Are aspects of study design associated with the reported prevalence of female sexual difficulties?

Objective: To investigate associations between the prevalence of sexual  difficulties reported in published studies and design features of those studies to determine if differences in design contribute to variation in prevalence estimates.
Design: Systematic review, multivariate analysis.
Setting: Studies published internationally in English.
Patient(s): Not applicable.
Intervention(s): None.
Main Outcome Measure(s): Prevalence estimates of difficulty with desire, arousal, orgasm, and sexual pain reported in published studies.
Result(s): Our systematic literature search identified 1,380 publications. Fifty-five studies met our inclusion criteria (reporting prevalence, sample size and response rate, sample size greater than 100, not clinic based). Reported prevalence of sexual difficulty varied across studies (up to tenfold). Eleven aspects of research conduct in these studies were included in our multivariate analysis as explanatory variables. Five aspects of study design and conduct (data collection procedures, inclusion criteria, duration of sexual difficulty recorded, sample size, and response rate) were associated with the reported prevalence of at least one type of sexual difficulty independently of likely predictors of true variation in prevalence: study location, study year, and age range of participants.
Conclusion(s): This review provides evidence that study design may influence reported prevalence estimates of female sexual difficulties and contribute to the wide variation in published estimates.

Measuring the success of intervention programmes designed to increase the participation rate by women in computing

Many intervention programmes to encourage greater female participation in computer education and careers have been conducted in the last twenty years. These intervention programmes take considerable time, effort and money to design and implement. If success were to be measured by an increase in the percentage of female students undertaking computing courses then these programmes would have to be considered a failure. This paper describes a research project which examined fourteen intervention programmes in detail. From the perspective of the programme champions each of the intervention programmes was considered successful, even when this success was restricted to specific areas or limited to small groups of individuals. Formal evaluation appeared to have been an afterthought rather than a priority of many of the programme champions. Some programmes appeared to be less effective due to the lack of targeted and clear goals or predetermined evaluation criteria. It is recommended that during the initial planning phase for intervention programmes a clear objective is to consider what a successful programme would look like and what the evaluation criteria would be. Further work is needed to understand how intervention programmes can be better designed and evaluated so that their impact and success can be expanded.

Motivational interviewing and cognitive behaviour therapy in the treatment of adolescent overweight and obesity : study design and methodology

Background

Despite the high prevalence and negative physical and psychosocial consequences of overweight and obesity in adolescents, very little research has evaluated treatment in this population. Consequently, clinicians working with overweight and obese adolescents have little empirical research on which to base their practise. Cognitive behavioural therapy has demonstrated efficacy in promoting behaviour change in many treatment resistant disorders. Motivational interviewing has been used to increase motivation for change and improve treatment outcomes. In this paper we describe the rationale and design of a randomised controlled trial testing the efficacy of motivational interviewing and cognitive behaviour therapy in the treatment of overweight and obese adolescents.
Methods

Participants took part in a motivational interview or a standard semi-structured assessment interview and were then randomly allocated to a cognitive behavioural intervention or a wait-list control condition. The cognitive behavioural intervention, the CHOOSE HEALTH Program, consisted of 13 individual treatment sessions (12 face-to-face, 1 phone call) followed by 9 maintenance sessions (7 phone calls, 2 face-to-face). Assessments were conducted prior to participation, after the treatment phase and after the maintenance phase of intervention. Improvement in body composition was the primary outcome; secondary outcomes included improved cardiovascular fitness, eating and physical activity habits, family and psychosocial functioning.
Conclusion

Despite the demonstrated effectiveness of motivational interviewing and cognitive behavioural therapy in the long-term management of many treatment resistant disorders, these approaches have been under-utilised in adolescent overweight and obesity treatment. This study provides baseline data and a thorough review of the study design and treatment approach to allow for the assessment of the efficacy of motivational interviewing and cognitive behavioural therapy in the treatment of adolescent overweight and obesity. Data obtained in this study will also provide much needed information about the behavioural and psychosocial factors associated with adolescent overweight and obesity.

