Mobile health, exercise and metabolic risk: a randomized controlled trial.
Ontology highlight
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]
Similar Datasets
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.
| S-EPMC8406106 | biostudies-literature
Project description:Aims/hypothesis: Dietary restriction (DR) reduces adiposity and improves metabolism in patients with one or more symptoms of the metabolic syndrome. Nonetheless, it remains elusive whether the benefits of DR in humans are mediated by calorie or nutrient restriction. This study was conducted to identify whether isocaloric dietary protein restriction is sufficient to confer the beneficial effects of dietary restriction in patients with metabolic syndrome. Methods: We performed a prospective, randomized controlled dietary intervention under constant nutritional and medical supervision. A total of 21 individuals diagnosed with the metabolic syndrome was randomly assigned for caloric restriction (CR; n = 11, mean age 49 ± 8.5 years, female 63%; diet of 5,941 ± 686 KJ per day) or isocaloric dietary protein restriction (PR; n = 10, mean age 51.6 ± 8.9 years, female 50%; diet of 8,409 ± 2,360 KJ per day) and followed for 27 days. Results: Like CR, PR promoted weight loss (-6.6%, P= 0.0041) due to reduction in adiposity (-9.9%, P= 0.0007), associated with reductions in blood glucose (-52.7%, P= 0.0002), lipid levels (cholesterol, -35.4%, P= 0.0010; triglycerides, -39.5% P= 0.0022) and blood pressure (systolic, -37.7 P< 0.0001; diastolic, -73.2% P< 0.0001). PR resulted in enrichment of metabolic pathways related to the immune system such as B cell proliferation, lymphocyte proliferation and leukocyte proliferation in subcutaneous adipose tissue. Hence, a reduction in calorie intake or changes in the gut microbiome are not necessary to confer the metabolic benefits of DR. Instead, a reduction in protein intake with a mild increase in carbohydrate intake to maintain the isocaloric balance of the diet is sufficient to improve metabolic control. Conclusions/interpretation: Protein restriction is sufficient to confer almost the same clinical outcomes as calorie restriction without the need for a reduction in calorie intake. The isocaloric characteristic of the PR intervention makes this approach a more attractive and less drastic dietary strategy in clinical settings and has greater potential to be used as adjuvant therapy for people with the metabolic syndrome.
2022-06-20 | GSE192587 | GEO
Project description:BackgroundWomen significantly decrease their activity levels in the transition to motherhood. Digital health technologies are low cost, scalable, and can provide an effective delivery mechanism for behavior change. This is the first study that examines the use of videoconferencing and mobile apps to create exercise groups for mothers.ObjectiveThe aim of the study was to test the feasibility, acceptability, and effectiveness of an individually adaptive and socially supportive physical activity intervention incorporating videoconferencing and mobile apps for mothers.MethodsThe Moms Online Video Exercise Study was an 8-week, 2-armed, Web-based randomized trial comparing the effectiveness of a group exercise intervention with a waitlist control. Healthy mothers with at least 1 child under the age of 12 years were recruited through Facebook and email listservs. Intervention participants joined exercise groups using videoconferencing (Google Hangouts) every morning on weekdays and exercised together in real time, guided by exercise mobile apps (eg, Nike+, Sworkit) of their choice. Waitlist control participants had access to recommended mobile apps and an invitation to join an exercise group after the 8-week study period. Main outcomes assessed included changes in self-reported moderate, vigorous, and moderate to vigorous physical activity (MVPA) minutes per week in aggregate and stratified by whether women met Centers for Disease Control and Prevention guidelines for sufficient aerobic activity at baseline. Outcomes were measured through self-assessed Web-based questionnaires at baseline and 8 weeks.ResultsThe intervention was effective at increasing exercise for inactive women and proved to be feasible and acceptable to all participants. A total of 64 women were randomized, 30 to intervention and 34 to control. Women attended 2.8 sessions per week. There was a strong, but not statistically significant, trend toward increasing moderate, vigorous, and MVPA minutes for all women. As hypothesized, in the prespecified stratum of women who were inactive at baseline (n=51), intervention participants significantly increased their activity by an average of 50 (95% CI 4.0-95.9, P=.03) MVPA minutes per week more than control participants. They had a corresponding statistically significant net increase of 19 (95% CI 3.2-34.8, P=.02) minutes of vigorous activity. Inactive women in the intervention arm also experienced promising reductions in depression, reporting a statistically significant net decrease in their depression score (-3.8, 95% CI -7.0 to -0.6; P=.02).ConclusionsWe found that a group exercise intervention using videoconferencing and mobile apps was a feasible and acceptable way to deliver a physical activity intervention to mothers. The intervention increased physical activity in inactive mothers. Further studies are needed to better establish how long these changes in physical activity can be maintained and whether these findings can be reproduced in a more diverse population.Trial registrationClinicalTrials.gov NCT02805140; https://clinicaltrials.gov/ct2/show/NCT02805140 (Archived by WebCite at http://www.webcitation.org/6yYZwRveg).
