Mobile health, exercise and metabolic risk: a randomized controlled trial.
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ABSTRACT:
SUBMITTER: Petrella RJ
PROVIDER: S-EPMC4210561 | biostudies-literature | 2014 Oct
REPOSITORIES: biostudies-literature
Publications
Mobile health, exercise and metabolic risk: a randomized controlled trial.
Petrella Robert J RJ Stuckey Melanie I MI Shapiro Sheree S Gill Dawn P DP
BMC public health 20141018
<h4>Background</h4>It was hypothesized that a mobile health (mHealth) intervention would elicit greater improvements in systolic blood pressure and other cardiometabolic risk factors at 12 weeks, which would be better maintained over 52 weeks, compared to the active control intervention.<h4>Methods</h4>Eligible participants (≥2 metabolic syndrome risk factors) were randomized to the mHealth intervention (n = 75) or the active control group (n = 74). Blood pressure and other cardiometabolic risk ...[more]
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Project description:BackgroundMobile health interventions are intended to support complex health care needs in chronic diseases digitally, but they are mainly targeted at general health improvement and neglect disease-specific requirements. Therefore, we designed TrackPAD, a smartphone app to support supervised exercise training in patients with peripheral arterial disease.ObjectiveThis pilot study aimed to evaluate changes in the 6-minute walking distance (meters) as a primary outcome measure. The secondary outcome measures included changes in physical activity and assessing the patients' peripheral arterial disease-related quality of life.MethodsThis was a pilot two-arm, single-blinded, randomized controlled trial. Patients with symptomatic PAD (Fontaine stage IIa/b) and access to smartphones were eligible. Eligible participants were randomly assigned to the study, with the control group stratified by the distance covered in the 6-minute walking test using the TENALEA software. Participants randomized to the intervention group received usual care and the mobile intervention (TrackPAD) for the follow-up period of 3 months, whereas participants randomized to the control group received routine care only. TrackPAD records the frequency and duration of training sessions and pain levels using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (the 6-minute walk test and self-reported quality of life). The usability and quality of the app were determined using the Mobile Application Rating Scale user version.ResultsThe intervention group (n=19) increased their mean 6-minute walking distance (83 meters, SD 72.2), while the control group (n=20) decreased their mean distance after 3 months of follow-up (-38.8 meters, SD 53.7; P=.01). The peripheral arterial disease-related quality of life increased significantly in terms of "symptom perception" and "limitations in physical functioning." Users' feedback showed increased motivation and a changed attitude toward performing supervised exercise training.ConclusionsBesides the rating providing a valuable support tool for the user group, the mobile intervention TrackPAD was linked to a change in prognosis-relevant outcome measures combined with enhanced coping with the disease. The influence of mobile interventions on long-term prognosis must be evaluated in the future.Trial registrationClinicalTrials.gov NCT04947228; https://clinicaltrials.gov/ct2/show/NCT04947228.
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Project description: Not available
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Project description:BackgroundSubthreshold exercise, defined as aerobic exercise below the level that causes symptoms, has been utilized as a treatment for youth with persistent postconcussive symptoms (PPCS), but there is currently little evidence to guide use. In addition, prior studies of exercise for PPCS have all required multiple in-person visits. We developed a virtual approach for delivering subthreshold exercise to youth with PPCS called the Mobile Subthreshold Exercise Program (MSTEP), and we have now been funded to conduct a large national randomized controlled trial (RCT) to test its efficacy for reducing concussive symptoms and improving health-related quality of life.MethodsThis investigation is an RCT comparing MSTEP to an active control. We will recruit 200 adolescents 11-18 years old with postconcussive symptoms persisting for at least 1 week but less than 1 year. Youth will be randomized to receive either 6 weeks of subthreshold exercise (MSTEP) or a stretching condition (control). Youth and parents will complete surveys of concussive symptoms at baseline, weekly during the intervention, and at 3 and 6 months. The primary outcomes will be trajectory of concussive symptoms and health-related quality of life over the 6 months of the study. Secondary outcomes will include depression, anxiety, and sleep quality. We will also assess potential mediators of treatment effects including moderate-vigorous physical activity and fear avoidance of concussive symptoms.DiscussionThis multisite RCT of MSTEP will provide vital information regarding the efficacy of a virtually delivered subthreshold exercise program for youth with PPCS, and insight regarding potential mediators of treatment effects, including objectively measured physical activity and fear avoidance of concussive symptoms.Trial registrationClinicalTrials.gov NCT04688255. Registered on December 29, 2020.
