Comprehensive Approach to Lower Blood Pressure (CALM-BP): a randomized controlled trial of a multifactorial lifestyle intervention.
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ABSTRACT:
SUBMITTER: Ziv A
PROVIDER: S-EPMC3775127 | biostudies-other | 2013 Oct
REPOSITORIES: biostudies-other
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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.
| S-EPMC2219825 | biostudies-other
Project description:To evaluate the effects of a 2-month lifestyle intervention for dry eye disease in office workers.Prospective interventional study (randomized controlled study). Forty-one middle-aged Japanese office workers (men, 22; women, 19; 39.2±8.0 years) with definite and probable dry eye disease were enrolled and randomized to an intervention group (n = 22) and a control group (n = 19). The intervention aimed at modifying diet, increasing physical activity, and encouraging positive thinking. The primary outcome was change in dry eye disease diagnoses. Secondary outcome was change in disease parameters, including dry eye symptoms, as assessed using the Dry Eye-Related Quality of Life Score, corneal and conjunctival staining scores, tear break-up time, and Schirmer test results.A total of 36 participants (intervention group, 17; control group, 19) completed the study. The number of definite dry eye disease diagnoses decreased from four to none (p =.05), and the dry eye symptom score showed a significant decrease in the intervention group (p =.03). In contrast, the corneal and conjunctival staining scores, tear break-up time, and Schirmer test results did not differ significantly between groups.The 2-month lifestyle intervention employed in this study improved dry eye disease status among office workers, with a considerable decrease in subjective symptoms. Lifestyle intervention may be a promising management option for dry eye disease, although further investigation of long-term effects are required.
| S-EPMC6078845 | biostudies-other
Project description:Background Limited data exist on the benefits of lifestyle behavior change delivered using telehealth and web-based applications with varied support on blood pressure (BP). Methods and Results We conducted a 2-site randomized controlled trial at Geisinger (January 2019-March 2021) to compare the efficacy of 2 remotely delivered strategies using web-based applications in participants with 24-hour systolic BP 120-160 mm Hg and body mass index ≥25 kg/m2. Both arms received access to web-based applications and the same lifestyle guidance per American Heart Association guidelines. One arm received minimal nonclinical staff support, and the other arm received dietitian support with motivational interviewing during weekly calls. The primary outcome was 12-week change in 24-hour systolic BP. A total of 187 participants were randomly assigned, with 156 (83.4%) completing the trial. In both arms, 24-hour systolic BP was reduced at follow-up, but the difference in BP change was not significant (dietitian-led arm, -6.73 mm Hg [95% CI, -8.64 to -4.82]; minimal-support arm, -4.92 [95% CI, -7.01 to -2.77]; P comparing groups=0.2). The dietitian-support arm had greater 12-week improvements in the secondary outcomes sleep systolic BP (mean, -6.92 versus -1.45; P=0.004), sleep diastolic BP (-3.31 versus 0.73; P=0.001), and self-reported physical activity (866 versus -243 metabolic equivalent task minutes per week; P=0.01) and tended to have improvements in weight loss (-5.11 versus -3.89 kg; P=0.1) and Healthy Eating Index-2015 score (9.23 versus 6.43 units; P=0.09). Conclusions Both the dietitian- and minimal-support interventions reduced 24-hour systolic BP similarly, although the dietitian-led intervention led to greater improvements in several secondary cardiometabolic outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03700710.
