Comparative effectiveness of lifestyle interventions on cardiovascular risk factors among a Dutch overweight working population: A randomized controlled trial

Background  

Overweight (Body Mass Index [BMI] ≥ 25 kg/m²) and obesity (BMI≥ 30 kg/m²) are associated with increased cardiovascular risk, posing a considerable burden to public health. The main aim of this study was to investigate lifestyle intervention effects on cardiovascular risk factors in healthy overweight employees.     

Brisk walking, fitness, and cardiovascular risk: a randomized controlled trial in primary care

STUDY OBJECTIVE: To examine the effects of 30 min of self-paced, non-supervised, brisk walking, 5 days per week on the health and fitness of people aged 50-65 years. DESIGN: Randomized controlled trial. Members of the intervention group (n = 21) were directed to walk briskly for 30 min, 5 days per week, for 12 weeks. Individuals were given the choice to complete the 30 min of walking in one session or in shorter bouts of no less than 10 min. They were asked to record in a diary the time spent walking and the number of steps taken during a single walk using a pedometer. Participants in the control group (n = 10) were asked to maintain their habitual lifestyle and not change their activity or dietary habits. Measurements of body mass index (BMI), waist/hip ratio (WHR), blood pressure, functional capacity, total cholesterol, triglyceride, and lipoprotein subfractions were taken before and after the program. Changes in 10-year risk estimate for coronary heart disease and stroke were calculated using Framingham risk equations. SETTING: Three urban general practices patients: 31 healthy, sedentary 50- to 65-year-old participants recruited following contact by their general practitioner. MAIN RESULTS: The mean time spent walking by the intervention group was 27.72 (+/-9.79) min/day: their adherence to the protocol was 90.3%. Significant decreases in systolic and diastolic blood pressure, reduction in stroke risk, and increased functional capacity were found within the walking group between baseline and 12-week measurements. No changes were found in these parameters within the control group. Significant reductions in 10-year risk of CHD were observed in both groups. No significant changes were found in lipid levels or anthropometric measurements in either group. CONCLUSIONS: The study provides evidence for the benefit to fitness and cardiovascular risk of the "30-min brisk walking, 5 days a week" message to people aged 50-65 years who participated in an unsupervised home-based walking program. Further study to overcome the problem of poor recruitment and determine the minimum effective dose of exercise to improve cardiovascular risk prediction scores is required.     

Absolute cardiovascular disease risk and shared decision making in primary care: a randomized controlled trial

PURPOSE We wanted to determine the effect of promoting the effective communication of absolute cardiovascular disease (CVD) risk and shared decision making through disseminating a simple decision aid for use in family practice consultations.METHODS The study was based on a pragmatic, cluster randomized controlled trial (phase III) with continuing medical education (CME) groups of family physicians as the unit of randomization. In the intervention arm, 44 physicians (7 CME groups) consecutively recruited 550 patients in whom cholesterol levels were measured. Forty-seven physicians in the control arm (7 CME groups) similarly included 582 patients. Four hundred sixty patients (83.6%) of the intervention arm and 466 patients (80.1%) of the control arm were seen at follow-up. Physicians attended 2 interactive CME sessions and received a booklet, a paper-based risk calculator, and individual summary sheets for each patient. Control physicians attended 1 CME-session on an alternative topic. Main outcome measures were patient satisfaction and participation after the index consultation, change in CVD risk status, and decisional regret at 6 months’ follow-up.RESULTS Intervention patients were significantly more satisfied with process and result (Patient Participation Scale, difference 0.80, P<.001). Decisional regret was significantly lower at follow-up (difference 3.39, P = .02). CVD risk decreased in both groups without a significant difference between study arms.CONCLUSION A simple transactional decision aid based on calculating absolute individual CVD risk and promoting shared decision making in CVD prevention can be disseminated through CME groups and may lead to higher patient satisfaction and involvement and less decisional regret, without negatively affecting global CVD risk.     

