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A Personalized eHealth Intervention for Lifestyle Changes in Patients With Cardiovascular Disease: Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Behavior change methods involving new ambulatory technologies may improve lifestyle and cardiovascular disease outcomes. OBJECTIVE:This study aimed to provide proof-of-concept analyses of an intervention aiming to increase (1) behavioral flexibility, (2) lifestyle change, and (3) quality of life. The feasibility and patient acceptance of the intervention were also evaluated. METHODS:Patients with cardiovascular disease (N=149; mean age 63.57, SD 8.30 years; 50/149, 33.5% women) were recruited in the Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) trial and randomized to the Do CHANGE intervention or care as usual (CAU). The intervention involved a 3-month behavioral program in combination with ecological momentary assessment and intervention technologies. RESULTS:The intervention was perceived to be feasible and useful. A significant increase in lifestyle scores over time was found for both groups (F2,146.6=9.99; P<.001), which was similar for CAU and the intervention group (F1,149.9=0.09; P=.77). Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean -1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02). No significant treatment effects were observed for behavioral flexibility (F1,149.0=0.48; P=.07). CONCLUSIONS:The Do CHANGE 1 intervention was perceived as useful and easy to use. However, no long-term treatment effects were found on the outcome measures. More research is warranted to examine which components of behavioral interventions are effective in producing long-term behavior change. TRIAL REGISTRATION:ClinicalTrials.gov NCT02946281; https://www.clinicaltrials.gov/ct2/show/NCT02946281.

SUBMITTER: Broers ER

PROVIDER: S-EPMC7381027 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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A Personalized eHealth Intervention for Lifestyle Changes in Patients With Cardiovascular Disease: Randomized Controlled Trial.

Broers Eva Rosalinde ER Kop Willem Johan WJ Denollet Johan J Widdershoven Jos J Wetzels Mart M Ayoola Idowu I Piera-Jimenez Jordi J Habibovic Mirela M

Journal of medical Internet research 20200522 5

<h4>Background</h4>Behavior change methods involving new ambulatory technologies may improve lifestyle and cardiovascular disease outcomes.<h4>Objective</h4>This study aimed to provide proof-of-concept analyses of an intervention aiming to increase (1) behavioral flexibility, (2) lifestyle change, and (3) quality of life. The feasibility and patient acceptance of the intervention were also evaluated.<h4>Methods</h4>Patients with cardiovascular disease (N=149; mean age 63.57, SD 8.30 years; 50/14 ...[more]

PMID: 32441658

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Project description:BACKGROUND: Intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals. OBJECTIVE: It is not known whether a program of moderate intervention might effectively reduce metabolic abnormalities in the general population. DESIGN: Two-arm randomized controlled 1-year trial. PATIENTS: Three hundred and thirty-five patients participated from a dysmetabolic population-based cohort of 375 adults aged 45-64 years in northwestern Italy. MEASUREMENTS: We compared the effectiveness of a general recommendation-based program of lifestyle intervention carried out by trained professionals versus standard unstructured information given by family physicians at reducing the prevalence of multiple metabolic and inflammatory abnormalities. RESULTS: At baseline, clinical/anthropometric/laboratory and lifestyle characteristics of the intervention (n = 169) and control (n = 166) groups were not significantly different. The former significantly reduced total/saturated fat intake and increased polyunsaturated fat/fiber intake and exercise level compared to the controls. Weight, waist circumference, high-sensitivity C-reactive protein, and most of the metabolic syndrome components decreased in the intervention group and increased in the controls after 12 months. Lifestyle intervention significantly reduced metabolic syndrome (odds ratio [OR] = 0.28; 95% CI 0.18-0.44), with a 31% (21-41) absolute risk reduction, corresponding to 3.2 (2-5) patients needing to be treated to prevent 1 case after 12 months. The intervention significantly reduced the prevalence of central obesity (OR = 0.33; 0.20-0.56), and hypertriglyceridemia (OR = 0.48; 0.31-0.75) and the incidence of diabetes (OR = 0.23; 0.06-0.85). CONCLUSION: A lifestyle intervention based on general recommendations was effective in reducing multiple metabolic/inflammatory abnormalities. The usual care by family physicians was ineffective at modifying progressive metabolic deterioration in high-risk individuals.

