Dataset Information

A cluster-randomised controlled trial of a physical activity and nutrition programme in retirement villages: a study protocol.

ABSTRACT:

Introduction

Physical activity levels of Australia's ageing population are declining and coincidentally rates of overweight and obesity are increasing. Adequate levels of physical activity and a healthy diet are recognised as important lifestyle factors for the maintenance of a healthy weight and prevention of chronic diseases. Retirement village (RV) residents rarely engage in physical activity and nutrition programmes offered, with poor attendance and low use of existing facilities such as on-site fitness centres and classes and nutrition seminars. The RV provides a unique setting to access and engage with this older target group, to test the effectiveness of strategies to increase levels of physical activity, improve nutrition and maintain a healthy weight.

Method and analysis

This cluster-randomised controlled trial will evaluate a physical activity, nutrition and healthy weight management intervention for insufficiently active ('not achieving 150 min of moderate-intensity physical activity per week') adults aged 60-75 residing in RV's. A total of 400 participants will be recruited from 20 randomly selected RV's in Perth, Western Australia. Villages will be assigned to either the intervention group (n=10) or the control group (n=10) each containing 200 participants. The Retirement Village Physical Activity and Nutrition for Seniors (RVPANS) programme is a home-based physical activity and nutrition programme that includes educational resources, along with facilitators who will motivate and guide the participants during the 6-month intervention. Descriptive statistics and mixed regression models will be performed to assess the intervention effects. This trial will evaluate an intervention for the modification of health risk factors in the RV setting. Such research conducted in RV's has been limited.

Ethics and dissemination

Curtin University Human Research Ethics Committee (approval number: HR128/2012). Dissemination of the study results will occur through publications, reports, conference presentations and community seminars.

Trial registration number

Australia and New Zealand Clinical Trial Registry (ACTRN12612001168842).

SUBMITTER: Holt AM

PROVIDER: S-EPMC4179572 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Publications

A cluster-randomised controlled trial of a physical activity and nutrition programme in retirement villages: a study protocol.

Holt Anne-Marie AM Jancey Jonine J Lee Andy H AH Kerr Deborah A DA Hills Andrew P AP Anderson Annie S AS Howat Peter A PA

BMJ open 20140925 9

<h4>Introduction</h4>Physical activity levels of Australia's ageing population are declining and coincidentally rates of overweight and obesity are increasing. Adequate levels of physical activity and a healthy diet are recognised as important lifestyle factors for the maintenance of a healthy weight and prevention of chronic diseases. Retirement village (RV) residents rarely engage in physical activity and nutrition programmes offered, with poor attendance and low use of existing facilities suc ...[more]

PMID: 25256185

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Project description:BACKGROUND:Most physical activity interventions in children focus on the school setting; however, children typically engage in more sedentary activities and spend more time eating when at home. The primary aim of this cluster randomised controlled trial was to investigate the effects of a compulsory, health-related homework programme on physical activity, dietary patterns, and body size in primary school-aged children. METHODS:A total of 675 children aged 7-10 years from 16 New Zealand primary schools participated in the Healthy Homework study. Schools were randomised into intervention and control groups (1:1 allocation). Intervention schools implemented an 8-week applied homework and in-class teaching module designed to increase physical activity and improve dietary patterns. Physical activity was the primary outcome measure, and was assessed using two sealed pedometers that monitored school- and home-based activity separately. Secondary outcome measures included screen-based sedentary time and selected dietary patterns assessed via parental proxy questionnaire. In addition, height, weight, and waist circumference were measured to obtain body mass index (BMI) and waist-to-height ratio (WHtR). All measurements were taken at baseline (T0), immediately post-intervention (T1), and 6-months post-intervention (T2). Changes in outcome measures over time were estimated using generalised linear mixed models (GLMMs) that adjusted for fixed (group, age, sex, group x time) and random (subjects nested within schools) effects. Intervention effects were also quantified using GLMMs adjusted for baseline values. RESULTS:Significant intervention effects were observed for weekday physical activity at home (T1 [P < 0.001] and T2 [P = 0.019]), weekend physical activity (T1 [P < 0.001] and T2 [P < 0.001]), BMI (T2 only [P = 0.020]) and fruit consumption (T1 only [P = 0.036]). Additional analyses revealed that the greatest improvements in physical activity occurred in children from the most socioeconomically deprived schools. No consistent effects on sedentary time, WHtR, or other dietary patterns were observed. CONCLUSIONS:A compulsory health-related homework programme resulted in substantial and consistent increases in children's physical activity - particularly outside of school and on weekends - with limited effects on body size and fruit consumption. Overall, our findings support the integration of compulsory home-focused strategies for improving health behaviours into primary education curricula. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry, ACTRN12618000590268 . Registered 17 April 2018.

