Equity-specific effects of interventions to promote physical activity among middle-aged and older adults: results from applying a novel equity-specific re-analysis strategy.

BACKGROUND: Reducing inequalities in physical activity (PA) and PA-associated health outcomes is a priority for public health. Interventions to promote PA may reduce inequalities, but may also unintentionally increase them. Thus, there is a need to analyze equity-specific intervention effects. However, the potential for analyzing equity-specific effects of PA interventions has not yet been sufficiently exploited. The aim of this study was to set out a novel equity-specific re-analysis strategy tried out in an international interdisciplinary collaboration. METHODS: The re-analysis strategy comprised harmonizing choice and definition of outcomes, exposures, socio-demographic indicators, and statistical analysis strategies across studies, as well as synthesizing results. It was applied in a collaboration of a convenience sample of eight European PA intervention studies in adults aged ≥45 years. Weekly minutes of moderate-to-vigorous PA was harmonized as outcome. Any versus no intervention was harmonized as exposure. Gender, education, income, area deprivation, and marital status were harmonized as socio-demographic indicators. Interactions between the intervention and socio-demographic indicators on moderate-to-vigorous PA were analyzed using multivariable linear regression and random-effects meta-analysis. RESULTS: The collaborative experience shows that the novel re-analysis strategy can be applied to investigate equity-specific effects of existing PA interventions. Across our convenience sample of studies, no consistent pattern of equity-specific intervention effects was found. Pooled estimates suggested that intervention effects did not differ by gender, education, income, area deprivation, and marital status. CONCLUSIONS: To exploit the potential for equity-specific effect analysis, we encourage future studies to apply the strategy to representative samples of existing study data. Ensuring sufficient representation of 'hard to reach' groups such as the most disadvantaged in study samples is of particular importance. This will help to extend the limited evidence required for the design and prioritization of future interventions that are most likely to reduce health inequalities.

Enhanced motivational interviewing for reducing weight and increasing physical activity in adults with high cardiovascular risk: the MOVE IT three-arm RCT.

BACKGROUND: Motivational interviewing (MI) enhanced with behaviour change techniques (BCTs) and deployed by health trainers targeting multiple risk factors for cardiovascular disease (CVD) may be more effective than interventions targeting a single risk factor. OBJECTIVES: The clinical effectiveness and cost-effectiveness of an enhanced lifestyle motivational interviewing intervention for patients at high risk of CVD in group settings versus individual settings and usual care (UC) in reducing weight and increasing physical activity (PA) were tested. DESIGN: This was a three-arm, single-blind, parallel randomised controlled trial. SETTING: A total of 135 general practices across all 12 South London Clinical Commissioning Groups were recruited. PARTICIPANTS: A total of 1742 participants aged 40-74 years with a ≥ 20.0% risk of a CVD event in the following 10 years were randomised. INTERVENTIONS: The intervention was designed to integrate MI and cognitive-behavioural therapy (CBT), delivered by trained healthy lifestyle facilitators in 10 sessions over 1 year, in group or individual format. The control group received UC. RANDOMISATION: Simple randomisation was used with computer-generated randomisation blocks. In each block, 10 participants were randomised to the group, individual or UC arm in a 4 : 3 : 3 ratio. Researchers were blind to the allocation. MAIN OUTCOME MEASURES: The primary outcomes are change in weight (kg) from baseline and change in PA (average number of steps per day over 1 week) from baseline at the 24-month follow-up, with an interim follow-up at 12 months. An economic evaluation estimates the relative cost-effectiveness of each intervention. Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. RESULTS: The mean age of participants was 69.75 years (standard deviation 4.11 years), 85.5% were male and 89.4% were white. At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI) -288 to 147.9 steps, and mean 7.24 steps, 95% CI -224.01 to 238.5 steps, respectively] or in reducing weight (mean -0.03 kg, 95% CI -0.49 to 0.44 kg, and mean -0.42 kg, 95% CI -0.93 to 0.09 kg, respectively). At the 12-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA (mean 131.1 steps, 95% CI -85.28 to 347.48 steps, and mean 210.22 steps, 95% CI -19.46 to 439.91 steps, respectively), but there were reductions in weight for the group and individual intervention arms compared with UC (mean -0.52 kg, 95% CI -0.90 to -0.13 kg, and mean -0.55 kg, 95% CI -0.95 to -0.14 kg, respectively). The group intervention arm was not more effective than the individual intervention arm in improving outcomes at either follow-up point. The group and individual interventions were not cost-effective. CONCLUSIONS: Enhanced MI, in group or individual formats, targeted at members of the general population with high CVD risk is not effective in reducing weight or increasing PA compared with UC. Future work should focus on ensuring objective evidence of high competency in BCTs, identifying those with modifiable factors for CVD risk and improving engagement of patients and primary care. TRIAL REGISTRATION: Current Controlled Trials ISRCTN84864870. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 69. See the NIHR Journals Library website for further project information. This research was part-funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.

