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Reducing cardiometabolic risk in adults with a low socioeconomic position: protocol of the Supreme Nudge parallel cluster-randomised controlled supermarket trial.

ABSTRACT: BACKGROUND:Unhealthy lifestyle behaviours such as unhealthy dietary intake and insufficient physical activity (PA) tend to cluster in adults with a low socioeconomic position (SEP), putting them at high cardiometabolic disease risk. Educational approaches aiming to improve lifestyle behaviours show limited effect in this population. Using environmental and context-specific interventions may create opportunities for sustainable behaviour change. In this study protocol, we describe the design of a real-life supermarket trial combining nudging, pricing and a mobile PA app with the aim to improve lifestyle behaviours and lower cardiometabolic disease risk in adults with a low SEP. METHODS:The Supreme Nudge trial includes nudging and pricing strategies cluster-randomised on the supermarket level, with: i) control group receiving no intervention; ii) group 1 receiving healthy food nudges (e.g., product placement or promotion); iii) group 2 receiving nudges and pricing strategies (taxing of unhealthy foods and subsidizing healthy foods). In collaboration with a Dutch supermarket chain we will select nine stores located in low SEP neighbourhoods, with the nearest competitor store at > 1 km distance and managed by a committed store manager. Across the clusters, a personalized mobile coaching app targeting walking behaviour will be randomised at the individual level, with: i) control group; ii) a group receiving the mobile PA app. All participants (target n = 1485) should be Dutch-speaking, aged 45-75 years with a low SEP and purchase more than half of their household grocery shopping at the selected supermarkets. Participants will be recruited via advertisements and mail-invitations followed by community-outreach methods. Primary outcomes are changes in systolic blood pressure, LDL-cholesterol, HbA1c and dietary intake after 12 months follow-up. Secondary outcomes are changes in diastolic blood pressure, blood lipid markers, waist circumference, steps per day, and behavioural factors including healthy food purchasing, food decision style, social cognitive factors related to nudges and to walking behaviours and customer satisfaction after 12 months follow-up. The trial will be reflexively monitored to support current and future implementation. DISCUSSION:The findings can guide future research and public health policies on reducing lifestyle-related health inequalities, and contribute to a supermarket-based health promotion intervention implementation roadmap. TRIAL REGISTRATION:Dutch Trial Register ID NL7064, 30th of May, 2018.

SUBMITTER: Stuber JM

PROVIDER: S-EPMC7236937 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundRecruiting participants for lifestyle programmes is known to be challenging. Insights into recruitment strategies, enrolment rates and costs are valuable but rarely reported. We provide insight into the costs and results of used recruitment strategies, baseline characteristics and feasibility of at-home cardiometabolic measurements as part of the Supreme Nudge trial investigating healthy lifestyle behaviours. This trial was conducted during the COVID-19 pandemic, requiring a largely remote data collection approach. Potential sociodemographic differences were explored between participants recruited through various strategies and for at-home measurement completion rates.MethodsParticipants were recruited from socially disadvantaged areas around participating study supermarkets (n = 12 supermarkets) across the Netherlands, aged 30-80 years, and regular shoppers of the participating supermarkets. Recruitment strategies, costs and yields were logged, together with completion rates of at-home measurements of cardiometabolic markers. Descriptive statistics are reported on recruitment yield per used method and baseline characteristics. We used linear and logistic multilevel models to assess the potential sociodemographic differences.ResultsOf 783 recruited, 602 were eligible to participate, and 421 completed informed consent. Most included participants were recruited via letters/flyers at home (75%), but this strategy was very costly per included participant (89 Euros). Of paid strategies, supermarket flyers were the cheapest (12 Euros) and the least time-invasive (< 1 h). Participants who completed baseline measurements (n = 391) were on average 57.6 (SD 11.0) years, 72% were female and 41% had high educational attainment, and they often completed the at-home measurements successfully (lipid profile 88%, HbA1c 94%, waist circumference 99%). Multilevel models suggested that males tended to be recruited more often via word-of-mouth (ORfemales 0.51 (95%CI 0.22; 1.21)). Those who failed the first attempt at completing the at-home blood measurement were older (β 3.89 years (95% CI 1.28; 6.49), whilst the non-completers of the HbA1c (β - 8.92 years (95% CI - 13.62; - 4.28)) and LDL (β - 3.19 years (95% CI - 6.53; 0.09)) were younger.ConclusionsSupermarket flyers were the most cost-effective paid strategy, whereas mailings to home addresses recruited the most participants but were very costly. At-home cardiometabolic measurements were feasible and may be useful in geographically widespread groups or when face to face contact is not possible.Trial registrationDutch Trial Register ID NL7064, 30 May 2018, https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7302.