Project description:BackgroundMaternal overweight has a substantial impact on reproductive, maternal, pregnancy, and neonatal outcomes with long-term and transgenerational health consequences. Interventions that aim to optimize periconception maternal lifestyle can improve maternal and fetal health during pregnancy and throughout the life course. However, it remains difficult to change and adopt adequate lifestyle behaviors. We hypothesize that additional psychological therapy targeting cognitive and affective factors substantially contribute to the effectiveness of these interventions.ObjectiveThe proposed study aims to examine the feasibility and effectiveness of a blended personalized periconception lifestyle care intervention with additional psychological therapy aimed at women with a BMI≥25 and who are contemplating pregnancy or are already pregnant (≤12 weeks) in reducing inadequate lifestyle behaviors and improving early and late pregnancy outcome.MethodsThe eHealth and Face-to-face Counseling (eFUSE) study follows a single-center two-arm randomized controlled trial design at the Erasmus MC, University Medical Center, with a multicenter regional referral. The female patients with overweight (BMI≥25), together with their male partner, will be stratified by pregnancy status (preconception vs pregnant) and randomized to receive either the blended personalized periconception lifestyle care intervention with additional psychological therapy (n=313) or usual care (n=313). The primary outcome is a change in the lifestyle risk score (between baseline and 24 weeks) between the randomization arms (difference in differences). Secondary outcomes include measurements defined as most relevant by the International Consortium for Health Outcomes Measurement, including behavioral determinants, patient satisfaction, provider feasibility, and maternal pregnancy and neonatal complications.ResultsThe study will be open for recruitment from Fall 2021 onward. Data collection is expected to be completed by the beginning of 2023, and the results are expected to be published by Fall 2023.ConclusionsThis study will evaluate the feasibility and effectiveness of a blended periconception lifestyle intervention with additional psychological therapy, aimed at women with a BMI≥25. Positive results of this innovative care approach will be used for implementation in routine medical care of all women with overweight, with the ultimate aim to improve clinical outcomes of these high-risk pregnancies.Trial registrationNetherlands Trial Register NL9264; https://www.trialregister.nl/trial/9264.International registered report identifier (irrid)PRR1-10.2196/28600.

Project description:The impact of personalized exercise training and a healthy dietary lifestyle in healthy volunteers on coronary flow reserve and cardiovascular function remains to be investigated in a controlled study setting.To examine the effects of a Mediterranean-inspired diet combined with regular physical exercise (standard) and a personalized supervised exercise program (DAPS) on coronary flow reserve and cardiovascular function.The number of males were 10 (59%) and 9 (47%) and mean age was 54 ± 12 and 55 ± 5 years in standard versus DAPS group, respectively. Primary outcomes were in addition to improved body composition and aerobic capacity, increased TDE-CFR (5.0%, CI:1.62,8.64, p = 0.005) and left ventricle ejection fraction (LVEF) during hyperemia (10.2%, CI:1.62,19.4, p = 0.022) in DAPS adjusted for the control period. Also, plasma fibrinogen decreased (-12.1%, CI:-22.0,-0.92, p = 0.035) in the DAPS group. Secondary outcomes, after adjusting DAPS intervention effects for the standard-training period, TDE-CFR and hyperemic LVEF remained significantly improved.This randomized, controlled clinical trial (URL: http://www.clinicaltrials.gov NCT02713724) included 36 healthy volunteers who underwent exercise ECG before randomization to standard or DAPS groups. Standard-group was given gym-membership with limited instructions and general dietary advice. DAPS-group received personalized supervised exercise programs and more detailed dietary advice with regular contact with a personal trainer. Effects were evaluated after 3 months. All participants underwent coronary flow reserve by transthoracic ultrasound (TDE-CFR), blood marker analysis and examinations of vascular function. Standard-group was evaluated pre-control, post-control (=pre-intervention) and post-intervention. DAPS-group was examined at pre-intervention and post-intervention.A personalized supervised training- and diet program improves cardiovascular status in healthy subjects with a physically inactive lifestyle and may be a promising approach for cardiovascular prevention in the general population.