People who have a high risk of heart disease can reduce this risk by changing their lifestyles, such as by improving their diets and increasing their physical activity levels. However, there is no good evidence on how best to support people to change and then maintain healthier lifestyles. It is thought that support from others might be helpful. An intervention based on two talking therapies, called motivational interviewing and cognitive­behavioural therapy, to help people make a commitment to living healthier lives was developed. People from the local community with a health-related background were recruited and trained in these skills. Then general practitioners invited patients on their register who were at high risk of heart disease to participate. Those patients who replied and met the study criteria were randomly allocated to one of three arms. Participants received either group- or individual-based intensive lifestyle sessions or usual care. Those who were randomised to the lifestyle course were offered 10 sessions of therapy over 12 months by lifestyle trainers. Two years later, it was found that there were no differences in weight or physical activity levels between the three arms. The lifestyle interventions were not cost-effective compared with usual care. When the possible explanations were studied, it was found that those who could have benefited the most from the therapy (such as those who were most overweight, those from poorer backgrounds and those who were of African Caribbean ethnicity) were less likely to participate. Whether or not the skills of the therapists made a difference could not be properly assessed. Sometimes, patients and their doctors were not sure why they were invited. Future research should focus on people who have lifestyles that can be changed (e.g. more overweight individuals with unhealthy diets), on finding ways of improving the quality of the intervention and on ensuring that patients have more information.

Equity-Specific Effects of Interventions to Promote Physical Activity among Middle-Aged and Older Adults: Development of a Collaborative Equity-Specific Re-Analysis Strategy.

Reducing social inequalities in physical activity (PA) has become a priority for public health. However, evidence concerning the impact of interventions on inequalities in PA is scarce. This study aims to develop and test the application of a strategy for re-analyzing equity-specific effects of existing PA intervention studies in middle-aged and older adults, as part of an international interdisciplinary collaboration. This article aims to describe (1) the establishment and characteristics of the collaboration; and (2) the jointly developed equity-specific re-analysis strategy as a first result of the collaboration. To develop the strategy, a collaboration based on a convenience sample of eight published studies of individual-level PA interventions among the general population of adults aged ≥45 years was initiated (UK, n = 3; The Netherlands, n = 3; Belgium, n = 1; Germany, n = 1). Researchers from these studies participated in a workshop and subsequent e-mail correspondence. The developed strategy will be used to investigate social inequalities in intervention adherence, dropout, and efficacy. This will allow for a comprehensive assessment of social inequalities within intervention benefits. The application of the strategy within and beyond the collaboration will help to extend the limited evidence regarding the effects of interventions on social inequalities in PA among middle-aged and older adults.

Measuring change in trials of physical activity interventions: a comparison of self-report questionnaire and accelerometry within the PACE-UP trial.

BACKGROUND: Few trials have compared estimates of change in physical activity (PA) levels using self-reported and objective PA measures when evaluating trial outcomes. The PACE-UP trial offered the opportunity to assess this, using the self-administered International Physical Activity Questionnaire (IPAQ) and waist-worn accelerometry. METHODS: The PACE-UP trial (N = 1023) compared usual care (n = 338) with two pedometer-based walking interventions, by post (n = 339) or with nurse support (n = 346). Participants wore an accelerometer at baseline and 12 months and completed IPAQ for the same 7-day periods. Main outcomes were weekly minutes, all in ≥10 min bouts as per UK PA guidelines of: i) accelerometer moderate-to-vigorous PA (Acc-MVPA) ii) IPAQ moderate+vigorous PA (IPAQ-MVPA) and iii) IPAQ walking (IPAQ-Walk). For each outcome, 12 month values were regressed on baseline to estimate change. RESULTS: Analyses were restricted to 655 (64%) participants who provided data on all outcomes at baseline and 12 months. Both intervention groups significantly increased their accelerometry MVPA minutes/week compared with control: postal group 42 (95% CI 22, 61), nurse group 43 (95% CI 24, 63). IPAQ-Walk minutes/week also increased: postal 57 (95% CI 2, 112), nurse 43 (95% CI -11, 97) but IPAQ-MVPA minutes/week showed non-significant decreases: postal -11 (95% CI -65, 42), nurse -34 (95% CI -87, 19). CONCLUSIONS: Our results demonstrate the necessity of using a questionnaire focussing on the activities being altered, as with IPAQ-Walk questions. Even then, the change in PA was estimated with far less precision than with accelerometry. Accelerometry is preferred to self-report measurement, minimising bias and improving precision when assessing effects of a walking intervention. TRIAL REGISTRATION: ISRCTN, ISRCTN98538934 . Registered 2 March 2012.

Short-term and long-term cost-effectiveness of a pedometer-based exercise intervention in primary care: a within-trial analysis and beyond-trial modelling.