Reducing obesity in early childhood : results from romp & chomp, an Australian community-wide intervention program

Background: There is growing evidence that community-based interventions can reduce childhood obesity in older children.
Objective: We aimed to determine the effectiveness of the Romp & Chomp intervention in reducing obesity and promoting healthy eating and active play in children aged 0–5 y.
Design: Romp & Chomp was a community-wide, multisetting, multistrategy intervention conducted in Australia from 2004 to 2008. The intervention occurred in a large regional city (Geelong) with a target group of 12,000 children and focused on community capacity building and environmental (political, sociocultural, and physical) changes to increase healthy eating and active play in early-childhood care and educational settings. The evaluation was repeat cross-sectional with a quasiexperimental design and comparison sample. Main outcome measures were body mass index (BMI), standardized BMI (zBMI; according to the Centers for Disease Control and Prevention 2000 reference charts), and prevalence of overweight/obesity and obesity-related behaviors in children aged 2 and 3.5 y.
Results: After the intervention there was a significantly lower mean weight, BMI, and zBMI in the 3.5-y-old subsample and a significantly lower prevalence of overweight/obesity in both the 2- and 3.5-y-old subsamples (by 2.5 and 3.4 percentage points, respectively) than in the comparison sample (a difference of 0.7 percentage points; P < 0.05) compared with baseline values. Intervention child-behavioral data showed a significantly lower intake of packaged snacks (by 0.23 serving), fruit juice (0.52 serving), and cordial (0.43 serving) than that in the comparison sample (all P < 0.05).
Conclusion: A community-wide multisetting, multistrategy intervention in early-childhood settings can reduce childhood obesity and improve young children's diets. This trial was registered with the Australian Clinical Trials Registry at anzctr.org.au as ACTRN12607000374460.

Evaluation of a community pharmacy-based intervention for improving patient adherence to antihypertensives: a randomised controlled trial

Background
The majority of patients using antihypertensive medications fail to achieve their recommended target blood pressure. Poor daily adherence with medication regimens and a lack of persistence with medication use are two of the major reasons for failure to reach target blood pressure. There is no single intervention to improve adherence with antihypertensives that is consistently effective. Community pharmacists are in an ideal position to promote adherence to chronic medications. This study aims to test a specific intervention package that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and/or persistence with antihypertensive medications - Hypertension Adherence Program in Pharmacy (HAPPY).

Methods/Design
The HAPPY trial is a multi-centre prospective randomised controlled trial. Fifty-six pharmacies have been recruited from three Australian states. To identify potential patients, a software application (MedeMine CVD) extracted data from a community pharmacy dispensing software system (FRED Dispense®). The pharmacies have been randomised to either 'Pharmacist Care Group' (PCG) or 'Usual Care Group' (UCG). To check for 'Hawthorne effect' in the UCG, a third group of patients 'Hidden Control Group' (HCG) will be identified in the UCG pharmacies, which will be made known to the pharmacists at the end of six months. Each study group requires 182 patients. Data will be collected at baseline, three and six months in the PCG and at baseline and six months in the UCG. Changes in patient adherence and persistence at the end of six months will be measured using the self-reported Morisky score, the Tool for Adherence Behaviour Screening and medication refill data.

Discussion
To our knowledge, this is the first research testing a comprehensive package of evidence-based interventions that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and/or persistence with antihypertensive medications. The unique features of the HAPPY trial include the use of MedeMine CVD to identify patients who could potentially benefit from the service, control for the 'Hawthorne effect' in the UCG and the offer of the intervention package at the end of six months to patients in the UCG, a strategy that is expected to improve retention.

Trial Registration
Australian New Zealand Clinical Trial Registry ACTRN12609000705280

Scaling up community-based obesity prevention in Australia : background and evaluation design of the health promoting communities : being active eating well initiative

Background : There is only limited evidence available on how best to prevent childhood obesity and community-based interventions hold promise, as several successful interventions have now been published. The Victorian Government has recently funded six disadvantaged communities across Victoria, Australia for three years to promote healthy eating and physical activity for children, families, and adults in a community-based participatory manner. Five of these intervention communities are situated in Primary Care Partnerships and are the subject of this paper. The interventions will comprise a mixture of capacity-building, environmental, and whole-of-community approaches with targeted and population-level interventions. The specific intervention activities will be determined locally within each community through stakeholder and community consultation. Implementation of the interventions will occur through funded positions in primary care and local government. This paper describes the design of the evaluation of the five primary care partnership-based initiatives in the 'Go for your life' Health Promoting Communities: Being Active Eating Well (HPC:BAEW) initiative.

Methods/Design : A mixed method and multi-level evaluation of the HPC:BAEW initiative will capture process, impact and outcome data and involve both local and state-wide evaluators. There will be a combined analysis across the five community intervention projects with outcomes compared to a comparison group using a cross-sectional, quasi-experimental design. The evaluation will capture process, weight status, socio-demographic, obesity-related behavioral and environmental data in intervention and comparison areas. This will be achieved using document analysis, paper-based questionnaires, interviews and direct measures of weight, height and waist circumference from participants (children, adolescents and adults).

