Efficacy of personalized mobile-Health coaching program during pregnancy on maternal diet, supplement use and physical activity: A protocol for a Parallel-Group Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Rozina Nuruddin ◽  
Khadija Barkat Ali Vadsaria ◽  
Nuruddin Mohammed ◽  
Saleem Sayani

BACKGROUND Adequate intake of macro and micronutrients and adoption of an active lifestyle during pregnancy are essential for optimum maternal and fetal health and offspring development. Dietary counselling and advice for adequate physical activity make integral components of antenatal care. Personalized coaching through the use of mobile health (m-Health) which supports behaviour modification is an innovative approach that needs exploration. OBJECTIVE Our primary objective is to assess the efficacy of an m-Health program in improving diet, supplement use and physical activity during pregnancy. Secondary objectives include evaluation of its effect on maternal and offspring health outcomes and assessment of its compliance and usability. METHODS A randomized control trial is initiated at the Aga Khan University Hospital, Karachi in January 2020. We aim to recruit 300 pregnant women in their first trimester having smartphones and without co-morbid or on medications. The intervention group would be trained to use an m-Health application named as PurUmeed Aaghaz. Through this application, the subjects would report information about their diet, supplement use and physical activity and would receive personalized advice and 3 push messages as weekly reminders. Research Assistant would obtain similar information from the non-intervention group on a paperless questionnaire who would receive standard face-to-face counselling on diet, supplement use and physical activity. Data would be collected at enrolment and on 4 follow-ups scheduled 6 weeks apart. Primary study outcomes include improvement in the diet (change in mean Dietary Risk Score (DRS) from baseline to each follow-up), supplement use (change in mean supplement use score and biochemical levels of folic acid, iron, calcium and vitamin D on a study subset) and mean duration of reported physical activity (minutes). Secondary study outcomes relate to maternal (gestational diabetes mellitus, gestational hypertension, preeclampsia and gestational weight gain), newborn (birth weight and length and gestational age at delivery) and infant health (body mass index and blood pressure at 1 year of age). Compliance would be determined by proportion completing coaching program at 6 months and usability would be assessed based on features related to design, interface, content, coaching, perception and personal benefit. RESULTS The study is approved by the Ethical Review Committee in 2017. As of June 01, 2021, 258 participants have been enrolled. Recruitment will be completed by July 2021 and results are expected to be released by early 2023. CONCLUSIONS This study will be an important step towards evaluating the role of m-Health in improving behaviours related to the consumption of healthy diet and supplement use, for promoting physical activity during pregnancy and in influencing maternal and offspring outcomes. If proven effective, m-health intervention can be scaled up and included in antenatal care package at tertiary care hospitals of Low Middle-Income Countries. CLINICALTRIAL Clinicaltrials.gov NCT04216446. Registered January 2, 2020.

2020 ◽  
Author(s):  
Cindy K Blair ◽  
Elizabeth Harding ◽  
Charles Wiggins ◽  
Huining Kang ◽  
Matthew Schwartz ◽  
...  