OBJECTIVES: A short-term and long-term cost-effectiveness analysis (CEA) of two pedometer-based walking interventions compared with usual care. DESIGN: (A) Short-term CEA: parallel three-arm cluster randomised trial randomised by household. (B) Long-term CEA: Markov decision model. SETTING: Seven primary care practices in South London, UK. PARTICIPANTS: (A) Short-term CEA: 1023 people (922 households) aged 45-75 years without physical activity (PA) contraindications. (b) Long-term CEA: a cohort of 100 000 people aged 59-88 years. INTERVENTIONS: Pedometers, 12-week walking programmes and PA diaries delivered by post or through three PA consultations with practice nurses. PRIMARY AND SECONDARY OUTCOME MEASURES: Accelerometer-measured change (baseline to 12 months) in average daily step count and time in 10 min bouts of moderate to vigorous PA (MVPA), and EQ-5D-5L quality-adjusted life-years (QALY). METHODS: Resource use costs (£2013/2014) from a National Health Service perspective, presented as incremental cost-effectiveness ratios for each outcome over a 1-year and lifetime horizon, with cost-effectiveness acceptability curves and willingness to pay per QALY. Deterministic and probabilistic sensitivity analyses evaluate uncertainty. RESULTS: (A) Short-term CEA: At 12 months, incremental cost was £3.61 (£109)/min in ≥10 min MVPA bouts for nurse support compared with control (postal group). At £20 000/QALY, the postal group had a 50% chance of being cost saving compared with control. (B) Long-term CEA: The postal group had more QALYs (+759 QALYs, 95% CI 400 to 1247) and lower costs (-£11 million, 95% CI -12 to -10) than control and nurse groups, resulting in an incremental net monetary benefit of £26 million per 100 000 population. Results were sensitive to reporting serious adverse events, excluding health service use, and including all participant costs. CONCLUSIONS: Postal delivery of a pedometer intervention in primary care is cost-effective long term and has a 50% chance of being cost-effective, through resource savings, within 1 year. Further research should ascertain maintenance of the higher levels of PA, and its impact on quality of life and health service use. TRIAL REGISTRATION NUMBER: ISRCTN98538934; Pre-results.

A pedometer-based walking intervention in 45- to 75-year-olds, with and without practice nurse support: the PACE-UP three-arm cluster RCT.

BACKGROUND: Guidelines recommend walking to increase moderate to vigorous physical activity (MVPA) for health benefits. OBJECTIVES: To assess the effectiveness, cost-effectiveness and acceptability of a pedometer-based walking intervention in inactive adults, delivered postally or through dedicated practice nurse physical activity (PA) consultations. DESIGN: Parallel three-arm trial, cluster randomised by household. SETTING: Seven London-based general practices. PARTICIPANTS: A total of 11,015 people without PA contraindications, aged 45-75 years, randomly selected from practices, were invited. A total of 6399 people were non-responders, and 548 people self-reporting achieving PA guidelines were excluded. A total of 1023 people from 922 households were randomised to usual care (n = 338), postal intervention (n = 339) or nurse support (n = 346). The recruitment rate was 10% (1023/10,467). A total of 956 participants (93%) provided outcome data. INTERVENTIONS: Intervention groups received pedometers, 12-week walking programmes advising participants to gradually add '3000 steps in 30 minutes' most days weekly and PA diaries. The nurse group was offered three dedicated PA consultations. MAIN OUTCOME MEASURES: The primary and main secondary outcomes were changes from baseline to 12 months in average daily step counts and time in MVPA (in ≥ 10-minute bouts), respectively, from 7-day accelerometry. Individual resource-use data informed the within-trial economic evaluation and the Markov model for simulating long-term cost-effectiveness. Qualitative evaluations assessed nurse and participant views. A 3-year follow-up was conducted. RESULTS: Baseline average daily step count was 7479 [standard deviation (SD) 2671], average minutes per week in MVPA bouts was 94 minutes (SD 102 minutes) for those randomised. PA increased significantly at 12 months in both intervention groups compared with the control group, with no difference between interventions; additional steps per day were 642 steps [95% confidence interval (CI) 329 to 955 steps] for the postal group and 677 steps (95% CI 365 to 989 steps) for nurse support, and additional MVPA in bouts (minutes per week) was 33 minutes per week (95% CI 17 to 49 minutes per week) for the postal group and 35 minutes per week (95% CI 19 to 51 minutes per week) for nurse support. Intervention groups showed no increase in adverse events. Incremental cost per step was 19p and £3.61 per minute in a ≥ 10-minute MVPA bout for nurse support, whereas the postal group took more steps and cost less than the control group. The postal group had a 50% chance of being cost-effective at a £20,000 per quality-adjusted life-year (QALY) threshold within 1 year and had both lower costs [-£11M (95% CI -£12M to -£10M) per 100,000 population] and more QALYs [759 QALYs gained (95% CI 400 to 1247 QALYs)] than the nurse support and control groups in the long term. Participants and nurses found the interventions acceptable and enjoyable. Three-year follow-up data showed persistent intervention effects (nurse support plus postal vs. control) on steps per day [648 steps (95% CI 272 to 1024 steps)] and MVPA bouts [26 minutes per week (95% CI 8 to 44 minutes per week)]. LIMITATIONS: The 10% recruitment level, with lower levels in Asian and socioeconomically deprived participants, limits the generalisability of the findings. Assessors were unmasked to the group. CONCLUSIONS: A primary care pedometer-based walking intervention in 45- to 75-year-olds increased 12-month step counts by around one-tenth, and time in MVPA bouts by around one-third, with similar effects for the nurse support and postal groups, and persistent 3-year effects. The postal intervention provides cost-effective, long-term quality-of-life benefits. A primary care pedometer intervention delivered by post could help address the public health physical inactivity challenge. FUTURE WORK: Exploring different recruitment strategies to increase uptake. Integrating the Pedometer And Consultation Evaluation-UP (PACE-UP) trial with evolving PA monitoring technologies. TRIAL REGISTRATION: Current Controlled Trials ISRCTN98538934. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 37. See the NIHR Journals Library website for further project information.