| S-EPMC9673709 | biostudies-literature
Project description:to test whether an occupation-based lifestyle intervention can sustain and improve the mental well-being of adults aged 65 years or over compared to usual care, using an individually randomised controlled trial.288 independently living adults aged 65 years or over, with normal cognition, were recruited from two UK sites between December 2011 and November 2015.lifestyle Matters is a National Institute for Health and Care Excellence recommended multi-component preventive intervention designed to improve the mental well-being of community living older people at risk of decline. It involves weekly group sessions over 4 months and one to one sessions.the primary outcome was mental well-being at 6 months (mental health (MH) dimension of the SF-36). Secondary outcomes included physical health dimensions of the SF-36, extent of depression (PHQ-9), quality of life (EQ-5D) and loneliness (de Jong Gierveld Loneliness Scale), assessed at 6 and 24 months.data on 262 (intervention = 136; usual care = 126) participants were analysed using intention to treat analysis. Mean SF-36 MH scores at 6 months differed by 2.3 points (95 CI: -1.3 to 5.9; P = 0.209) after adjustments.analysis shows little evidence of clinical or cost-effectiveness in the recruited population with analysis of the primary outcome revealing that the study participants were mentally well at baseline. The results pose questions regarding how preventive interventions to promote well-being in older adults can be effectively targeted in the absence of proactive mechanisms to identify those who at risk of decline.ISRCTN67209155.
| S-EPMC5860501 | biostudies-other
Project description:Although epidemiological research demonstrates that there is an association between lifestyle factors and risk of breast cancer recurrence, progression of disease, and mortality, no comprehensive lifestyle change clinical trials have been conducted to determine if changing multiple risk factors leads to changes in biobehavioral processes and clinical outcomes in women with breast cancer. This article describes the design, feasibility, adherence to the intervention and data collection, and patient experience of a comprehensive lifestyle change clinical trial (CompLife).CompLife is a randomized, controlled trial of a multiple-behavior intervention focusing on diet, exercise, and mind-body practice along with behavioral counseling to support change. The initial exposure to the intervention takes place during the 4 to 6 weeks of radiotherapy (XRT) for women with stage III breast cancer and then across the subsequent 12 months. The intervention group will have 42 hours of in-person lifestyle counseling during XRT (7-10 hours a week) followed by up to 30 hours of counseling via video connection for the subsequent 12 months (weekly sessions for 6 months and then monthly for 6 months). The primary outcome is disease-free survival. Multiple secondary outcomes are being evaluated, including: (1) biological pathways; (2) overall survival; (3) patient-reported outcomes; (4) dietary patterns/fitness levels, anthropometrics, and body composition; and (5) economic outcomes. Qualitative data of the patient experience in the trial is collected from exit interviews, concluding remarks, direct email correspondences, and web postings from patients.Fifty-five patients have been recruited and randomized to the trial to date. Accrual of eligible patients is high (72%) and dropout rates extremely low (5%). Attendance to the in-person sessions is high (95% attending greater than 80% of sessions) as well as to the 30 hours of video counseling (88% attending more than 70% of sessions). Adherence to components of the behavior change intervention is high and compliance with the intensive amount of data collection is exceptional. Qualitative data collected from the participants reveals testimonials supporting the importance of the comprehensive nature of intervention, especially the mind-body/mindfulness component and social support, and meaningful lifestyle transformations.Conducting a comprehensive, multicomponent, lifestyle change clinical trial for women with breast was feasible and collection of biobehavioral outcomes successful. Adherence to behavior change was high and patient experience was overwhelmingly positive.
