Designing and Developing A Mobile App (BeBo) in a Randomized Controlled Trial Study to Promote Breastfeeding Among Vietnamese mothers (Preprint)

2020 ◽  
Author(s):  
Thi Thuy Duong Doan ◽  
Chuyen Trung Tran ◽  
Minh Ngoc Pham ◽  
Yun Zhao ◽  
Hoa Thi Phuong Dinh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Exclusive Breastfeeding ◽  
Urban Areas ◽  
Large Scale ◽  
Mobile Apps ◽  
Controlled Trial ◽  
Mobile App ◽  
High Rate ◽  
World Health ◽  
Randomized Controlled

BACKGROUND Breastfeeding has substantial benefits for both mothers and children. The World Health Organization and the Vietnam Ministry of Health recommend exclusive breastfeeding for 6 months. However, this target was reached by fewer than 17% of Vietnamese infants and in urban areas such as Hanoi, was only about 12.6%. Many factors influence breastfeeding, but mothers are the most influential in achieving breastfeeding success. The high rate of use of smart mobile phones among mothers in urban areas offers unique opportunities to promote breastfeeding OBJECTIVE This study is to document the process of designing, developing, and evaluating a mobile app that is tailored to Vietnamese culture and aims to increase breastfeeding rates, particularly exclusive breastfeeding, and duration in Vietnamese women METHODS To design and develop the mobile app we used a 4-step mixed methods approach. We firstly reviewed studies on using mHealth and mobile apps for improving breastfeeding as well as barriers and facilitators of breastfeeding in Vietnam. We then conducted 22 in-depth interviews with mothers about key barriers, facilitators, and ideas about the apps. Self-administered online questionnaires were responded to by 49 mothers and fathers about the main features and contents of the apps. After that, we identified and developed the app among the research team to have two versions of the app (intervention vs. control version) and a mechanism that ensured a triple-blinded, randomized controlled trial study. In the next step, we tested the app messages with mothers of 3 focus groups and invited external experts for reviewing the library content. Finally, team members tested and adjusted the prototype before conducting a large-scale test of its effectiveness RESULTS Participants were most interested in information on the mental health and wellbeing of mothers during pregnancy and after delivery, preparation for delivery, and avoiding food and beverages. Regarding breastfeeding, mothers were most concerned about nutrition for mothers during breastfeeding, preventing and reducing difficulties on breastfeeding, and initiation of breastfeeding. Three key features to be included in the prototype app were identified from the formative research: (1) notifications; (2) an information library; and (3) searching function. The app should be installed during pregnancy rather than after delivery. Push notifications that convey the main messages should be sent 2 – 3 times per week to remind mothers of using the app. CONCLUSIONS The development of the app, called BeBo followed a best practice approach, including the involvement of related stakeholders and grounding in behavior change theory. To the best of our knowledge, it is the first mobile app that enables us to evaluate the effectiveness of mHealth interventions in a well-conducted randomised controlled trial. CLINICALTRIAL ACTRN12619000531112

Large-scale influenza vaccination promotion on a mobile app platform: A randomized controlled trial

Vaccine ◽  
2020 ◽  
Vol 38 (18) ◽  
pp. 3508-3514
Author(s):  
Wei-Nchih Lee ◽  
David Stück ◽  
Kevin Konty ◽  
Caitlin Rivers ◽  
Courtney R. Brown ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Influenza Vaccination ◽  
Large Scale ◽  
Controlled Trial ◽  
Mobile App ◽  
Randomized Controlled

Unexpected Effects of a System-Distributed Mobile Application in Maternity Care: A Randomized Controlled Trial

2017 ◽  
Vol 45 (3) ◽  
pp. 323-330 ◽  
Author(s):  
Christy J. W. Ledford ◽  
Jasmyne J. Womack ◽  
Heather A. Rider ◽  
Angela B. Seehusen ◽  
Stephen J. Conner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Education ◽  
Clinical Setting ◽  
Mobile Apps ◽  
Controlled Trial ◽  
Patient Activation ◽  
Mobile App ◽  
Analysis Of Covariance ◽  
Health Clinic ◽  
Randomized Controlled