Interpreting population reach of a large, successful physical activity trial delivered through primary care.

BACKGROUND: Failure to include socio-economically deprived or ethnic minority groups in physical activity (PA) trials may limit representativeness and could lead to implementation of interventions that then increase health inequalities. Randomised intervention trials often have low recruitment rates and rarely assess recruitment bias. A previous trial by the same team using similar methods recruited 30% of the eligible population but was in an affluent setting with few non-white residents and was limited to those over 60 years of age. METHODS: PACE-UP is a large, effective, population-based walking trial in inactive 45-75 year-olds that recruited through seven London general practices. Anonymised practice demographic data were available for all those invited, enabling investigation of inequalities in trial recruitment. Non-participants were invited to complete a questionnaire. RESULTS: From 10,927 postal invitations, 1150 (10.5%) completed baseline assessment. Participation rate ratios (95% CI), adjusted for age and gender as appropriate, were lower in men 0.59 (0.52, 0.67) than women, in those under 55 compared with those ≥65, 0.60 (0.51, 0.71), in the most deprived quintile compared with the least deprived 0.52 (0.39, 0.70) and in Asian individuals compared with whites 0.62 (0.50, 0.76). Black individuals were equally likely to participate as white individuals. Participation was also associated with having a co-morbidity or some degree of health limitation. The most common reasons for non-participation were considering themselves as being too active or lack of time. CONCLUSIONS: Conducting the trial in this diverse setting reduced overall response, with lower response in socio-economically deprived and Asian sub-groups. Trials with greater reach are likely to be more expensive in terms of recruitment and gains in generalizability need to be balanced with greater costs. Differential uptake of successful trial interventions may increase inequalities in PA levels and should be monitored. TRIAL REGISTRATION: ISRCTN.com ISRCTN98538934 . Registered 2nd March 2012.

Comparisons of depression, anxiety, well-being, and perceptions of the built environment amongst adults seeking social, intermediate and market-rent accommodation in the former London Olympic Athletes' Village.

The Examining Neighbourhood Activities in Built Living Environments in London (ENABLE London) study provides a unique opportunity to examine differences in mental health and well-being amongst adults seeking social, intermediate (affordable rent), and market-rent housing in a purpose built neighbourhood (East Village, the former London 2012 Olympic Athletes' Village), specifically designed to encourage positive health behaviours. Multi-level logistic regression models examined baseline differences in levels of depression, anxiety and well-being across the housing groups. Compared with the intermediate group, those seeking social housing were more likely to be depressed, anxious and had poorer well-being after adjustment for demographic and health status variables. Further adjustments for neighbourhood perceptions suggest that compared with the intermediate group, perceived neighbourhood characteristics may be an important determinant of depression amongst those seeking social housing, and lower levels of happiness the previous day amongst those seeking market-rent housing. These findings add to the extensive literature on inequalities in health, and provide a strong basis for future longitudinal work that will examine change in depression, anxiety and well-being after moving into East Village, where those seeking social housing potentially have the most to gain.

Do health checks for adults with intellectual disability reduce emergency hospital admissions? Evaluation of a natural experiment.