BACKGROUND Older cancer survivors are at risk of the development or worsening of both age- and treatment-related morbidity. Sedentary behavior increases the risk of or exacerbates these chronic conditions. Light-intensity physical activity (LPA) is more common in older adults and is associated with better health and well-being. Thus, replacing sedentary time with LPA may provide a more successful strategy to reduce sedentary time and increase physical activity. OBJECTIVE This study primarily aims to evaluate the feasibility, acceptability, and preliminary efficacy of a home-based mobile health (mHealth) intervention to interrupt and replace sedentary time with LPA (standing and stepping). The secondary objective of this study is to examine changes in objective measures of physical activity, physical performance, and self-reported quality of life. METHODS Overall, 54 cancer survivors (aged 60-84 years) were randomized in a 1:1:1 allocation to the tech support intervention group, tech support plus health coaching intervention group, or waitlist control group. Intervention participants received a Jawbone UP2 activity monitor for use with their smartphone app for 13 weeks. Tech support and health coaching were provided via 5 telephone calls during the 13-week intervention. Sedentary behavior and physical activity were objectively measured using an activPAL monitor for 7 days before and after the intervention. RESULTS Participants included survivors of breast cancer (21/54, 39%), prostate cancer (16/54, 30%), and a variety of other cancer types; a mean of 4.4 years (SD 1.6) had passed since their cancer diagnosis. Participants, on average, were 70 years old (SD 4.8), 55% (30/54) female, 24% (13/54) Hispanic, and 81% (44/54) overweight or obese. Malfunction of the Jawbone trackers occurred in one-third of the intervention group, resulting in enrollment stopping at 54 rather than the initial goal of 60 participants. Despite these technical issues, the retention in the intervention was high (47/54, 87%). Adherence was high for wearing the tracker (29/29, 100%) and checking the app daily (28/29, 96%) but low for specific aspects related to the sedentary features of the tracker and app (21%-25%). The acceptability of the intervention was moderately high (81%). There were no significant between-group differences in total sedentary time, number of breaks, or number of prolonged sedentary bouts. There were no significant between-group differences in physical activity. The only significant within-group change occurred within the health coaching group, which increased by 1675 daily steps (95% CI 444-2906; <i>P</i>=.009). This increase was caused by moderate-intensity stepping rather than light-intensity stepping (+15.2 minutes per day; 95% CI 4.1-26.2; <i>P</i>=.008). CONCLUSIONS A home-based mHealth program to disrupt and replace sedentary time with stepping was feasible among and acceptable to older cancer survivors. Future studies are needed to evaluate the optimal approach for replacing sedentary behavior with standing and/or physical activity in this population. CLINICALTRIAL ClinicalTrials.gov NCT03632694; https://clinicaltrials.gov/ct2/show/NCT03632694


JMIR Cancer ◽  
10.2196/18819 ◽  
2021 ◽  
Vol 7 (2) ◽  
pp. e18819
Author(s):  
Cindy K Blair ◽  
Elizabeth Harding ◽  
Charles Wiggins ◽  
Huining Kang ◽  
Matthew Schwartz ◽  
...  

Background Older cancer survivors are at risk of the development or worsening of both age- and treatment-related morbidity. Sedentary behavior increases the risk of or exacerbates these chronic conditions. Light-intensity physical activity (LPA) is more common in older adults and is associated with better health and well-being. Thus, replacing sedentary time with LPA may provide a more successful strategy to reduce sedentary time and increase physical activity. Objective This study primarily aims to evaluate the feasibility, acceptability, and preliminary efficacy of a home-based mobile health (mHealth) intervention to interrupt and replace sedentary time with LPA (standing and stepping). The secondary objective of this study is to examine changes in objective measures of physical activity, physical performance, and self-reported quality of life. Methods Overall, 54 cancer survivors (aged 60-84 years) were randomized in a 1:1:1 allocation to the tech support intervention group, tech support plus health coaching intervention group, or waitlist control group. Intervention participants received a Jawbone UP2 activity monitor for use with their smartphone app for 13 weeks. Tech support and health coaching were provided via 5 telephone calls during the 13-week intervention. Sedentary behavior and physical activity were objectively measured using an activPAL monitor for 7 days before and after the intervention. Results Participants included survivors of breast cancer (21/54, 39%), prostate cancer (16/54, 30%), and a variety of other cancer types; a mean of 4.4 years (SD 1.6) had passed since their cancer diagnosis. Participants, on average, were 70 years old (SD 4.8), 55% (30/54) female, 24% (13/54) Hispanic, and 81% (44/54) overweight or obese. Malfunction of the Jawbone trackers occurred in one-third of the intervention group, resulting in enrollment stopping at 54 rather than the initial goal of 60 participants. Despite these technical issues, the retention in the intervention was high (47/54, 87%). Adherence was high for wearing the tracker (29/29, 100%) and checking the app daily (28/29, 96%) but low for specific aspects related to the sedentary features of the tracker and app (21%-25%). The acceptability of the intervention was moderately high (81%). There were no significant between-group differences in total sedentary time, number of breaks, or number of prolonged sedentary bouts. There were no significant between-group differences in physical activity. The only significant within-group change occurred within the health coaching group, which increased by 1675 daily steps (95% CI 444-2906; P=.009). This increase was caused by moderate-intensity stepping rather than light-intensity stepping (+15.2 minutes per day; 95% CI 4.1-26.2; P=.008). Conclusions A home-based mHealth program to disrupt and replace sedentary time with stepping was feasible among and acceptable to older cancer survivors. Future studies are needed to evaluate the optimal approach for replacing sedentary behavior with standing and/or physical activity in this population. Trial Registration ClinicalTrials.gov NCT03632694; https://clinicaltrials.gov/ct2/show/NCT03632694


