Factors associated with non-participation and drop-out in a lifestyle intervention for workers with an elevated risk of cardiovascular disease

Background  

Non-response and drop-out are problems that are commonly encountered in health promotion trials. Understanding the health-related characteristics of non-participants and drop-outs and the reasons for non-participation and drop-out may be beneficial for future intervention trials.     

A randomized trial of lifestyle intervention in primary healthcare for the modification of cardiovascular risk factors

AIMS: To evaluate the effects of a lifestyle intervention programme in primary healthcare, targeted to patients with moderate to high risk of cardiovascular disease in terms of cardiovascular risk factors, physical activity, and quality of life. METHOD: Randomized controlled trial with one-year follow-up, carried out in a primary healthcare centre in Northern Sweden. A total of 151 middle-aged men and women, with hypertension, dyslipidemia, type 2 diabetes, or obesity were enrolled. The subjects were randomized to either the intervention (n = 75) or the control group (n = 76). A total of 123 subjects completed the one-year follow-up. Interventions: Exercise: supervised endurance and circuit training in groups three times a week for three months. Diet: five group sessions of diet counselling with a dietitian. Follow- up meetings with a physiotherapist were conducted monthly thereafter. Primary outcomes were changes in anthropometry, maximal oxygen uptake, health-related quality of life, and self-reported physical activity. The secondary outcomes were changes in blood pressure and metabolic variables. RESULTS: After one year the intervention group significantly increased maximal oxygen uptake, physical activity, and quality of life and significantly decreased body weight, waist and hip circumference, body mass index, waist-hip ratio, systolic and diastolic blood pressure, triglycerides, and glycosylated haemoglobin. There were significant differences between groups, mean changes (and their 95% confidence intervals, CI) in waist circumference -1.9 cm (-2.80 to -0.90; p<0.001), in waist-hip ratio -0.01 (-.02 to -0.004; p<0.01) and in diastolic blood pressure -2.3 mmHg (-4.04 to -0.51; p<0.05). CONCLUSION: A prevention programme in primary healthcare with a focus on physical activity and diet counselling followed by structured follow-up meetings can favourably influence several risk factors for cardiovascular diseases and quality of life in high-risk subjects for at least one year.     

Design of a RCT evaluating the (cost-) effectiveness of a lifestyle intervention for male construction workers at risk for cardiovascular disease: The Health under Construction study

Background  

Of all workers in Dutch construction industry, 20% has an elevated risk of cardiovascular disease (CVD). A major risk factor for CVD risk is an unhealthy lifestyle. The aim of our study is to design a lifestyle intervention for construction workers with an elevated CVD risk, and to evaluate its (cost-) effectiveness.     

A lifestyle program for treated hypertensives improved health-related behaviors and cardiovascular risk factors, a randomized controlled trial

OBJECTIVE: To assess effects of a cognitively based program on health-related behaviors and cardiovascular risk factors in overweight drug-treated hypertensives. STUDY DESIGN AND SETTING: In a clinical trials center, volunteers, recruited by advertisement, were randomized to usual care (N=118) or to a 4-month program (N=123) incorporating weight loss; a low-sodium diet, high in fruit, vegetables, and fish; and increased physical activity. Diet, physical activity, weight, blood lipids, glucose, and insulin were measured at 4 and 16 months. RESULTS: Ninety-eight usual care and 106 program participants completed the 4-month assessment; 90 and 102, respectively, completed follow-up. Using intention-to-treat analysis, relative to usual care, net changes with the program at 4 months were as follows: dietary fat (-2.6% energy; P<0.001); sodium (-290mg/d; P=0.004); energy (-313mJ/d; P=0.005); fish (+2.1 serves/wk; P<0.001); vegetables (+3.0 serves/wk; P<0.001); physical activity (+37min/wk; P=0.004); weight (-2.8kg; P<0.001); waist girth (-3.1cm; P<0.001); total cholesterol (-0.2mmol/L; P=0.017); and triacylglycerols (-0.12mmol/L; P=0.002). One year later, net changes included dietary fat (-2.2% energy; P<0.001); sodium (-150mg/d; P=0.029); fish (+2.0 serves/wk; P<0.001); vegetables (+4.3 serves/wk; P<0.001); weight (-2.5kg; P=0.001); waist girth (-3.1cm; P<0.001); high-density lipoprotein cholesterol (+0.03mmol/L; P=0.031). CONCLUSION: Improvements in behaviors and risk factors, several maintained long term, suggest the potential for long-term benefits in hypertensives.     

