Factors influencing participation in a vascular disease prevention lifestyle program among participants in a cluster randomized trial

Background
Previous research suggests that lifestyle intervention for the prevention of diabetes and cardiovascular disease (CVD) are effective, however little is known about factors affecting participation in such programs. This study aims to explore factors influencing levels of participation in a lifestyle modification program conducted as part of a cluster randomized controlled trial of CVD prevention in primary care.

Methods
This concurrent mixed methods study used data from the intervention arm of a cluster RCT which recruited 30 practices through two rural and three urban primary care organizations. Practices were randomly allocated to intervention (n = 16) and control (n = 14) groups. In each practice up to 160 eligible patients aged between 40 and 64 years old, were invited to participate. Intervention practice staff were trained in lifestyle assessment and counseling and referred high risk patients to a lifestyle modification program (LMP) consisting of two individual and six group sessions over a nine month period. Data included a patient survey, clinical audit, practice survey on capacity for preventive care, referral and attendance records at the LMP and qualitative interviews with Intervention Officers facilitating the LMP. Multi-level logistic regression modelling was used to examine independent predictors of attendance at the LMP, supplemented with qualitative data from interviews with Intervention Officers facilitating the program.

Results
A total of 197 individuals were referred to the LMP (63% of those eligible). Over a third of patients (36.5%) referred to the LMP did not attend any sessions, with 59.4% attending at least half of the planned sessions. The only independent predictors of attendance at the program were employment status - not working (OR: 2.39 95% CI 1.15-4.94) and having high psychological distress (OR: 2.17 95% CI: 1.10-4.30). Qualitative data revealed that physical access to the program was a barrier, while GP/practice endorsement of the program and flexibility in program delivery facilitated attendance.

Conclusion
Barriers to attendance at a LMP for CVD prevention related mainly to external factors including work commitments and poor physical access to the programs rather than an individuals’ health risk profile or readiness to change. Improving physical access and offering flexibility in program delivery may enhance future attendance. Finally, associations between psychological distress and attendance rates warrant further investigation.

Implementing guidelines to routinely prevent chronic vascular disease in primary care: the preventive evidence into practice cluster randomised controlled trial

Objective: To evaluate an intervention to improve implementation of guidelines for the prevention of chronic vascular disease. Setting: 32 urban general practices in 4 Australian states. Randomisation: Stratified randomisation of practices. Participants: 122 general practitioners (GPS) and practice nurses (PNs) were recruited at baseline and 97 continued to 12 months. 21 848 patient records were audited for those aged 40-69 years who attended the practice in the previous 12 months without heart disease, stroke, diabetes, chronic renal disease, cognitive impairment or severe mental illness. Intervention: The practice level intervention over 6 months included small group training of practice staff, feedback on audited performance, practice facilitation visits and provision of patient education and referral information. Outcome measures: Primary: 1. Change in proportion of patients aged 40-69 years with smoking status, alcohol intake, body mass index (BMI), waist circumference (WC), blood pressure (BP) recorded and for those aged 45-69 years with lipids, fasting blood glucose and cardiovascular risk in the medical record. 2. Change in the level of risk for each factor. Secondary: change in self-reported frequency and confidence of GPS and PNs in assessment. Results: Risk recording improved in the intervention but not the control group for WC (OR 2.52 (95% CI 1.30 to 4.91)), alcohol consumption (OR 2.19 (CI 1.04 to 4.64)), smoking status (OR 2.24 (1.17 to 4.29)) and cardiovascular risk (OR 1.50 (1.04 to 2.18)). There was no change in recording of BP, lipids, glucose or BMI and no significant change in the level of risk factors based on audit data. The confidence but not reported practices of GPS and PNs in the intervention group improved in the assessment of some risk factors. Conclusions: This intervention was associated with improved recording of some risk factors but no change in the level of risk at the follow-up audit. Trial registration number: Australian and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000578808, results.

Health improvement and prevention study (HIPS) - evaluation of an intervention to prevent vascular disease in general practice

Background

The Health Improvement and Prevention Study (HIPS) study aims to evaluate the capacity of general practice to identify patients at high risk for developing vascular disease and to reduce their risk of vascular disease and diabetes through behavioural interventions delivered in general practice and by the local primary care organization.