10.2196/16925 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e16925
Author(s):  
Sarah Browne ◽  
M-Tahar Kechadi ◽  
Shane O'Donnell ◽  
Mckenzie Dow ◽  
Louise Tully ◽  
...  

Background Multicomponent family interventions underline current best practice in childhood obesity treatment. Mobile health (mHealth) adjuncts that address eating and physical activity behaviors have shown promise in clinical studies. Objective This study aimed to describe process methods for applying an mHealth intervention to reduce the rate of eating and monitor physical activity among children with obesity. Methods The study protocol was designed to incorporate 2 mHealth apps as an adjunct to usual care treatment for obesity. Children and adolescents (aged 9-16 years) with obesity (BMI ≥98th centile) were recruited in person from a weight management service at a tertiary health care center in the Republic of Ireland. Eligible participants and their parents received information leaflets, and informed consent and assent were signed. Participants completed 2 weeks of baseline testing, including behavioral and quality of life questionnaires, anthropometry, rate of eating by Mandolean, and physical activity level using a smart watch and the myBigO smartphone app. Thereafter, participants were randomized to the (1) intervention (usual clinical care+Mandolean training to reduce the rate of eating) or (2) control (usual clinical care) groups. Gender and age group (9.0-12.9 years and 13.0-16.9 years) stratifications were applied. At the end of a 4-week treatment period, participants repeated the 2-week testing period. Process evaluation measures included recruitment, study retention, fidelity parameters, acceptability, and user satisfaction. Results A total of 20 participants were enrolled in the study. A web-based randomization system assigned 8 participants to the intervention group and 12 participants to the control group. Attrition rates were higher among the participants in the intervention group (5/8, 63%) than those in the control group (3/12, 25%). Intervention participants undertook a median of 1.0 training meal using Mandolean (25th centile 0, 75th centile 9.3), which represented 19.2% of planned intervention exposure. Only 50% (9/18) of participants with smart watches logged physical activity data. Significant differences in psychosocial profile were observed at baseline between the groups. The Child Behavior Checklist (CBCL) mean total score was 71.7 (SD 3.1) in the intervention group vs 57.6 (SD 6.6) in the control group, t-test P<.001, and also different among those who completed the planned protocol compared with those who withdrew early (CBCL mean total score 59.0, SD 9.3, vs 67.9, SD 5.6, respectively; t-test P=.04). Conclusions A high early attrition rate was a key barrier to full study implementation. Perceived task burden in combination with behavioral issues may have contributed to attrition. Low exposure to the experimental intervention was explained by poor acceptability of Mandolean as a home-based tool for treatment. Self-monitoring using myBigO and the smartwatch was acceptable among this cohort. Further technical and usability studies are needed to improve adherence in our patient group in the tertiary setting.


2018 ◽  
Author(s):  
Alexandra M Lee ◽  
Sarah Chavez ◽  
Jiang Bian ◽  
Lindsay A Thompson ◽  
Matthew J Gurka ◽  
...  