BACKGROUND: Annual health checks for adults with intellectual disability (ID) have been incentivised by National Health Service (NHS) England since 2009, but it is unclear what impact they have had on important health outcomes such as emergency hospitalisation. METHODS: An evaluation of a 'natural experiment', incorporating practice and individual-level designs, to assess the effectiveness of health checks for adults with ID in reducing emergency hospital admissions using a large English primary care database. For practices, changes in admission rates for adults with ID between 2009-2010 and 2011-2012 were compared in 126 fully participating versus 68 non-participating practices. For individuals, changes in admission rates before and after the first health check for 7487 adults with ID were compared with 46 408 age-sex-practice matched controls. Incident rate ratios (IRRs) comparing changes in admission rates are presented for: all emergency, preventable emergency (for ambulatory care sensitive conditions (ACSCs)) and elective emergency. RESULTS: Practices with high health check participation showed no change in emergency admission rate among patients with ID over time compared with non-participating practices (IRR=0.97, 95% CI 0.78 to 1.19), but emergency admissions for ACSCs did fall (IRR=0.74, 0.58 to 0.95). Among individuals with ID, health checks had no effect on overall emergency admissions compared with controls (IRR=0.96, 0.87 to 1.07), although there was a relative reduction in emergency admissions for ACSCs (IRR=0.82, 0.69 to 0.99). Elective admissions showed no change with health checks in either analysis. CONCLUSIONS: Annual health checks in primary care for adults with ID did not alter overall emergency admissions, but they appeared influential in reducing preventable emergency admissions.

Health characteristics and consultation patterns of people with intellectual disability: a cross-sectional database study in English general practice.

BACKGROUND: People with intellectual disability (ID) are a group with high levels of healthcare needs; however, comprehensive information on these needs and service use is very limited. AIM: To describe chronic disease, comorbidity, disability, and general practice use among people with ID compared with the general population. DESIGN AND SETTING: This study is a cross-sectional analysis of a primary care database including 408 English general practices in 2012. METHOD: A total of 14 751 adults with ID, aged 18-84 years, were compared with 86 221 age-, sex- and practice-matched controls. Depending on the outcome, prevalence (PR), risk (RR), or odds (OR) ratios comparing patients with ID with matched controls are shown. RESULTS: Patients with ID had a markedly higher prevalence of recorded epilepsy (18.5%, PR 25.33, 95% confidence interval [CI] = 23.29 to 27.57), severe mental illness (8.6%, PR 9.10, 95% CI = 8.34 to 9.92), and dementia (1.1%, PR 7.52, 95% CI = 5.95 to 9.49), as well as moderately increased rates of hypothyroidism and heart failure (PR>2.0). However, recorded prevalence of ischaemic heart disease and cancer was approximately 30% lower than the general population. The average annual number of primary care consultations was 6.29 for patients with ID, compared with 3.89 for matched controls. Patients with ID were less likely to have longer doctor consultations (OR 0.73, 95% CI = 0.69 to 0.77), and had lower continuity of care with the same doctor (OR 0.77, 95% CI = 0.73 to 0.82). CONCLUSION: Compared with the general population, people with ID have generally higher overall levels of chronic disease and greater primary care use. Ensuring access to high-quality chronic disease management, especially for epilepsy and mental illness, will help address these greater healthcare needs. Continuity of care and longer appointment times are important potential improvements in primary care.

Comparing the effectiveness of an enhanced MOtiVational intErviewing InTervention (MOVE IT) with usual care for reducing cardiovascular risk in high risk subjects: study protocol for a randomised controlled trial.

BACKGROUND: Interventions targeting multiple risk factors for cardiovascular disease (CVD), including poor diet and physical inactivity, are more effective than interventions targeting a single risk factor. A motivational interviewing (MI) intervention can provide modest dietary improvements and physical activity increases, while adding cognitive behaviour therapy (CBT) skills may enhance the effects of MI. We designed a randomised controlled trial (RCT) to examine whether specific behaviour change techniques integrating MI and CBT result in favourable changes in weight and physical activity in those at high risk of CVD. A group and individual intervention will be compared to usual care. A group intervention offers potential benefits from social support and may be more cost effective. METHODS/DESIGN: Individuals aged between 40 and 74 years in 11 South London Clinical Commissioning Groups who are at high risk of developing CVD (≥20%) in the next 10 years will be recruited. A sample of 1,704 participants will be randomised to receive the enhanced MI intervention, delivered by trained healthy lifestyle facilitators (HLFs), in group or individual formats, in 10 sessions (plus an introductory session) over one year, or usual care. Randomisation will be conducted by King's College London Clinical Trials Unit and researchers collecting outcome data will be blinded to treatment allocation. At 12-month and 24-month follow-up assessments, primary outcomes will be change in weight and physical activity (average steps per day). Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. Incidence of CVD events since baseline will be recorded. A process evaluation will be conducted to evaluate factors which impact on delivery, adherence and outcome. An economic evaluation will estimate relative cost-effectiveness of each type of intervention delivery. DISCUSSION: This RCT assesses the effectiveness of a healthy lifestyle intervention for people at high risk of CVD. Benefits of the study include the ethnic and socioeconomic diversity of the study population and that, via social support within the group setting and long-term follow-up period, the intervention offers the potential to support maintenance of a healthy lifestyle. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry (identifier: ISRCTN84864870, registered 15 May 2012).

Numbers are not the whole story: a qualitative exploration of barriers and facilitators to increased physical activity in a primary care based walking intervention.

