scholarly journals An App-Based Intervention for Caregivers to Prevent Unintentional Injury Among Preschoolers: Cluster Randomized Controlled Trial

10.2196/13519 ◽  
2019 ◽  
Vol 7 (8) ◽  
pp. e13519 ◽  
Author(s):  
Peishan Ning ◽  
Peixia Cheng ◽  
David C Schwebel ◽  
Yang Yang ◽  
Renhe Yu ◽  
...  
Keyword(s):  
Injury Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Unintentional Injury ◽  
Control Group ◽  
Injury Incidence ◽  
Child Injury ◽  
Randomized Controlled ◽  
Cluster Randomized

Background App-based interventions have the potential to reduce child injury in countries with limited prevention resources, but their effectiveness has not been rigorously examined. Objective This study aimed to assess the effectiveness of an app-based intervention for caregivers of preschoolers to prevent unintentional injury among Chinese preschoolers. Methods A 6-month cluster randomized controlled trial was conducted from December 2017 to June 2018. Recruitment was conducted through preschools, which were randomly allocated to either the control group (ie, app-based parenting education excluding unintentional injury prevention) or the intervention group (ie, app-based parenting education including unintentional injury prevention). A total of 2920 caregivers of preschoolers aged 3-6 years from 20 preschools in Changsha, China, were recruited offline through the schools. The primary outcome was unintentional injury incidences among preschoolers in the past 3 months; this measure was assessed through an online caregiver-report at the baseline visit and at 3-month and 6-month follow-up visits. Secondary outcome measures included caregivers’ self-reported attitudes and behaviors concerning child supervision during the last week. Generalized estimating equations (GEEs) were used to assess the effectiveness of the app-based intervention on responses at 3 and 6 months after adjusting for sociodemographic variables, baseline level of the outcome variable, and engagement with interventions in the assigned group. All analyses were intention-to-treat. A per-protocol sensitivity analysis was also conducted. Results In total, 1980 of the 2920 caregivers completed the study. The mean age of participants was 32.0 years (SD 5.5) and 68.99% (1366/1980) of them were female. During the 6-month follow-up visit, unintentional injury incidence did not change significantly in either group: incidence in the intervention group went from 8.76% (94/1073) to 8.11% (87/1073), P=.59; incidence in the control group went from 9.4% (85/907) to 7.5% (69/907), P=.15. The changes did not differ between the groups (odds ratio [OR] 1.14, 95% CI 0.80-1.62). Changes in the average score in attitude concerning unintentional injury prevention were also similar between the groups (B .05, 95% CI -0.03 to 0.13). Changes in unintentional injury prevention behaviors were greater in the intervention group than in the control group after the intervention (B .87, 95% CI 0.33-1.42). Analyses of individual injury prevention behaviors showed that the intervention reduced three risky behaviors: unsafe feeding of children (OR 0.73, 95% CI 0.60-0.89); incorrectly placing children in cars (OR 0.73, 95% CI 0.57-0.93); and allowing children to ride bicycles, electric bicycles, or motorcycles unsupervised (OR 0.80, 95% CI 0.64-0.99). The intervention also improved scores on three safety-focused behaviors: testing water temperature before giving children a bath (OR 1.26, 95% CI 1.05-1.52); properly storing sharp objects (OR 1.24, 95% CI 1.01-1.52); and safely storing medicines, detergents, and pesticides (OR 1.24, 95% CI 1.02-1.51). Conclusions The app-based intervention did not reduce unintentional injury incidence among preschoolers but significantly improved caregivers’ safety behaviors. This app-based intervention approach to improve caregiver behaviors surrounding child injury risk offers promise to be modified and ultimately disseminated broadly. Trial Registration Chinese Clinical Trial Registry ChiCTR-IOR-17010438; http://www.chictr.org.cn/showproj.aspx?proj=17376 (Archived by WebCite at http://www.webcitation.org/75jt17X84) International Registered Report Identifier (IRRID) RR2-10.1186/s12889-018-5790-1