Methods/Design

HIPS is a stratified randomized controlled trial involving 30 general practices in NSW, Australia. Practices are randomly allocated to an 'intervention' or 'control' group. General practitioners (GPs) and practice nurses (PNs) are offered training in lifestyle counselling and motivational interviewing as well as practice visits and patient educational resources. Patients enrolled in the trial present for a health check in which the GP and PN provide brief lifestyle counselling based on the 5As model (ask, assess, advise, assist, and arrange) and refer high risk patients to a diet education and physical activity program. The program consists of two individual visits with a dietician or exercise physiologist and four group sessions, after which patients are followed up by the GP or PN. In each practice 160 eligible patients aged between 40 and 64 years are invited to participate in the study, with the expectation that 40 will be eligible and willing to participate. Evaluation data collection consists of (1) a practice questionnaire, (2) GP and PN questionnaires to assess preventive care attitudes and practices, (3) patient questionnaire to assess self-reported lifestyle behaviours and readiness to change, (4) physical assessment including weight, height, body mass index (BMI), waist circumference and blood pressure, (5) a fasting blood test for glucose and lipids, (6) a clinical record audit, and (7) qualitative data collection. All measures are collected at baseline and 12 months except the patient questionnaire which is also collected at 6 months. Study outcomes before and after the intervention is compared between intervention and control groups after adjusting for baseline differences and clustering at the level of the practice.

Discussion

This study will provide evidence of the effectiveness of a primary care intervention to reduce the risk of cardiovascular disease and diabetes in general practice patients. It will inform current policies and programs designed to prevent these conditions in Australian primary health care.

Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial

Background

Cardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP) offered as part of a cluster randomised controlled trial (RCT) of prevention of vascular disease in primary care.

Methods

Data from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors.

Results

Of 301 eligible patients, 190 (63.1%) were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47), physical inactivity (OR 2.90 95%CI:1.36,6.14), contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03), rural location (OR 12.50 95%CI:1.43, 109.7) and smaller practice size (1–3 GPs) (OR 16.05 95%CI:2.74, 94.24).

Conclusions

Providing a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs.

Prevalence of vitamin D insufficiency and risk factors for type 2 diabetes and cardiovascular disease among African migrant and refugee adults in Melbourne

Migration to industrialised countries poses a “double whammy” for type 2 diabetes among sub-Saharan African migrant and refugee adults. This population group has been found to be at an increased risk of obesity and type 2 diabetes, which may be further aggravated by inadequate vitamin D status. Thus, this study aimed to describe the demographics of vitamin D insufficiency, obesity, and risk factors for type 2 diabetes among sub-Saharan African migrants and refugees aged 20 years or older living in Melbourne, Australia (n=49). Data were obtained by a questionnaire, medical assessment, and fasting blood samples. The mean serum 25-hydroxyvitamin D level was 27.3 nmol/L (95% CI: 22.2, 32.4 nmol/L); with 25-hydroxyvitamin D levels <50 nmol/L occurring in 88% of participants. Participants displayed a cluster of risk factors for type 2 diabetes and cardiovascular disease: 62% were overweight or obese, 47% had insulin resistance (HOMA-IR ≥2), 25% had low density lipoprotein cholesterol levels ≥3.5 mmol/L, 24.5% had high density lipoprotein cholesterol levels ≤1.03 mmol/L, 34.6% had borderline or high levels of total cholesterol (≥5.2 mmol/L), 18.2% had borderline or high levels of triglyceride (≥1.7 mmol/L), and 16% had hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg). These findings suggest that sub-Saharan African migrants and refugees may be at risk of type 2 diabetes and atherosclerosis-related diseases such as ischemic heart disease, stroke, and peripheral vascular disease. Well-designed vitamin D interventions that incorporate lifestyle changes are urgently needed in this sub-population.

A cluster randomised controlled trial of vascular risk factor management in general practice

Letter to the editor: Harris and colleagues report failure to obtain reduction in several important risk factor-based intermediate outcomes for vascular disease from their lifestyle intervention in the Health Improvement and Prevention Study (HIPS).1 Using intention-to-treat analysis, if only 117 of 384 participants completed at least two of six group sessions, a positive result could not be expected. We know that interventions for prevention of cardiovascular disease (CVD) and diabetes can be run successfully in Australian primary care, which raises questions about the design of Harris et al’s intervention.

How feasible are lifestyle modification programs for disease prevention in general practice?