BACKGROUND: The majority of mid-life and older adults in the UK are not achieving recommended physical activity levels and inactivity is associated with many health problems. Walking is a safe, appropriate exercise. The PACE-UP trial sought to increase walking through the structured use of a pedometer and handbook, with and without support from a practice nurse trained in behaviour change techniques (BCTs). Understanding barriers and facilitators to engagement with a primary care based physical activity intervention is essential for future trials and programmes. METHODS: We conducted semi-structured telephone interviews using a topic guide with purposive samples of participants who did and did not increase their walking from both intervention groups. Interviews were audio-recorded, transcribed and coded independently by researchers prior to performing a thematic analysis. Responsiveness to the specific BCTs used was also analysed. RESULTS: Forty-three trial participants were interviewed in early 2014. Almost all felt they had benefitted, irrespective of their change in step-count, and that primary care was an appropriate setting.Important facilitators included a desire for a healthy lifestyle, improved physical health, enjoyment of walking in the local environment, having a flexible routine allowing for an increase in walking, appropriate self and external monitoring and support from others.Important barriers included physical health problems, an inflexible routine, work and other commitments, the weather and a mistrust of the monitoring equipment.BCTs that were reported to have the most impact included: providing information about behaviour-health link; prompting self-monitoring and review of goals and outcomes; providing feedback; providing specific information about how to increase walking; planning social support/change; and relapse prevention. Rewards were unhelpful. CONCLUSIONS: Despite our expectation that there would be a difference between the experiences of those who did and did not objectively increase their walking, we found that most participants considered themselves to have succeeded in the trial and benefitted from taking part. Barriers and facilitators were similar across demographic groups and trial outcomes. Findings indicated several BCTs on which PA trial and programme planners could focus efforts with the expectation of greatest impact as well as strong support for primary care as an appropriate venue. TRIAL REGISTRATION: ISRCTN98538934.

PACE-UP (Pedometer and consultation evaluation--UP)--a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45-75 years: study protocol for a randomised controlled trial.

BACKGROUND: Most adults do not achieve the 150 minutes weekly of at least moderate intensity activity recommended for health. Adults' most common physical activity (PA) is walking, light intensity if strolling, moderate if brisker. Pedometers can increase walking; however, most trials have been short-term, have combined pedometer and support effects, and have not reported PA intensity. This trial will investigate whether pedometers, with or without nurse support, can help less active 45-75 year olds to increase their PA over 12 months. DESIGN: Primary care-based 3-arm randomized controlled trial with 12-month follow-up and health economic and qualitative evaluations. PARTICIPANTS: Less active 45-75 year olds (n = 993) will be recruited by post from six South West London general practices, maximum of two per household and households randomised into three groups. Step-count and time spent at different PA intensities will be assessed for 7 days at baseline, 3 and 12 months by accelerometer. Questionnaires and anthropometric assessments will be completed. INTERVENTION: The pedometer-alone group will be posted a pedometer (Yamax Digi-Walker SW-200), handbook and diary detailing a 12-week pedometer-based walking programme, using targets from their baseline assessment. The pedometer-plus-support group will additionally receive three practice nurse PA consultations. The handbook, diary and consultations include behaviour change techniques (e.g., self-monitoring, goal-setting, relapse prevention planning). The control group will receive usual care. OUTCOMES: Changes in average daily step-count (primary outcome), time spent sedentary and in at least moderate intensity PA weekly at 12 months, measured by accelerometry. Other outcomes include change in body mass index, body fat, self-reported PA, quality of life, mood and adverse events. Cost-effectiveness will be assessed by the incremental cost of the intervention to the National Health Service and incremental cost per change in step-count and per quality adjusted life year. Qualitative evaluations will explore reasons for trial non-participation and the interventions' acceptability. DISCUSSION: The PACE-UP trial will determine the effectiveness and cost-effectiveness of a pedometer-based walking intervention delivered by post or practice nurse to less active primary care patients aged 45-75 years old. Approaches to minimise bias and challenges anticipated in delivery will be discussed. TRIAL REGISTRATION: ISRCTN98538934.

Are ethnic and gender specific equations needed to derive fat free mass from bioelectrical impedance in children of South asian, black african-Caribbean and white European origin? Results of the assessment of body composition in children study.