Discussion : This study will add significant evidence on how to prevent obesity at a population level in disadvantaged and ethnically diverse communities. The outcomes will have direct influence on policy and practice and guide the development and implementation of future obesity prevention efforts in Australia and internationally.

The effect of folic acid supplementation on dna biomarkers of colorectal cancer risk (uracil misincorporation, global and gene-specific dna hypomethylation) : a randomised intervention study

Background - Alterations in folate status are associated with colorectal carcinogenesis. Folate’s role has been postulated to be either via prevention of changes in DNA methylation or uracil misincorporation.
Objective - To investigate the effect of folic acid supplementation on colonocyte folate status and DNA biomarkers.
Design - Twenty individuals harbouring colonic adenomas were randomised to receive folic acid (600 g daily) or placebo for 6 months post polypectomy. Systemic and colonocyte folate status was determined at baseline and following the intervention. Modified Comet assays were used to determine uracil misincorporation and global DNA hypomethylation at the site adjacent to the polyp and a site distal to the polyp.
Outcomes - Supplementation resulted in increased colonocyte folate, which approached significance, at the site adjacent to the polyp (P= 0.06) but not distal to the polyp (P= 0.36); correspondingly there was a reduction in uracil misincorporation at the site adjacent to the polyp (P = 0.02) and the distal site showed no such trend (P= 0.39). There were no significant changes in global DNA hypomethylation at either site post-intervention.
Conclusions - Folic acid supplementation resulted in increased colonocyte folate and decreased uracil misincorporation at the site of the adenoma but not distal to the adenoma. This supports the hypothesis that localised areas of folate deficiency may exist in human colonic mucosa which respond to folic acid supplementation through increasing colonocyte folate and improving folate-related DNA biomarkers of cancer risk.

Evidence-based development of school-based and family-involved prevention of overweight across Europe : the ENERGY-project's design and conceptual framework

Background
There is an urgent need for more carefully developed public health measures in order to curb the obesity epidemic among youth. The overall aim of the "EuropeaN Energy balance Research to prevent excessive weight Gain among Youth" (ENERGY)-project is the development and formative evaluation of a theory-informed and evidence-based multi-component school-based and family-involved intervention program ready to be implemented and evaluated for effectiveness across Europe. This program aims at promoting the adoption or continuation of health behaviors that contribute to a healthy energy balance among school-aged children. Earlier studies have indicated that school and family environments are key determinants of energy-balance behaviors in schoolchildren. Schools are an important setting for health promotion in this age group, but school-based interventions mostly fail to target and involve the family environment.

Methods
Led by a multidisciplinary team of researchers from eleven European countries and supported by a team of Australian experts, the ENERGY-project is informed by the Environmental Research Framework for Weight gain Prevention, and comprises a comprehensive epidemiological analysis including 1) systematic reviews of the literature, 2) secondary analyses of existing data, 3) focus group research, and 4) a cross European school-based survey.

Results and discussion
The theoretical framework and the epidemiological analysis will subsequently inform stepwise intervention development targeting the most relevant energy balance-related behaviors and their personal, family-environmental and school-environmental determinants applying the Intervention Mapping protocol. The intervention scheme will undergo formative and pilot evaluation in five countries. The results of ENERGY will be disseminated among key stakeholders including researchers, policy makers and the general population.

Conclusions
The ENERGY-project is an international, multidisciplinary effort to develop and test an evidence-based and theory-informed intervention program for obesity prevention among school-aged children.

A family-based intervention to increase fruit and vegetable consumption in adolescents : a pilot study

Objective: To evaluate the feasibility and effectiveness of a pilot family-based newsletter intervention to increase fruit and vegetable (FV) consumption among adolescents.
Design: Family-based, two-group randomised control trial with baseline, postintervention and follow-up measures. The intervention group received two FV newsletter packs over a 1 month period by postal mail. Social cognitive and behavioural choice theories provide the theoretical framework for the design and development of intervention materials. Control families were provided with all intervention materials at the end of the study. Adolescent FV consumption was assessed by an FFQ. Adolescent-reported barriers to eating FV, FV habits and preferences were the secondary outcomes, along with parent FV consumption, and parents reported knowledge, encouragement, home availability and accessibility of FV. Repeated-measures ANOVA was used to detect differences in behavioural and psychosocial outcomes between groups, time and group-by-time.
Setting: East Midlands, UK.
Subjects: Forty-nine parents and adolescents aged 12–14 years.
Results: Process evaluation indicated high reach, dose acceptability and fidelity of the intervention. At post-intervention and 6 weeks later at follow-up, adolescents in the intervention group had significantly higher fruit: (P0<·01) and vegetable (P<0·05) consumption and higher preferences for vegetables (P<0·01), compared with the control group. At post-intervention and follow-up, parents in the intervention group had significantly higher fruit (P<0·001) and vegetable (P<0·01) consumption and reported higher accessibility of fruit and vegetables (P<0·001), compared with those in the control group.
Conclusions: Family-based, newsletter interventions promoting FV consumption to adolescents appear to be feasible and effective at increasing FV consumption.

