Study protocol for "Moving bright, eating smart"- a phase 2 clinical trial on the acceptability and feasibility of a diet and physical activity intervention to prevent recurrence in colorectal cancer survivors

Background: Colorectal cancer is the second most common cancer and cancer-killer in Hong Kong with an alarming increasing incidence in recent years. The latest World Cancer Research Fund report concluded that foods low in fibre, and high in red and processed meat cause colorectal cancer whereas physical activity protects against
colon cancer. Yet, the influence of these lifestyle factors on cancer outcome is largely unknown even though cancer survivors are eager for lifestyle modifications. Observational studies suggested that low intake of a Western-pattern diet and high physical activity level reduced colorectal cancer mortality. The Theory of Planned
Behaviour and the Health Action Process Approach have guided the design of intervention models targeting a wide range of health-related behaviours.
Methods/design: We aim to demonstrate the feasibility of two behavioural interventions intended to improve colorectal cancer outcome and which are designed to increase physical activity level and reduce consumption of a Western-pattern diet. This three year study will be a multicentre, randomised controlled trial in a 2x2 factorial
design comparing the “Moving Bright, Eating Smart” (physical activity and diet) programme against usual care. Subjects will be recruited over a 12-month period, undertake intervention for 12 months and followed up for a further 12 months. Baseline, interim and three post-intervention assessments will be conducted. Two hundred and twenty-two colorectal cancer patients who completed curative treatment without evidence of recurrence will be recruited into the study. Primary outcome measure will be whether physical activity and dietary targets are met at the end of the 12-month intervention. Secondary outcome measures include the magnitude and
mechanism of behavioural change, the degree and determinants of compliance, and the additional health benefits and side effects of the intervention.
Discussion: The results of this study will establish the feasibility of targeting the two behaviours (diet and physical activity) and demonstrate the magnitude of behaviour change. The information will facilitate the design of a further larger phase III randomised controlled trial with colorectal cancer outcome as the study endpoint to determine whether this intervention model would reduce colorectal cancer recurrence and mortality.

The effect of physical activity on psychological distress, cortisol and obesity: results of the farming fit intervention program

Background:
Rural and regional Australians have a higher likelihood of mental illness throughout their lifetime than people living in major cities, although the underlying reasons are not yet well defined. Additionally, rural populations experience more lifestyle associated co-morbidities including obesity, diabetes and cardiovascular disease. Research conducted by the National Centre for Farmer Health between 2004 and 2009 revealed a positive correlation between obesity and psychological distress among the farming community. Chronic stress is known to overstimulate the regulation of the hypothalamic-pituitary-adrenal (HPA) axis and cortisol secretion which are associated with abdominal adiposity. Increasing physical activity may normalise cortisol secretion and thereby positively impact both physical and mental health. This paper assesses the effects of increasing physical activity on obesity, health behaviors and mental health in Victorian farming men and women.

Methods:
Farming Fit was a six month quasi-experimental (convenience sample) longitudinal design control-intervention study. Overweight or obese (BMI ?25?kg/m2) farm men (n?=?43) and women (n?=?29) were recruited with demographic, health behaviors, anthropometric, blood pressure and biochemistry data collected at baseline and at a six months. Salivary cortisol and depression anxiety stress scale results were collected at baseline, three and six months. The intervention group (n?=?37) received a personalized exercise program and regular phone coaching to promote physical activity.

Results:
The intervention group showed significant reductions in body weight and waist circumference. Results indicated that following the six month exercise program, the intervention group were 2.64???0.65?kg lighter (p?<?0.001), had reduced waist circumference by 2.01???0.86?cm (p?=?0.02) and BMI by 0.97???0.22?kg/m2 (p?<?0.001) relative to the control group.

Conclusion:
Increasing physical activity altered measures of obesity in farm men and women but did not affect mental health measures or cortisol secretion levels.

Systematic review of lifestyle interventions to limit postpartum weight retention: implications for future opportunities to prevent maternal overweight and obesity following childbirth

Postpartum weight retention can predict future weight gain and long-term obesity. Moreover, failure to lose weight gained during pregnancy can lead to increased body mass index for subsequent pregnancies, increasing the risk of adverse maternal and foetal pregnancy outcomes. This systematic review evaluates the effectiveness of lifestyle interventions aimed at reducing postpartum weight retention. Seven electronic databases were searched for intervention studies and trials enrolling women with singleton pregnancies and published in English from January 1990 to October 2012. Studies were included when postpartum weight was a main outcome and when diet and/or exercise and/or weight monitoring were intervention components. No limitations were placed on age, body mass index or parity. Eleven studies were identified as eligible for inclusion in this review, of which 10 were randomized controlled trials. Seven studies were successful in decreasing postpartum weight retention, six of which included both dietary and physical activity components, incorporated via a range of methods and delivered by a variety of health practitioners. Few studies utilized modern technologies as alternatives to traditional face-to-face support and cost-effectiveness was not assessed in any of the studies. These results suggest that postpartum weight loss is achievable, which may form an important component of obesity prevention in mothers; however, the optimal setting, delivery, intervention length and recruitment approach remains unclear.