BACKGROUND Increasing physical activity (PA) levels in adolescents aged 12 to 18 years is associated with prevention of unhealthy weight gain and improvement in cardiovascular fitness. The widespread availability of mobile health (mHealth) and wearable devices offers self-monitoring and motivational features for increasing PA levels and improving adherence to exercise programs. OBJECTIVE The aim of this scoping review was to identify the efficacy or effectiveness of mHealth intervention strategies for facilitating PA among adolescents aged 12 to 18 years. METHODS We conducted a systematic search for peer-reviewed studies published between 2008 and 2018 in the following electronic databases: PubMed, Google Scholar, PsychINFO, or SportDiscus. The search terms used included mHealth or “mobile health” or apps, “physical activity” or exercise, children or adolescents or teens or “young adults” or kids, and efficacy or effectiveness. Articles published outside of the date range (July 2008 to October 2018) and non-English articles were removed before abstract review. Three reviewers assessed all abstracts against the inclusion and exclusion criteria. Any uncertainties or differences in opinion were discussed as a group. The inclusion criteria were that the studies should (1) have an mHealth component, (2) target participants aged between 12 and 18 years, (3) have results on efficacy or effectiveness, and (4) assess PA-related outcomes. Reviews, abstracts only, protocols without results, and short message service text messaging–only interventions were excluded. We also extracted potentially relevant papers from reviews. At least 2 reviewers examined all full articles for fit with the criteria and extracted data for analysis. Data extracted from selected studies included study population, study type, components of PA intervention, and PA outcome results. RESULTS Overall, 126 articles were initially identified. Reviewers pulled 18 additional articles from excluded review papers. Only 18 articles were passed onto full review, and 16 were kept for analysis. The included studies differed in the sizes of the study populations (11-607 participants), locations of the study sites (7 countries), study setting, and study design. Overall, 5 mHealth intervention categories were identified: website, website+wearable, app, wearable+app, and website+wearable+app. The most common measures reported were subjective weekly PA (4/13) and objective daily moderate-to-vigorous PA (5/13) of the 19 different PA outcomes assessed. Furthermore, 5 of 13 studies with a control or comparison group showed a significant improvement in PA outcomes between the intervention group and the control or comparison group. Of those 5 studies, 3 permitted isolation of mHealth intervention components in the analysis. CONCLUSIONS PA outcomes for adolescents improved over time through mHealth intervention use; however, the lack of consistency in chosen PA outcome measures, paucity of significant outcomes via between-group analyses, and the various study designs that prevent separating the effects of intervention components calls into question their true effect.


2019 ◽  
Author(s):  
Sarah Browne ◽  
M-Tahar Kechadi ◽  
Shane O'Donnell ◽  
Mckenzie Dow ◽  
Louise Tully ◽  
...  

BACKGROUND Multicomponent family interventions underline current best practice in childhood obesity treatment. Mobile health (mHealth) adjuncts that address eating and physical activity behaviors have shown promise in clinical studies. OBJECTIVE This study aimed to describe process methods for applying an mHealth intervention to reduce the rate of eating and monitor physical activity among children with obesity. METHODS The study protocol was designed to incorporate 2 mHealth apps as an adjunct to usual care treatment for obesity. Children and adolescents (aged 9-16 years) with obesity (BMI ≥98th centile) were recruited in person from a weight management service at a tertiary health care center in the Republic of Ireland. Eligible participants and their parents received information leaflets, and informed consent and assent were signed. Participants completed 2 weeks of baseline testing, including behavioral and quality of life questionnaires, anthropometry, rate of eating by Mandolean, and physical activity level using a smart watch and the myBigO smartphone app. Thereafter, participants were randomized to the (1) intervention (usual clinical care+Mandolean training to reduce the rate of eating) or (2) control (usual clinical care) groups. Gender and age group (9.0-12.9 years and 13.0-16.9 years) stratifications were applied. At the end of a 4-week treatment period, participants repeated the 2-week testing period. Process evaluation measures included recruitment, study retention, fidelity parameters, acceptability, and user satisfaction. RESULTS A total of 20 participants were enrolled in the study. A web-based randomization system assigned 8 participants to the intervention group and 12 participants to the control group. Attrition rates were higher among the participants in the intervention group (5/8, 63%) than those in the control group (3/12, 25%). Intervention participants undertook a median of 1.0 training meal using Mandolean (25th centile 0, 75th centile 9.3), which represented 19.2% of planned intervention exposure. Only 50% (9/18) of participants with smart watches logged physical activity data. Significant differences in psychosocial profile were observed at baseline between the groups. The Child Behavior Checklist (CBCL) mean total score was 71.7 (SD 3.1) in the intervention group vs 57.6 (SD 6.6) in the control group, <i>t</i>-test <i>P</i>&lt;.001, and also different among those who completed the planned protocol compared with those who withdrew early (CBCL mean total score 59.0, SD 9.3, vs 67.9, SD 5.6, respectively; <i>t</i>-test <i>P</i>=.04). CONCLUSIONS A high early attrition rate was a key barrier to full study implementation. Perceived task burden in combination with behavioral issues may have contributed to attrition. Low exposure to the experimental intervention was explained by poor acceptability of Mandolean as a home-based tool for treatment. Self-monitoring using myBigO and the smartwatch was acceptable among this cohort. Further technical and usability studies are needed to improve adherence in our patient group in the tertiary setting.