A cluster randomised trial of a telephone-based intervention for parents to increase fruit and vegetable consumption in their 3-to 5-year-old children : study protocol

Background: Inadequate fruit and vegetable consumption in childhood increases the risk of developing chronic disease. Despite this, a substantial proportion of children in developed nations, including Australia, do not consume sufficient quantities of fruits and vegetables. Parents are influential in the development of dietary habits of young children but often lack the necessary knowledge and skills to promote healthy eating in their children. The aim of this study is to assess the efficacy of a telephone-based intervention for parents to increase the fruit and vegetable consumption of their 3- to 5-year-old children.
Methods/Design: The study, conducted in the Hunter region of New South Wales, Australia, employs a cluster randomised controlled trial design. Two hundred parents from 15 randomly selected preschools will be randomised to receive the intervention, which consists of print resources and four weekly 30-minute telephone support calls delivered by trained telephone interviewers. The calls will assist parents to increase the availability and accessibility of fruit and vegetables in the home, create supportive family eating routines and role-model fruit and vegetable consumption. A further two hundred parents will be randomly allocated to the control group and will receive printed nutrition information only. The primary outcome of the trial will be the change in the child's consumption of fruit and vegetables as measured by the fruit and vegetable subscale of the Children's Dietary Questionnaire. Pre-intervention and post-intervention parent surveys will be administered over the telephone. Baseline surveys will occur one to two
weeks prior to intervention delivery, with follow-up data collection calls occurring two, six, 12 and 18 months following baseline data collection.
Discussion: If effective, this telephone-based intervention may represent a promising public health strategy to increase fruit and vegetable consumption in childhood and reduce the risk of subsequent chronic disease.
Trial registration: Australian Clinical Trials Registry ACTRN12609000820202

RCT of a client-centred, caseworker-delivered smoking cessation intervention for a socially disadvantaged population

Background: Disadvantaged groups are an important target for smoking cessation intervention. Smoking rates are markedly higher among severely socially disadvantaged groups such as indigenous people, the homeless, people with a mental illness or drug and alcohol addiction, and the unemployed than in the general population. This proposal aims to evaluate the efficacy of a client-centred, caseworker delivered cessation support intervention at increasing validated self reported smoking cessation rates in a socially disadvantaged population.
Methods/Design: A block randomised controlled trial will be conducted. The setting will be a non-government organisation, Community Care Centre located in New South Wales, Australia which provides emergency relief and counselling services to predominantly government income assistance recipients. Eligible clients identified as smokers during a baseline touch screen computer survey will be recruited and randomised by a trained research assistant located in the waiting area. Allocation to intervention or control groups will be determined by time periods with clients randomised in one-week blocks. Intervention group clients will receive an intensive client centred smoking cessation intervention offered by the caseworker over two face-to-face and two telephone contacts. There will be two primary outcome measures obtained at one, six, and 12 month follow-up: 1) 24-hour expired air CO validated self-reported smoking cessation and 2) 7-day self-reported smoking cessation. Continuous abstinence will also be measured at six and 12 months follow up.
Discussion: This study will generate new knowledge in an area where the current information regarding the most effective smoking cessation approaches with disadvantaged groups is limited.

