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:BackgroundMobility limitations in old age can greatly reduce quality of life, generate substantial health and social care costs, and increase mortality. Through the Retirement in Action (REACT) trial, we aimed to establish whether a community-based active ageing intervention could prevent decline in lower limb physical functioning in older adults already at increased risk of mobility limitation.MethodsIn this pragmatic, multicentre, two-arm, single-blind, parallel-group, randomised, controlled trial, we recruited older adults (aged 65 years or older and who are not in full-time employment) with reduced lower limb physical functioning (Short Physical Performance Battery [SPPB] score 4-9) from 35 primary care practices across three sites (Bristol and Bath; Birmingham; and Devon) in England. Participants were randomly assigned to receive brief advice (three healthy ageing education sessions) or a 12-month, group-based, multimodal physical activity (64 1-h exercise sessions) and behavioural maintenance (21 45-min sessions) programme delivered by charity and community or leisure centre staff in local communities. Randomisation was stratified by site and adopted a minimisation approach to balance groups by age, sex, and SPPB score, using a centralised, online, randomisation algorithm. Researchers involved in data collection and analysis were masked but participants were not because of the nature of the intervention. The primary outcome was change in SPPB score at 24 months, analysed by intention to treat. This trial is registered with ISRCTN, ISRCTN45627165.FindingsBetween June 20, 2016, and Oct 30, 2017, 777 participants (mean age 77·6 [SD 6·8] years; 66% female; mean SPPB score 7·37 [1·56]) were randomly assigned to the intervention (n=410) and control (n=367) groups. Primary outcome data at 24 months were provided by 628 (81%) participants (294 in the control group and 334 in the intervention group). At the 24-month follow-up, the SPPB score (adjusted for baseline SPPB score, age, sex, study site, and exercise group) was significantly greater in the intervention group (mean 8·08 [SD 2·87]) than in the control group (mean 7·59 [2·61]), with an adjusted mean difference of 0·49 (95% CI 0·06-0·92; p=0·014), which is just below our predefined clinically meaningful difference of 0·50. One adverse event was related to the intervention; the most common unrelated adverse events were heart conditions, strokes, and falls.InterpretationFor older adults at risk of mobility limitations, the REACT intervention showed that a 12-month physical activity and behavioural maintenance programme could help prevent decline in physical function over a 24-month period.FundingNational Institute for Health Research Public Health Research Programme (13/164/51).

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Project description:BackgroundChildhood undernutrition remains a public health issue that can lead to unfavourable effects in later life. These effects tend to be more devastating among urban poor young children, especially in light of the recent COVID-19 pandemic. There is an immediate need to introduce interventions to reduce childhood undernutrition. This paper described the study protocol of a nutrition programme that was developed based on the positive deviance approach and the evaluation of the effectiveness of the programme among urban poor children aged 3 to 5 years old.MethodsThis mixed-method study will be conducted in two phases at low-cost flats in Kuala Lumpur. Phase one will involve a focus group discussion with semi-structured interviews to explore maternal feeding practices and the types of food fed to the children. Phase two will involve a two-armed cluster randomised controlled trial to evaluate the effectiveness of a programme developed based on the positive deviance approach. The programme will consist of educational lessons with peer-led cooking demonstrations, rehabilitation, and growth monitoring sessions. Intervention group will participate in the programme conducted by the researcher for three months whereas the comparison group will only receive all the education materials and menus used in the programme after data collection has been completed. For both groups, data including height, weight, and dietary intake of children as well as the nutritional knowledge and food security status of mothers will be collected at baseline, immediate post-intervention, and 3-month post-intervention.Expected resultsThe positive deviance approach helps to recognise the common feeding practices and the local wisdom unique to the urban poor population. Through this programme, mothers may learn from and be empowered by their peers to adopt new feeding behaviours so that their children can achieve healthy weight gain.Trial registrationThis study was registered with clinicaltrials.gov: NCT04688515 on 29 December 2020, https://www.clinicaltrials.gov/ct2/show/NCT04688515.

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.

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.

Similar Datasets

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