Vascular disease is a leading cause of death and disability. While it is preventable, little is known about the feasibility or acceptability of implementing interventions to prevent vascular disease in Australian primary health care. We conducted a cluster randomised controlled trial assessing prevention of vascular disease in patients aged 40–65 by providing a lifestyle modification program in general practice. Interviews with 13 general practices in the intervention arm of this trial examined their views on implementing the lifestyle modification program in general practice settings. Qualitative study, involving thematic analysis of semi-structured interviews with 11 general practitioners, four practice nurses and five allied health providers between October 2009 and April 2010. Providing brief lifestyle intervention fitted well with routine health-check consultations; however, acceptance and referral to the program was dependent on the level of facilitation provided by program coordinators. Respondents reported that patients engaged with the advice and strategies provided in the program, which helped them make lifestyle changes. Practice nurse involvement was important to sustaining implementation in general practice, while the lack of referral services for people at risk of developing vascular disease threatens maintenance of lifestyle changes as few respondents thought patients would continue lifestyle changes without long-term follow up. Lifestyle modification programs to prevent vascular disease are feasible in general practice but must be provided in a flexible format, such as being offered out of hours to facilitate uptake, with ongoing support and follow up to assist maintenance. The newly formed Medicare Locals may have an important role in facilitating lifestyle modification programs for this target group.

How do the Australian guidelines for lipid-lowering drugs perform in practice? Cardiovascular disease risk in the AusDiab Study, 1999-2000

OBJECTIVE: To determine how well the current Pharmaceutical Benefits Scheme (PBS) eligibility criteria for subsidy of lipid-lowering drugs compare with current national guidelines for determining the population at high risk of developing cardiovascular disease (CVD). DESIGN AND PARTICIPANTS: Analyses of the population-based, cross-sectional Australian Diabetes, Obesity and Lifestyle (AusDiab) study, conducted in 1999-2000. The 1991 Framingham risk prediction equation was used to compute 5-year risk of developing first-time CVD in 8286 participants aged 30-74 years with neither CVD nor diabetes. Based on the National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand guidelines, people with either 5-year CVD risk > or = 15% or with 5-year CVD risk of 10%-< 15% and the metabolic syndrome were defined as having estimated high absolute CVD risk. MAIN OUTCOME MEASURES: 5-year CVD risk; estimated population with high CVD risk. RESULTS: Among participants without prevalent CVD or diabetes, 7.9% of men and 1.5% of women had a 5-year CVD risk > or = 15%. Of the estimated residential Australian population in 2000 aged 30-74 years without CVD or diabetes, 717 000 people were considered to be at high absolute CVD risk. Among the high-risk AusDiab participants without CVD or diabetes, only 16.9% of men and 15.4% of women were being treated with lipid-lowering drugs. Of the 9.6% of participants free of CVD and diabetes who were untreated but eligible for subsidy under PBS criteria, only 27.4% had an estimated high absolute CVD risk. CONCLUSION: Strategies for CVD prevention using lipid-lowering medications can be improved by adoption of the absolute-risk approach.

A cluster randomised controlled trial of vascular risk factor management in general practice

Objective: To evaluate the impact of a lifestyle intervention in Australian general practice to reduce the risk of vascular disease.

Design, setting and participants: Stratified cluster randomised controlled trial among 30 general practices in New South Wales from July 2008 to January 2010. Patients aged 40–64 years were invited to participate. The subgroup who were 40–55 years of age were included only if they had either hypertension or dyslipidaemia.

Intervention: A general practice-based health-check with brief lifestyle counselling and referral of high-risk patients to a program consisting of one to two individual visits with an exercise physiologist or dietitian, and six group sessions.

Main outcome measures: Outcomes at baseline, 6 and 12 months included the behavioural and physiological risk factors for vascular disease — self-reported diet and physical activity, and measured weight, body mass index, waist circumference, blood lipid and blood sugar levels, and blood pressure.

Results: Of the 3128 patients who were invited, 958 patients (30.6%) responded and 814 were eligible to participate. Of these, 699 commenced the study, and 655 remained in the study at 12 months. Physical activity levels increased to a greater extent in the intervention group than the control group at 6 and 12 months (P = 0.005). There were no other changes in behavioural or physiological outcomes or in estimated absolute risk of cardiovascular disease at 12 months. Of the 384 enrolled in the intervention group, 117 patients (30.5%) attended the minimum number of group program sessions and lost more weight (mean weight loss, 1.06 kg) than those who did not attend the minimum number of sessions (mean weight gain, 0.73 kg).

Conclusion: While patients who received counselling by their general practitioner increased self-reported physical activity, only those who attended the group sessions sustained an improvement in weight. However, more research is needed to determine whether group programs offer significant benefits over individual counselling in general practice.