| S-EPMC5984277 | biostudies-literature
Project description:Lung transplant recipients are encouraged to perform self-management behaviors, including (i) monitoring health indicators, (ii) adhering to their regimen, and (iii) reporting abnormal health indicators to the transplant coordinator, yet performance is suboptimal. When hospital discharge was imminent, this two-group trial randomized 201 recipients to use either the mobile health (mHealth) intervention (n = 99) or usual care (n = 102), to compare efficacy for promoting self-management behaviors (primary outcomes) and self-care agency, rehospitalization, and mortality (secondary outcomes) at home during the first year after transplantation. The mHealth intervention group performed self-monitoring (odds ratio [OR] 5.11, 95% confidence interval [CI] 2.95-8.87, p < 0.001), adhered to medical regimen (OR 1.64, 95% CI 1.01-2.66, p = 0.046), and reported abnormal health indicators (OR 8.9, 95% CI 3.60-21.99, p < 0.001) more frequently than the usual care group. However, the two groups did not differ in rehospitalization (OR 0.78, 95% CI 0.36-1.66, p = 0.51) or mortality (hazard ratio 1.71, 0.68-4.28, p = 0.25). The positive impact of the mHealth intervention on self-management behaviors suggests that the intervention holds promise and warrants further testing.
| S-EPMC4925283 | biostudies-other
Project description:BACKGROUND:High positive mental health, including the ability to cope with the normal stresses of life, work productively, and be able to contribute to one's community, has been associated with various health outcomes. The role of positive mental health is therefore increasingly recognized in national mental health promotion programs and policies. Mobile health (mHealth) interventions could be a cost-effective way to disseminate positive psychological interventions to the general population. OBJECTIVE:The aim of this study was to estimate the effect of a fully automated mHealth intervention on positive mental health, and anxiety and depression symptomology among Swedish university students using a randomized controlled trial design. METHODS:A 2-arm, single-blind (researchers), parallel-groups randomized controlled trial with an mHealth positive psychology program intervention group and a relevant online mental health information control group was employed to estimate the effect of the novel intervention. Participants were recruited using digital advertising through student health care centers in Sweden. Inclusion criteria were (1) university students, (2) able to read and understand Swedish, (3) and have access to a mobile phone. Exclusion criteria were high positive mental health, as assessed by the Mental Health Continuum Short Form (MHC-SF), or high depression and anxiety symptomology, as assessed by the Hospital Anxiety Depression Scale (HADS). The primary outcome was positive mental health (MHC-SF), and the secondary outcomes were depression and anxiety symptomatology (HADS). The subscales of MHC-SF were also analyzed as exploratory outcomes. Outcomes were measured 3 months after randomization through questionnaires completed on the participants' mobile phones. RESULTS:A total of 654 participants (median age 25 years), including 510 (78.0%) identifying as female, were randomized to either the intervention (n=348) or control group (n=306). At follow-up, positive mental health was significantly higher in the intervention group compared with the control group (incidence rate ratio [IRR]=1.067, 95% CI 1.024-1.112, P=.002). For both depression and anxiety symptomatology, the intervention group showed significantly lower scores at follow-up compared with the control group (depression: IRR=0.820, 95% CI 0.714-0.942, P=.005; anxiety: IRR=0.899, 95% CI 0.840-0.962, P=.002). Follow-up rates were lower than expected (58.3% for primary outcomes and 52.3% for secondary outcomes); however, attrition analyses did not identify any systematic attrition with respect to baseline variables. CONCLUSIONS:The mHealth intervention was estimated to be superior to usual care in increasing positive mental health among university students. A protective effect of the intervention was also found on depressive and anxiety symptoms. These findings demonstrate the feasibility of using an automated mobile phone format to enhance positive mental health, which offers promise for the use of mHealth solutions in public mental health promotion. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Registry ISRCTN54748632; http://www.isrctn.com/ISRCTN54748632.