Project description:BackgroundUptake of colorectal cancer screening is low in the English NHS Bowel Cancer Screening Programme (BCSP). Participation in screening is strongly associated with socioeconomic status. The aim of this study was to determine whether a supplementary leaflet providing the 'gist' of guaiac-based Faecal Occult Blood test (gFOBt) screening for colorectal cancer could reduce the socioeconomic status (SES) gradient in uptake in the English NHS BCSP.MethodsThe trial was integrated within routine BCSP operations in November 2012. Using a cluster randomised controlled design all adults aged 59-74 years who were being routinely invited to complete the gFOBt were randomised based on day of invitation. The Index of Multiple Deprivation was used to create SES quintiles. The control group received the standard information booklet ('SI'). The intervention group received the SI booklet and the Gist leaflet ('SI + Gist') which had been designed to help people with lower literacy engage with the invitation. Blinding of hubs was not possible and invited subjects were not made aware of a comparator condition. The primary outcome was the gradient in uptake across IMD quintiles.ResultsIn November 2012, 163,525 individuals were allocated to either the 'SI' intervention (n = 79,104) or the 'SI + Gist' group (n = 84,421). Overall uptake was similar between the intervention and control groups (SI: 57.3% and SI + Gist: 57.6%; OR = 1.02, 95% CI: 0.92-1.13, p = 0.77). Uptake was 42.0% (SI) vs. 43.0% (SI + Gist) in the most deprived quintile and 65.6% vs. 65.8% in the least deprived quintile (interaction p = 0.48). The SES gradient in uptake was similar between the study groups within age, gender, hub and screening round sub-groups.ConclusionsProviding supplementary simplified information in addition to the standard information booklet did not reduce the SES gradient in uptake in the NHS BCSP. The effectiveness of the Gist leaflet when used alone should be explored in future research.Trial registrationISRCTN74121020 , registered: 17/20/2012.

Project description:BACKGROUND:Mosquito-borne viruses are imposing an ever increasing health burden worldwide. In addition to the recent Zika and chikungunya virus epidemics, dengue viruses have become the fastest growing problem with a 40-fold increase in the number of reported cases over the past five decades. Current mosquito control techniques involving larval source reduction, larviciding, and space spray of adulticides are costly, laborious, and of debatable efficacy. There remains an urgent need for the development of intervention methods that can be reasonably implemented in the context of modern day urbanisation. Auto-dissemination (AD) of insecticide by adult mosquitoes offers a potentially practical and useful tool in an integrated vector control programme. Recently, an immediately employable AD device, the In2Care® mosquito trap, has been commercialised and shows promise as an effective tool. However, there remains a lack of demonstration of epidemiological efficacy. METHODS/DESIGN:This trial aims to assess the extent to which implementation of In2Care® mosquito traps can reduce vector Aedes (Stegomyia) spp. adult mosquito densities and dengue virus transmission as measured by sequential sero-conversion rates in children 6-16?years of age in a dengue endemic location: Lipa City, Philippines. To achieve this, we will carry out a parallel, two-armed cluster randomised trial evaluating AD efficacy for reducing the incidence of dengue over a 2-year period with 4 consecutive months of vector control during peak dengue transmission each year. DISCUSSION:For decades, it has been commonly accepted that an integrated approach to mosquito control is required. The World Health Organization (WHO) Global Strategic Framework for Integrated Vector Management recommends a range of interventions, in combination, to increase control impact to reduce transmission. This efficacy trial of the first commercial product using the AD approach will be informative in assessing the general utility of AD in reducing not only adult vector densities but, more importantly, reducing the incidence of dengue. The AD technique may complement source reduction and larviciding campaigns by more efficiently targeting the most productive containers and those beyond human reach. If successful, this mosquito control strategy could prove an invaluable tool in the fight against urban mosquito vectors and a reduction in the burden of associated disease. TRIAL REGISTRATION:ISRCTN44272773 . Registered on 31 January 2019.