A worksite prevention program for construction workers: design of a randomized controlled trial

Background  

A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program compared with usual care for construction workers.     

The effects of a lifestyle intervention on leisure-time sedentary behaviors in adults at risk: The Hoorn Prevention Study,a randomized controlled trial

Objective

This study set out to assess the short- and long-term effects of a primary care-based lifestyle intervention on different domains of leisure-time sedentary behaviors in Dutch adults at risk of type 2 diabetes and cardiovascular diseases.

Methods

Between 2007 and 2009, adults (n = 622) at risk were randomly assigned to a counseling intervention aimed at adopting healthy lifestyle behaviors, or a control group that only received health brochures. Follow-up measures were done after 6, 12 and 24 months. Linear regression analysis was used to examine between-group differences in self-report minutes per day sedentary behaviors, adjusted for baseline values. Stratified analyses were performed for sex and educational attainment.

Results

Seventy-nine percent (n = 490) of participants completed the last follow-up. Mean baseline sedentary behaviors were 254.6 min per day (SD = 136.2). Intention-to-treat analyses showed no significant differences in overall or domain-specific sedentary behaviors between the two groups at follow-up. Stratified analyses for educational attainment revealed a small and temporary between-group difference in favor of the intervention group, in those who finished secondary school.

Conclusions

A primary care-based general lifestyle intervention was not more effective in reducing leisure-time sedentary behaviors than providing brochures in adults at risk for chronic diseases.     

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.     

Home-based lifestyle intervention for rural adults improves metabolic syndrome parameters and cardiovascular risk factors: A randomised controlled trial

The presence of metabolic syndrome (MetS) increases the risk of developing type 2 diabetes and cardiovascular disease. Targeted interventions to reduce MetS for high risk populations are crucial for the prevention of these chronic diseases. This study evaluated the effectiveness of a 6-month home-based physical activity and diet intervention for rural adults with, or at risk of MetS. The randomised controlled trial was conducted in Albany and surrounding towns, Western Australia, 2014–2015. Participants were screened for MetS using the International Diabetes Federation criteria, and eligible participants were randomly assigned to the intervention (n = 201) or control (n = 200) group. The intervention group received printed and online programme materials and motivational support, and the control group was waitlisted to receive the programme after post-test data collection. Anthropometry, lipid profiles, glycaemic status, and blood pressure were measured at baseline and 6-months post-test. In total, 312 (77.8%) participants completed post-test data collection and were included in the anthropometric analysis, and 274 (68.3%) participants were included in the blood sample analysis. After controlling for confounders, the intervention group significantly improved their triglyceride (− 0.10 mM, p = 0.002), total cholesterol (− 0.09 mM, p = 0.02), and non-HDL cholesterol (− 0.08 mM, p = 0.02) concentrations compared to the control group. Waist circumference (− 2.11 cm, p = 0.03), waist-to-hip ratio (− 0.01, p = 0.04), weight (− 0.70 kg, p = 0.01), and body mass index (− 0.20 kg/m², p < 0.001) were also improved. These findings suggest that comprehensive home-based prevention programmes that include a combination of dietary and physical activity interventions are a promising means to prevent the onset of chronic disease in rural adults.Trial registration:anzctr.org.au Identifier: ACTRN12614000512628     

An occupational health intervention programme for workers at risk for early retirement; a randomised controlled trial

Aims: To evaluate an occupational health intervention programme for workers at risk for early retirement.

Methods: Between April 1997 and May 1998, 116 employees of a large company who were older than 50 years indicated that they would not be able to work up to their retirement. They were randomly assigned to an intervention (n = 61) or control group (n = 55). The intervention programme lasted six months and was executed by an occupational physician. Job position and number of sick leave days after two years were collected from the company's computer database. A questionnaire was sent to the employees at baseline, after six months, and after two years; it included the Work Ability Index, the Utrecht Burn Out Scale, and the Nottingham Health Profile measuring quality of life.

Results: Fewer employees (11%) in the intervention group retired early than in the control group (28%). The total average number of sick leave days in two years was 82.3 for the intervention group and 107.8 for the control group. Six months after baseline, employees in the intervention group had better work ability, less burnout, and better quality of life than employees in the control group. Two years after randomisation no differences between the two groups were found.