Reducing sitting time in office workers: short-term efficacy of a multicomponent intervention

Objective To investigate the short-term efficacy of a multicomponent intervention to reduce office workers' sitting time. Methods Allocation for this non-randomized controlled trial (n = 43 participants; 56% women; 26–62 years; Melbourne, Australia) was by office floor, with data collected during July–September 2011. The 4-week intervention emphasized three key messages: “Stand Up, Sit Less, Move More” and comprised organizational, environmental, and individual elements. Changes in minutes/day at the workplace spent sitting (primary outcome), in prolonged sitting (sitting time accumulated in bouts ≥ 30 min), standing, and moving were objectively measured (activPAL3). Results Relative to the controls, the intervention group significantly reduced workplace sitting time (mean change [95%CI]: − 125 [− 161, − 89] min/8-h workday), with changes primarily driven by a reduction in prolonged sitting time (− 73 [− 108, − 40] min/8-h workday). Workplace sitting was almost exclusively replaced by standing (+ 127 [+ 92, + 162] min/8-h workday) with non-significant changes to stepping time (− 2 [− 7, + 4] min/8-h workday) and number of steps (− 70 [− 350, 210]). Conclusions This multicomponent workplace intervention demonstrated that substantial reductions in sitting time are achievable in an office setting. Larger studies with longer timeframes are needed to assess sustainability of these changes, as well as their potential longer-term impacts on health and work-related outcomes.

Challenges in lifestyle and community interventions research

Earlier this year the BMC portfolio was enriched by a new journal BMC Obesity. Here, we present the aims and objectives of the section on Lifestyle and Community Interventions. Innovative research is needed. Preventing or managing obesity requires addressing different determinants across multiple levels where diverse levers and stakeholders can play a critical role. Interactions of these determinants within and between systems need to be studied. How to leverage, manage and measure this complexity underlies the innovation that is needed in the next generation of obesity interventions. The ambition of the Lifestyle and Community Interventions section is to provide a space for innovative research, including research that falls outside the traditional comfort zone. We welcome studies of heterogeneous designs, including those of qualitative, quantitative, mixed and systems methodologies. Studies of interest include not only outcomes research of interventions but also process evaluation, cost effectiveness or cost-benefit analysis, and implementation and dissemination research. Innovations that integrate diverse intervention levers or combine primary and secondary levels of prevention are particularly encouraged. The general aim of BMC Obesity’ s Lifestyle and Community Interventions section is to advance our ability to decide on what combinations of approaches will be required to effectively and equitably prevent obesity.

Effectiveness and implementation of an obesity prevention intervention: the HeLP-her Rural cluster randomised controlled trial

To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities.

A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomized controlled trial

BACKGROUND: Childhood obesity is an increasing health problem globally. Overweight and obesity may be established as early as 2-5 years of age, highlighting the need for evidence-based effective prevention and treatment programs early in life. In adults, mobile phone based interventions for weight management (mHealth) have demonstrated positive effects on body mass, however, their use in child populations has yet to be examined. The aim of this paper is to report the study design and methodology of the MINSTOP (Mobile-based Intervention Intended to Stop Obesity in Preschoolers) trial.

METHODS/DESIGN: A two-arm, parallel design randomized controlled trial in 300 healthy Swedish 4-year-olds is conducted. After baseline measures, parents are allocated to either an intervention- or control group. The 6- month mHealth intervention consists of a web-based application (the MINSTOP app) to help parents promote healthy eating and physical activity in children. MINISTOP is based on the Social Cognitive Theory and involves the delivery of a comprehensive, personalized program of information and text messages based on existing guidelines for a healthy diet and active lifestyle in pre-school children. Parents also register physical activity and intakes of candy, soft drinks, vegetables as well as fruits of their child and receive feedback through the application. Primary outcomes include body fatness and energy intake, while secondary outcomes are time spent in sedentary, moderate, and vigorous physical activity, physical fitness and intakes of fruits and vegetables, snacks, soft drinks and candy. Food and energy intake (Tool for Energy balance in Children, TECH), body fatness (pediatric option for BodPod), physical activity (Actigraph wGT3x-BT) and physical fitness (the PREFIT battery of five fitness tests) are measured at baseline, after the intervention (six months after baseline) and at follow-up (12 months after baseline).