Background. As pregnant mothers increasingly engage in shared decision making regarding prenatal decisions, such as induction of labor, the patient’s level of activation may influence pregnancy outcomes. One potential tool to increase patient activation in the clinical setting is mobile applications. However, research is limited in comparing mobile apps with other modalities of patient education and engagement tools. Aim. This study was designed to test the effectiveness of a mobile app as a replacement for a spiral notebook guide as a patient education and engagement tool in the prenatal clinical setting. Method. This randomized controlled trial was conducted in the Women’s Health Clinic and Family Health Clinic of three hospitals. Repeated-measures analysis of covariance was used to test intervention effects in the study sample of 205 patients. Results. Mothers used a mobile app interface to more frequently record information about their pregnancy; however, across time, mothers using a mobile app reported a significant decrease in patient activation. Discussion. The unexpected negative effects in the group of patients randomized to the mobile app prompt these authors to recommend that health systems pause before distributing their own version of mobile apps that may decrease patient activation. Conclusion. Mobile apps can be inherently empowering and engaging, but how a system encourages their use may ultimately determine their adoption and success.

scholarly journals Research and Implementation Lessons Learned From a Youth-Targeted Digital Health Randomized Controlled Trial (the ARMADILLO Study)

10.2196/13005 ◽  
2019 ◽  
Vol 7 (8) ◽  
pp. e13005
Author(s):  
Lianne Gonsalves ◽  
Winnie Wangari Njeri ◽  
Megan Schroeder ◽  
Jefferson Mwaisaka ◽  
Peter Gichangi
Keyword(s):  
Randomized Controlled Trial ◽  
Digital Health ◽  
Controlled Trial ◽  
Text Message ◽  
Health Interventions ◽  
World Health ◽  
Intervention Period ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Client Side

Background Evidence is lacking on the efficacy of sexual and reproductive health (SRH) communication interventions for youth (aged 15-24 years), especially from low- and middle-income countries. Therefore, the World Health Organization initiated the Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) program, a free, menu-based, on-demand text message (SMS, short message service) platform providing validated SRH content developed in collaboration with young people. A randomized controlled trial (RCT) assessing the effect of the ARMADILLO intervention on SRH-related outcomes was implemented in Kwale County, Kenya. Objective This paper describes the implementation challenges related to the RCT, observed during enrollment and the intervention period, and their implications for digital health researchers and program implementers. Methods This was an open, three-armed RCT. Following completion of a baseline survey, participants were randomized into the ARMADILLO intervention (arm 1), a once-a-week contact SMS text message (arm 2), or usual care (arm 3, no intervention). The intervention period lasted seven weeks, after which participants completed an endline survey. Results Two study team decisions had significant implications for the success of the trial’s enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu. As a result, three weeks after recruitment began, 660 participants had been randomized; however, 107 (53%) participants in arm 1 and 136 (62%) in arm 2 were “stuck” at the language menu. The research team called 231 of these nonengaging participants and successfully reached 136 to learn reasons for nonengagement. Thirty-two phone numbers were found to be either not linked to our participants (a wrong number) or not in their primary possession (a shared phone). Among eligible participants, 30 participants indicated that they had assumed the introductory message was a scam or spam. Twenty-seven participants were confused by some aspect of the system. Eleven were apathetic about engaging. Twenty-four nonengagers experienced some sort of technical issue. All participants eventually started their seven-week study period. Conclusions The ARMADILLO study’s implementation challenges provide several lessons related to both researching and implementing client-side digital health interventions, including (1) have meticulous phone data collection protocols to reduce wrong numbers, (2) train participants on the digital intervention in efficacy assessments, and (3) recognize that client-side digital health interventions have analog discontinuation challenges. Implementation lessons were (1) determine whether an intervention requires phone ownership or phone access, (2) digital health campaigns need to establish a credible presence in a busy digital space, and (3) interest in a service can be sporadic or fleeting. Clinical Trial International Standard Randomized Controlled Trial Number (ISRCTN): 85156148; http://www.isrctn. com/ISRCTN85156148

scholarly journals Effect of a breastfeeding educational intervention: a randomized controlled trial

2020 ◽  
Vol 28 ◽  
Author(s):  
Erdnaxela Fernandes do Carmo Souza ◽  
Alfredo Almeida Pina-Oliveira ◽  
Antonieta Keiko Kakuda Shimo
Keyword(s):  
Randomized Controlled Trial ◽  
Educational Intervention ◽  
Exclusive Breastfeeding ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
P Value ◽  
Postpartum Women ◽  
Significance Level ◽  
Randomized Controlled

