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Sustainability of mHealth Effects on Cardiometabolic Risk Factors: Five-Year Results of a Randomized Clinical Trial.

ABSTRACT: BACKGROUND:The long-term effects of mobile health (mHealth) interventions have not been documented, especially in resource-constrained settings. OBJECTIVE:This study aimed to assess the effects of a 1-year mHealth intervention on blood pressure levels and body weight in low-resource urban settings in Peru, 4 years after the completion of the original study. METHODS:Four years after the original Grupo de Investigación en Salud Móvil en America Latina (GISMAL) study, we attempted to contact the 212 individuals originally enrolled in the study in Peru. The primary outcomes were systolic and diastolic blood pressure levels and hypertension incidence. Secondary outcome measures were body weight, BMI, and self-reported target behaviors. The study personnel collecting the data were masked to the group assignment. Linear mixed models were used to evaluate the effects of the intervention on primary and secondary outcomes in an intention-to-treat analysis. RESULTS:Data from 164 (77.4%) of the 212 originally enrolled participants were available and analyzed (80 in the intervention group and 84 in the control group). The intervention did not result in changes in systolic (-2.54 mm Hg, 95% CI -8.23 to 3.15) or diastolic (3.41 mm Hg, 95% CI -0.75 to 7.57) blood pressure compared with the control group. The intervention reduced the risk of developing hypertension, but the result was not significant (risk ratio (RR) 0.76, 95% CI 0.45-1.28). However, those who received the intervention had lower body weight (-5.42 kg, 95% CI -10.4 to -0.48) and BMI (-2.56 kg/m2, 95% CI -4.46 to -0.66). In addition, compared to the control participants, those who received ?50% of the scheduled calls during the intervention had greater reductions in body weight (-6.23 kg, 95% CI -11.47 to -0.99) and BMI (-2.81 kg/m2, 95% CI -4.77 to -0.85). CONCLUSIONS:An mHealth intervention comprising motivational interview calls and SMS text messaging appears to have effects on health 4 years after intervention completion. Although there were no effects on blood pressure levels, important reductions in body weight and BMI were seen 5 years after randomization. Thus, mHealth appears to be a promising preventive strategy for noncommunicable diseases in resource-constrained settings. TRIAL REGISTRATION:Clinicaltrials.gov NCT01295216; https://clinicaltrials.gov/ct2/show/NCT01295216.

SUBMITTER: Bernabe-Ortiz A

PROVIDER: S-EPMC7201320 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Sustainability of mHealth Effects on Cardiometabolic Risk Factors: Five-Year Results of a Randomized Clinical Trial.

Bernabe-Ortiz Antonio A Pauschardt Julia J Diez-Canseco Francisco F Miranda J Jaime JJ

Journal of medical Internet research 20200421 4

<h4>Background</h4>The long-term effects of mobile health (mHealth) interventions have not been documented, especially in resource-constrained settings.<h4>Objective</h4>This study aimed to assess the effects of a 1-year mHealth intervention on blood pressure levels and body weight in low-resource urban settings in Peru, 4 years after the completion of the original study.<h4>Methods</h4>Four years after the original Grupo de Investigación en Salud Móvil en America Latina (GISMAL) study, we attem ...[more]