2020 ◽  
Author(s):  
THERESIA JOHN MASOI ◽  
Stephen M. Kibusi ◽  
Alex Ernest ◽  
Athanase G. Lilungulu

Abstract Background Antenatal care provides a platform for important health care functions during pregnancy, including health promotion, screening, and diagnosis and disease prevention. Timely and appropriate utilization of antenatal care can prevent complications and ensure better maternal and newborn health care. The aim of this study was to assess the effectiveness of interactive mobile health technologies in improving antenatal care service utilization in Dodoma region, Tanzania Methods A controlled quasi-experimental study was carried. Random selection of participants was employed to achieve a sample size of 450 pregnant women (Intervention=150 and Control=300). Interventions were matched to controls by gravidity and gestational age at a ratio of 1:2.The intervention group was enrolled in an interactive mobile messaging system and received health education messages. The control group continued with the standard antenatal care services being offered in local clinics. Pregnant women were followed from their initial visit to the point of delivery. Independent two-sample T-tests and logistic regression were used to test the effect of the intervention. Results The mean age of the participants was found to be 25.6 years with a range of 16 to 48 years. 77.3% of participants in the intervention group utilize ANC services as compared to 57.7% in the control group. The mean score was (M=2.77, SD 0.420) in the intervention group against (M=2.58, SD=0.495) in the control with (t=4.172, P<0.01) at 95% CI . Interactive SMS alert system,was observed to be effective on improving Antenatal care service utilization (AOR=2.164, P<0.05, 95% CI=1.351-3.466) as compared to conventional Antenatal care health education given in our health facilities. Conclusion The Interactive mobile health technologies used in this study has the potential of empowering pregnant women through greater access to information and in improving antenatal care service utilization in our setting.


2020 ◽  
Author(s):  
Shao-Wei Yeh ◽  
Chun-Yan Yuan ◽  
Yu-Feng Wu ◽  
Rui Shen

BACKGROUND Promoting physical activity for adolescence is a global challenge in public health. Physical inactivity and sedentary behaviors have been regarded to cause harmful chronic diseases to adolescent lifespan. However, high engagement in mobile technology for students may provide opportunities to help change adolescent unhealthy behaviors. Therefore, school sectors may play an important key role, such as implementing mobile health (mHealth) intervention to change students’ unhealthy behaviors and promote regular physical exercise behaviors, especially during the transition from adolescence to young adult. OBJECTIVE This study aimed to explore university students’ daily exercise patterns upon intervention of school-based mHealth project. METHODS Students’ physical exercise participation was recorded with students’ mobile application. With 4152 university freshmen (1476 males, 2676 females) and 335898 of their exercise records were analyzed (mean frequency of 38.2 ±16.10 in males, 45.1±10.81 in females) during the semester. RESULTS Under the school intervention project, students that exercised on Friday and Saturday was lower than that on other days, which indicated that the participation in exercise were more active on weekdays than on weekends. Among the participants who completed the requirement set by the school intervention project, both males and females used weekends to do exercise. On the other hand, overweight male university students participated in physical activity more than the requirement of the school intervention project and their exercise duration were found to be significantly higher than other participants. CONCLUSIONS Understanding a week of daily exercise patterns among youth upon the school mHealth Apps intervention can benefit in developing efficient and flexible projects to promote physical health and improve regular exercise participation in youth.


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