Project description:There is evidence that physical activity (PA) can attenuate the influence of the fat mass- and obesity-associated (FTO) genotype on the risk to develop obesity. However, whether providing personalized information on FTO genotype leads to changes in PA is unknown.The purpose of this study was to determine if disclosing FTO risk had an impact on change in PA following a 6-month intervention.The single nucleotide polymorphism (SNP) rs9939609 in the FTO gene was genotyped in 1279 participants of the Food4Me study, a four-arm, Web-based randomized controlled trial (RCT) in 7 European countries on the effects of personalized advice on nutrition and PA. PA was measured objectively using a TracmorD accelerometer and was self-reported using the Baecke questionnaire at baseline and 6 months. Differences in baseline PA variables between risk (AA and AT genotypes) and nonrisk (TT genotype) carriers were tested using multiple linear regression. Impact of FTO risk disclosure on PA change at 6 months was assessed among participants with inadequate PA, by including an interaction term in the model: disclosure (yes/no) × FTO risk (yes/no).At baseline, data on PA were available for 874 and 405 participants with the risk and nonrisk FTO genotypes, respectively. There were no significant differences in objectively measured or self-reported baseline PA between risk and nonrisk carriers. A total of 807 (72.05%) of the participants out of 1120 in the personalized groups were encouraged to increase PA at baseline. Knowledge of FTO risk had no impact on PA in either risk or nonrisk carriers after the 6-month intervention. Attrition was higher in nonrisk participants for whom genotype was disclosed (P=.01) compared with their at-risk counterparts.No association between baseline PA and FTO risk genotype was observed. There was no added benefit of disclosing FTO risk on changes in PA in this personalized intervention. Further RCT studies are warranted to confirm whether disclosure of nonrisk genetic test results has adverse effects on engagement in behavior change.ClinicalTrials.gov NCT01530139; http://clinicaltrials.gov/show/NCT01530139 (Archived by WebCite at: http://www.webcitation.org/6XII1QwHz).

Project description:BackgroundDigital health interventions could help to prevent age-related diseases, but little is known about how older adults engage with such interventions, especially in the long term, or whether engagement is associated with changes in clinical, behavioral, or biological outcomes in this population. Disparities in engagement levels with digital health interventions may exist among older people and be associated with health inequalities.ObjectiveThis study aimed to describe older adults' engagement with an eHealth intervention, identify factors associated with engagement, and examine associations between engagement and changes in cardiovascular and dementia risk factors (blood pressure, cholesterol, BMI, physical activity, diet, and cardiovascular and dementia risk scores).MethodsThis was a secondary analysis of the 18-month randomized controlled Healthy Ageing Through Internet Counselling in the Elderly trial of a tailored internet-based intervention encouraging behavior changes, with remote support from a lifestyle coach, to reduce cardiovascular and cognitive decline risk in 2724 individuals aged ≥65 years, recruited offline in the Netherlands, Finland, and France. Engagement was assessed via log-in frequency, number of lifestyle goals set, measurements entered and messages sent to coaches, and percentage of education materials read. Clinical and biological data were collected during in-person visits at baseline and 18 months. Lifestyle data were self-reported on a web-based platform.ResultsOf the 1389 intervention group participants, 1194 (85.96%) sent at least one message. They logged in a median of 29 times, and set a median of 1 goal. Higher engagement was associated with significantly greater improvement in biological and behavioral risk factors, with evidence of a dose-response effect. Compared with the control group, the adjusted mean difference (95% CI) in 18-month change in the primary outcome, a composite z-score comprising blood pressure, BMI, and cholesterol, was -0.08 (-0.12 to -0.03), -0.04 (-0.08 to 0.00), and 0.00 (-0.08 to 0.08) in the high, moderate, and low engagement groups, respectively. Low engagers showed no improvement in any outcome measures compared with the control group. Participants not using a computer regularly before the study engaged much less with the intervention than those using a computer up to 7 (adjusted odds ratio 5.39, 95% CI 2.66-10.95) or ≥7 hours per week (adjusted odds ratio 6.58, 95% CI 3.21-13.49). Those already working on or with short-term plans for lifestyle improvement at baseline, and with better cognition, engaged more.ConclusionsGreater engagement with an eHealth lifestyle intervention was associated with greater improvement in risk factors in older adults. However, those with limited computer experience, who tended to have a lower level of education, or who had poorer cognition engaged less. Additional support or forms of intervention delivery for such individuals could help minimize potential health inequalities associated with the use of digital health interventions in older people.