PMID: 32314970

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Project description:BackgroundIntensive lifestyle interventions (ILIs) are the first-line approach to effectively treat obesity and manage associated cardiometabolic risk factors. Because few people have access to ILIs in academic health centers, primary care must implement similar approaches for a meaningful effect on obesity and cardiometabolic disease prevalence. To date, however, effective lifestyle-based obesity treatment in primary care is limited. We examined the effectiveness of a pragmatic ILI for weight loss delivered in primary care among a racially diverse, low-income population with obesity for improving cardiometabolic risk factors over 24 months.MethodsThe PROPEL trial (Promoting Successful Weight Loss in Primary Care in Louisiana) randomly allocated 18 clinics equally to usual care or an ILI and subsequently enrolled 803 (351 usual care, 452 ILI) adults (67% Black, 84% female) with obesity from participating clinics. The usual care group continued to receive their normal primary care. The ILI group received a 24-month high-intensity lifestyle-based obesity treatment program, embedded in the clinic setting and delivered by health coaches in weekly sessions initially and monthly sessions in months 7 through 24.ResultsAs recently demonstrated, participants receiving the PROPEL ILI lost significantly more weight over 24 months than those receiving usual care (mean difference, -4.51% [95% CI, -5.93 to -3.10]; P<0.01). Fasting glucose decreased more in the ILI group compared with the usual care group at 12 months (mean difference, -7.1 mg/dL [95% CI, -12.0 to -2.1]; P<0.01) but not 24 months (mean difference, -0.8 mg/dL [95% CI, -6.2 to 4.6]; P=0.76). Increases in high-density lipoprotein cholesterol were greater in the ILI than in the usual care group at both time points (mean difference at 24 months, 4.6 mg/dL [95% CI, 2.9-6.3]; P<0.01). Total:high-density lipoprotein cholesterol ratio and metabolic syndrome severity (z score) decreased more in the ILI group than in the usual care group at both time points, with significant mean differences of the change of -0.31 (95% CI, -0.47 to -0.14; P<0.01) and -0.21 (95% CI, -0.36 to -0.06; P=0.01) at 24 months, respectively. Changes in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and blood pressure did not differ significantly between groups at any time point.ConclusionsA pragmatic ILI consistent with national guidelines and delivered by trained health coaches in primary care produced clinically relevant improvements in cardiometabolic health in an underserved population over 24 months. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02561221.

Project description:Background : Public health programs are charged with implementing evidence-based interventions to support public health improvement, however, to achieve long term population based benefit these interventions must be sustained. Empirical evidence suggests that program sustainability can be improved through training and technical assistance, but few resources are available to support public health programs in building capacity for sustainability. Methods: This study sought to build capacity for sustainability among state tobacco control programs through a multiyear, group-randomized trial that developed, tested, and evaluated a novel Program Sustainability Action Planning Model and Training Curricula . Using Kolb's experiential learning theory, we developed this action-oriented training model to address the program-related domains proven to impact capacity for sustainability as outlined in the Program Sustainability Framework. We evaluated the intervention using a longitudinal mixed-effects model using Program Sustainability Assessment (PSAT) scores from three time points. The main predictors in our model included group (control vs intervention) and type of dosage (active and passive). Covariates included state level American Lung Association score (proxy for tobacco control policy environment) and percent of CDC-recommended funding (proxy for program resources). Results : Twenty-three of the 24 state tobacco control programs were included in the analyses: 11 received the training intervention and 12 were control. Results of the longitudinal mixed-effects linear regression model, where the annual PSAT score was the outcome, showed that states in the intervention condition reported significantly higher PSAT scores. The effects for CDC-recommended funding and American Lung Association smoke-free scores (proxy for policy environment) were small but statistically significant. Conclusion: This study found that the Program Sustainability Action Planning Model and Training Curricula was effective in building capacity for sustainability. The training was most beneficial for programs that had made less policy progress than others, implying that tailored training may be most appropriate for programs possibly struggling to make progress. Finally, while funding had a small, statistically significant effect in our model, it virtually made no difference for the average program in our study. This suggests that other factors may be more or equally important as the level of funding a program receives. Trial registration : NCT03598114, Registered on July 26, 2018 (clnicaltrials.gov/NCT03598114).