Project description:BackgroundThe majority of retirement village residents are at risk of medication misadventure. In a recent survey of retirement village residents in Victoria, two-thirds had at least one medication-related risk factor, and hence were eligible to receive a government-subsidised Home Medicines Review (HMR). However, only 6% of eligible residents had received a HMR in the previous 12 months. Reasons for the poor uptake of HMR, and interventions for improving HMR uptake, have been identified and developed with input from stakeholders. The trial will test the effect of Pharmacist-conducted HMR to Address the Risk of Medication-related Events in Retirement Villages (PHARMER) in improving the uptake of HMRs among retirement village residents.Methods/designThis is a multicentre prospective cluster randomised controlled trial. Ten retirement villages in Victoria, Australia will be recruited for this trial. Retirement villages will be selected in consultation with the Residents of Retirement Villages Victoria Inc. (RRVV), based on geographical locations (e.g. northeast or southwest), size and other factors. Residents from selected villages will be recruited with the help of RRVV Resident Liaison Officers using a range of strategies. Randomisation will be by geographical location to minimise contamination. Participating villages and residents will be allocated to either Pharmacist Intervention Group (PIG) or Usual Care Group (UCG). Each group will include five retirement villages and will have at least 77 residents in total. The intervention (PHARMER) comprises educating residents regarding HMR, and using a risk assessment checklist by residents to notify their General Practitioners of their medication risk. Uptake of HMR and medication adherence will be assessed in both PIG and UCG at three and six months using telephone interviews and questionnaires.DiscussionThis study is the first to develop and test an intervention to improve the uptake of HMR among Australian residents in retirement villages, with a view to decreasing medication risk. A multi-faceted interventional approach will be used as suggested by stakeholders. The trial is expected to be complete by late 2011 and results will be available in 2012.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12611000109909).

Project description:The majority of the older Singaporean women aged 50 years and above are physically inactive and have unhealthy dietary habits, placing them at 'high risk' of non-communicable diseases (NCDs). The adoption of regular physical activity (PA) and a healthy diet are essential lifestyle behaviours to reduce this risk. This randomised controlled trial (RCT) involves the development, implementation and evaluation of a PA and nutrition programme for community-dwelling Singaporean women who currently attend recreational centres (RCs are public facilities supporting social leisure activities) in their local area. The intervention will be developed after conducting formative evaluation with RC attendees and managers through focus group discussions and pilot testing of resources (i.e. surveys, accelerometers, and health booklets). Programme ambassadors (trained, certified fitness instructors and nutritionists) will deliver all sessions in English and Mandarin; implement classes to meet participants' varying needs; and conduct sessions at different times at convenient venues. Social Cognitive Theory (SCT) has been selected as the theoretical framework to inform intervention strategies as it explores the interactions of human behaviour with the environment and has been found to be valuable when developing behavioural change interventions particularly in older adults (J Gerontol B Psychol Sci Soc Sci 67B(1):18-26, 2012; Obesity Reviews 15(12):983-95, 2014). Its major construct, self-efficacy, is invaluable in achieving successful behaviour change, such as increasing levels of PA or improving dietary intake (Trials. 2017; https://doi.org/10.1186/s13063-016-1771-9 ; Psychol Health Med 18(6):714-24, 2013).The development and implementation of the PA and nutrition intervention strategies will be guided by SCT and Motivational interviewing (MI) and implemented by trained programme ambassadors at the RCs. Sixty RCs located in Singapore will be selected from five major geographical districts and randomly allocated to the intervention (n = 30) or control (n = 30) cluster. A sample of 600 (intervention n = 300; control n = 300) women aged 50 years and above will then be recruited from these 60 centres and only the intervention group will be enrolled into the PA and nutrition intervention. It is hypothesised that by the end of the intervention, the intervention group participants compared to the control group will show significantly greater improvements in the following outcome variables: PA and dietary behaviours, health-related quality of life, objective measures of PA, anthropometric, lipid and glucose profiles. Data will be collected at baseline and 6 months and analysed using mixed regression models.It is anticipated that recruitment, retention and compliance of participants will be challenging due to the target group being unfamiliar with such community-based research programmes.Australian and New Zealand Clinical Trials Registry, ACTRN12617001022358. Registered on 14 July 2017. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372984&isReview=true.