scholarly journals An App-Based Intervention for Caregivers to Prevent Unintentional Injury Among Preschoolers: Cluster Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Peishan Ning ◽  
Peixia Cheng ◽  
David C Schwebel ◽  
Yang Yang ◽  
Renhe Yu ◽  
...  
Keyword(s):  
Injury Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Unintentional Injury ◽  
Control Group ◽  
Injury Incidence ◽  
Child Injury ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND App-based interventions have the potential to reduce child injury in countries with limited prevention resources, but their effectiveness has not been rigorously examined. OBJECTIVE This study aimed to assess the effectiveness of an app-based intervention for caregivers of preschoolers to prevent unintentional injury among Chinese preschoolers. METHODS A 6-month cluster randomized controlled trial was conducted from December 2017 to June 2018. Recruitment was conducted through preschools, which were randomly allocated to either the control group (ie, app-based parenting education excluding unintentional injury prevention) or the intervention group (ie, app-based parenting education including unintentional injury prevention). A total of 2920 caregivers of preschoolers aged 3-6 years from 20 preschools in Changsha, China, were recruited offline through the schools. The primary outcome was unintentional injury incidences among preschoolers in the past 3 months; this measure was assessed through an online caregiver-report at the baseline visit and at 3-month and 6-month follow-up visits. Secondary outcome measures included caregivers’ self-reported attitudes and behaviors concerning child supervision during the last week. Generalized estimating equations (GEEs) were used to assess the effectiveness of the app-based intervention on responses at 3 and 6 months after adjusting for sociodemographic variables, baseline level of the outcome variable, and engagement with interventions in the assigned group. All analyses were intention-to-treat. A per-protocol sensitivity analysis was also conducted. RESULTS In total, 1980 of the 2920 caregivers completed the study. The mean age of participants was 32.0 years (SD 5.5) and 68.99% (1366/1980) of them were female. During the 6-month follow-up visit, unintentional injury incidence did not change significantly in either group: incidence in the intervention group went from 8.76% (94/1073) to 8.11% (87/1073), P=.59; incidence in the control group went from 9.4% (85/907) to 7.5% (69/907), P=.15. The changes did not differ between the groups (odds ratio [OR] 1.14, 95% CI 0.80-1.62). Changes in the average score in attitude concerning unintentional injury prevention were also similar between the groups (B .05, 95% CI -0.03 to 0.13). Changes in unintentional injury prevention behaviors were greater in the intervention group than in the control group after the intervention (B .87, 95% CI 0.33-1.42). Analyses of individual injury prevention behaviors showed that the intervention reduced three risky behaviors: unsafe feeding of children (OR 0.73, 95% CI 0.60-0.89); incorrectly placing children in cars (OR 0.73, 95% CI 0.57-0.93); and allowing children to ride bicycles, electric bicycles, or motorcycles unsupervised (OR 0.80, 95% CI 0.64-0.99). The intervention also improved scores on three safety-focused behaviors: testing water temperature before giving children a bath (OR 1.26, 95% CI 1.05-1.52); properly storing sharp objects (OR 1.24, 95% CI 1.01-1.52); and safely storing medicines, detergents, and pesticides (OR 1.24, 95% CI 1.02-1.51). CONCLUSIONS The app-based intervention did not reduce unintentional injury incidence among preschoolers but significantly improved caregivers’ safety behaviors. This app-based intervention approach to improve caregiver behaviors surrounding child injury risk offers promise to be modified and ultimately disseminated broadly. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR-IOR-17010438; http://www.chictr.org.cn/showproj.aspx?proj=17376 (Archived by WebCite at http://www.webcitation.org/75jt17X84) INTERNATIONAL REGISTERED REPOR RR2-10.1186/s12889-018-5790-1

scholarly journals Five-year follow-up of a cluster-randomized controlled trial of a client-centred activities of daily living intervention for people with stroke