Project description:BACKGROUND:Physical inactivity is one of the leading risk factors contributing to the rising rates of chronic diseases and has been associated with deleterious health outcomes in patients with chronic disease conditions. We developed a mobile phone app, FeatForward, to increase the level of physical activity in patients with cardiometabolic risk (CMR) factors. This intervention is expected to result in an overall improvement in patient health outcomes. OBJECTIVE:The objective of this study is to evaluate the effect of a mobile phone-based app, FeatForward, on physical activity levels and other CMR factors in patients with chronic conditions. METHODS:The study will be implemented as a 2-arm randomized controlled trial with 300 adult patients with chronic conditions over a 6-month follow-up period. Participants will be assigned to either the intervention group receiving the FeatForward app and standard care versus a control group who will receive only usual care. The difference in physical activity levels between the control group and intervention group will be measured as the primary outcome. We will also evaluate the effect of this intervention on secondary measures including clinical outcome changes in global CMR factors (glycated hemoglobin, fasting blood glucose, blood pressure, waist circumference, Serum lipids, C-reactive protein), health-related quality of life, health care usage, including attendance of scheduled clinic visits and hospitalizations, usability, and satisfaction, participant engagement with the FeatForward app, physician engagement with physician portal, and willingness to engage in physical activity. Instruments that will be used in evaluating secondary outcomes include the Short-Form (SF)-12, app usability and satisfaction questionnaires, physician satisfaction questionnaire. The intention-to-treat approach will be used to evaluate outcomes. All outcomes will be measured longitudinally at baseline, midpoint (3 months), and 6 months. Our primary outcome, physical activity, will be assessed by mixed-model analysis of variance with intervention assignment as between-group factor and time as within-subject factor. A similar approach will be used to analyze continuous secondary outcomes while categorical outcomes will be analyzed by chi-square test. RESULTS:The study is still in progress and we hope to have the results by the end of 2016. CONCLUSIONS:The mobile phone-based app, FeatForward, could lead to significant improvements in physical activity and other CMR factors in patients.

Project description:BackgroundPostpartum women with overweight/obesity and a history of adverse pregnancy outcomes are at elevated risk for cardiometabolic disease. Postpartum weight loss and lifestyle changes can decrease these risks, yet traditional face-to-face interventions often fail. We adapted the Diabetes Prevention Program into a theory-based mobile health (mHealth) program called Fit After Baby (FAB) and tested FAB in a randomized controlled trial.MethodsThe FAB program provided 12 weeks of daily evidence-based content, facilitated tracking of weight, diet, and activity, and included weekly coaching and gamification with points and rewards. We randomized women at 6 weeks postpartum 2:1 to FAB or to the publicly available Text4baby (T4B) app (active control). We measured weight and administered behavioral questionnaires at 6 weeks, and 6 and 12 months postpartum, and collected app user data.Results81 eligible women participated (77% White, 2% Asian, 15% Black, with 23% Hispanic), mean baseline BMI 32±5 kg/m2 and age 31±5 years. FAB participants logged into the app a median of 51/84 (IQR 25,71) days, wore activity trackers 66/84 (IQR 43,84) days, logged weight 17 times (IQR 11,24), and did coach check-ins 5.5/12 (IQR 4,9) weeks. The COVID-19 pandemic interrupted data collection for the primary 12-month endpoint, and impacted diet, physical activity, and body weight for many participants. At 12 months postpartum women in the FAB group lost 2.8 kg [95% CI -4.2,-1.4] from baseline compared to a loss of 1.8 kg [95% CI -3.8,+0.3] in the T4B group (p = 0.42 for the difference between groups). In 60 women who reached 12 months postpartum before the onset of the COVID-19 pandemic, women randomized to FAB lost 4.3 kg [95% CI -6.0,-2.6] compared to loss in the control group of 1.3 kg [95% CI -3.7,+1.1] (p = 0.0451 for the difference between groups).ConclusionsThere were no significant differences between groups for postpartum weight loss for the entire study population. Among those unaffected by the COVID pandemic, women randomized to the FAB program lost significantly more weight than those randomized to the T4B program. The mHealth FAB program demonstrated a substantial level of engagement. Given the scalability and potential public health impact of the FAB program, the efficacy for decreasing cardiometabolic risk by increasing postpartum weight loss should be tested in a larger trial.

