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Protocol for a cluster randomised trial evaluating a multifaceted intervention starting preconceptionally-Early Interventions to Support Trajectories for Healthy Life in India (EINSTEIN): a Healthy Life Trajectories Initiative (HeLTI) Study.
Kumaran, K, Krishnaveni, GV, Suryanarayana, KG, Prasad, MP, Belavendra, A, Atkinson, S, Balasubramaniam, R, Bandsma, RHJ, Bhutta, ZA, Chandak, GR, et al
BMJ open. 2021;(2):e045862
Abstract
INTRODUCTION The Healthy Life Trajectories Initiative is an international consortium comprising four harmonised but independently powered trials to evaluate whether an integrated intervention starting preconceptionally will reduce non-communicable disease risk in their children. This paper describes the protocol of the India study. METHODS AND ANALYSIS The study set in rural Mysore will recruit ~6000 married women over the age of 18 years. The village-based cluster randomised design has three arms (preconception, pregnancy and control; 35 villages per arm). The longitudinal multifaceted intervention package will be delivered by community health workers and comprise: (1) measures to optimise nutrition; (2) a group parenting programme integrated with cognitive-behavioral therapy; (3) a lifestyle behaviour change intervention to support women to achieve a diverse diet, exclusive breast feeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foods, and adopt appropriate hygiene measures; and (4) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance.The primary outcome is adiposity in children at age 5 years, measured by fat mass index. We will report on a host of intermediate and process outcomes. We will collect a range of biospecimens including blood, urine, stool and saliva from the mothers, as well as umbilical cord blood, placenta and specimens from the offspring.An intention-to-treat analysis will be adopted to assess the effect of interventions on outcomes. We will also undertake process and economic evaluations to determine scalability and public health translation. ETHICS AND DISSEMINATION The study has been approved by the institutional ethics committee of the lead institute. Findings will be published in peer-reviewed journals. We will interact with policy makers at local, national and international agencies to enable translation. We will also share the findings with the participants and local community through community meetings, newsletters and local radio. TRIAL REGISTRATION NUMBER ISRCTN20161479, CTRI/2020/12/030134; Pre-results.
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Altering product placement to create a healthier layout in supermarkets: Outcomes on store sales, customer purchasing, and diet in a prospective matched controlled cluster study.
Vogel, C, Crozier, S, Penn-Newman, D, Ball, K, Moon, G, Lord, J, Cooper, C, Baird, J
PLoS medicine. 2021;(9):e1003729
Abstract
BACKGROUND Previous product placement trials in supermarkets are limited in scope and outcome data collected. This study assessed the effects on store-level sales, household-level purchasing, and dietary behaviours of a healthier supermarket layout. METHODS AND FINDINGS This is a prospective matched controlled cluster trial with 2 intervention components: (i) new fresh fruit and vegetable sections near store entrances (replacing smaller displays at the back) and frozen vegetables repositioned to the entrance aisle, plus (ii) the removal of confectionery from checkouts and aisle ends opposite. In this pilot study, the intervention was implemented for 6 months in 3 discount supermarkets in England. Three control stores were matched on store sales and customer profiles and neighbourhood deprivation. Women customers aged 18 to 45 years, with loyalty cards, were assigned to the intervention (n = 62) or control group (n = 88) of their primary store. The trial registration number is NCT03518151. Interrupted time series analysis showed that increases in store-level sales of fruits and vegetables were greater in intervention stores than predicted at 3 (1.71 standard deviations (SDs) (95% CI 0.45, 2.96), P = 0.01) and 6 months follow-up (2.42 SDs (0.22, 4.62), P = 0.03), equivalent to approximately 6,170 and approximately 9,820 extra portions per store, per week, respectively. The proportion of purchasing fruits and vegetables per week rose among intervention participants at 3 and 6 months compared to control participants (0.2% versus -3.0%, P = 0.22; 1.7% versus -3.5%, P = 0.05, respectively). Store sales of confectionery were lower in intervention stores than predicted at 3 (-1.05 SDs (-1.98, -0.12), P = 0.03) and 6 months (-1.37 SDs (-2.95, 0.22), P = 0.09), equivalent to approximately 1,359 and approximately 1,575 fewer portions per store, per week, respectively; no differences were observed for confectionery purchasing. Changes in dietary variables were predominantly in the expected direction for health benefit. Intervention implementation was not within control of the research team, and stores could not be randomised. It is a pilot study, and, therefore, not powered to detect an effect. CONCLUSIONS Healthier supermarket layouts can improve the nutrition profile of store sales and likely improve household purchasing and dietary quality. Placing fruits and vegetables near store entrances should be considered alongside policies to limit prominent placement of unhealthy foods. TRIAL REGISTRATION ClinicalTrials.gov NCT03518151 (pre-results).