2018 ◽  
Vol 33 (2) ◽  
pp. 262-276 ◽  
Author(s):  
Annicka Hedman ◽  
Gunilla Eriksson ◽  
Lena von Koch ◽  
Susanne Guidetti
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Significant Others ◽  
Control Group ◽  
Randomized Controlled ◽  
Stroke Impact Scale ◽  
Impact Scale ◽  
Cluster Randomized ◽  
Changes Over Time

Objective: To compare five-year outcomes and changes over time of a client-centred activities of daily living (ADL) intervention versus usual ADL interventions for people with stroke and their significant others. Design: Five-year follow-up of a cluster-randomized controlled trial where a client-centred ADL intervention ( n = 129) or usual ADL interventions ( n = 151) were delivered to people with stroke. Setting: Multicentre study including 16 inpatient or home-based rehabilitation units. Participants: People with stroke and significant others. Intervention: The client-centred ADL intervention aimed at enabling agency in daily activities and participation in everyday life and at reducing caregiver burden. Main measures: For people with stroke, perceived participation (Stroke Impact Scale), independence in ADL, life satisfaction, and use of formal/informal care were measured. For significant others, caregiver burden, life satisfaction, and mood (Hospital Anxiety and Depression Scale) were assessed. Results: Five years post-intervention, data were collected from 145 people with stroke (intervention group: n = 71/control group: n = 74) and 75 significant others (intervention group: n = 36/control group: n = 39). For those with stroke, the Participation domain of the Stroke Impact Scale showed no group differences at year five (68.9 vs 75.4, P = 0.062) or in changes over time. At year five, the control group had better outcomes regarding Other help/supervision. Significant others in the control group were more likely to show signs of depression at year five (odds ratio = 22.3; P < 0.001). Conclusion: The client-centred ADL intervention appears to render similar long-term effects as usual ADL interventions for people with stroke, but for significant others signs of depression might be reduced.

Effectiveness of a WeChat group-based parental intervention in preventing unintentional injuries among children aged 0–3 years in China: A randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Xueqi Ma ◽  
Qi Zhang ◽  
Ruo Jiang ◽  
Jun Lu ◽  
Kaiyue Chen ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Unintentional Injury ◽  
Control Group ◽  
Unintentional Injuries ◽  
Randomized Controlled ◽  
Parental Intervention ◽  
One Year ◽  
Group B

BACKGROUND Unintentional injuries are a major public health problem to children worldwide. With the widespread use of smartphones in China, social networking mobile applications, such as WeChat, are potential ways to implement parent-based interventions. OBJECTIVE This study aimed to evaluate the effectiveness of WeChat group-based parental intervention programs in preventing unintentional injuries in children aged 0–3 years in China. METHODS We conducted a randomized controlled trial from March 2019 to March 2020. A total of 365 parents of children aged 0–3 years in Shanghai were randomly allocated to intervention and control groups, and 276 participants completed the follow-up. We used generalized estimation equations to assess intervention effectiveness at baseline and after one year. Outcome measures included children’s unintentional injury incidences, parents’ knowledge, attitudes, and behaviors. RESULTS During the one year follow-up, unintentional injury incidences increased from 9.00% to 11.70% in the intervention group and from 9.90% to 22.90% in the control group. The changes did not differ between the groups (odds ratio [OR] 0.67, 95% confidence interval [CI] 0.13-3.48). Changes in the parents’ attitudes toward injury attribution (b 0.10, 95% CI 0.09-0.21) and preventability (b 0.16, 95% CI 0.01-0.33) did not differ between the two groups. Changes in parents’ attitudes toward responsibility in the intervention group were greater than those in the control group (b 0.33, 95% CI 0.15, 0.51). Changes in parents' daily supervision behavior in the intervention group was greater than those in the control group (b 0.43, 95% CI 0.02-0.84), and changes in behaviors of preventing specific injuries were significantly different between the groups (b 1.60, 95% CI 1.05-2.16). CONCLUSIONS Although WeChat group-based parental intervention cannot directly reduce the occurrence of children’s unintentional injuries, it can improve parents’ knowledge, attitudes, and behaviors pertaining to prevention of unintentional injuries. CLINICALTRIAL China Clinical Trials Registry ChiCTR1900020753; http://www.chictr.org.cn/index.aspx

scholarly journals O7C.3 Effectiveness of a multi-faceted intervention to prevent musculoskeletal pain in nurses and aides: results of a cluster-randomized controlled trial