Improving patient adherence to lifestyle advice (IMPALA): a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol)

Background  

Many patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on diet, physical exercise, smoking and alcohol, have moderate, but potentially relevant effects in these patients, adherence to lifestyle advice in general practice is not optimal. The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics. The aim of this paper is to describe the design and methods of a study to evaluate an intervention aimed at involving patients in cardiovascular risk management.     

The use of text messaging to improve attendance in primary care: a randomized controlled trial

BACKGROUND: Non-attendance is common in primary care and previous studies have reported that reminders were useful in reducing broken appointments. OBJECTIVE: To determine the effectiveness of a text messaging reminder in improving attendance in primary care. DESIGN: Multicentre three-arm randomized controlled trial. SETTING: Seven primary care clinics in Malaysia. Participants. Patients (or their caregivers) who required follow-up at the clinics between 48 hours and 3 months from the recruitment date. Interventions. Two intervention arms consisted of text messaging and mobile phone reminders 24-48 hours prior to scheduled appointments. Control group did not receive any intervention. Outcome measures. Attendance rates and costs of interventions. RESULTS: A total of 993 participants were eligible for analysis. Attendance rates of control, text messaging and mobile phone reminder groups were 48.1, 59.0 and 59.6%, respectively. The attendance rate of the text messaging reminder group was significantly higher compared with that of the control group (odds ratio 1.59, 95% confidence interval 1.17 to 2.17, P = 0.005). There was no statistically significant difference in attendance rates between text messaging and mobile phone reminder groups. The cost of text messaging reminder (RM 0.45 per attendance) was lower than mobile phone reminder (RM 0.82 per attendance). CONCLUSIONS: Text messaging reminder system was effective in improving attendance rate in primary care. It was more cost-effective compared with the mobile phone reminder.     

Community pharmacist intervention in depressed primary care patients (PRODEFAR study): randomized controlled trial protocol

Background  

Treatment of depression, the most prevalent and costly mental disorder, needs to be improved. Non-concordance with clinical guidelines and non-adherence can limit the efficacy of pharmacological treatment of depression. Through pharmaceutical care, pharmacists can improve patients' compliance and wellbeing. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a community pharmacist intervention developed to improve adherence and outcomes of primary care patients with depression.     

Sexual risk avoidance and sexual risk reduction interventions for middle school youth: a randomized controlled trial

PurposeTo evaluate the efficacy of two, theory-based, multimedia, middle school sexual education programs in delaying sexual initiation.MethodsThree-armed, randomized controlled trial comprising 15 urban middle schools; 1,258 predominantly African American and Hispanic seventh grade students followed into ninth grade. Both programs included group and individualized, computer-based activities addressing psychosocial variables. The risk avoidance (RA) program met federal abstinence education guidelines; the risk reduction (RR) program emphasized abstinence and included computer-based condom skills-training. The primary outcome assessed program impact on delayed sexual initiation; secondary outcomes assessed other sexual behaviors and psychosocial outcomes.ResultsParticipants were 59.8% females (mean age: 12.6 years). Relative to controls, the RR program delayed any type of sexual initiation (oral, vaginal, or anal sex) in the overall sample (adjusted odds ratio [AOR]: .65, 95% CI: .54–.77), among females (AOR: .43, 95% CI: .31–.60), and among African Americans (AOR: .38, 95% CI: .18–.79). RR students also reduced unprotected sex at last intercourse (AOR: .67, 95% CI: .47–.96), frequency of anal sex in the past 3 months (AOR: .53, 95% CI: .33–.84), and unprotected vaginal sex (AOR: .59, 95% CI: .36–.95). The RA program delayed any sexual initiation among Hispanics (AOR: .40, 95% CI: .19–.86), reduced unprotected sex at last intercourse (AOR: .70, 95% CI: .52–.93), but increased the number of recent vaginal sex partners (AOR: 1.69, 95% CI: 1.01–2.82). Both programs positively affected psychosocial outcomes.ConclusionsThe RR program positively affected sexually inexperienced and experienced youth, whereas the RA program delayed initiation among Hispanics and had mixed effects among sexually experienced youth.     