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A systematic review and meta-analysis of school-based interventions with health education to reduce body mass index in adolescents aged 10 to 19 years.
Jacob, CM, Hardy-Johnson, PL, Inskip, HM, Morris, T, Parsons, CM, Barrett, M, Hanson, M, Woods-Townsend, K, Baird, J
The international journal of behavioral nutrition and physical activity. 2021;18(1):1
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Obesity in childhood and adolescence is associated with an increased risk of non-communicable diseases such as Type 2 diabetes, cardiovascular disease, chronic obstructive lung disease and some forms of cancer. The aim of this study was to investigate the effectiveness of health education interventions delivered in school settings to prevent overweight and obesity and/ or reduce BMI in adolescents, and to explore the key features of effectiveness. This study is a systematic review and meta-analysis of 39 publications based on 33 studies. Six studies recruited adolescent girls only, one adolescent boys only and one study included parent-student dyad. Results show that: - Most of the effective interventions were delivered by teachers who were trained prior to the intervention. - School-based interventions are often delivered through school-staff, however, appropriate training/ CPD prior to the intervention could be a crucial component to support the provision and uptake of the intervention. - Many of the effective interventions included parental involvement and modifications to the school environment. - Interventions should target the biological, psychosocial, environmental, and behavioural influences on diet and physical activity. Authors conclude that school-based health education interventions could potentially help in improving BMI outcomes in the adolescent age group.
Abstract
BACKGROUND Adolescents are increasingly susceptible to obesity, and thus at risk of later non-communicable diseases, due to changes in food choices, physical activity levels and exposure to an obesogenic environment. This review aimed to synthesize the literature investigating the effectiveness of health education interventions delivered in school settings to prevent overweight and obesity and/ or reduce BMI in adolescents, and to explore the key features of effectiveness. METHODS A systematic search of electronic databases including MEDLINE, CINAHL, PsychINFO and ERIC for papers published from Jan 2006 was carried out in 2020, following PRISMA guidelines. Studies that evaluated health education interventions in 10-19-year-olds delivered in schools in high-income countries, with a control group and reported BMI/BMI z-score were selected. Three researchers screened titles and abstracts, conducted data extraction and assessed quality of the full text publications. A third of the papers from each set were cross-checked by another reviewer. A meta-analysis of a sub-set of studies was conducted for BMI z-score. RESULTS Thirty-three interventions based on 39 publications were included in the review. Most studies evaluated multi-component interventions using health education to improve behaviours related to diet, physical activity and body composition measures. Fourteen interventions were associated with reduced BMI/BMI z-score. Most interventions (n = 22) were delivered by teachers in classroom settings, 19 of which trained teachers before the intervention. The multi-component interventions (n = 26) included strategies such as environment modifications (n = 10), digital interventions (n = 15) and parent involvement (n = 16). Fourteen studies had a low risk of bias, followed by 10 with medium and nine with a high risk of bias. Fourteen studies were included in a random-effects meta-analysis for BMI z-score. The pooled estimate of this meta-analysis showed a small difference between intervention and control in change in BMI z-score (- 0.06 [95% CI -0.10, - 0.03]). A funnel plot indicated that some degree of publication bias was operating, and hence the effect size might be inflated. CONCLUSIONS Findings from our review suggest that school-based health education interventions have the public health potential to lower BMI towards a healthier range in adolescents. Multi-component interventions involving key stakeholders such as teachers and parents and digital components are a promising strategy.