Project description:BackgroundSuccessful implementation and long-term maintenance of healthy supermarkets initiatives are crucial to achieving potential population health benefits. Understanding barriers and enablers of implementation of real-world trials will enhance wide-scale implementation. This process evaluation of a healthy supermarket intervention sought to describe (i) customer, retailer and stakeholder perspectives on the intervention; (ii) intervention implementation; and (iii) implementation barriers and enablers.MethodsEat Well @ IGA was a 12-month randomised controlled trial conducted in 11 Independent Grocers of Australia (IGA) chain supermarkets in regional Victoria, Australia (5 intervention and 6 wait-listed control stores). Intervention components included trolley and basket signage, local area and in-store promotion, and shelf tags highlighting the healthiest packaged foods. A sequential mixed-methods process evaluation was undertaken. Customer exit surveys investigated demographics, and intervention recall and perceptions. Logistic mixed-models estimated associations between customer responses and demographics, with store as random effect. Supermarket staff surveys investigated staff demographics, interactions with customers, and intervention component feedback. Semi-structured stakeholder interviews with local government, retail and academic partners explored intervention perceptions, and factors which enabled or inhibited implementation, maintenance and scalability. Interviews were inductively coded to identify key themes.ResultsOf 500 customers surveyed, 33%[95%CI:23,44] recalled the Eat Well @ IGA brand and 97%[95%CI:93,99] agreed that IGA should continue its efforts to encourage healthy eating. The 82 staff surveyed demonstrated very favourable intervention perceptions. Themes from 19 interviews included that business models favour sales of unhealthy foods, and that stakeholder collaboration was crucial to intervention design and implementation. Staff surveys and interviews highlighted the need to minimise staff time for project maintenance and to regularly refresh intervention materials to increase and maintain salience among customers.ConclusionsThis process evaluation found that interventions to promote healthy diets in supermarkets can be perceived as beneficial by retailers, customers, and government partners provided that barriers including staff time and intervention salience are addressed. Collaborative partnerships in intervention design and implementation, including retailers, governments, and academics, show potential for encouraging long-term sustainability of interventions.Trial registrationISRCTN, ISRCTN37395231 Registered 4 May 2017.

Project description:Studies that have examined the impact of a physical activity intervention on cardiometabolic risk factors have yielded conflicting results. The objective of this study was to assess the impact of a standardized physical activity program on adiposity and cardiometabolic risk factors in schoolchildren.Cluster randomized trial study of 712 schoolchildren, 8-10 years, from 20 public schools in the Province of Cuenca, Spain. The intervention (MOVI-2) consisted of play-based and non-competitive activities. MOVI-2 was conducted during two 90-minute sessions on weekdays and one 150-minute session on Saturday mornings every week between September 2010 and May 2011. We measured changes in adiposity (overweight/obesity prevalence, body mass index [BMI], triceps skinfold thickness [TST], body fat %, fat-free mass, waist circumference) and other cardiometabolic risk factors (LDL-cholesterol, triglycerides/HDL-cholesterol ratio, insulin, C-reactive protein and blood pressure). The analyses used mixed regression models to adjust for baseline covariates under cluster randomization.Among girls, we found a reduction of adiposity in intervention versus control schools, with a decrease in TST (-1.1 mm; 95% confidence interval [CI] -2.3 to -0.7), body fat % (-0.9%; 95% CI -1.3 to -0.4), waist circumference (-2.7 cm; 95% CI -4.5 to -0.9), and an increase in fat-free mass (0.3 kg; 95% CI 0.01 to 0.6). The intervention also led to lower serum LDL-cholesterol and insulin levels. Among boys, a reduction in waist circumference (-1.4 cm; 95% CI -2.6 to -0.1; P?=?0.03), and an increase in fat-free mass (0.5 kg; 95% CI 0.2 to 0.9; P?=?0.003) was associated with the intervention versus control schools. The prevalence of overweight/obesity or underweight, BMI, and other cardiometabolic risk factors was not modified by the intervention. No important adverse events were registered.An extracurricular intervention of non-competitive physical activity during an academic year, targeting all schoolchildren regardless of body weight, is a safe and effective measure to reduce adiposity in both genders and to improve cardiometabolic risk profile in girls.Clinical trials NCT01277224.

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Reducing cardiometabolic risk in adults with a low socioeconomic position: protocol of the Supreme Nudge parallel cluster-randomised controlled supermarket trial.

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