Project description:BACKGROUND:Frequent sickness absence-that is, 3 or more episodes of sickness absence in 1 year-is a problem for employers and employees. Many employees who have had frequent sickness absence in a prior year also have frequent sickness absence in subsequent years: 39% in the first follow-up year and 61% within 4 years. Moreover, 19% have long-term sickness absence (≥6 weeks) in the first follow-up year and 50% within 4 years. We developed an electronic health (eHealth) intervention, consisting of fully automated feedback and advice, to use either as a stand-alone tool (eHealth intervention-only) or combined with consultation with an occupational physician (eHealth intervention-occupational physician). OBJECTIVE:This study aimed to evaluate the effect of the eHealth intervention, with or without additional occupational physician consultation, to reduce sickness absence frequency for employees with frequent sickness absence, versus care as usual (CAU). METHODS:This study was a three-armed randomized controlled trial. Employees with frequent sickness absence received invitational letters, which were distributed by their employers. The primary outcome measure was the number of register-based sickness absence episodes 12 months after completing the baseline questionnaire. Secondary outcome measures were register-based total sickness absence days and self-assessed burnout, engagement, and work ability. In a process evaluation 3 months after baseline, we examined adherence to the intervention and additional actions such as general practitioner and occupational physician visit, communication with the manager, and lifestyle change. RESULTS:A total of 82 participants were included in the analyses, 21 in the eHealth intervention-only group, 31 in the eHealth intervention-occupational physician group, and 30 in the CAU group. We found no significant difference in sickness absence frequency between the groups at 1-year follow-up. Sickness absence frequency decreased in the eHealth intervention-only group from 3 (interquartile range, IQR 3-4) to 1 episode (IQR 0.3-2.8), in the eHealth intervention-occupational physician group from 4 (IQR 3-5) to 3 episodes (IQR 1-4), and in the CAU group from 3 (IQR 3-4) to 2 episodes (IQR 1-3). For secondary outcomes, we found no significant differences between the intervention groups and the control group. The process evaluation showed that only 3 participants from the eHealth intervention-occupational physician group visited the occupational physician on invitation. CONCLUSIONS:Among employees with frequent sickness absence, we found no effect from the eHealth intervention as a stand-alone tool in reducing sickness absence frequency, nor on total sickness absence days, burnout, engagement, or work ability. This might be due to low adherence to the intervention because of insufficient urgency to act. We cannot draw any conclusion on the effect of the eHealth intervention tool combined with an occupational physician consultation (eHealth intervention-occupational physician), due to very low adherence to the occupational physician consultation. An occupational physician consultation could increase a sense of urgency and lead to more focus and appropriate support. As this was the first effectiveness study among employees with frequent sickness absence, strategies to improve recruitment and adherence in occupational eHealth are included. TRIAL REGISTRATION:Netherlands Trial Register NTR4316; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4316 (Archived by WebCite at http://www.webcitation.org/713DHhOFU).

Project description:RationalePhysical inactivity is associated with poor outcomes among patients with chronic obstructive pulmonary disease (COPD).ObjectivesTo determine effectiveness of a behavioral intervention intended to increase daily physical activity with the goal of improving health-related quality of life and functional performance.MethodsWe conducted a randomized trial among patients with COPD cared for in primary care and pulmonary clinics. The patients were at least 45 years of age and eligible for pulmonary rehabilitation. All patients received self-management education during a 6-week run-in period. Subsequently, patients were randomized to usual care or the intervention delivered over 20 weeks.Measurements and main resultsCo-primary outcomes were change from baseline in Chronic Respiratory Questionnaire dyspnea domain score and 6-minute-walk distance measured at 6, 12, and 18 months after randomization. A total of 325 patients were enrolled, with 156 randomized to receive usual care and 149 to receive the intervention. At 18 months, there was no overall statistical or clinically significant change in the dyspnea domain in either group. However, for 6-minute-walk distance, there were statistically significant declines in both groups. In contrast, 6-minute-walk distance remained stable (5.3 m; P = 0.54) among patients in the intervention group with moderate spirometric impairment, but it was associated with clinically and statistically significant declines (-28.7 m; P = 0.0001) among usual care patients with moderate spirometric impairment. Overall, there was no increase in adverse events associated with the intervention, which was associated with a lower prevalence of hospitalization for COPD exacerbations (28.3%) compared with usual care (49.5%).ConclusionsDuring this 18-month trial among outpatients with COPD, a health coach-based behavioral intervention did not improve scores in the dyspnea domain of the Chronic Respiratory Questionnaire or 6-minute-walk test distance. However, subgroup analyses suggested that there may be differential effects for specific outcomes that vary with severity of COPD. Specifically, benefits of this low-intensity intervention may be limited to 6-minute walk distance among patients with moderate spirometric impairment. Clinical trial registered with www.clinicaltrials.gov (NCT1108991).

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A Personalized eHealth Intervention for Lifestyle Changes in Patients With Cardiovascular Disease: Randomized Controlled Trial.

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A Personalized eHealth Intervention for Lifestyle Changes in Patients With Cardiovascular Disease: Randomized Controlled Trial.

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