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Findings from an exploration of a social network intervention to promote diet quality and health behaviours in older adults with COPD: a feasibility study.
Bloom, I, Welch, L, Vassilev, I, Rogers, A, Jameson, K, Cooper, C, Robinson, S, Baird, J
Pilot and feasibility studies. 2020;:15
Abstract
BACKGROUND Diet quality in older people with chronic obstructive pulmonary disease (COPD) is associated with better health and lung function. Social factors, such as social support, social networks and participation in activities, have been linked with diet quality in older age. A social network tool-GENIE (Generating Engagement in Network Involvement)-was implemented in a COPD community care context. The study aimed to assess the feasibility of the GENIE intervention to promote diet quality and other health behaviours in COPD. METHODS Twenty-two community-dwelling older adults with COPD were recruited from a local COPD service. Participants were offered usual care or the GENIE intervention. Process evaluation methods were used to assess intervention implementation, context and mechanisms of impact; these included observations of patient interactions with the intervention, documented in observational field notes and in films of a patient group discussion. Diet quality was assessed by food frequency questionnaire; 'prudent' diet scores were used to describe diet quality at baseline and at 3-month follow-up. Change in diet quality was expressed per month, from baseline to follow-up. RESULTS Feasibility data showed that the GENIE intervention could be implemented in this sample of community-living older people. The intervention was acceptable to clinicians and older people with COPD, especially for those with less severe disease, when facilitated appropriately and considering the levels of literacy of participants. There was no significant change in diet quality in the intervention group over the follow-up period (median change in prudent diet score per month (interquartile range (IQR), 0.03 (- 0.24-0.07)), whereas an overall fall in diet quality was observed in the control group (- 0.15 (- 0.24-0.03)). CONCLUSION The process evaluation findings suggest that this intervention is feasible and acceptable to both patients and clinicians. Although the sample size achieved in this study was small, findings suggest that the intervention may have a protective effect against declines in diet quality, and other health behaviours, in an older COPD population. Findings from this feasibility study indicate that further evaluation of the GENIE intervention is warranted in a larger study, with a longer follow-up. TRIAL REGISTRATION ClinicalTrials.gov, NCT02935452. NIH U.S. National Library of Medicine. Registered 17 October 2016.
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A systematic review of the influences of food store product placement on dietary-related outcomes.
Shaw, SC, Ntani, G, Baird, J, Vogel, CA
Nutrition reviews. 2020;(12):1030-1045
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CONTEXT Product placement strategies have been used to influence customers' food purchases in food stores for some time; however, assessment of the evidence that these techniques can limit unhealthy, and promote healthy, food choices has not been completed. OBJECTIVE This systematic review aimed to determine how product placement strategies, availability, and positioning, in physical retail food stores located in high-income countries, influence dietary-related behaviors. DATA SOURCES From a search of 9 databases, 38 articles, 17 observational studies, and 22 intervention studies met the study inclusion criteria. DATA EXTRACTION Two reviewers independently extracted data relating to study design, study population, exposures, outcomes, and key results. Each study was also assessed for risk of bias in relation to the research question. DATA ANALYSIS Meta-analysis was not possible owing to heterogeneous study designs and outcomes. As recommended by Cochrane, results were synthesized in effect direction plots using a vote-counting technique which recorded the direction of effect and significance level according to the expected relationship for health improvement. CONCLUSIONS The majority of studies showed that greater availability and more prominent positioning of healthy foods, or reduced availability and less prominent positioning of unhealthy foods, related to better dietary-related behaviors. A large number of results, however, were nonsignificant, which likely reflects the methodological difficulties inherent in this research field. Adequately powered intervention studies that test both the independent and additive effects of availability and positioning strategies are needed. SYSTEMATIC REVIEW REGISTRATION PROSPERO registration no. 42016048826.
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Behaviour change interventions: getting in touch with individual differences, values and emotions.