DISCUSSION: This novel study will evaluate the effectiveness of a mHealth program for mitigating gain in body fatness among 4-year-old children. If the intervention proves effective it has great potential to be implemented in child-health care to counteract childhood overweight and obesity.

Is there scope for community health nurses to address lifestyle risk factors? The community nursing SNAP trial

Background
This paper examines the opportunity and need for lifestyle interventions for patients attending generalist community nursing services in Australia. This will help determine the scope for risk factor management within community health care by generalist community nurses (GCNs).

Methods
This was a quasi-experimental study conducted in four generalist community nursing services in NSW, Australia. Prior to service contacts, clients were offered a computer-assisted telephone interview to collect baseline data on socio-demographics, health conditions, smoking status, physical activity levels, alcohol consumption, height and weight, fruit and vegetable intake and 'readiness-to-change' for lifestyle risk factors.

Results
804 clients participated (a response rate of 34.1%). Participants had higher rates of obesity (40.5% vs 32.1%) and higher prevalence of multiple risk factors (40.4% vs 29.5%) than in the general population. Few with a SNAPW (S moking-N utrition-A lcohol-P hysical-Activity-Weight) risk factor had received advice or referral in the previous 3 months. The proportion of clients identified as at risk and who were open to change (i.e. contemplative, in preparation or in action phase) were 65.0% for obese/overweight; 73.8% for smokers; 48.2% for individuals with high alcohol intake; 83.5% for the physically inactive and 59.0% for those with poor nutrition.

Conclusions
There was high prevalence of lifestyle risk factors. Although most were ready to change, few clients recalled having received any recent lifestyle advice. This suggests that there is considerable scope for intervention by GCNs. The results of this trial will shed light on how best to implement the lifestyle risk factor management in routine practice.

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.

Should I and Can I?: a mixed methods study of clinician beliefs and attitudes in the management of lifestyle risk factors in primary health care

Background
Primary health care (PHC) clinicians have an important role to play in addressing lifestyle risk factors for chronic diseases. However they intervene only rarely, despite the opportunities that arise within their routine clinical practice. Beliefs and attitudes have been shown to be associated with risk factor management practices, but little is known about this for PHC clinicians working outside general practice. The aim of this study was to explore the beliefs and attitudes of PHC clinicians about incorporating lifestyle risk factor management into their routine care and to examine whether these varied according to their self reported level of risk factor management.

Methods
A cross sectional survey was undertaken with PHC clinicians (n = 59) in three community health teams. Clinicians' beliefs and attitudes were also explored through qualitative interviews with a purposeful sample of 22 clinicians from the teams. Mixed methods analysis was used to compare beliefs and attitudes for those with high and low levels of self reported risk factor management.

Results
Role congruence, perceived client acceptability, beliefs about capabilities, perceived effectiveness and clinicians' own lifestyle were key themes related to risk factor management practices. Those reporting high levels of risk factor screening and intervention had different beliefs and attitudes to those PHC clinicians who reported lower levels.

Conclusion
PHC clinicians' level of involvement in risk factor management reflects their beliefs and attitudes about it. This provides insights into ways of intervening to improve the integration of behavioural risk factor management into routine practice.

The increase of dairy intake is the main dietary factor associated with reduction of body weight in overweight adults after lifestyle change program

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Changes in malondialdehyde and C-reactive protein concentrations after lifestyle modification are related to different metabolic syndrome-associated pathophysiological processes

Metabolic syndrome (MetS) is often accompanied by pro-oxidative and pro-inflammatory processes. Lifestyle modification (LiSM) may act as primary treatment for these processes. This study aimed to elucidate influencing factors on changes of malondialdehyde (MDA) and C-reactive protein (CRP) concentrations after a LiSM intervention. Sixty subjects (53 yrs, 84% women) clinically approved to attend a 20 weeks LiSM-program were submitted to weekly nutritional counseling and physical activities combining aerobic (3 times/week) and resistance (2 times/week) exercises. Before and after intervention they were assessed for anthropometric, clinical, cardiorespiratory fitness test (CRF) and laboratory markers. Statistical analyses performed were multiple regression analysis and backward stepwise with p<0.05 and R(2) as influence index. LiSM was responsible for elevations in CRF, healthy eating index (HEI), total plasma antioxidant capacity (TAP) and HDL-C along with reductions in waist circumference measures and MetS (47-40%) prevalence. MDA and CRP did not change after LiSM, however, we observed that MDA concentrations were positively influenced (R(2)=0.35) by fasting blood glucose (β=0.64) and HOMA-IR (β=0.58) whereas CRP concentrations were by plasma gamma-glutamyltransferase activity (β=0.54; R(2)=0.29). Pro-oxidant and pro-inflammatory states of MetS can be attenuated after lifestyle modification if glucose metabolism homeostasis were recovered and if liver inflammation were reduced, respectively.

