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.

The Healthy Migrant Families Initiative: Development of a culturally competent obesity prevention intervention for African migrants Disease epidemiology - Chronic

Background: Although obesity among immigrants remains an important area of study given the increasing migrant population in Australia and other developed countries, research on factors amenable to intervention is sparse. The aim of the study was to develop a culturally-competent obesity prevention program for sub-Saharan African (SSA) families with children aged 12-17 years using a community-partnered participatory approach. Methods: A community-partnered participatory approach that allowed the intervention to be developed in collaborative partnership with communities was used. Three pilot studies were carried out in 2008 and 2009 which included focus groups, interviews, and workshops with SSA parents, teenagers and health professionals, and emerging themes were used to inform the intervention content. A cultural competence framework containing 10 strategies was developed to inform the development of the program. Using findings from our scoping research, together with community consultations through the African Review Panel, a draft program outline (skeleton) was developed and presented in two separate community forums with SSA community members and health professionals working with SSA communities in Melbourne. Results: The 'Healthy Migrant Families Initiative (HMFI): Challenges and Choices' program was developed and designed to assist African families in their transition to life in a new country. The program consists of nine sessions, each approximately 1 1/2 hours in length, which are divided into two modules based on the topic. The first module 'Healthy lifestyles in a new culture' (5 sessions) focuses on healthy eating, active living and healthy body weight. The second module 'Healthy families in a new culture' (4 sessions) focuses on parenting, communication and problem solving. The sessions are designed for a group setting (6-12 people per group), as many of the program activities are discussion-based, supported by session materials and program resources. Conclusion: Strong partnerships and participation by SSA migrant communities enabled the design of a culturally competent and evidence-based intervention that addresses obesity prevention through a focus on healthy lifestyles and healthy families. Program implementation and evaluation will further inform obesity prevention interventions for ethnic minorities and disadvantaged communities.

Diabetes prevention research: a systematic review of external validity in lifestyle interventions

Context

Type 2 diabetes is a major contributor to disease burden globally. A number of systematic reviews support the efficacy of lifestyle interventions in preventing Type 2 diabetes in adults; however, relatively little attention has been paid to the generalizability of study findings. This study systematically reviews the reporting of external validity components and generalizability of diabetes prevention studies.

Evidence acquisition

Lifestyle intervention studies for the prevention of Type 2 diabetes in adults with at least 6 months' follow-up, published between 1990 and 2011, were identified through searches of major electronic databases. External validity reporting was rated using an assessment tool, and all analysis was undertaken in 2011.

Evidence synthesis

A total of 31 primary studies (n=95 papers) met the selection criteria. All studies lacked full reporting on external validity elements. Description of the study sample, intervention, delivery agents, and participant attrition rates were reported by most studies. However, few studies reported on the representativeness of individuals and settings, methods for recruiting settings and delivery agents, costs, and how interventions could be institutionalized into routine service delivery. It is uncertain to what extent the findings of diabetes prevention studies apply to men, socioeconomically disadvantaged individuals, those living in rural and remote communities, and to low- and middle-income countries.

Conclusions

Reporting of external validity components in diabetes prevention studies needs to be enhanced to improve the evidence base for the translation and dissemination of these programs into policy and practice.

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.

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.

Explaining the variation in the management of lifestyle risk factors in primary health care: a multilevel cross sectional study

Background

Despite evidence for the effectiveness of interventions to modify lifestyle behaviours in the primary health care (PHC) setting, assessment and intervention for these behaviours remains low in routine practice. Little is known about the relative importance of various determinants of practice.

This study aimed to examine the relative importance of provider characteristics and attitudes, patient characteristics and consultation factors in determining the rate of assessment and intervention for lifestyle risk factors in PHC.

Methods

A prospective audit of assessment and intervention for lifestyle risk factors was undertaken by PHC nurses and allied health providers (n = 57) for all patients seen (n = 732) over a two week period. Providers completed a survey to assess key attitudes related to addressing lifestyle issues. Multi-level logistic regression analysis of patient audit records was undertaken. Associations between variables from both data sources were examined, together with the variance explained by patient and consultation (level 1) and provider (level 2) factors.

Results

There was significant variance between providers in the assessment and intervention for lifestyle risk factors. The consultation type and reason for the visit were the most important in explaining the variation in assessment practices, however these factors along with patient and provider variables accounted for less than 20% of the variance. In contrast, multi-level models showed that provider factors were most important in explaining the variance in intervention practices, in particular, the location of the team in which providers worked (urban or rural) and provider perceptions of their effectiveness and accessibility of support services. After controlling for provider variables, patients' socio-economic status, the reason for the visit and providers' perceptions of the 'appropriateness' of addressing risk factors in the consultation were all significantly associated with providing optimal intervention. Together, measured patient consultation and provider variables accounted for most (80%) of the variation in intervention practices between providers.