BACKGROUND: Bioelectrical impedance analysis (BIA) is a potentially valuable method for assessing lean mass and body fat levels in children from different ethnic groups. We examined the need for ethnic- and gender-specific equations for estimating fat free mass (FFM) from BIA in children from different ethnic groups and examined their effects on the assessment of ethnic differences in body fat. METHODS: Cross-sectional study of children aged 8-10 years in London Primary schools including 325 South Asians, 250 black African-Caribbeans and 289 white Europeans with measurements of height, weight and arm-leg impedance (Z; Bodystat 1500). Total body water was estimated from deuterium dilution and converted to FFM. Multilevel models were used to derive three types of equation {A: FFM = linear combination(height+weight+Z); B: FFM = linear combination(height(2)/Z); C: FFM = linear combination(height(2)/Z+weight)}. RESULTS: Ethnicity and gender were important predictors of FFM and improved model fit in all equations. The models of best fit were ethnicity and gender specific versions of equation A, followed by equation C; these provided accurate assessments of ethnic differences in FFM and FM. In contrast, the use of generic equations led to underestimation of both the negative South Asian-white European FFM difference and the positive black African-Caribbean-white European FFM difference (by 0.53 kg and by 0.73 kg respectively for equation A). The use of generic equations underestimated the positive South Asian-white European difference in fat mass (FM) and overestimated the positive black African-Caribbean-white European difference in FM (by 4.7% and 10.1% respectively for equation A). Consistent results were observed when the equations were applied to a large external data set. CONCLUSIONS: Ethnic- and gender-specific equations for predicting FFM from BIA provide better estimates of ethnic differences in FFM and FM in children, while generic equations can misrepresent these ethnic differences.

Randomised controlled trial of a complex intervention by primary care nurses to increase walking in patients aged 60-74 years: protocol of the PACE-Lift (Pedometer Accelerometer Consultation Evaluation - Lift) trial.

BACKGROUND: Physical activity is essential for older peoples' physical and mental health and for maintaining independence. Guidelines recommend at least 150 minutes weekly, of at least moderate intensity physical activity, with activity on most days. Older people's most common physical activity is walking, light intensity if strolling, moderate if brisker. Less than 20% of United Kingdom 65-74 year olds report achieving the guidelines, despite most being able to. Effective behaviour change techniques include strategies such as goal setting, self-monitoring, building self-efficacy and relapse prevention. Primary care physical activity consultations allow individual tailoring of advice. Pedometers measure step-counts and accelerometers measure physical activity intensity. This protocol describes an innovative intervention to increase walking in older people, incorporating pedometer and accelerometer feedback within a primary care nurse physical activity consultation, using behaviour change techniques. DESIGN: Randomised controlled trial with intervention and control (usual care) arms plus process and qualitative evaluations. PARTICIPANTS: 300 people aged 60-74 years registered with 3 general practices within Oxfordshire and Berkshire West primary care trusts, able to walk outside and with no restrictions to increasing their physical activity. INTERVENTION: 3 month pedometer and accelerometer based intervention supported by practice nurse physical activity consultations. Four consultations based on behaviour change techniques, physical activity diary, pedometer average daily steps and accelerometer feedback on physical activity intensity. Individual physical activity plans based on increasing walking and other existing physical activity will be produced. OUTCOMES: Change in average daily steps (primary outcome) and average time spent in at least moderate intensity physical activity weekly (secondary outcome) at 3 months and 12 months, assessed by accelerometry. Other outcomes include quality of life, mood, exercise self-efficacy, injuries. Qualitative evaluations will explore reasons for trial non-participation, the intervention's acceptability to patients and nurses and factors enhancing or acting as barriers for older people in increasing their physical activity levels. DISCUSSION: The PACE-Lift trial will determine the feasibility and efficacy of an intervention for increasing physical activity among older primary care patients. Steps taken to minimise bias and the challenges anticipated will be discussed. Word count 341. TRIAL REGISTRATION NUMBER: ISRCTN42122561.

Do good health and material circumstances protect older people from the increased risk of death after bereavement?

An increased risk of death in persons who have suffered spousal bereavement has been described in many populations. The impact of modifying factors, such as chronic disease and material circumstances, is less well understood. The authors followed 171,720 [corrected] couples 60 years of age or older in a United Kingdom primary care database between 2005 and 2010 for an average of 4 years. A total of 26,646 (15.5%) couples experienced bereavement, with mean follow up after bereavement of 2 years. In a model adjusted for age, sex, comorbid conditions at baseline, material deprivation based on area of residence, season, and smoking status, the hazard ratio for mortality in the first year after bereavement was 1.25 (95% confidence interval: 1.18, 1.33). Further adjustment for changes in comorbid conditions throughout follow up did not alter the hazard ratio for bereavement (hazard ratio = 1.27, 95% confidence interval: 1.19, 1.35). The association was strongest in individuals with no significant chronic comorbid conditions throughout follow up (hazard ratio = 1.50, 95% confidence interval: 1.28, 1.77) and in more affluent couples (P = 0.035). In the first year after bereavement, the association between bereavement and death is not primarily mediated through worsening or new onset of chronic disease. Good health and material circumstances do not protect individuals from increased mortality rates after bereavement.

Ethnic and socioeconomic influences on childhood blood pressure: the Child Heart and Health Study in England.