| S-EPMC5558265 | biostudies-other
Project description:ObjectiveTo determine the effectiveness of an individually-tailored multifactorial intervention in reducing falls among at risk older adult fallers in a multi-ethnic, middle-income nation in South-East Asia.DesignPragmatic, randomized-controlled trial.SettingEmergency room, medical outpatient and primary care clinic in a teaching hospital in Kuala Lumpur, Malaysia.ParticipantsIndividuals aged 65 years and above with two or more falls or one injurious fall in the past 12 months.InterventionIndividually-tailored interventions, included a modified Otago exercise programme, HOMEFAST home hazards modification, visual intervention, cardiovascular intervention, medication review and falls education, was compared against a control group involving conventional treatment.Primary and secondary outcome measuresThe primary outcome was any fall recurrence at 12-month follow-up. Secondary outcomes were rate of fall and time to first fall.ResultsTwo hundred and sixty-eight participants (mean age 75.3 ±7.2 SD years, 67% women) were randomized to multifactorial intervention (n = 134) or convention treatment (n = 134). All participants in the intervention group received medication review and falls education, 92 (68%) were prescribed Otago exercises, 86 (64%) visual intervention, 64 (47%) home hazards modification and 51 (38%) cardiovascular intervention. Fall recurrence did not differ between intervention and control groups at 12-months [Risk Ratio, RR = 1.037 (95% CI 0.613-1.753)]. Rate of fall [RR = 1.155 (95% CI 0.846-1.576], time to first fall [Hazard Ratio, HR = 0.948 (95% CI 0.782-1.522)] and mortality rate [RR = 0.896 (95% CI 0.335-2.400)] did not differ between groups.ConclusionIndividually-tailored multifactorial intervention was ineffective as a strategy to reduce falls. Future research efforts are now required to develop culturally-appropriate and affordable methods of addressing this increasingly prominent public health issue in middle-income nations.Trial registrationISRCTN Registry no. ISRCTN11674947.
| S-EPMC6075745 | biostudies-literature
Project description:Patients with ulcerative colitis suffer from impaired health-related quality of life (HrQoL). Comprehensive lifestyle-modification might increase HrQoL and decrease disease activity. Ninety-seven patients in clinical remission with impaired HrQoL were randomly assigned to a 10 week comprehensive lifestyle-modification program (LSM; n = 47; 50.28 ± 11.90 years) or control (n = 50; 45.54 ± 12.49 years) that received a single workshop of intense training in naturopathic self-help strategies. Primary outcome was HrQoL (Inflammatory Bowel Disease Questionnaire; IBDQ) at week 12. Secondary outcomes included IBDQ subscales; generic HrQoL; disease activity and microbiome. Both groups showed improvement in HrQoL from baseline to post-treatment at week 12. The IBDQ sum score showed no significant group difference (p = 0.251). If patients attended more than 50% of the training sessions, a significant group effect (p = 0.034) was evident in favor of LSM. In addition, the SF-36 mental component summary (p = 0.002) was significantly different between the groups in favor of LSM. Disease activity microbiome and adverse events did not differ. Both a single workshop and a 10-week comprehensive lifestyle-modification program can improve HrQoL in patients with ulcerative colitis in remission with no apparent effects on clinical disease activity. A treatment difference was observed when examining a subsample of patients who attended ≥ 50% of sessions.
| S-EPMC7599849 | biostudies-literature
Project description:Background and aimsHTN affects nearly 50% of U.S. adults and is the leading modifiable cardiovascular risk factor. A healthy diet and exercise can improve BP control, but adherence to these interventions is low. We tested whether a multimodal mind-body program, Mindful Awareness Practices (MAP) could improve BP and lifestyle behaviors associated with HTN when compared to a Health Promotion Program (HPP).MethodsAdults with BP >120/80 were randomized to MAP or HPP. Outcome measurements of BP, self-reported diet, and exercise were analyzed with intent-to-treat group comparisons using repeated measures linear mixed models.ResultsThere was an MAP-HPP between-group difference in interactions of time-by-systolic BP (P = 0.005) and time-by-diastolic BP (P = .003). The mean drops in SBP from baseline to week 13 for the MAP group was 19 mm Hg (138 ± 15 mm Hg-119 ± 6 mm Hg) compared to 7 mm Hg (134 ± 18 mm Hg-127 ± 22 mm Hg) in the HPP group. Similarly, a greater reduction in DBP was observed in the MAP group compared to the HPP group, 12 mm Hg (89 mm Hg ± 11-77 ± 7 mm Hg) and 1 mm Hg (81 ± 16 mm Hg-80 ± 18 mm Hg), respectively. Mediational analysis of the MAP group showed the total effect of mindfulness practice minutes on SBP with indirect effect (ab) of -.057 was significant, resulting in a 40% lower SBP for total effect (c) compared to direct (c') effect alone. The mediational model suggests MAP has a modest positive influence on participants initiating lifestyle behavior change, which partially explains the greater reduction in BP by the MAP group.ConclusionOur findings suggest a multimodal mind-body program involving mindfulness practice may improve BP control in adults with HTN.