Objective: to assess the effect of a breastfeeding educational intervention on the counseling provided to postpartum women. Method: this is a randomized controlled trial including 104 postpartum women (intervention group = 52 and control group = 52) from a private hospital, whose educational intervention was based on the pragmatic theory and on the use of a soft-hard technology called Breastfeeding Educational Kit (Kit Educativo para Aleitamento Materno, KEAM). Women were followed-up for up to 60 days after childbirth. Chi-Squared Test, Fischer’s Exact Test, and Generalized Estimating Equation were used, with a significance level of 5% (p-value <0.05). The analyses were performed using the Statistical Package for the Social Sciences, version 24. Results: the postpartum women in the intervention group had fewer breastfeeding difficulties and a higher percentage of exclusive breastfeeding at all time points compared with those in the control group. Conclusion: the educational intervention based on active methodologies and stimulating instructional resources was effective in developing greater practical mastery among postpartum women with regard to adherence and maintenance of exclusive breastfeeding. Registry REBEC RBR – 8p9v7v.

scholarly journals Participant Evaluation of Energy Conservation Course for People With Multiple Sclerosis

2006 ◽  
Vol 8 (3) ◽  
pp. 98-106 ◽  
Author(s):  
Virgil Mathiowetz ◽  
Melody L. Busch
Keyword(s):  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Energy Conservation ◽  
Controlled Trial ◽  
Descriptive Statistics ◽  
Course Evaluations ◽  
High Rate ◽  
Descriptive Data ◽  
Participant Satisfaction ◽  
Randomized Controlled

This article discusses how people with multiple sclerosis (MS) perceive an energy conservation (EC) course. The study included 140 people with MS who reported fatigue secondary to MS and participated in a randomized controlled trial of an EC course. Descriptive data from course evaluations collected during the trial were analyzed to determine how participants perceived the quality and helpfulness of the course and ways to improve it. Descriptive statistics, percentages, and frequency of comments demonstrated that the course was rated highly among participants. Participants found the major concepts of the course and the opportunity to interact with others particularly helpful. Suggestions as to how to improve the course included small modifications to the format. The high rate of participant satisfaction supports the use of this EC course for people with MS.

scholarly journals Effect of a Low-fodmap Diet for the Management of Functional Abdominal Pain Disorders in Children: A Study Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Agata Stróżyk ◽  
Andrea Horvath ◽  
Jane Muir ◽  
Hania Szajewska
Keyword(s):  
Randomized Controlled Trial ◽  
Abdominal Pain ◽  
Controlled Trial ◽  
Well Being ◽  
World Health ◽  
Reliable Change Index ◽  
Functional Abdominal Pain ◽  
Regular Diet ◽  
Randomized Controlled ◽  
Fodmap Diet

Abstract Background Evidence from studies in adults documents that fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) may be triggers of symptoms in individuals with functional abdominal pain disorders (FAPDs). However, in children, the evidence is very limited. We aim to assess the effects of a low-FODMAP diet compared with a regular diet for the management of children with FAPDs. Methods We will perform a randomized, quadruple-blinded, controlled trial. Seventy-four children aged 8 to 18 years with a FAPD (Irritable Bowel Syndrome or Functional Abdominal Pain-Not Otherwise Specified), diagnosed according to the Rome IV criteria, will be randomly allocated to receive either a low-FODMAP diet or a regular diet for 4 weeks. The primary outcome will be the percentage of the responders, defined as the participants who have at least 30% improvement in abdominal pain intensity on a Visual Analogue Scale (VAS) during the last week of the trial compared with baseline, that is at least equal to the Reliable Change Index (≥ 25 mm change on VAS). Other outcomes will include changes in stool consistency, abdominal pain frequency, total scores on the Gastrointestinal Symptom Rating Scale, KIDSCREEN-10 Index and World Health Organization Five Well-Being Index, child’s school attendance and parents’ work absenteeism, and BMI-for-age z-score. Compliance, tolerability of the low-FODMAP diet, and adverse events also will be evaluated. Each FAPD subtype will be assessed separately.DiscussionThere is a need for high-quality evidence regarding the dietary management of children with FAPDs. This randomized controlled trial (RCT) of rigorous methodological design will help to establish the effectiveness, if any, of a low-FODMAP diet for the management of FAPDs in the pediatric population. The findings of this RCT will assist with the development of guidelines and influence the direction of further research. Trial registration: NCT04528914

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