-week program of iCBT (n=72) or an active control participating in a Web-based discussion forum (online discussion forum [ODF], n=72). The iCBT program, which included 7 modules, was adapted to fit patients with CVD. Nurses with an experience of CVD care provided feedback and a short introduction to cognitive behavioral therapy. The primary outcome, depression, was measured using PHQ-9. Secondary outcomes were depression measured using the Montgomery-Åsberg Depression Rating Scale–self-rating version (MADRS-S), health-related quality of life (HRQoL) measured using Short Form 12 (SF-12) survey and EuroQol Visual Analogue Scale (EQ-VAS), and the level of adherence. An intention-to-treat analysis with multiple imputations was used. Between-group differences in the primary and secondary outcomes were determined by the analysis of covariance, and a sensitivity analysis was performed using mixed models. Results Compared with ODF, iCBT had a significant and moderate treatment effect on the primary outcome depression (ie, PHQ-9; mean group difference=−2.34 [95% CI −3.58 to −1.10], P<.001, Cohen d=0.62). In the secondary outcomes, compared with ODF, iCBT had a significant and large effect on depression (ie, MADRS-S; P<.001, Cohen d=0.86) and a significant and moderate effect on the mental component scale of the SF-12 (P<.001, Cohen d=0.66) and the EQ-VAS (P<.001, Cohen d=0.62). Overall, 60% (n=43) of the iCBT group completed all 7 modules, whereas 82% (n=59) completed at least half of the modules. No patients were discontinued from the study owing to a high risk of suicide or deterioration in depression. Conclusions Nurse-delivered iCBT can reduce depression and improve HRQoL in patients with CVD, enabling treatment for depression in their own homes and at their preferred time. Trial Registration ClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074

scholarly journals Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rasmus Kramer Mikkelsen ◽  
Lars Blønd ◽  
Lisbeth Rosenkrantz Hölmich ◽  
Cecilie Mølgaard ◽  
Anders Troelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adipose Tissue ◽  
Knee Injury ◽  
Primary Outcome ◽  
Morphological Changes ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Outcome Score ◽  
Patient Reported

Abstract Background Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro-fragmented adipose tissue has been suggested to relieve symptoms. Methods/Design The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grades 2–3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro-fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total, 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months; the Tegner activity score; treatment failure; and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. Discussion This trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient’s opinion about their knee and associated problems when suffering from osteoarthritis.

scholarly journals Imaginal retraining decreases craving for high-calorie food in overweight and obese women: A randomized controlled trial

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Steffen Moritz ◽  
Anja S. Göritz ◽  
Stella Schmotz ◽  
Roland Weierstall-Pust ◽  
Josefine Gehlenborg ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Overweight And Obesity ◽  
Medium Effect ◽  
Favorable Effect ◽  
Control Group ◽  
Obese Women ◽  
Randomized Controlled ◽  
High Calorie

AbstractOverweight and obesity are epidemic conditions. Obesity is associated with somatic and psychological sequelae, including serious life-shortening disorders (e.g., diabetes). This study aimed to evaluate the efficacy of a newly developed imaginal variant of approach bias modification (i.e., imaginal retraining) for the reduction of craving for high-calorie food. In a randomized controlled trial, 384 women with a body mass index above 25 were allocated to a wait-list control group or to two variants of imaginal retraining (ratio: 1; 0.5; 0.5). The two intervention groups were sent a manual on imaginal retraining. One group was explicitly encouraged and instructed to use electronic reminders (RER); the standard retraining group (RS) was not encouraged to use electronic reminders. Assessments were 6 weeks apart and were carried out online. Craving for high-calorie food represented the primary outcome (based on the Visual Analog Scale, VAS). Secondary outcomes included the Food Cravings Questionnaire (FCQ-T-R). The study was registered as DRKS00017220. Women in the RER group utilized the retraining technique more often than those in the RS condition, and utilization frequency in turn was associated with improvement on craving and eating behavior scales. Both intention-to-treat and per-protocol analyses showed a favorable effect of the RER group, which achieved significance on the primary outcome, as well as on several other outcomes relative to controls at a small to medium effect size. For those participants who measured their weight before and after the assessment using a scale, weight loss in the RER group was significantly greater compared to the control group. Both retraining groups (RER: 39.4%; RS: 31.1%) reduced their subjective amount of eating relative to controls (24.2%). Approximately two-thirds of the sample (68.3%) performed the exercises at least once during the study period. The present results show that, when used regularly, imaginal retraining may reduce craving for high-calorie food in overweight and obese women. Of note, there was also evidence suggestive of weight reduction, although no diet or lifestyle change was recommended in the manual. Because a large subgroup neither read the manual nor performed the exercises, we recommend that future imaginal retraining be conveyed via short video clips.