Low-literacy interventions to promote discussion of prostate cancer: a randomized controlled trial

BACKGROUND: Professional organizations recommend that physicians discuss prostate cancer with patients to make individual screening decisions. However, few studies have tested strategies to encourage such discussions, particularly among high-risk populations. We examined the effects of two low-literacy interventions on the frequency of prostate cancer discussion and screening. DESIGN: Randomized, blinded, controlled trial with concealed allocation. SETTING/PARTICIPANTS: Inner-city primary care clinic, serving a predominately African-American population. Participants were men aged 45-70 with no history of prostate cancer, presenting for a regular appointment. INTERVENTIONS: While waiting to see their physician, patients received a patient education handout on prostate cancer screening (PtEd), a handout simply encouraging patients to talk to their doctor about prostate cancer (Cue), or a control handout. The interventions did not advocate for or against screening. MEASURES: Patient-reported discussion of prostate cancer with the physician and chart reviews determine prostate-specific antigen (PSA) test orders and performance of digital rectal examination (DRE). Adjusted odds ratios (aOR) and 95% confidence intervals (CI) were computed. Data were collected in 2003, and analyses were completed in 2006. RESULTS: Most of the 250 subjects (90.4%) were African American and 78.8% read below the ninth grade level. Overall, 48.4% reported discussing prostate cancer during the appointment. Compared to the control group (37.3%), discussions were significantly more common in the Cue group (58.0%, aOR=2.39 [1.26-4.52]), as well as in the PtEd group (50.0%, aOR=1.92 [1.01-3.65]). When prostate cancer was discussed, patients in the intervention groups more commonly initiated the conversation (47.6% PtEd and 40.0% Cue, vs 9.7% control, p<0.01 for each comparison to control). Compared to the control group (2.4%), PSA test orders increased in the PtEd group (14.1%, aOR=7.62 [1.62-35.83]) and in the Cue group (12.3%, aOR=5.86 [1.24-27.81]). Documentation of DRE did not change significantly (4.7% PtEd, 6.2% Cue, and 6.0% control). CONCLUSIONS: Two simple low-literacy interventions significantly increased discussion of prostate cancer and PSA test orders but not performance of DRE. Both interventions were effective in empowering low-literacy patients to initiate conversations about prostate cancer with their physician.     

Evaluation of a community-based randomized controlled prenatal care trial in rural China

Background  

A community-based randomized control prenatal care trial was performed in a rural county of China during 2000-2003. The purpose of this paper is to describe the trial implementation and the impact of the trial on the utilization of prenatal care and perinatal outcomes.     

正式发布死亡率呈平台期走势

目的分析社区高血压细节管理对社区高血压患者血压控制的效果及其影响因素,为完善社区高血压细节管理模式提供依据。方法按照入选标准,选取400例上海市枫林社区当年新发现的原发性高血压患者,随机分为干预组和对照组,每组200人。干预组采用群体健康教育和个性化指导相结合的方式进行管理,对照组采取常规的高血压分组管理。在干预前(2007年1月)和干预后(2015年1月)比较两组的血压控制情况。结果干预后,干预组的平均收缩压(SBP)和平均舒张压(DBP)较对照组分别低8.03 mmHg和6.55 mmHg,差异均有统计学意义(P < 0.01)。在血压达标率、危险分层及服药依从性方面干预组均优于对照组(P值均 < 0.05);影响血压控制效果的主要因素为性别、体质指数、高盐膳食和吸烟。结论上海市社区高血压疾病细节管理对高血压患者的血压控制效果显著,是促进高血压患者血压稳定的有效途径。     

Cost-utility analysis of osteopathy in primary care: results from a pragmatic randomized controlled trial