| S-EPMC8178963 | biostudies-literature
Project description:BackgroundPrevious studies have suggested that psychological interventions may be effective in reducing blood pressure. Using rigorous methodology and 24-hour monitoring of ambulatory blood pressure, we compared 2 psychological interventions with treatment using a first-line antihypertensive drug in terms of their efficacy in lowering blood pressure in patients with mild primary hypertension.MethodsIn this prospective, open-label randomized controlled trial (RCT), 65 adult patients with mild, uncomplicated hypertension were randomly assigned to receive one of the following interventions for 12 weeks: (1) pharmacotherapy with hydrochlorothiazide 12.5 titrated to 25 mg/d ; (2) individualized behavioural psychotherapy, consisting of ten 1-hour sessions of stress reduction training with a psychologist; or (3) self-help psychotherapy, consisting of a 1.5-hour session with a psychologist and then daily sessions that involved reading a self-help manual and listening to an audiotape. The primary outcome measure was mean change in ambulatory blood pressure from baseline to week 12. Resting blood pressure readings were taken in the clinic, and adverse events were recorded.ResultsMonitoring of ambulatory blood pressure over 24 hours showed that hydrochlorothiazide therapy significantly reduced both systolic and diastolic blood pressure relative to baseline, and that this reduction was significantly greater than that achieved with either individualized behavioural psychotherapy or self-help psychotherapy (mean reduction [standard error; SE] -11.03 [2.53] / -6.06 [1.56] mm Hg v. -0.08 [2.38] / 0.29 [1.47] mm Hg v. -1.23 [2.83] / -0.71 [1.75] mm Hg, respectively; p = 0.01). Neither form of psychological therapy significantly lowered 24-hour ambulatory blood pressure relative to baseline.ConclusionFor patients with primary elevated blood pressure, 2 psychological interventions did not lower 24-hour ambulatory blood pressure, whereas hydrochlorothiazide reduced blood pressure, as expected. The findings of this RCT represent an important addition to the evidence for health care practitioners and for patients seeking psychological interventions to reduce blood pressure.
| S-EPMC2765772 | biostudies-literature
Project description:BackgroundThe purpose of this study was to assess the effectiveness of a multifactorial intervention to reduce falls among the oldest-old people, including individuals with cognitive impairment or comorbidities.MethodsA randomized, single-blind, parallel-group clinical trial was conducted from January 2009 to December 2010 in seven primary health care centers in Baix Llobregat (Barcelona). Of 696 referred people who were born in 1924, 328 were randomized to an intervention group or a control group. The intervention model used an algorithm and was multifaceted for both patients and their primary care providers. Primary outcomes were risk of falling and time until falls. Data analyses were by intention-to-treat.ResultsSixty-five (39.6%) subjects in the intervention group and 48 (29.3%) in the control group fell during follow-up. The difference in the risk of falls was not significant (relative risk 1.28, 95% confidence interval [CI] 0.94-1.75). Cox regression models with time from randomization to the first fall were not significant. Cox models for recurrent falls showed that intervention had a negative effect (hazard ratio [HR] 1.46, 95% CI 1.03-2.09) and that functional impairment (HR 1.42, 95% CI 0.97-2.12), previous falls (HR 1.09, 95% CI 0.74-1.60), and cognitive impairment (HR 1.08, 95% CI 0.72-1.60) had no effect on the assessment.ConclusionThis multifactorial intervention among octogenarians, including individuals with cognitive impairment or comorbidities, did not result in a reduction in falls. A history of previous falls, disability, and cognitive impairment had no effect on the program among the community-dwelling subjects in this study.
| S-EPMC3940644 | biostudies-literature