Dietary counseling to increase natural folate intake: a ransomized placebo-controlled trial in free-living subjects to assess effects on serum folate and plasma total homocysteine.

BACKGROUND: The association between vascular disease and elevated plasma total homocysteine (tHcy) concentrations is caused, in part, by inadequate intakes of dietary folate. Increasing folate intake either through supplements or foods naturally rich in folates has been shown to decrease tHcy concentrations. OBJECTIVE: The aim of this study was to determine whether a similar reduction in tHcy was possible in free-living persons receiving dietary counseling. DESIGN: The study included a 4-wk placebo-controlled dietary intervention trial in which participants consumed either unfortified breakfast cereal (control group) or an extra 350 micro g folate derived from food/d (dietary group). Serum folate and tHcy concentrations in both groups were measured before and after the intervention period, and the concentrations in the dietary group were also measured 17 wk after the intervention period. RESULTS: During the 4-wk intervention, mean dietary folate intake in the dietary group increased from 263 (95% CI: 225, 307) to 618 micro g/d (535, 714), resulting in a mean increase in serum folate of 37% (15%, 63%) and a decrease in tHcy from 12.0 (10.9, 13.3) to 11.3 micro mol/L (10.2, 12.5). A further decrease in tHcy occurred in the dietary group during follow-up, with a final tHcy concentration of 9.7 micro mol/L (8.8, 10.8). CONCLUSIONS: Increasing natural folate intake improved folate status and decreased tHcy concentrations to an extent that may significantly reduce the risk of vascular disease. Dietary modification may have advantages over folic acid fortification because the altered food-consumption patterns lead to increased intakes of several vitamins and minerals and decreased intakes of saturated fatty acids.

Maternal and neonatal influences on, and reproducibility of, neonatal aortic pulse wave velocity

Aortic pulse wave velocity (aPWV), a noninvasive measure of vascular stiffness, is an independent predictor of cardiovascular disease both before and in overt vascular disease. Its characteristics in early life and its relationship to maternal factors have hardly been studied. To test the hypothesis that infant aPWV was positively related to maternal anthropometry and blood pressure (BP) at 28 weeks gestation, after adjusting for neonatal anthropometry and BP, 148 babies born in Manchester were measured 1 to 3 days after birth. A high reproducibility of aPWV, assessed in 30 babies within 3 days of birth, was found with a mean difference between occasions of –0.04 m/s (95% CI: –0.08 to 0.16 m/s). Contrary to our hypothesis, a significant inverse relation was found between neonatal aPWV (mean: 4.6 m/s) and maternal systolic BP (mean: 108.9 mm Hg; r=–0.57; 95% CI: –0.67 to –0.45) but not maternal height nor weight. Neonatal aPWV was positively correlated with birth length, birth weight, and systolic BP. In multiple regression, neonatal aPWV remained significantly inversely associated with maternal systolic BP (adjusted ß coefficient: –0.032; 95% CI: –0.040 to –0.024; P<0.001), after adjustment for maternal age, birth weight, length, and neonatal BP (all independently and positively related to aPWV) and for gestational age, maternal weight, and height (unrelated). These results suggest that infant aPWV may be a useful index of infant vascular status, is less disturbing to measure than infant BP, and is sensitive to the gestational environment marked by maternal BP.

Foot complications in Type 2 diabetes : an Australian population-based study

Aims To determine the prevalence and risk factors for neuropathy and peripheral vascular disease (PVD) in the Australian diabetic population and identify those at high risk of foot ulceration.

Methods The Australian Diabetes Obesity and Lifestyle study included 11 247 adults aged ≥ 25 years in 42 randomly selected areas of Australia. Neuropathy and PVD were assessed in participants identified as having diabetes (based on self report and oral glucose tolerance test), impaired fasting glucose, impaired glucose tolerance and in a random sample with normal glucose tolerance (total n = 2436).

Results The prevalence of peripheral neuropathy was 13.1% in those with known diabetes (KDM) and 7.1% in those with newly diagnosed (NDM). The prevalence of PVD was 13.9% in KDM and 6.9% in NDM. Of those with diabetes, 19.6% were at risk of foot ulceration. Independent risk factors for peripheral neuropathy were diabetes duration (odds ratio (95% CI) 1.73 (1.33–2.28) per 10 years), height (1.42 (1.08–1.88) per 10 cm), age (2.57 (1.94–3.40) per 10 years) and uric acid (1.59 (1.21–2.09) per 0.1 mmol/l). Risk factors for PVD were diabetes duration (1.64 (1.25–2.16) per 10 years), age (2.45 (1.86–3.22) per 10 years), smoking (2.07 (1.00–4.28)), uric acid (1.03 (1.00–1.06) per 0.1 mmol/l) and urinary albumin/creatinine ratio (1.11 (1.01–1.21) per 1 mg/mmol).