Obesity prevention in the family day care setting : impact of the romp & chomp intervention on opportunities for children's physical activity and healthy eating

Background The Romp & Chomp intervention reduced the prevalence of overweight/obesity in pre-school children in Geelong, Victoria, Australia through an intervention promoting healthy eating and active play in early childhood settings. This study aims to determine if the intervention successfully created more health promoting family day care (FDC) environments.
Methods The evaluation had a cross-sectional, quasi-experimental design with the intervention FDC service in Geelong and a comparison sample from 17 FDC services across Victoria. A 45-item questionnaire capturing nutrition- and physical activity-related aspects of the policy, socio-cultural and physical environments of the FDC service was completed by FDC care providers (in 2008) in the intervention (n = 28) and comparison (n = 223) samples.
Results Select results showed intervention children spent less time in screen-based activities (P = 0.03), organized active play (P < 0.001) and free inside play (P = 0.03) than comparison children. There were more rules related to healthy eating (P < 0.001), more care provider practices that supported children’s positive meal experiences (P < 0.001), fewer unhealthy food items allowed (P = 0.05), higher odds of staff being trained in nutrition (P = 0.04) and physical activity (P < 0.001), lower odds of having set minimum times for outside (P < 0.001) and organized (P = 0.01) active play, and of rewarding children with food (P < 0.001).
Conclusions Romp & Chomp improved the FDC service to one that discourages sedentary behaviours and promotes opportunities for children to eat nutritious foods. Ongoing investment to increase children’s physical activity within the setting and improving the capacity and health literacy of care providers is required to extend and sustain the improvements.

The Alcohol Intervention Training Program (AITP) : a response to alcohol misuse in the farming community

Background
Farm men and women in Australia have higher levels of problematic alcohol use than their urban counterparts and experience elevated health risks associated with excessive alcohol consumption. The Sustainable Farm Families (SFF) program has worked successfully with farm men and women to address health, well- being and safety and has identified that further research and training is required to understand and address alcohol misuse behaviours. This project will add an innovative component to the program by training health professionals working with farm men and women to discuss and respond to alcohol-related physical and mental health problems.

Methods/Design
A mixed method design with multi-level evaluation will be implemented following the development and delivery of a training program (The Alcohol Intervention Training Program {AITP}) for Sustainable Farm Families health professionals. Pre-, post- and follow-up surveys will be used to assess both the impact of the training on the knowledge, confidence and skills of the health professionals to work with alcohol misuse and associated problems, and the impact of the training on the attitudes, behaviour and mental health of farm men and women who participate in the SFF project. Evaluations will take a range of forms including self-rated outcome measures and interviews.

Discussion
The success of this project will enhance the health and well-being of a critical population, the farm men and women of Australia, by producing an evidence-based strategy to assist them to adopt more positive alcohol-related behaviours that will lead to better physical and mental health.

Intervention for depression among palliative care patients and their families : a study protocol for evaluation of a training program for professional care staff

Background: Clinical depression is highly prevalent yet under-detected and under-treated in palliative care settings and is associated with a number of adverse medical and psychological outcomes for patients and their family members. This article presents a study protocol to evaluate a training intervention for non-physician palliative care staff to improve the recognition of depression and provide support for depressed patients and their family members. Details of the hypotheses and expected outcomes, study design, training program development and evaluation measures are described.
Methods and Design: A randomised controlled trial will be implemented across two palliative care services to evaluate the “Training program for professional carers to recognise and manage depression in palliative care settings”. Pre-, post- and three-month follow-up data will be collected to assess: the impact of the training on the knowledge, attitudes, self-efficacy and perceived barriers of palliative care staff when working with depression; referral rates for depression; and changes to staff practices. Quantitative and qualitative methods, in the form of self-report questionnaires and interviews with staff and family members, will be used to evaluate the effectiveness of the intervention.
Discussion: This study will determine the effectiveness of an intervention that aims to respond to the urgent need for innovative programs to target depression in the palliative care setting. The expected outcome of this study is the validation of an evidence-based training program to improve staff recognition and appropriate referrals for depression, as well as improve psychosocial support for depressed patients and their family members.

Factors influencing quality of behaviour support plans and the impact of plan quality on restrictive intervention use

Background: The quality and effectiveness of the support provided to people with disability who show challenging behaviour can be influenced by the design and content of their behaviour support plans (BSPs). This study examined some of the factors that might influence the quality of behaviour support plans and the impact of quality of BSPs on the use of restrictive intervention.

Method: An audit of the quality of a sample of BSPs submitted to the Senior Practitioner in Victoria in the years 2009 and 2010 was conducted using the Behavior Support Plan Quality Evaluation, 2nd Edition (BSP-QE II).

Results: Factors found to positively influence quality of BSPs included: involvement of behaviour consultants and involvement of clinicians from the Office of the Senior Practitioner (Office). Overall quality of plans was also negatively related to restrictive intervention use over time.

Conclusions: The findings support the need for behaviour intervention and provision of clinical support. The findings also provide tentative support for the notion that the inclusion of evidence-based quality components into behaviour support plan formats may reduce the use of restrictive interventions.