Project description:BackgroundUntreated heterozygous familial hypercholesterolaemia (FH) causes high low-density lipoprotein cholesterol (LDL-C) levels and increased cardiovascular disease (CVD) risk. Despite pharmacological treatment, many treated individuals remain at higher CVD risk than non-affected individuals. This may be due to LDL-C targets not being met and presence of other CVD risk factors. Adhering to dietary and physical activity (PA) recommendations developed for individuals with FH may further reduce CVD risk. However, there is insufficient research to support the efficacy of adhering to these guidelines on LDL-C and other CVD risk factors. The need for studies to investigate the effectiveness of nutrition and PA interventions in the FH population has been widely recognised and recommended. This paper describes the protocol of a pilot, randomised controlled trial designed to evaluate the feasibility and acceptability of a specifically developed nutrition and PA intervention aimed at improving the dietary intakes and PA levels of families with FH.MethodsA two-arm randomised waitlist-controlled pilot trial will be conducted across three National Health Service (NHS) sites in England, UK. Twenty-four young people with FH, aged 10-18 years, and their affected parent, will be recruited and randomly assigned to the intervention or waitlist and usual care control. The primary aim is to provide evidence for the feasibility and acceptability of delivering the intervention, explored quantitatively (rates of recruitment, retention and outcome measure completeness) and qualitatively (qualitative interviews). The secondary aim is to provide evidence for the potential efficacy of the intervention on dietary intake, PA, sedentary time, body composition, CVD risk factors and quality of life determined at baseline and endpoint assessments. The intervention will involve an hour-long consultation with a dietitian at baseline and four follow-up contacts across the 12-week intervention. It has been specifically developed for use with individuals with FH and incorporates behavioural change techniques to target identified enablers and barriers to adherence in this population.DiscussionThis trial will estimate the feasibility and acceptability of the nutrition and PA intervention delivered to young people and parents with FH. If appropriate, this study can be used to inform the design of an adequately powered definitive trial.Trial registrationISRCTN, ISRCTN24880714. Registered 07/06/2018, http://www.isrctn.com/ISRCTN24880714.

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Project description:IntroductionEvery year, up to 1 billion children are victims of violence worldwide. Most child abuse takes place in the context of punishment. The Families First Programme, an adaptation of the Positive Discipline in Everyday Parenting Programme to the West Java context, is a parenting support programme anchored on children's rights that gives parents guidance on child development, parenting and positive discipline practices. This trial will evaluate the effectiveness of the Families First Programme compared with a waitlist control group.Methods and analysisThis is a pragmatic, parallel-group, stratified, cluster-randomised controlled trial. Twenty rural and urban villages in the Cianjur District, Indonesia, involving 720 caregivers of children up to 7 years of age, will be randomised. Villages will receive either a parenting programme consisting of 10 group sessions and four home visits over 3 months and standard community health and social services or just the latter. After completion of the trial period, the programme will be offered to those in the delayed group. Outcome data will be collected before randomisation (baseline), immediately postintervention (3 months postrandomisation) and 6 months later (9 months postrandomisation). The primary outcome will be frequency of physical and emotional punishment as measured by a weighted sum from three self-report items. Primary outcome analysis will use Poisson regression with generalised estimating equations and assess the interaction between intervention and time over baseline and 3 and 9 months postrandomisation assessments. Concurrent process evaluation will be conducted to assess programme satisfaction and facilitators and barriers to the implementation of the programme generalisable to other settings.Ethics and disseminationEthics approval was obtained from McGill University and Universitas Katolik Indonesia Atma Jaya. Results will be published in peer-reviewed journals and presented at scientific conferences and events for decision-makers, including in the participating communities.Trial registration numberNCT03374761.

Project description:BackgroundAdolescent girls are less physically active than recommended for health, and levels decline further as they approach adulthood. Peers can influence adolescent girls' physical activity. Interventions capitalising on peer support could positively impact physical activity behaviour in this group. Building on promising feasibility work, the purpose of this cluster randomised controlled trial is to assess whether the Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A) increases adolescent girls' physical activity and is cost effective.MethodsPLAN-A is a two-arm secondary school-based cluster randomised controlled trial, conducted with girls aged 13-14?years from twenty schools in the south west of England. The intervention requires participants to nominate influential girls within their year group to become peer supporters. The top 15% of girls nominated in each school receive three days of training designed to prepare them to support their peers to be more physically active during a ten-week intervention period. Data will be collected at two time points, at baseline (T0) and 5-6?months post-intervention (T1). Schools will be randomly allocated to the intervention (n?=?10) or control (n?=?10) arm after T0. At each time point, all consenting participants will wear an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity. Multivariable mixed effects linear regression will be used to estimate differences in the primary outcome between the two arms and will be examined on an Intention-to-Treat (ITT) basis. A self-report psychosocial questionnaire will be completed by participants to assess self-esteem and physical activity motivation. Resource use and quality of life will be measured for the purposes of an economic evaluation. A mixed-methods process evaluation will be conducted to explore intervention fidelity, acceptability and sustainability. Analysis of quantitative process evaluation data will be descriptive, and the framework method will be used to analyse qualitative data.DiscussionThis paper describes the protocol for the PLAN-A cluster randomised controlled trial, a novel approach to increasing adolescent girls' physical activity levels through peer support.Trial registrationISRCTN14539759-31 May, 2018.

Dataset Information

A cluster-randomised controlled trial of a physical activity and nutrition programme in retirement villages: a study protocol.

Introduction

Method and analysis

Ethics and dissemination

Trial registration number

Publications

A cluster-randomised controlled trial of a physical activity and nutrition programme in retirement villages: a study protocol.

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