Project description:Introduction: Volume and intensity are major variables governing exercise training-mediated beneficial effects in both athletes and patients. Although polarized endurance training optimizes and maximizes physiological gains in highly trained individuals, its cardiometabolic protective-effects have not been established. The purpose of the present single site, randomized-controlled trial was to compare the effects of 12-weeks of high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), and polarized volume training (POL) programs on cardiometabolic risk factors in young overweight and obese women. Materials and Methods: A total of 64 overweight/obese young women (age 23.3 ± 3.8 years, body mass index 33.8 ± 3.8 kg/m2) were randomly assigned to four groups: control group (CTRL), polarized volume training group, moderate-intensity endurance training group, and HIIT group. The cardiorespiratory capacity, glycemic and lipid profiles, whole-body substrate utilization, and body composition were assessed before and after the intervention. Results: After the intervention, VO2peak and power output at VO2peak increased in all exercised-groups (time effect: p < 0.0001). Power output at VT1 was increased only in the POL group compared to the CTRL group (p = 0.019). Relative fold changes in fasting plasma glucose concentrations decreased only in POL group (p = 0.002). Training induced a significant increase in relative fat oxidation in all the groups (time effect: p < 0.001). Relative fat oxidation increased only in the POL group compared to the CTRL group (training effect: p = 0.032). Conclusion: Twelve-weeks of polarized volume training showed overall superior effects on cardiorespiratory fitness, basal glycemic control, and substrate oxidation in comparison to MICT and HIIT training modalities. These data suggest that polarized volume training is an effective non-pharmacological treatment strategy for reducing cardiovascular disease risk factors in young overweight and obese women. The trial is registered at ISRCTN, number ISRCTN34421723.

Project description:ObjectiveTo evaluate the safety and efficacy of golimumab through 5 years in adults with active rheumatoid arthritis (RA) who had not previously received methotrexate (MTX).MethodsIn the GO-BEFORE study, 637 MTX-naive adult patients with active RA were randomized (1:1:1:1) to placebo?+?MTX (group 1), golimumab 100 mg?+?placebo (group 2), golimumab 50 mg?+?MTX (group 3), or golimumab 100 mg?+?MTX (group 4). Inadequate responders in groups 1, 2, and 3 entered early escape at week 28 to golimumab 50 mg?+?MTX, golimumab 100 mg?+?MTX, or golimumab 100 mg?+?MTX, respectively; remaining patients in group 1 could cross over to golimumab 50 mg?+?MTX at week 52. Assessments included the American College of Rheumatology 20%/50%/70% improvement criteria (ACR20/50/70) response, the Disease Activity Score in 28 joints (DAS28) using C-reactive protein (CRP) level, and the modified Sharp/van der Heijde score (SHS). Efficacy was analyzed using an intent-to-treat (ITT) analysis. Pharmacokinetics and immunogenicity were evaluated at selected visits.ResultsA total of 422 patients completed golimumab treatment through week 256. At week 256, 72.8%, 54.6%, and 38.0% of all patients in the full ITT population (n?=?637) had an ACR20/50/70 response, respectively; 84.1% had a good or moderate DAS28-CRP response; and 72.7% had a clinically meaningful improvement in physical function. Radiographic progression was minimal in all treatment groups through week 256, and the overall mean change from baseline in SHS was 1.36. Serum trough golimumab concentrations were approximately dose proportional and maintained through week 256. Antibodies to golimumab occurred in 9.6% of patients through week 256. Infections were the most common type of adverse event (AE); 204 of 616 patients (33.1%) had ?1 serious AE.ConclusionClinical efficacy with golimumab treatment was maintained through week 256 of the GO-BEFORE trial of MTX-naive RA patients. No unexpected AEs occurred; safety results through 5 years are consistent with earlier reports.

Dataset Information

Sustainability of mHealth Effects on Cardiometabolic Risk Factors: Five-Year Results of a Randomized Clinical Trial.

Publications

Sustainability of mHealth Effects on Cardiometabolic Risk Factors: Five-Year Results of a Randomized Clinical Trial.

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