Enhanced early sensory outcome after nerve repair as a result of immediate post-operative re-learning: a randomized controlled trial

2014 ◽  
Vol 40 (6) ◽  
pp. 598-606 ◽  
Author(s):  
B. Rosén ◽  
P. Vikström ◽  
S. Turner ◽  
D. A. McGrouther ◽  
R. W. Selles ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Nerve Repair ◽  
Intervention Group ◽  
Control Group ◽  
Level Of Evidence ◽  
Test Part ◽  
Randomized Controlled ◽  
Identification Test

We assessed the use of guided plasticity training to improve the outcome in the first 6 months after nerve repair. In a multicentre randomized controlled trial, 37 adults with median or ulnar nerve repair at the distal forearm were randomized to intervention, starting the first week after surgery with sensory and motor re-learning using mirror visual feedback and observation of touch, or to a control group with re-learning starting when reinnervation could be detected. The primary outcome at 3 and 6 months post-operatively was discriminative touch (shape texture identification test, part of the Rosen score). At 6 months, discriminative touch was significantly better in the early intervention group. Improvement of discriminative touch between 3 and 6 months was also significantly greater in that group. There were no significant differences in motor function, pain or in the total score. We conclude that early re-learning using guided plasticity may have a potential to improve the outcomes after nerve repair. Level of evidence: II

scholarly journals Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial

2019 ◽  
Author(s):  
Jian-Feng Tu ◽  
Jing-Wen Yang ◽  
Li-Qiong Wang ◽  
Yang Wang ◽  
Jin-ling Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Knee Osteoarthritis ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Sham Acupuncture ◽  
Manual Acupuncture ◽  
Randomized Controlled ◽  
Secondary Outcomes

Abstract Background: Acupuncture therapies are widely used for knee osteoarthritis (KOA), despite contradictory evidences. Current study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA. Methods/design: Current study is a multi-center, three-arm, randomized controlled trial which will enroll 480 participants with KOA in China. Participants will be randomly assigned (1:1:1) to receive 24 sessions of electro-acupuncture, manual acupuncture, or sham acupuncture over 8 weeks. The primary outcome is the response rate - the proportion of patients who simultaneously achieve minimal clinically important improvement in pain and function domains at 8 weeks. The primary outcome will be analyzed using Z-test with intention-to-treat set. Secondary outcomes contain pain, function, global patient assessment and quality of life. Full details of the statistical analysis plan for the primary and secondary outcomes will be described in this article. The statistical analysis plan was written and submitted without knowledge of the study data. Discussion: The data will be analyzed according to this pre-specified statistical analysis plan to avoid data-driven analysis and enhance the transparency of current trial. The trial will provide high-quality evidence on the efficacy of acupuncture for KOA.

scholarly journals Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial

2020 ◽  
Vol 8 (1) ◽  
pp. e000954
Author(s):  
Louis Potier ◽  
Maud François ◽  
Dured Dardari ◽  
Marilyne Feron ◽  
Narimene Belhatem ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Diabetic Foot ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Foot And Ankle ◽  
End Points ◽  
Randomized Controlled ◽  
Ankle Joints