BACKGROUND: Spinal pain is common and costly to health services and society. Management guidelines have encouraged primary care referral for spinal manipulation, but the evidence base is weak. More economic evaluations alongside pragmatic trials have been recommended. OBJECTIVE: Our aim was to assess the cost-utility of a practice-based osteopathy clinic for subacute spinal pain. METHODS: A cost-utility analysis was performed alongside a pragmatic single-centre randomized controlled trial in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. Patients with back pain of 2-12 weeks duration were randomly allocated to treatment with osteopathy plus usual GP care or usual GP care alone. Costs were measured from a National Health Service (NHS) perspective. All primary and secondary health care interventions recorded in GP notes were collected for the study period. We calculated quality adjusted life year (QALY) gains based on EQ-5D responses from patients in the trial, and then cost per QALY ratios. Confidence intervals (CIs) were estimated using non-parametric bootstrapping. RESULTS: Osteopathy plus usual GP care was more effective but resulted in more health care costs than usual GP care alone. The point estimate of the incremental cost per QALY ratio was 3560 pounds (80% CI 542 pounds-77,100 pounds). Sensitivity analysis examining spine-related costs alone and total costs excluding outliers resulted in lower cost per QALY ratios. CONCLUSION: A primary care osteopathy clinic may be a cost-effective addition to usual GP care, but this conclusion was subject to considerable random error. Rigorous multi-centre studies are needed to assess the generalizability of this approach.     

Corticosteroid injections for greater trochanteric pain syndrome: a randomized controlled trial in primary care

PURPOSE We undertook a study to evaluate the effectiveness of corticosteroid injections in primary care patients with greater trochanteric pain syndrome (GTPS).METHODS We evaluated the effect of corticosteroid injections compared with expectant treatment (usual care) in a pragmatic, multicenter, open-label, randomized clinical trial in the Netherlands. Patients (aged 18 to 80 years) with GTPS visiting 81 participating primary care physicians were randomly allocated to receive either local corticosteroid injections (n = 60) or usual care (n = 60). Primary outcomes of pain severity (numerical rating scale 0 to 10) and recovery (yes or no total or major recovery) were evaluated at 3-month and 12-month follow-up visits. Adverse events were collected at 6 weeks.RESULTS At the 3-month follow-up visit, 34% of the patients in the usual care group had recovered compared with 55% in the injection group (adjusted OR = 2.38; 95% CI, 1.14–5.00, number needed to treat = 5). Pain severity at rest and on activity decreased in both groups, but the decrease was greater in the injection group, for an adjusted difference in pain at rest of 1.18 (95% CI, 0.31–2.05) and in pain with activity of 1.30 (95% CI, 0.32–2.29). At the 12-month follow-up, 60% of the patients in the usual care group had recovered compared with 61% in the injection group (OR = 1.05; 95% CI, 0.50–2.27). Pain severity at rest and on activity decreased in both groups and the 12-month follow-up showed no significant differences, with adjusted differences of 0.14 (95% CI, −0.75 to 1.04) for pain at rest and 0.45 (95% CI, −0.55 to 1.46) for pain with activity. Aside from a short period with superficial pain at the site of the injection, no differences in adverse events were found.CONCLUSION In this first randomized controlled trial assessing the effectiveness of corticosteroid injections vs usual care in GTPS, a clinically relevant effect was shown at a 3-month follow-up visit for recovery and for pain at rest and with activity. At a 12-month follow-up visit, the differences in outcome were no longer present.     

Changes in cognitive measures associated with a lifestyle program for treated hypertensives: a randomized controlled trial (ADAPT)

Cognitive changes are reported infrequently in programs targetingcardiovascular risk. We examined self-efficacy, behavioral barriersand health beliefs in a lifestyle program for drug-treated hypertensivesthat aimed to reduce blood pressure, antihypertensive drug needsand cardiovascular risk. In a randomized controlled trial, wecompared usual care (controls) and a 4-month program focusingon weight loss, diet and exercise. Outcomes were assessed atbaseline, 4 months and 1-year follow-up. Of 241 individualsrandomized, 102/123 in the program and 90/118 of controls completedfollow-up. In the program group, dietary barriers fell by 14%at 4 months (controls 2%, P = 0.025) and by 8% at follow-up(controls 3%, P = 0.010). Exercise barriers fell by 11% at 4months (controls 3%, P = 0.020) and 17% (controls 4%, P = 0.002)at follow-up. Dietary self-efficacy improved by 3% at 4 months(controls –1%, P = 0.003) and by 2% at follow-up (controls–1%, P = 0.051). Exercise self-efficacy increased by 8%at 4 months (controls 3%, P < 0.001) and by 5% at follow-up(controls 3%, P = 0.130). Changes in cognitive variables predictedchanges in health-related behaviors at 4 months and follow-up.A cognitively based lifestyle program in treated hypertensivesis associated with improvements in cognitive measures in theshorter and longer term. Received on March 8, 2007; accepted on March 27, 2007     