Conclusions The prevalence of neuropathy and PVD was lower in this population than has been reported in other populations. This may reflect differences in sampling methods between community and hospital-based populations. Nevertheless, a substantial proportion of the diabetic population had risk factors for foot ulceration.

Effect of low and high glycaemic index diets on developing the risk of metabolic syndrome in rats

Several observational studies have shown that the chronic consumption of high glycaemic index diet is associated with an increased risk of developing metabolic syndrome.  This study was performed to identify the direct influences on the lipid profile and the adipose tissue deposition and the subsequent development of the risk of metabolic syndrome in rats by feeding diets of low glycaemic index (LGI) and high glycaemic index (HGI). Fifty rat weanlings (three weeks old) were equally divided into two groups and fed on either low glycaemic index diet based on high amylose, or isocaloric high glycacmic index diet for 12 weeks. Postprandial blood and tissue samples were collected at the end of the 12 weeks of feeding. The total white adipose tissue weights of the HGl fed rats (24.74 ± 0.53 glrat) were significantly higher than the LGl fed rats (15.37 ± 0.36 gh·at). The HO! led rats had higher postprandial leptin concentrations (1.86 ± 0.17 ng/ml) than LGI fed rats (1.34 ± 0.12 ng/ml). The postprandial insulin, and postprandial insulin glucose ratio were higher in the HGI fed rats (7.06 ± 0.90 ng/ml and 0.67 ± 0.01 ng/mlxmM) compared to the LGl fed rats (3.91 ± 0.4 ng/ml and 0.44 ± 0.01 ng/mlxmM). Triglycerides of the l-IGI fed rats showed higher values (I .56 ± 0.10 mM) than the LO! fed rats (l.07 ± 0.08 mM). The results indicated that LGI feeding was beneficial in preventing the conditions enhancing the cardio vascular disease whereas long-term feeding of HGI diet may increase the risk of developing metabolic syndrome in rats.

Getting your life back on track after stroke : a phase II multi-centered, single-blind, randomized, controlled trial of the Stroke Self-Management Program vs. the Stanford Chronic Condition Self-Management Program or standard care in stroke survivors

Background Self-management is seen as a primary mechanism to support the optimization of care for people with chronic diseases such as symptomatic vascular disease. There are no established and evidence-based stroke-specific chronic disease self-management programs. Our aim is to evaluate whether a stroke-specific program is safe and feasible as part of a Phase II randomized-controlled clinical trial.
Methods Stroke survivors are recruited from a variety of sources including: hospital stroke services, local paper advertisements, Stroke South Australia newsletter (volunteer peer support organization), Divisions of General Practice, and community service providers across Adelaide, South Australia. Subjects are invited to participate in a multi-center, single-blind, randomized, controlled trial. Eligible participants are randomized to either;
• standard care,
• standard care plus a six week generic chronic condition self-management group education program, or,
• standard care plus an eight week stroke specific self-management education group program.
Interventions are conducted after discharge from hospital. Participants are assessed at baseline, immediate post intervention and six months.
Study Outcomes The primary outcome measures determine study feasibility and safety, measuring, recruitment, participation, compliance and adverse events.
Secondary outcomes include:
• positive and active engagement in life measured by the Health Education Impact Questionnaire,
• improvements in quality of life measured by the Assessment of Quality of Life instrument,
• improvements in mood measured by the Irritability, Depression and Anxiety Scale,
• health resource utilization measured by a participant held diary and safety.

Conclusion The results of this study will determine whether a definitive Phase III efficacy trial is justified.

The development of a national salt reduction strategy for Australia

Excess dietary salt is a well established cause of high blood pressure and vascular disease. National and international bodies recommend a significant reduction in population salt intakes on the basis of strong evidence for health gains that population salt reduction strategies could achieve. The Australian Division of World Action on Salt and Health (AWASH) coordinates the Drop the Salt! campaign in Australia. This aims to reduce the average amount of salt consumed by Australians to six grams per day over five years through three main implementation strategies targeting the food industry, the media and government. This strategy has the potential to achieve a rapid and significant reduction in dietary salt consumption in Australia. With industry and government engagement, this promises to be a highly effective, low cost option for preventing chronic disease.