IntroductionThe offloading is crucial to heal neuropathic diabetic foot ulcer (DFU). Removable offloading are the most used devices. Orthèse diabète is a new customized removable knee-high offloading device immobilizing foot and ankle joints, with some specific and innovative features that may improve offloading. We aimed to evaluate the efficiency of this device in DFU healing.Research, design and methodsThe evaluation of Offloading using a new removable ORTHOsis in DIABetic foot study is a French multicenter (13 centers) randomized controlled trial with blinded end points evaluation. Adults with neuropathic DFU were randomly assigned to either Orthèse Diabète (experimental device), or any type of conventional (usually used in France) removable offloading devices (control group). The primary outcome was the 3-month proportion of patients with fully healed DFU.ResultsAmong 112 randomized patients (men 78%, age 62±10 years), the primary outcome occurred in 19 (33%) participants using conventional device vs 19 (35%) Orthèse Diabète users (p=0.79). Study groups were also comparable in terms of prespecified secondary end points including occurrence of new DFU (25% vs 27% in conventional and experimental groups), ipsilateral lower-limb amputation (4% vs 10%) or infectious complications (14% vs 13%) (p>0.05 for all). Adverse events were comparable between groups, including 4 deaths unrelated to study allocation (1 sudden death, 2 ventricular arrhythmias and 1 pancreatic cancer). Adverse events believed to be related to the device were higher in the Orthèse Diabète group than in the control group (15% vs 4%). Orthèse Diabète was less frequently worn than conventional devices (46% vs 66%, p=0.04).ConclusionsOrthèse Diabète, a new removable offloading orthosis immobilizing foot and ankle joints did not show superiority compared with conventional removable devices in neuropathic DFU healing and cannot be recommended to heal DFU.Trial registration numberNCT01956162.

scholarly journals Exploring the Experiences of Individuals Allocated to a Control Setting: Findings From a Mobile Health Smoking Cessation Trial (Preprint)

2018 ◽  
Author(s):  
Ulrika Müssener ◽  
Catharina Linderoth ◽  
Marcus Bendtsen
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
University Students ◽  
Mobile Health ◽  
Controlled Trial ◽  
Text Messages ◽  
Control Group ◽  
Free Text ◽  
Randomized Controlled ◽  
Quit Smoking

BACKGROUND Tobacco smoking is the primary cause of preventable premature disease and death worldwide. Evidence of the efficacy of text messaging interventions to reduce smoking behavior is well established, but there is still a need for studies targeting young people, especially because young adult smokers are less likely to seek treatment than older adults. A mobile health intervention, Nicotine Exit (NEXit), targeting smoking among university students was developed to support university students to quit smoking. Short-term effectiveness was measured through a randomized controlled trial, which found that immediately after the 12-week intervention, 26% of smokers in the intervention group had prolonged abstinence compared with 15% in the control group. OBJECTIVE The objective of this study was to explore the experience of being allocated to the control group in the NEXit smoking cessation intervention. METHODS We asked students who were allocated to the control group in the main NEXit randomized controlled trial to report their experiences. An email was sent to the participants with an electronic link to a short questionnaire. We assessed the distribution of the responses to the questionnaire by descriptive analysis. We analyzed free-text comments to 4 questions. RESULTS The response rate for the questionnaire was 33.8% (258/763), and we collected 143 free-text comments. Of the responders, 60.9% (157/258) experienced frustration, disappointment, and irritation about being allocated to the control group; they felt they were being denied support by having to wait for the intervention. Monthly text messages during the waiting period thanking them for taking part in the trial were perceived as negative by 72.3% (189/258), but for some the messages served as a reminder about the decision to quit smoking. Of the responders, 61.2% (158/258) chose to wait to quit smoking until they had access to the intervention, and 29.8% (77/258) decided to try to quit smoking without support. Of the respondents, 77.5% (200/258) claimed they were still smoking and had signed up or were thinking about signing up for the smoking cessation program at the time of the questionnaire. CONCLUSIONS Most of the respondents reported negative feelings about having to wait for the support of the intervention and that they had decided to continue smoking. A similar number decided to wait to quit smoking until they had access to the intervention, and these respondents reported a high interest in the intervention. Free-text comments indicated that some control group participants believed that they had been excluded from the trial, while others were confused when asked to sign up for the intervention again. CLINICALTRIAL ISRCTN Registry ISRCTN75766527; http://www.isrctn.com/ISRCTN75766527 (Archived by WebCite at http://www.webcitation.org/7678sUKbR)

scholarly journals Efficacy of acupuncture based on acupoint combination theory for irritable bowel syndrome: study protocol for a multicenter randomized controlled trial