OBJECTIVES: Compared to UK white European adults, UK black African-Caribbean adults have higher mean SBP and DBP; UK South Asian adults have higher mean DBP but lower SBP. Information on blood pressure (BP) in UK children from different ethnic groups is limited. The aim of this study was to compare BP levels in UK children of black African-Caribbean, South Asian and white European origin. METHODS: BP and body build were measured in 5666 children in a cross-sectional study of UK primary school children of South Asian, black African-Caribbean and white European origin aged 9-10 years. Ethnic and socioeconomic differences in BP were obtained from multilevel linear regression models. RESULTS: After adjustment for height and adiposity, black African-Caribbean children had lower mean SBP than white Europeans [difference 1.62  mmHg, 95% confidence interval (CI) 0.86-2.38  mmHg], whereas mean DBP was similar (difference 0.58  mmHg, 95% CI -0.12 to 1.28  mmHg). The lower SBP was particularly marked in black African rather than Caribbean children (P  =  0.002). South Asian children had lower mean SBP (difference 1.10  mmHg, 95% CI 0.34-1.86  mmHg) than white Europeans and higher mean DBP (difference 1.07  mmHg, 95% CI 0.37-1.76  mmHg). The higher mean DBP was particularly marked among Indian and Bangladeshi, rather than Pakistani, children (P  =  0.01). BP was unrelated to socioeconomic circumstances; ethnic differences in BP were not affected by socioeconomic adjustment. CONCLUSION: A BP pattern similar to that in adults is present in UK South Asian but not in UK black African-Caribbean children at 9-10 years.

Socio-economic position and type 2 diabetes risk factors: patterns in UK children of South Asian, black African-Caribbean and white European origin.

BACKGROUND: Socio-economic position (SEP) and ethnicity influence type 2 diabetes mellitus (T2DM) risk in adults. However, the influence of SEP on emerging T2DM risks in different ethnic groups and the contribution of SEP to ethnic differences in T2DM risk in young people have been little studied. We examined the relationships between SEP and T2DM risk factors in UK children of South Asian, black African-Caribbean and white European origin, using the official UK National Statistics Socio-economic Classification (NS-SEC) and assessed the extent to which NS-SEC explained ethnic differences in T2DM risk factors. METHODS AND FINDINGS: Cross-sectional school-based study of 4,804 UK children aged 9-10 years, including anthropometry and fasting blood analytes (response rates 70%, 68% and 58% for schools, individuals and blood measurements). Assessment of SEP was based on parental occupation defined using NS-SEC and ethnicity on parental self-report. Associations between NS-SEC and adiposity, insulin resistance (IR) and triglyceride differed between ethnic groups. In white Europeans, lower NS-SEC status was related to higher ponderal index (PI), fat mass index, IR and triglyceride (increases per NS-SEC decrement [95%CI] were 1.71% [0.75, 2.68], 4.32% [1.24, 7.48], 5.69% [2.01, 9.51] and 3.17% [0.96, 5.42], respectively). In black African-Caribbeans, lower NS-SEC was associated with lower PI (-1.12%; [-2.01, -0.21]), IR and triglyceride, while in South Asians there were no consistent associations between NS-SEC and T2DM risk factors. Adjustment for NS-SEC did not appear to explain ethnic differences in T2DM risk factors, which were particularly marked in high NS-SEC groups. CONCLUSIONS: SEP is associated with T2DM risk factors in children but patterns of association differ by ethnic groups. Consequently, ethnic differences (which tend to be largest in affluent socio-economic groups) are not explained by NS-SEC. This suggests that strategies aimed at reducing social inequalities in T2DM risk are unlikely to reduce emerging ethnic differences in T2DM risk.

Combined analysis of CHRNA5, CHRNA3 and CYP2A6 in relation to adolescent smoking behaviour.

CYP2A6 influences smoking uptake in adolescence. Genetic variation in the CHRNA5-CHRNA3 region influences smoking behaviour in adults. However, their combined effects on smoking in adolescence have not been tested to date. We present data on 1450 adolescents from the Ten Towns Heart Health Study (TTHHS) extensively phenotyped for smoking-related traits during adolescence. Single nucleotide polymorphisms from CHRNA5 and CHRNA3 (previously associated with smoking), were typed in our study population, previously genotyped for CYP2A6. Association analyses between each genotype and both smoking status and behavioural markers of smoking were performed. rs16969968 in CHRNA5 was associated both at 13-15 years and 18 years with current smoking amongst adolescents who had tried smoking (OR = 1.82, CI = 1.10-3.01, p = 0.02 at age 13-15; OR = 2.39, CI = 1.37-4.17, p = 0.002 at age 18). No association was found for rs578776 in CHRNA3. The effects of CHRNA5 and CYP2A6 genotypes in TTHHS appeared to be independent, with each approximately doubling the odds of being a regular smoker by age 18 years. CYP2A6 genotype insufficiency increases adolescent likelihood of being a regular smoker but increases later life quitting likelihood and reduces average consumption. In contrast, CHRNA5 genotype, acting recessively, affects smoking similarly in adolescents and older adults. These contrasting actions, in digenic combination, illustrate behavioural genetic complexity.