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Randomized experiments are a type of design that randomly allocates individuals to different experimental groups. This case study discusses the designing and undertaking of a randomized experiment in the field of Health Psychology to assess the effectiveness of an intervention to reduce hazardous alcohol consumption among university students. The case study will explain the topic of the research that was conducted, as well as the methodology of the research, including the research aims, design, ethical considerations, sampling and recruiting, outcome measures, randomization, analysis, and reporting of results. Furthermore, challenges arising from this research and how they were tackled are discussed.

Objectives: In a qualitative substudy, we sought to elicit participants' perspectives of their behavioural change and maintenance of new behaviours towards intervention optimisation. Setting: The intervention was delivered in leisure and community settings in a local authority, which according to the UK government statistics ranks as 1 of the 10 most socioeconomically deprived areas in England. Participants: We recruited 218 adults aged 40-65 years at elevated risk of type 2 diabetes (Finnish Diabetes Risk Score≥11) to the intervention. Follow-up at 12 months was completed by 134 (62%). We recruited 15 participants, purposively sampled for physical activity increase, to the qualitative substudy. Intervention: Lifestyle intervention can prevent type 2 diabetes, but translation to service provision remains challenging. The 'New life, New you' intervention aimed to promote physical activity, healthy eating and weight loss, and included supervised group physical activity sessions. Behavioural change and weight loss at 12-month follow-up were encouraging. Design: We conducted 15 individual semistructured interviews. The Framework approach, with a comparison of emerging themes, was used in analysis of the transcribed data and complemented by the Theory Domains Framework. Results: Themes emerging from the data were grouped as perceptions that promoted initiating, enacting and maintaining behavioural change. The data were then categorised in accordance with the Theory Domains Framework: intentions and goals; reinforcement; knowledge; social role and identity; social influences; skills and beliefs about capabilities; behavioural regulation, memory, emotion, attention and decision processes and environmental context and resources. Participant perceptions of intervention features that facilitated behavioural change processes were then similarly analysed. Conclusions: Social influences, reference to social role and identity (eg, peer support), and intentions and goals (eg, to lose weight) were dominant themes across the ...

Afterweightloss,mostindividualsregainlostweight.Interventionsto supportthetransitionfromsuccessfullosstoweightlossmaintenance (WLM),regardlessofthemethodofpriorweightloss,areneeded.The aims of this study were to (1) develop a face-to-face behavioural intervention session to support overweight and obese individuals who have recently lost a clinically significant amount of weight in the transition to WLM; (2) to assess the single-session intervention for acceptability and feasibility prior to its use in a larger, 12-month, multi-component trial; and (3) to optimise the intervention session for future use based on participant feedback. Participants with a Body Mass Index of ≥25 kg/m2 prior to a ≥5% weight loss in the previous 12 months were recruited via the local government authority and community-based advertisements. Each attended the one-hour session with a trained facilitator, which focused on setting maintenance-relevant weight, eating, and physical activity goals. Semi-structured interviews were carried out immediately postsession to obtain feedback on the acceptability of this intervention component. Data were used to generate recommendations for changes to the session, which were discussed by the team, and used to optimise the session. Seventeen participants (13 female; median WL=13%) were recruited. All participants evaluated the intervention session positively; 11 participants suggested improvements including reducing information provision in favour ofgreaterfocusonidentifyingandcopingwithbarriers,andtheinclusion of practical examples. The systematic refinement and optimisation process resulted in an acceptable and feasible face-to-face behavioural intervention session (described here), which will be tested as part of a multi-component intervention. We anticipate the session could be used to supplement existing support including online services, and has the potential to benefit people who have lost a clinically significant amount of weight to achieve WLM over the long term.

After weight loss, most individuals regain lost weight. Interventions to support the transition from successful loss to weight loss maintenance (WLM), regardless of the method of prior weight loss, are needed. The aims of this study were to (1) develop a face-to-face behavioural intervention session to support overweight and obese individuals who have recently lost a clinically significant amount of weight in the transition to WLM; (2) to assess the single-session intervention for acceptability and feasibility prior to its use in a larger, 12-month, multi-component trial; and (3) to optimise the intervention session for future use based on participant feedback. Participants with a Body Mass Index of ≥25 kg/m2 prior to a ≥5% weight loss in the previous 12 months were recruited via the local government authority and community-based advertisements. Each attended the one-hour session with a trained facilitator, which focused on setting maintenance-relevant weight, eating, and physical activity goals. Semi-structured interviews were carried out immediately post-session to obtain feedback on the acceptability of this intervention component. Data were used to generate recommendations for changes to the session, which were discussed by the team, and used to optimise the session. Seventeen participants (13 female; median WL = 13%) were recruited. All participants evaluated the intervention session positively; 11 participants suggested improvements including reducing information provision in favour of greater focus on identifying and coping with barriers, and the inclusion of practical examples. The systematic refinement and optimisation process resulted in an acceptable and feasible face-to-face behavioural intervention session (described here), which will be tested as part of a multi-component intervention. We anticipate the session could be used to supplement existing support including online services, and has the potential to benefit people who have lost a clinically significant amount of weight to achieve WLM over ...