2021 ◽  
Author(s):  
Jing-wen Sun ◽  
Zhi-gang Li ◽  
Ming-liang Sun ◽  
Da Li ◽  
Jun Zhao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Social Adjustment ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Self Rating ◽  
Multicenter Randomized Controlled Trial ◽  
Secondary Outcomes ◽  
Irritable Bowel

Abstract Background: Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain, diarrhea or constipation, and changes in defecation patterns. No organic disease has been found to explain these symptoms by routine clinical examination. This study aims to investigate the efficacy and safety of acupuncture therapy for IBS patients based on conventional treatments. We also want to explore the optimal acupoint combination recommended for IBS and clarify the clinical advantage of "multi-acupoint co-effect and synergistic effect".Methods and analysis: A total of 204 eligible patients who meet the Rome IV criteria for IBS will be randomly allocated to receive different acupuncture. Each patient will receive 12 acupuncture treatments over four weeks and will be followed up for four weeks. The primary outcome is the IBS-symptom severity score (IBS-SSS). The secondary outcomes include the Bristol stool form scale(BSFS), the work and social adjustment score (WSAS), the IBS-quality of life (IBS-QOL), self-rating anxiety scale (SAS), and the self-rating depression scale (SDS). Both the primary outcome and the secondary outcomes measures are collected at baseline, 2 weeks, and 4 weeks of the intervention, 6 weeks, and 8 weeks after the intervention.Ethics and dissemination: The entire project has been approved by the ethics committee of Beijing University of Chinese Medicine ( 2020BZYLL0903 ) .Discussion: This is a multicenter randomized controlled trial for IBS in China. This may shed light on the efficacy of acupuncture as an alternative to IBS. The results of the trial will be disseminated in peer-reviewed publications. Trial registration: Chinese Clinical Trials Register, ID: ChiCTR2000041215.First registered on 12 December 2020. http://www.chictr.org.cn/.

scholarly journals Increasing Awareness and Use of Mobile Health Technology Among Individuals With Hypertension in a Rural Community of Bangladesh: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Yasmin Jahan ◽  
Michiko Moriyama ◽  
Md Moshiur Rahman ◽  
Kana Kazawa ◽  
Atiqur Rahman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Health Education ◽  
Rural Community ◽  
Mobile Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Lifestyle Behaviors ◽  
Randomized Controlled ◽  
Mhealth Technology

BACKGROUND Hypertension remains one of the foremost noncommunicable diseases that most often lead to cardiovascular diseases and its different complications. The prevalence of hypertension in Bangladesh has been increasing. However, there are very limited studies that have evaluated the impact of health education and awareness development in mitigating the burden of hypertension and its complications in Bangladesh. OBJECTIVE This study aims to increase awareness, enhance knowledge, and change lifestyle behaviors through health education and the use of mobile health (mHealth) technology among individuals with hypertension living in a rural community of Bangladesh. METHODS A randomized controlled trial is underway in a Mirzapur subdistrict of Bangladesh. This trial compares two groups of individuals with hypertension: The comparison arm receives health education and the intervention arm receives health education and a periodic mobile phone–based text message intervention. The trial duration is 5 months. The primary end point is participants’ actual behavior changes brought about by increased awareness and knowledge. RESULTS Enrollment of participants started in August 2018, and collection of follow-up data was completed at the end of July 2019. A total of 420 participants volunteered to participate, and among them, 209 and 211 were randomly allocated to the intervention group and the control group, respectively. Among them, the ratio of males/females was 12.0/88.0 in the intervention group and 16.1/83.9 in the control group. Data cleaning and analyses have been completed and the results have been submitted for publication. CONCLUSIONS Periodic short education using mHealth technology in addition to face-to-face health education may be an effective method for increasing awareness and knowledge about behavioral changes and maintaining healthy lifestyle behaviors. CLINICALTRIAL Bangladesh Medical Research Council (BMRC) 06025072017; ClinicalTrials.gov NCT03614104, https://clinicaltrials.gov/ct2/show/NCT03614104; University hospital Medical Information Network (UMIN) R000033736, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_his_list.cgi?recptno=R000033736 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15523

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