A randomized controlled trial comparing community lifestyle interventions to improve adherence to diet and physical activity recommendations: the VitalUM study

European Journal of Epidemiology - Worldwide, adherence to national guidelines for physical activity (PA), and fruit and vegetable consumption is recommended to promote health and reduce the risk...     

Collaborative stepped care for anxiety disorders in primary care: aims and design of a randomized controlled trial

Background  

Panic disorder (PD) and generalized anxiety disorder (GAD) are two of the most disabling and costly anxiety disorders seen in primary care. However, treatment quality of these disorders in primary care generally falls beneath the standard of international guidelines. Collaborative stepped care is recommended for improving treatment of anxiety disorders, but cost-effectiveness of such an intervention has not yet been assessed in primary care. This article describes the aims and design of a study that is currently underway. The aim of this study is to evaluate effects and costs of a collaborative stepped care approach in the primary care setting for patients with PD and GAD compared with care as usual.     

Moderators and mediators of behaviour change in a lifestyle program for treated hypertensives: a randomized controlled trial (ADAPT)

We aimed to examine moderators and mediators of behaviour change in a cognitive lifestyle program for drug-treated overweight hypertensives in Perth, Australia. We collected data at baseline, 4 months (post-intervention) and 1-year follow-up in a randomized controlled trial of a program that focused on weight loss, diet, and exercise. Mediation analysis used regression models that estimate indirect effects with bootstrapped confidence limits. Outcomes examined were saturated fat intake (% energy) and physical activity (hours per week). In total, 90/118 individuals randomized to usual care and 102/123 to the program-completed follow-up. Sex was a moderator of response post-intervention for diet and physical activity, with a greater response among women with usual care and among men with the program. Change in self-efficacy was a mediator of dietary change post-intervention [effect size (ES) -0.055, 95% confidence interval (CI) -0.125, -0.005] and at follow-up (ES 0.054, 95% CI -0.127, -0.005), and in physical activity post-intervention (ES 0.059, 95% CI 0.003, 0.147). These findings highlight different responses of men and women to the program, and the importance of self-efficacy as a mediator. Mediators for physical activity in the longer term should be investigated in other models, with appropriate cognitive measurements, in future trials.     

Advising people to take more exercise is ineffective: a randomized controlled trial of physical activity promotion in primary care

BACKGROUND: Over the last 10 years 'exercise referral schemes' have been popular even though the evidence for effectiveness of any one-to-one intervention in primary care is deficient. We report the results of a primary care based one-to-one intervention that compared the effect of two communication styles with a no-intervention control group on self-reported physical activity at 12 months. METHODS: In all, 1658 middle-aged men and women were randomly assigned to 30 minutes of brief negotiation or direct advice in primary care or a no-intervention control group. The main outcome was self-reported physical activity at 12 months. Secondary outcome measures included change in blood pressure and body mass index. RESULTS: Intention-to-treat analysis revealed no significant differences in physical activity between groups. Brief negotiation group participants who completed the study increased their physical activity significantly more than controls. There was no change in body mass index in any group. The brief negotiation group produced a greater reduction in diastolic blood pressure than direct advice. CONCLUSION: If patients whose health may benefit from increased physical activity seek advice in primary care, 20-30 minutes of brief negotiation to increase physical activity is probably more effective than similar attempts to persuade or coerce. However, blanket physical activity promotion in primary care is not effective. The most effective way of increasing physical activity in primary care has yet to be determined.