| S-EPMC7125436 | biostudies-literature
Project description:BackgroundAndrogen deprivation therapy (ADT), a standard treatment for prostate cancer (PC), causes many physical side effects. In particular, it causes metabolic changes such as fasting glucose abnormalities or accumulation of body fat, and its continuation can lead to metabolic syndrome (MetS), which is closely related to diabetes and cardiovascular disease. Therefore, it is important to maintain and practice a healthy lifestyle in patients with PC.ObjectiveThis study aims to evaluate the effectiveness of a nurse-led mobile-based program that aims to promote a healthy lifestyle in patients with PC undergoing ADT with MetS risk factors.MethodsThis was a single-blind, randomized, waitlist control interventional study. A total of 48 patients were randomly assigned to the experimental and waitlist control groups at the urology cancer clinic of a tertiary general hospital in South Korea. The inclusion criteria were patients who had undergone ADT for >6 months, had at least 1 of the 5 MetS components in the abnormal range, and could access a mobile-based education program. The experimental group attended a 4-week mobile-based program on exercise and diet that included counseling and encouragement to maintain a healthy lifestyle, whereas the control group was placed on a waitlist and received usual care during the follow-up period, followed by the intervention. The primary outcome was a change in the lifestyle score. The secondary outcomes were changes in 5 MetS components, body composition, and health-related quality of life. The outcomes were measured at 6 weeks and 12 weeks after the initiation of the intervention. Each participant was assigned to each group in a sequential order of enrollment in a 4×4 permuted block design randomization table generated in the SAS (SAS Institute) statistical program. A linear mixed model was used for statistical analysis.ResultsA total of 24 participants were randomly assigned to each group; however, 2 participants in the experimental group dropped out for personal reasons before starting the intervention. Finally, 46 participants were included in the intention-to-treat analysis. The experimental group showed more positive changes in the healthy lifestyle score (β=29.23; P≤.001), level of each MetS component (fasting blood sugar: β=-12.0; P=.05 and abdominal circumference: β=-2.49; P=.049), body composition (body weight: β=-1.52; P<.001 and BMI: β=-0.55; P<.001), and the urinary irritative and obstructive domain of health-related quality of life (β=14.63; P<.001) over time than the waitlist control group.ConclusionsLifestyle changes through nurse-led education can improve level of each MetS components, body composition, and ADT side effects. Nurses can induce positive changes in patients' lifestyles and improve the self-management of patients starting ADT through this program.Trial registrationClinical Research Information Service KCT0006560; http://tinyurl.com/yhvj4vwh.
| S-EPMC10870207 | biostudies-literature
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.
| S-EPMC6160111 | biostudies-literature
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.
| S-EPMC7215523 | biostudies-literature
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.
| S-EPMC9979434 | biostudies-literature
Project description:BackgroundObesity is a major public health issue. Combining exercise training, nutrition, and therapeutic education in metabolic rehabilitation (MR) is recommended for obesity management. However, evidence from randomized controlled studies is lacking. In addition, MR is associated with poor patient adherence. Mobile health devices improve access to MR components.ObjectiveThe aim of this study is to compare the changes in body composition, anthropometric parameters, exercise capacity, and quality of life (QOL) within 12 weeks of patients in the telerehabilitation (TR) program to those of usual care patients with obesity.MethodsThis was a parallel-design randomized controlled study. In total, 50 patients with obesity (BMI>30 kg/m²) were included in a TR group (TRG) or a usual care group (UCG) for 12 weeks. Patients underwent biometric impedance analyses, metabolic exercise tests, actimetry, and QOL and satisfaction questionnaires. The primary outcome was the change in fat mass at 12 weeks from baseline. Secondary outcomes were changes in body weight, metabolic parameters, exercise capacity, QOL, patients' adhesion, and satisfaction.ResultsA total of 49 patients completed the study. No significant group × time interaction was found for fat mass (TRG: mean 1.7 kg, SD 2.6 kg; UCG: mean 1.2 kg, SD 2.4 kg; P=.48). Compared with the UCG, TRG patients tended to significantly improve their waist to hip ratios (TRG: -0.01 kg, SD 0.04; UCG: +0.01 kg, SD 0.06; P=.07) and improved QOL physical impact (TRG: +21.8, SD 43.6; UCG: -1.2, SD 15.4; P=.005). Significant time effects were observed for body composition, 6-minute walk test distance, exercise metabolism, sedentary time, and QOL. Adherence (95%) and satisfaction in the TRG were good.ConclusionsIn adults with obesity, the TR program was not superior to usual care for improving body composition. However, TR was able to deliver full multidisciplinary rehabilitation to patients with obesity and improve some health outcomes. Given the patients' adherence and satisfaction, pragmatic programs should consider mobile health devices to improve access to MR. Further studies are warranted to further establish the benefits that TR has over usual care.Trial registrationClinicalTrials.gov NCT03396666; http://clinicaltrials.gov/ct2/show/NCT03396666.
| S-EPMC8691412 | biostudies-literature