Strömmer, S, Lawrence, W, Shaw, S, Correia Simao, S, Jenner, S, Barrett, M, Vogel, C, Hardy-Johnson, P, Farrell, D, Woods-Townsend, K, et al
Journal of developmental origins of health and disease. 2020;(6):589-598
Abstract
Systematic reviews and meta-analyses suggest that behaviour change interventions have modest effect sizes, struggle to demonstrate effect in the long term and that there is high heterogeneity between studies. Such interventions take huge effort to design and run for relatively small returns in terms of changes to behaviour.So why do behaviour change interventions not work and how can we make them more effective? This article offers some ideas about what may underpin the failure of behaviour change interventions. We propose three main reasons that may explain why our current methods of conducting behaviour change interventions struggle to achieve the changes we expect: 1) our current model for testing the efficacy or effectiveness of interventions tends to a mean effect size. This ignores individual differences in response to interventions; 2) our interventions tend to assume that everyone values health in the way we do as health professionals; and 3) the great majority of our interventions focus on addressing cognitions as mechanisms of change. We appeal to people's logic and rationality rather than recognising that much of what we do and how we behave, including our health behaviours, is governed as much by how we feel and how engaged we are emotionally as it is with what we plan and intend to do.Drawing on our team's experience of developing multiple interventions to promote and support health behaviour change with a variety of populations in different global contexts, this article explores strategies with potential to address these issues.
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How can we best use opportunities provided by routine maternity care to engage women in improving their diets and health?
Lawrence, W, Vogel, C, Strömmer, S, Morris, T, Treadgold, B, Watson, D, Hart, K, McGill, K, Hammond, J, Harvey, NC, et al
Maternal & child nutrition. 2020;(1):e12900
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Pregnancy provides motivation for women to improve their diets and increase their physical activity. Opportunistic brief interventions delivered as part of routine primary care have produced improvements in patients' health behaviour. Consequently, there have been calls for midwives to use contacts during pregnancy in this way. This study explored the experiences of pregnant women and research midwives/nurses of a brief intervention called Healthy Conversation Skills (HCS) being delivered as part of a randomised control trial, assessing the acceptability and feasibility of including this intervention in routine maternity care. Three research questions were addressed using mixed methods to produce four datasets: face-to-face interviews with participants, a focus group with the HCS-trained midwives/nurses, case reports of participants receiving HCS and audio-recordings of mid-pregnancy telephone calls to the women which produced midwife/nurse HCS competency scores. Midwives/nurses used their HCS to support women to make plans for change and set goals. Women welcomed the opportunity to address their own health and well-being as distinct from that of their baby. Midwives/nurses were competent in using the skills and saw healthy conversations as an effective means of raising issues of diet and physical activity. Recent extension of maternity appointment times provides ideal opportunities to incorporate a brief intervention to support behaviour change. Incorporating HCS training into midwifery education and continuing professional development would facilitate this. HCS is a scalable, brief intervention with the potential to improve the diets and physical activity levels of women during pregnancy, and hence the health of themselves and their babies.
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Vegetarian Diet during Pregnancy Is Not Associated with Poorer Cognitive Performance in Children at Age 6-7 Years.
Crozier, SR, Godfrey, KM, Calder, PC, Robinson, SM, Inskip, HM, Baird, J, Gale, CR, Cooper, C, Sibbons, CM, Fisk, HL, et al
Nutrients. 2019;(12)
Abstract
Compared with omnivorous mothers, vegetarian mothers have lower intakes of some nutrients required for neurological development. However, there is a lack of information about the impact of vegetarianism during pregnancy on subsequent cognitive function in children. The aim of this study was to investigate whether vegetarianism during pregnancy is associated with altered maternal nutritional status and with cognitive function in children at six to seven years of age. Women aged 20-34 years participating in a prospective observational study who provided dietary data and blood samples in early pregnancy (11 weeks; 78 vegetarians and 2144 omnivores) or late pregnancy (34 weeks; 91 vegetarians and 2552 omnivores). Compared with omnivorous women, vegetarian women had lower blood concentrations of arachidonic acid, docosahexaenoic acid, and cobalamin in early and late pregnancy. Vegetarianism in pregnancy was linked to higher maternal educational attainment, longer breastfeeding duration, lower incidence of smoking during pregnancy and a tendency towards higher IQ in the mothers. Concentrations of some nutrients required for neurodevelopment were lower in maternal blood during gestation; however, after controlling for confounders consuming a vegetarian diet during pregnancy was not associated with poorer neurocognitive development of the children in this study.