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Project description:BACKGROUND:Recent studies on physical activity were analyzed by randomizing participants into either the intervention or control group. It is necessary to classify each intervention and control groups according to physical activity using the International Physical Activity Questionnaire (IPAQ). METHODS:This was a pilot project for SmartCare Services. The intervention group received obesity management services using a smartphone for 24 weeks, while the control group did not receive the interventions. Six anthropometric indices were analyzed: weight, body mass index (BMI), waist circumference, body fat, systolic blood pressure (SBP), and diastolic blood pressure (DBP). Five laboratory tests, including fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), and triglycerides (TGs), were also assessed. The final 324 participants were categorized using the IPAQ questionnaire, and anthropometric indices and laboratory tests were analyzed for within-group and between-group changes from baseline to final visit. RESULTS:Statistically significant decreases in the intervention group compared with the control group were observed in terms of insufficient activity (IA) (-1.6?±?3.03 vs -0.1?±?1.94?kg) and moderate activity (MA) (-2.5?±?3.81 vs -0.3?±?2.24?kg) for weight, IA (-0.7?±?1.14 vs -0.2?±?0.93?kg/m) and MA (-0.9?±?1.30 vs -0.2?±?0.86?kg/m) for BMI, and health-enhancing physical activity (HEPA) (-1.6?±?3.69% vs -0.1?±?3.15%) for body fat. For HbA1c, HEPA in the intervention group showed significant decreases (-0.2?±?0.67 vs 0.0?±?0.34?mg/dL) compared with the control group. CONCLUSION:Anthropometric indices and laboratory test results were improved in the smartphone-based intervention group. Especially, improvement of metabolic components in the group with more active physical activity was remarkable.
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Project description:BACKGROUND:Smoking cessation is a persistent leading public health challenge. Mobile health (mHealth) solutions are emerging to improve smoking cessation treatments. Previous approaches have proposed supporting cessation with tailored motivational messages. Some managed to provide short-term improvements in smoking cessation. Yet, these approaches were either static in terms of personalization or human-based nonscalable solutions. Additionally, long-term effects were neither presented nor assessed in combination with existing psychopharmacological therapies. OBJECTIVE:This study aimed to analyze the long-term efficacy of a mobile app supporting psychopharmacological therapy for smoking cessation and complementarily assess the involved innovative technology. METHODS:A 12-month, randomized, open-label, parallel-group trial comparing smoking cessation rates was performed at Virgen del Rocío University Hospital in Seville (Spain). Smokers were randomly allocated to a control group (CG) receiving usual care (psychopharmacological treatment, n=120) or an intervention group (IG) receiving psychopharmacological treatment and using a mobile app providing artificial intelligence-generated and tailored smoking cessation support messages (n=120). The secondary objectives were to analyze health-related quality of life and monitor healthy lifestyle and physical exercise habits. Safety was assessed according to the presence of adverse events related to the pharmacological therapy. Per-protocol and intention-to-treat analyses were performed. Incomplete data and multinomial regression analyses were performed to assess the variables influencing participant cessation probability. The technical solution was assessed according to the precision of the tailored motivational smoking cessation messages and user engagement. Cessation and no cessation subgroups were compared using t tests. A voluntary satisfaction questionnaire was administered at the end of the intervention to all participants who completed the trial. RESULTS:In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis. Lost data analysis and multinomial logistic models showed different patterns in participants who dropped out. Regarding safety, 14 of 120 (11.7%) IG participants and 13 of 120 (10.8%) CG participants had 19 and 23 adverse events, respectively (P=.84). None of the clinical secondary objective measures showed relevant differences between the groups. The system was able to learn and tailor messages for improved effectiveness in supporting smoking cessation but was unable to reduce the time between a message being sent and opened. In either case, there was no relevant difference between the cessation and no cessation subgroups. However, a significant difference was found in system engagement at 6 months (P=.04) but not in all subsequent months. High system appreciation was reported at the end of the study. CONCLUSIONS:The proposed mHealth solution complementing psychopharmacological therapy showed greater efficacy for achieving 1-year tobacco abstinence as compared with psychopharmacological therapy alone. It provides a basis for artificial intelligence-based future approaches. TRIAL REGISTRATION:ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/NCT03553173. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.2196/12464.
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Project description:BackgroundAlthough it is well known that regular physical activity and exercise, as well as maintaining adequate nutritional status is important to delaying symptom development and maintaining physical capacity and function in people with Parkinson's Disease (PD), many are unable to follow self-management recommendations. Active interventions have shown short-term effects, but there is a need for interventions that facilitate self-management over the course of the disease. Until now, no studies have combined exercise and nutritional interventions with an individual self-management approach in PD. Thus, we aim to examine the effect of a six-month mobile health technology(m-health)-based follow-up programme, focusing on self-management in exercise and nutrition, after an in-service interdisciplinary rehabilitation programme.MethodsA single-blinded, two-group randomised controlled trial. Participants are Adults aged 40 or older, with idiopathic PD, Hoehn and Yahr 1-3, living at home. The intervention group receives a monthly, individualized, digital conversation with a PT, combined with use of an activity tracker. People at nutritional risk get additional digital-follow-up from a nutritional specialist. The control group receives usual care. The primary outcome is physical capacity, measured by 6-min walk test (6MWT). Secondary outcomes are nutritional status, Health related quality of life (HRQOL), physical function and exercise adherence. All measurements are performed at baseline, after 3 months and after 6 months. Sample size, based on primary outcome, is set at 100 participants randomized into the two arms, including an estimated 20% drop out.DiscussionThe increasing prevalence of PD globally makes it even more important to develop evidence-based interventions that can increase motivation to stay active, promote adequate nutritional status and improve self-management in people with PD. The individually tailored digital follow-up programme, based on evidence-based practice, has the potential to promote evidence-based decision-making and to empower people with PD to implement exercise and optimal nutrition in their daily lives and, hopefully, increase adherence to exercise and nutritional recommendations.Trial registrationClinicalTrials.gov (NCT04945876). First registration 01.03.2021.
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