Conclusion

The findings highlight the importance of provider factors such as beliefs and attitudes, team location and work context in understanding variations in the provision of lifestyle intervention in PHC. Further studies of this type are required to identify variables that improve the proportion of variance explained in assessment practices.

An exploration of how clinician attitudes and beliefs influence the implementation of lifestyle risk factor management in primary healthcare: a grounded theory study

Background

Despite the effectiveness of brief lifestyle intervention delivered in primary healthcare (PHC), implementation in routine practice remains suboptimal. Beliefs and attitudes have been shown to be associated with risk factor management practices, but little is known about the process by which clinicians' perceptions shape implementation. This study aims to describe a theoretical model to understand how clinicians' perceptions shape the implementation of lifestyle risk factor management in routine practice. The implications of the model for enhancing practices will also be discussed.

Methods

The study analysed data collected as part of a larger feasibility project of risk factor management in three community health teams in New South Wales (NSW), Australia. This included journal notes kept through the implementation of the project, and interviews with 48 participants comprising 23 clinicians (including community nurses, allied health practitioners and an Aboriginal health worker), five managers, and two project officers. Data were analysed using grounded theory principles of open, focused, and theoretical coding and constant comparative techniques to construct a model grounded in the data.

Results

The model suggests that implementation reflects both clinician beliefs about whether they should (commitment) and can (capacity) address lifestyle issues. Commitment represents the priority placed on risk factor management and reflects beliefs about role responsibility congruence, client receptiveness, and the likely impact of intervening. Clinician beliefs about their capacity for risk factor management reflect their views about self-efficacy, role support, and the fit between risk factor management ways of working. The model suggests that clinicians formulate different expectations and intentions about how they will intervene based on these beliefs about commitment and capacity and their philosophical views about appropriate ways to intervene. These expectations then provide a cognitive framework guiding their risk factor management practices. Finally, clinicians' appraisal of the overall benefits versus costs of addressing lifestyle issues acts to positively or negatively reinforce their commitment to implementing these practices.

Conclusion

The model extends previous research by outlining a process by which clinicians' perceptions shape implementation of lifestyle risk factor management in routine practice. This provides new insights to inform the development of effective strategies to improve such practices.

Addressing healthy lifestyle behaviours amongst young people in out-of-home care

The aim of this thesis was to develop a program of research that evaluated enablers, barriers and pathways for establishing healthy lifestyle behaviours among young people living in residential out-of-home care. This included development of the Healthy Eating, Active Living (HEAL) intervention, and was the first program, nationally and internationally to evaluate a healthy lifestyle intervention in this setting.

Randomised controlled trial evaluating the effectiveness of behavioural interventions to modify cardiovascular risk factors in men and women with imparied glucose tolerance: outcomes at 6 months

Aims: To evaluate the efficacy of interventions to promote a healthy diet and physical activity in people with impaired glucose tolerance (IGT). Methods: A randomised controlled trial in Newcastle upon Tyne, UK, 1995–98. Participants included 67 adults (38 men; 29 women) aged 24–75 years with IGT. The intervention consisted of regular diet and physical activity counselling based on the stages of change model. Main outcome measures were changes between baseline and 6 months in nutrient intake; physical activity; anthropometric and physiological measurements including serum lipids; glucose tolerance; insulin sensitivity. Results: The difference in change in total fat consumption was significant between intervention and control groups (difference −21.8 (95% confidence interval (CI) −37.8 to −5.8) g/day, P=0.008). A significantly larger proportion of intervention participants reported taking up vigorous activity than controls (difference 30.1, (95% CI 4.3–52.7)%, P=0.021). The change in body mass index was significantly different between groups (difference −0.95 (95% CI −1.5 to −0.4) kg/m2, P=0.001). There was no significant difference in change in mean 2-h plasma glucose between groups (difference −0.19 (95% CI −1.1 to 0.71) mmol/l, NS) or in serum cholesterol (difference 0.02 (95% CI −0.26 to 0.31) mmol/l, NS). The difference in change in fasting serum insulin between groups was significant (difference −3.4 (95% CI −5.8 to −1.1) mU/l, P=0.005). Conclusions: After 6 months of intensive lifestyle intervention in participants with IGT, there were changes in diet and physical activity, some cardiovascular risk factors and insulin sensitivity, but not glucose tolerance. Further follow-up is in progress to investigate whether these changes are sustained or augmented over 2 years.