2019 ◽  
Vol 76 (Suppl 1) ◽  
pp. A65.1-A65
Author(s):  
Mercè Soler Font ◽  
José Maria Ramada Rodilla ◽  
Sander van Zon ◽  
Josué Almansa Ortega ◽  
Ute Bültmann ◽  
...  
Keyword(s):  
Health Promotion ◽  
Randomized Controlled Trial ◽  
Occupational Health ◽  
Sickness Absence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Cluster Randomized

BackgroundHealth workers are at high risk of developing musculoskeletal pain (MSP). This study aimed to evaluate a multi-faceted intervention in two public tertiary hospitals, encompassing three levels of prevention and health promotion to prevent and manage MSP.MethodsA two-armed cluster randomized controlled trial, with a late intervention control group was performed. Clusters were independent hospital units, and participants were the nursing staff. The intervention comprised three components: participatory ergonomics, case management, and health promotion. The control group received usual occupational health care. The intervention lasted one year and data were collected at baseline, 6 and 12 months follow-up. Primary outcomes were self-perceived MSP and its associated sickness absence. The process evaluation included recruitment, context, reach, dose administered and received, fidelity, satisfaction, implementation strategy, and discussion groups of experts and participants.ResultsEight clusters, including 445 participants, were randomized. In the intervention group a 20% statistically significant reduction of neck, shoulders and upper back pain compared to the control group (OR=0.37; 95% CI=0.14–0.96) was observed at 12 months follow-up. We found no significant differences in incidence and duration of sickness absence. Organizational culture (secondary outcome) improved significantly in the intervention group in the domains of ‘formal safety audits’, ‘availability of information for safety at work’, and ‘involvement of workers in decisions that affect their safety and health’ compared to the control group. The intervention was implemented with 96.6% fidelity, and participants’ adherence was 75.5%. Participant’s satisfaction was 9.1/10.ConclusionsThis intervention showed effectiveness to reduce MSP and improve organizational culture, through to an integral management of MSP. Although our results are modest, strategies should focus on multi-faceted interventions, and occupational health services might be excellent opportunity for.

scholarly journals Effects of a health educational intervention on cardiovascular disease knowledge, motivation and behavioral skills: A cluster randomized controlled trial

2019 ◽  
Author(s):  
John Amoah ◽  
Salmiah Md. ◽  
Lekhraj Rampal ◽  
Rosliza A Manaf ◽  
Normala Ibrahim ◽  
...  
Keyword(s):  
Risk Factors ◽  
Health Education ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
School Students ◽  
Behavioral Skills ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Cardiovascular diseases (CVD) are the number one public health challenge of the 21st century. Globally, the disease causes more deaths than any other cause. Unfortunately, many people are not aware of CVDs and its risk factors and because of this the disease burden keeps on rising. Objective of this study was to develop, implement and evaluate the effects of a health education program to improve CVD knowledge, motivation, and behavioral skills among secondary school students in Ghana. Methods A parallel single-blind cluster randomized controlled trial was carried out for a period of six-months with baseline and post intervention evaluations. Participants (n=848) were secondary school students of ages of 14-19 years from four schools (clusters) in Brong Ahafo, Ghana. Students in the intervention group received health education intervention whereas those of the control group received no intervention. The intervention included information on cardiovascular diseases and its risk factors, motivation, and behavioral skills modules. At six months, a follow-up data using same questionnaire were collected after the intervention was completed. The generalized linear mixed model (GLMM) was used to assess the overall effects of the intervention. Results Of the 848 students, 836 completed the follow-up assessment immediately after six-month. The GLMM showed the intervention was significant in improving 6.85(p<0.001), 0.90(p<0.001), 0.94(p<0.001) higher total CVD knowledge, motivation, and behavioral skills scores respectively for the intervention group when compared to the control group. Conclusions The intervention was effective in increasing CVD knowledge, motivation, and behavioral skills of students in the intervention arm of the study. It is recommended that the health education module be implemented into secondary schools education curricula in Ghana to improve CVD knowledge, motivation, and behavioral skills. Equipping students with the IMB will reduce CVD risk factors and prevent the onset of CVDs in future.

Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  
Keyword(s):  
International Students ◽  
Acculturative Stress ◽  
Educational Program ◽  
Public Universities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Policy Makers ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

scholarly journals Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Readmission ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

scholarly journals A Cluster Randomized Controlled Trial Feasibility Study of a WhatsApp-Delivered Intervention to Promote Healthy Eating Habits in Male Firefighters

2021 ◽  
Vol 18 (12) ◽  
pp. 6633
Author(s):  
Winnie Wing Man Ng ◽  
Anthony Siu Wo Wong ◽  
Kin Cheung
Keyword(s):  
Randomized Controlled Trial ◽  
Healthy Eating ◽  
Eating Habits ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Healthy Eating Habits ◽  
Cluster Randomized

This cluster randomized controlled trial (CRCT)-designed study aimed to explore the feasibility of a promotion pamphlet and/or WhatsApp as a suitable mode of delivery to promote healthy eating habits with fruit and vegetables (F&V) among firefighters. Convenience and snowball sampling methods were used. Forty-five firefighters from 23 fire stations were recruited and they all received the printed pamphlet, while the intervention group participants (n = 20) received additional teaching material through WhatsApp every two weeks for eight weeks. Feasibility outcomes included retention, practicality, and implementation. The participants reported high levels of satisfaction with the intervention. There were significant improvements in the mean numbers of days consuming F&V (p = 0.002; p = 0.031) in the intervention group, and for fruit consumption (p = 0.033) in the control group between the baseline (T0) and 3 months after completion of intervention (T1). High levels of participants’ satisfaction with the intervention revealed that a full-scale CRCT of the WhatsApp-delivered intervention promoting healthy eating could be feasible, especially as a means of increasing the numbers of days they consumed F&V and the numbers of servings of these consumed per day.

scholarly journals Factors Associated With Dropout of Participants in an App-Based Child Injury Prevention Study: Secondary Data Analysis of a Cluster Randomized Controlled Trial

10.2196/21636 ◽  
2021 ◽  
Vol 23 (1) ◽  
pp. e21636
Author(s):  
Jie Li ◽  
Peishan Ning ◽  
Peixia Cheng ◽  
David C Schwebel ◽  
Yang Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Demographic Characteristics ◽  
Parenting Education ◽  
Control Group ◽  
Child Injury ◽  
Factors Associated ◽  
Randomized Controlled ◽  
Study Participants

Background Mobile health (mHealth) interventions offer great potential to reach large populations and improve public health. However, high attrition rates threaten evaluation and implementation of mHealth intervention studies. Objective We explored factors associated with attrition of study participants in an mHealth randomized controlled trial (RCT) evaluating an intervention to reduce unintentional child injury risk in China. Methods The cluster RCT compared two groups of an app-based intervention for caregivers of 3-6–year-old children (Bao Hu San). The intervention group received unintentional child injury and parenting education, whereas only parenting education was implemented in the control group. The trial included 2920 study participants in Changsha, China, and lasted 6 months. Data on participant engagement (using the app) were collected electronically throughout the 6-month period. Associations between participant attrition and demographic characteristics, and between attrition and intervention engagement were tested and quantified separately for the intervention and control groups using the adjusted odds ratio (aOR) based on generalized linear mixed models. Results In total, 2920 caregivers from 20 eligible preschools participated, with 1510 in the intervention group and 1410 in the control group. The 6-month attrition rate differed significantly between the two groups (P<.001), at 28.9% (437/1510) in the intervention group and 35.7% (503/1410) in the control group. For the intervention group, the only significant predictor of attrition risk was participants who learned fewer knowledge segments (aOR 2.69, 95% CI 1.19-6.09). For the control group, significant predictors of attrition risk were lower monthly login frequency (aOR 1.48, 95% CI 1.00-2.18), learning fewer knowledge segments (aOR 1.70, 95% CI 1.02-2.81), and shorter learning durations during app engagement (aOR 2.39, 95% CI 1.11-5.15). Demographic characteristics were unrelated to attrition. Conclusions Engagement in the app intervention was associated with participant attrition. Researchers and practitioners should consider how to best engage participants in app-based interventions to reduce attrition. Trial Registration Chinese Clinical Trial Registry ChiCTR-IOR-17010438; http://www.chictr.org.cn/showproj.aspx?proj=17376 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-018-5790-1