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Intramedullary nails versus distal locking plates for fracture of the distal femur: results from the Trial of Acute Femoral Fracture Fixation (TrAFFix) randomised feasibility study and process evaluation.
Griffin, XL, Costa, ML, Phelps, E, Parsons, N, Dritsaki, M, Achten, J, Tutton, E, Lerner, RG, McGibbon, A, Baird, J, et al
BMJ open. 2019;(5):e026810
Abstract
OBJECTIVES This feasibility study and process evaluation assessed the likely success of a definitive trial of intramedullary fixation with locked retrograde nails versus extramedullary fixation with fixed angle plates for fractures of the distal femur. DESIGN & SETTING A multicentre, parallel, two-arm, randomised controlled feasibility study with an embedded process evaluation was conducted at seven NHS hospitals in England. Treatment was randomly allocated in 1:1 ratio, stratified by centre and chronic cognitive impairment. Participants, but not surgeons or research staff, were blinded to the allocation. PARTICIPANTS Patients 18 years and older with a fracture of the distal femur, who their surgeon believed would benefit from internal fixation, were eligible to take part.Participants were allocated to receive either a retrograde intramedullary nail or an anatomical locking plate. OUTCOMES The primary outcomes for this feasibility study were the recruitment rate and completion rate of the EQ-5D-5L at 4 months post-randomisation. Baseline characteristics, disability rating index, quality of life scores, measurements of social support and self-efficacy, resource use and radiographic assessments were also collected. The views of patients and staff were collected during interviews. RESULTS Recruitment and data completion were lower than expected. 23 of 82 eligible patients were recruited (nail, 11; plate, 12). The recruitment rate was estimated as 0.42 (95% CI 0.27 to 0.62) participants per centre-month. Data completeness of the EQ-5D-5L at 4 months was 61 per cent (95% CI 43% to 83%). The process evaluation demonstrated that the main barriers to recruitment were variation in treatment pathways across centres, lack of surgeon equipoise and confidence in using both interventions and newly formed research cultures that lacked cohesion. CONCLUSIONS A modified trial design, with embedded recruitment support intervention, comparing functional outcome in cognitively intact adults who have sustained a fragility fracture of the distal femur is feasible. ETHICS APPROVAL The Wales Research Ethics Committee 5 approved the study (ref: 16/WA/0225). TRIAL REGISTRATION NUMBER ISRCTN92089567; Pre-results.
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Diet Quality and Sarcopenia in Older Adults: A Systematic Review.
Bloom, I, Shand, C, Cooper, C, Robinson, S, Baird, J
Nutrients. 2018;(3)
Abstract
The increasing recognition of sarcopenia, the age-related loss of skeletal muscle mass and function (muscle strength and physical performance), as a determinant of poor health in older age, has emphasized the importance of understanding more about its aetiology to inform strategies both for preventing and treating this condition. There is growing interest in the effects of modifiable factors such as diet; some nutrients have been studied but less is known about the influence of overall diet quality on sarcopenia. We conducted a systematic review of the literature examining the relationship between diet quality and the individual components of sarcopenia, i.e., muscle mass, muscle strength and physical performance, and the overall risk of sarcopenia, among older adults. We identified 23 studies that met review inclusion criteria. The studies were diverse in terms of the design, setting, measures of diet quality, and outcome measurements. A small body of evidence suggested a relationship between "healthier" diets and better muscle mass outcomes. There was limited and inconsistent evidence for a link between "healthier" diets and lower risk of declines in muscle strength. There was strong and consistent observational evidence for a link between "healthier" diets and lower risk of declines in physical performance. There was a small body of cross-sectional evidence showing an association between "healthier" diets and lower risk of sarcopenia. This review provides observational evidence to support the benefits of diets of higher quality for physical performance among older adults. Findings for the other outcomes considered suggest some benefits, although the evidence is either limited in its extent (sarcopenia) or inconsistent/weak in its nature (muscle mass, muscle strength). Further studies are needed to assess the potential of whole-diet interventions for the prevention and management of sarcopenia.