Conclusions: This occupational health intervention programme proved to be a promising intervention in the prevention of early retirement.

     

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.     

Cost-effectiveness of an activating intervention by social workers for patients with minor mental disorders on sick leave: a randomized controlled trial

BACKGROUND: Sickness absence often occurs in patients with emotional distress or minor mental disorders. In several European countries, these patients are over-represented among those receiving illness benefits, and interventions are needed. The aim of this study was to evaluate the cost-effectiveness of an intervention conducted by social workers, designed to reduce sick leave duration in patients absent from work owing to emotional distress or minor mental disorders. METHODS: In this Randomized Controlled Trial, patients were recruited by GPs. The intervention group (N = 98) received an activating, structured treatment by social workers, the control group (N = 96) received routine GP care. Sick leave duration, clinical symptoms, and medical consumption (consumption of medical staffs' time as well as consumption of drugs) were measured at baseline and 3, 6, and 18 months later. RESULTS: Neither for sick leave duration nor for clinical improvement over time were significant differences found between the groups. Also the associated costs were not significantly lower in the intervention group. CONCLUSIONS: Compared with usual GP care, the activating social work intervention was not superior in reducing sick leave duration, improving clinical symptoms, and decreasing medical consumption. It was also not cost-effective compared with GP routine care in the treatment of minor mental disorders. Therefore, further implementation of the intervention is not justified. Potentially, programmes aimed at reducing sick leave duration in patients with minor mental disorders carried out closer to the workplace (e.g. by occupational physicians) are more successful than programmes in primary care.     

Stage-matched nutrition guidance for patients at elevated risk for cardiovascular disease: a randomized intervention study in family practice

OBJECTIVE: To examine stage-matched nutrition counseling by family physicians and its effect on dietary intake, anthropometry, and serum lipid levels in patients at elevated risk for cardiovascular disease. METHODS: In this controlled trial, patients randomized to intervention practices received nutrition information following the Stages-of-Change Model, and patients randomized to control practices received usual care. RESULTS: At both 6 and 12 months after baseline, total fat intake and saturated fat intake declined significantly more in the intervention group than in the control group: -5.7% and -2.6% of energy, respectively, at 6 months, and -3.6% and -1.7% of energy, respectively, at 12 months. For energy intake, body weight, and BMI, there were significant differences between groups only at 6 months: -0.8 megajoules (MJ), -0.7 kg, and -0.3 kg/m(2), respectively. None of the serum lipid values changed significantly between groups at 12 months. CONCLUSIONS: Nutritional counseling based on stages of change led to reductions in dietary fat intake and weight loss in the short term. However, we found no corresponding changes in serum lipid concentrations.     

Smart wearable devices as a psychological intervention for healthy lifestyle and quality of life: a randomized controlled trial

Quality of Life Research - Creating a healthy lifestyle is important across different life stages. Commercial smart wearable devices are an innovative and interesting approach as an early...     

Home-based exercise for middle-aged Chinese at diabetic risk: a randomized controlled trial

Objective

To evaluate short- (3 months) and long-term (9 months) effects of home-based exercise on adiponectin, exercise behavior and metabolic risk factors in middle-aged adults at diabetic risk.

Methods

One hundred and thirty-five middle-aged adults (38 men, 97 women) with at least one diabetic risk factor were randomly assigned to either a home-based exercise group (Ex-group) or a usual care group (C-group). Outcome measures included plasma adiponectin, exercise self-efficacy, physical activity, and metabolic risk factors, as follows: insulin levels, insulin resistance by homeostasis model assessment (HOMA-IR), physical fitness, and components of metabolic syndrome. This study was conducted in metropolitan Taipei from 2004 to 2005.

Results

The Ex-group had improvements in exercise self-efficacy (+ 2.5, p = 0.01), body mass index (BMI) (− 0.6 kg/m², p < 0.001) and flexibility (+ 2.4 cm, p < 0.001) at 3-month follow-up and maintained BMI and flexibility at 9-month follow-up. The Ex-group exhibited significantly increased physical activity while the C-group exhibited decreased physical activity at 9-month follow-up (p < 0.001). No intervention effect was found on adiponectin (p = 0.64) or other outcome measures over time.

Conclusions

Home-based exercise did not improve adiponectin levels, but significantly improved exercise behavior, and certain metabolic risk factors, with the effects maintained for 9-months in subjects with type 2 diabetic risk.     

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.