Effect of ICT-Based Self-Management System DialBeticsLite on Treating Abdominal Obesity: Randomized Controlled Trial. (Preprint)

2021 ◽  
Author(s):  
Masahiro Kondo ◽  
Teru Okitsu ◽  
Kayo Waki ◽  
Toshimasa Yamauchi ◽  
Masaomi Nangaku ◽  
...  
Keyword(s):  
Abdominal Obesity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Metabolic Parameters ◽  
Control Group ◽  
Physical Parameters ◽  
Lifestyle Behavior ◽  
Randomized Controlled

BACKGROUND Mobile health interventions, a more cost-effective approach compared to traditional methods of delivering lifestyle coaching in person, have been shown to improve physical parameters and lifestyle behavior among overweight populations. It is useful to know the efficacy of mobile apps in treating abdominal obesity, as it is a known risk factor for metabolic disorders and type 2 diabetes. OBJECTIVE This study aimed to determine whether a mobile self-management app (DialBeticsLite) could be used by patients with abdominal obesity to achieve a reduction in visceral fat area (VFA) and other physical parameters. METHODS This study was an open-label, 2-arm parallel-design randomized controlled trial. We recruited 122 people in September 2017, and randomly assigned them into either the intervention group or the control group. All participants attended an educational group session, which delivered information regarding diet and exercise. Additionally, participants in the intervention group were asked to use DialBeticsLite for 3 months. DialBeticsLite facilitated the daily recording of several physical parameters and lifestyle behavior, and provided feedback to encourage an improvement in behavior. The primary outcome was the change in VFA from baseline to the 3-month follow-up. Secondary outcomes included changes in both physical and metabolic parameters, from baseline to the 3-month follow-up. Welch t test was conducted to analyze the effects of DialBeticsLite on both the primary outcome and the secondary outcomes. RESULTS Out of the 122 participants recruited, 75 participants were analyzed due to 47 participants being excluded: 37 due to ineligibility and 10 due to withdrawal of consent. The mean age was 49.3 (standard deviation: SD 6.1) in the intervention group (n=41) and 48.5 (SD 5.3) in the control group (n=34), and all participants were male, though unintentionally. Baseline characteristics did not differ significantly between the intervention and control group, except for VFA. The averaged change of VFA was -23.5cm2 (SD 20.6) in the intervention group and +1.9cm2 (SD 16.2) in the control group (P<.001). Statistically significant differences were also found for the change of body weight, BMI and waist circumference. These findings did not change after adjusting for VFA at baseline. The intervention had no significant effect on any of the metabolic parameters. An exploratory analysis showed significant associations between the change in VFA and steps per day, and between the change in VFA and calorie intake per day within the intervention group. CONCLUSIONS Our findings indicate that although unsuccessful in improving metabolic parameters, a mobile health intervention facilitating the daily monitoring of several physical parameters and lifestyle behavior, can be highly effective in inducing visceral fat loss and weight loss among adults with abdominal obesity. CLINICALTRIAL Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042045 Retrospectively Registered; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000046495&type=summary&llanguag=J

Sign in / Sign up

Export Citation Format

Share Document