Prevention of type 2 diabetes in a primary health care setting interim results from the Greater Green Triangle (GGT) Diabetes Prevention Project

Although clinical trials have shown that lifestyle modifications reduce the risk of type 2 diabetes, translating lessons from trials to primary care remains a challenge. The aim of the study was to evaluate efficacy and feasibility of primary care-based diabetes prevention model with modest resource requirements in rural Australia. Three hundred and eleven subjects with at least a moderate risk of type 2 diabetes participated in a combined dietary and physical activity intervention. Clinical measurements and fasting blood samples were taken at the baseline and after intervention. After 3 months intervention, total (change −3.5%, p < 0.001) and LDL cholesterol (−4.8%, p < 0.001) plasma levels as well as body mass index (−2.5%, p < 0.001), weight (−2.5%, p < 0.001), and waist (−1.6%, p < 0.001) and hip (−2.7%, p < 0.001) circumferences reduced significantly. A borderline reduction was found in triglyceride levels (−4.8%, p = 0.058) while no changes were observed in HDL cholesterol (+0.6%, p = 0.525), glucose (+0.06%, p = 0.386), or systolic (−0.98%, p = 0.095) or diastolic (−1.06%, p = 0.134) blood pressure levels. In conclusion, a lifestyle intervention improved health outcomes – especially obesity and blood lipids – in a population at high risk of developing type 2 diabetes. Our results suggest that the present model is effective and feasible to carry out in primary care settings.

Sustained gains from a diabetes prevention program and the role of telephone support

Background
An evaluation of the sustainability of lifestyle changes was undertaken for participants completing a 12 month diabetes prevention program. This second part of the study also tested whether regular structured telephone calls could be effective in maintaining lifestyle changes.

Methods
Originally, 237 participants completed a 12 month group-based lifestyle intervention study. They were aged 40–75 years, with a moderate to high risk of developing type 2 diabetes. Participants were then randomised to telephone support (n = 107) or self-care only (n = 98) for 18 months, and re-assessed using anthropometric, clinical, psychological and general health measures.

Results
A total of 164 participants (85 telephone support and 79 self-care only) completed the follow-up. Changes between 12 and 30 months for the telephone support group were not significantly different from those found in the self-care only group. Beneficial lifestyle changes achieved by participants were generally sustained after the diabetes prevention program, with the exception of fasting plasma glucose and some psychological measures.

Conclusions
Positive outcomes achieved at 12 months were generally maintained after a further 18 months. Telephone support did not appear to produce additional benefits.

Implementation of diabetes prevention programs in rural areas : Montana and south-eastern Australia compared

Objective: To identify the key elements that enabled the Greater Green Triangle Diabetes Prevention Project (GGT DPP) and the Montana Cardiovascular Disease and Diabetes Prevention (CDDP) programs successful establishment and implementation in rural areas, as well as identifying specific challenges or barriers for implementation in rural communities.
Methods: Focus groups were held with the facilitators who delivered the GGT DPP in Australia and the Montana CDDP programs in the USA. Interview questions covered the facilitators’ experiences with recruitment, establishing the program, the components and influence of rurality on the program, barriers and challenges to delivering the program, attributes of successful participants, and the influence of community resources and partnerships on the programs.
Results: Four main themes emerged from the focus groups: establishing and implementing the diabetes prevention program in the community; strategies for recruitment and retention of participants; what works in lifestyle intervention programs; and rural-centred issues.
Conclusions: The results from this study have assisted in determining the factors that contribute to developing, establishing and implementing successful diabetes prevention programs in two rural areas. Recommendations to increase the likelihood of success of programs in rural communities include: securing funding early for the program; establishing support from community leaders and developing positive relationships with health care providers; creating a professional team with passion for the program; encouraging participants to celebrate their small and big successes; and developing procedures for providing post-intervention support to help participants maintain their success.

The spread and uptake of diabetes prevention programs around the world : a case study from Finland and Australia

Type 2 diabetes is a major public health issue in most countries around the world. Efficacy trials have demonstrated that lifestyle modification programs can significantly reduce the risk of type 2 diabetes. Two key challenges are: [1] to develop programs that are more feasible for “real world” implementation and [2] to extend the global reach of such programs, particularly to resource-poor countries where the burden of diabetes is substantial. This paper describes the development, implementation, and evaluation of such “real world” programs in Finland and Australia, the exchange between the two countries, and the wider uptake of such programs. Drawing on the lessons from these linked case studies, we discuss the implications for improving the “spread” of diabetes prevention programs by more effective uptake of lifestyle change programs and related strategies for more resource-poor countries and settings.

The Melbourne Diabetes Prevention Study (MDPS) : study protocol for a randomized controlled trial

Background
Worldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals.

As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program ‘Life! Taking action on diabetes’ (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program.

Methods/design
We intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only.

The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow the five goals of the Life! program.

Discussion
This study will determine whether the effect of this intervention is larger than the effect of usual care in reducing central obesity and cardiovascular risk factors and thus the risk of developing diabetes and cardiovascular disease. Also it will evaluate how these two options compare economically.

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.