Improvements of nutrition behavior fitness and body fatness with a short-term after school intervention program

The prevalence of childhood obesity has been increasing worldwide and lifestyle changes are the most important strategies in managing this prevalence. This study aimed to describe the intervention effects of nutrition and physical activities offered as an after school short-term on outcomes of healthy nutrition practices, fitness and lowering fatness. This quasi-experimental study was conducted with a convenience sample of 59 caucasian children, aged 7.7 ± 1.4 years old (52.5% girls) registered on a private school of a middle-size town located in Sao Paulo State, Brazil. The school-based 12-week intervention consisted of 2 weekly 60 minutes section, during 3 months, including a nutritional education and a physical activity curriculum. Anthropometric data was measured for all children at baseline and after 12 weeks. All parents were contacted and requested to complete questionnaire about child’s eating behavior at baseline and after the 12-week program. After the intervention, children showed an increasing in the intake of fruits (64.3%), vegetables (61.9%), and water (52.0%). Overall, 83.3% of the children changed eating behavior according to the questionnaire responded by the parents. Waist circumference was significantly lower and abdominal strength improved after participating in the intervention program. Mean height and weight were significantly higher in boys and girls after a 12-week intervention. Although mean values of BMI remained the same after the intervention it was observed a decreasing in the prevalence of obesity among the children. Thus our study showed that a school-based intervention program focused on nutritional education and physical activity program promoted waist circumference reduction and decreased obesity without affecting the height growth along with improved fitness and healthy eating behavior. This intervention program would be feasible and replicable in others schools around the country.

Benefits on quality of life concomitant to metabolic improvement in intervention program for prevention of diabetes mellitus

To evaluate whether an interdisciplinary intervention program on lifestyle results in better quality of life (QoL) and lower frequencies of depression and binge eating disorder (BED) in individuals at risk for type 2 diabetes mellitus. A total of 177 individuals (32.2% men, age 55.4 +/- A 12.5 years) at risk for diabetes were allocated to a 9-month traditional (TI) or intensive interdisciplinary intervention (II) on dietary habits and physical activity including psychoeducative groups. They were submitted to questionnaires and clinical and laboratory examinations. Predictors of non-adherence were analyzed by logistic regression. Only individuals submitted to II had blood pressure and plasma glucose levels reduced. Frequencies of depression reduced in both interventions but of BED only in II (28.0-4.0%, P < 0.001). Increments in the scores of SF-36 domains (physical functioning: 11.1 +/- A 14.0 vs. 5.3 +/- A 13.0, role-emotional: 20.4 +/- A 40.2 vs. 6.2 +/- A 43.8, P = 0.05) were greater in the II than in TI, respectively. Changes in SF-36 correlated with decreases in anthropometry, blood pressure and glucose levels, depression and BED scores. Male gender was independently associated with non-adherence to the II. In addition to metabolic benefits, an interdisciplinary approach may induce desirable extrametabolic effects, favoring the control of psychiatric disorders and improving the QoL of individuals at risk for diabetes.

The lifestyle of our kids (LOOK) project: outline of methods

This methods paper outlines the overall design of a community-based multidisciplinary longitudinal study with the intent to stimulate interest and communication from scientists and practitioners studying the role of physical activity in preventive medicine. In adults, lack of regular exercise is a major risk factor in the development of chronic degenerative diseases and is a major contributor to obesity, and now we have evidence that many of our children are not sufficiently active to prevent early symptoms of chronic disease. The lifestyle of our kids (LOOK) study investigates how early physical activity contributes to health and development, utilizing a longitudinal design and a cohort of eight hundred and thirty 7-8-year-old (grade 2) school children followed to age 11-12 years (grade 6), their average family income being very close to that of Australia. We will test two hypotheses, that (a) the quantity and quality of physical activity undertaken by primary school children will influence their psychological and physical health and development; (b) compared with existing practices in primary schools, a physical education program administered by visiting specialists will enhance health and development, and lead to a more positive perception of physical activity. To test the first hypothesis we will monitor all children longitudinally over the 4 years. To test the second we will involve an intervention group of 430 children who receive two 50min physical education classes every week from visiting specialists and a control group of 400 who continue with their usual primary school physical education with their class-room teachers. At the end of grades 2, 4, and 6 we will measure several areas of health and development including blood risk factors for chronic disease, cardiovascular structure and function, physical fitness, psychological characteristics and perceptions of physical activity, bone structure and strength, motor control, body composition, nutritional intake, influence of teachers and family, and academic performance.