After weight loss, most individuals regain lost weight. Interventions to support the transition from successful loss to weight loss maintenance (WLM), regardless of the method of prior weight loss, are needed. The aims of this study were to (1) develop a face-to-face behavioural intervention session to support overweight and obese individuals who have recently lost a clinically significant amount of weight in the transition to WLM; (2) to assess the single-session intervention for acceptability and feasibility prior to its use in a larger, 12-month, multi-component trial; and (3) to optimise the intervention session for future use based on participant feedback. Participants with a Body Mass Index of ≥25 kg/m(2) prior to a ≥5% weight loss in the previous 12 months were recruited via the local government authority and community-based advertisements. Each attended the one-hour session with a trained facilitator, which focused on setting maintenance-relevant weight, eating, and physical activity goals. Semi-structured interviews were carried out immediately post-session to obtain feedback on the acceptability of this intervention component. Data were used to generate recommendations for changes to the session, which were discussed by the team, and used to optimise the session. Seventeen participants (13 female; median WL = 13%) were recruited. All participants evaluated the intervention session positively; 11 participants suggested improvements including reducing information provision in favour of greater focus on identifying and coping with barriers, and the inclusion of practical examples. The systematic refinement and optimisation process resulted in an acceptable and feasible face-to-face behavioural intervention session (described here), which will be tested as part of a multi-component intervention. We anticipate the session could be used to supplement existing support including online services, and has the potential to benefit people who have lost a clinically significant amount of weight to achieve WLM over the long term.

The nutritional status of both women and men before conception has profound implications for the growth, development, and long-term health of their offspring. Evidence of the effectiveness of preconception interventions for improving outcomes for mothers and babies is scarce. However, given the large potential health return, and relatively low costs and risk of harm, research into potential interventions is warranted. We identified three promising strategies for intervention that are likely to be scalable and have positive effects on a range of health outcomes: supplementation and fortification; cash transfers and incentives; and behaviour change interventions. On the basis of these strategies, we suggest a model specifying pathways to effect. Pathways are incorporated into a life-course framework using individual motivation and receptiveness at different preconception action phases, to guide design and targeting of preconception interventions. Interventions for individuals not planning immediate pregnancy take advantage of settings and implementation platforms outside the maternal and child health arena, since this group is unlikely to be engaged with maternal health services. Interventions to improve women's nutritional status and health behaviours at all preconception action phases should consider social and environmental determinants, to avoid exacerbating health and gender inequalities, and be underpinned by a social movement that touches the whole population. We propose a dual strategy that targets specific groups actively planning a pregnancy, while improving the health of the population more broadly. Modern marketing techniques could be used to promote a social movement based on an emotional and symbolic connection between improved preconception maternal health and nutrition, and offspring health. We suggest that speedy and scalable benefits to public health might be achieved through strategic engagement with the private sector. Political theory supports the development of an advocacy coalition of groups interested in preconception health, to harness the political will and leadership necessary to turn high-level policy into effective coordinated action.

The nutritional status of women and men before conception has profound implications for the growth, development and long-term health of their offspring. Evidence of the effectiveness of preconception interventions in improving outcomes for mothers or babies is scarce, though given the large potential health return, relatively low costs and risk of harm, intervention is still warranted. We identify three promising strategies for intervention that are likely to be scalable and to have positive effects on a range of health outcomes: supplementation and fortification; cash transfers; and behaviour change interventions. Based on this, we suggest a model specifying pathways to effect. Pathways are incorporated into a lifecourse framework using individual motivation and receptiveness at different 'preconception action phases' to guide design and targeting of preconception interventions. Interventions with those not planning immediate pregnancy take advantage of settings and implementation platforms outside the maternal and child health arena, since this group is unlikely to be engaged with maternal health services. Interventions to improve women's nutritional status and health behaviours at all preconception action phases need to take account of social and environmental determinants to avoid exacerbating health and gender inequalities, and should be underpinned by a social movement that touches the whole population. A dual strategy that targets specific groups actively planning a pregnancy, while improving the health of the population more broadly, is proposed. The engagement of modern marketing techniques points to a social movement based on an emotional and symbolic connection between improved maternal nutrition and health prior to conception and offspring health. We suggest that speedy and scalable public health benefit might be achieved through strategic engagement with the private sector. Political theory supports the development of an advocacy coalition of groups interested in preconception health, to harness the ...

Financial (positive or negative) and non-financial incentives or rewards are increasingly used in attempts to influence health behaviours. While unintended consequences of incentive provision are discussed in the literature, evidence syntheses did not identify any primary research with the aim of investigating unintended consequences of incentive interventions for lifestyle behaviour change. Our objective was to investigate perceived positive and negative unintended consequences of incentive provision for a shortlist of seven promising incentive strategies for smoking cessation in pregnancy and breastfeeding. A multi-disciplinary, mixed-methods approach included involving two service-user mother and baby groups from disadvantaged areas with experience of the target behaviours as study co-investigators. Systematic reviews informed the shortlist of incentive strategies. Qualitative semi-structured interviews and a web-based survey of health professionals asked open questions on positive and negative consequences of incentives. The participants from three UK regions were a diverse sample with and without direct experience of incentive interventions: 88 pregnant women/recent mothers/partners/family members; 53 service providers; 24 experts/decision makers and interactive discussions with 63 conference attendees. Maternity and early years health professionals (n = 497) including doctors, midwives, health visitors, public health and related staff participated in the survey. Qualitative analysis identified ethical, political, cultural, social and psychological implications of incentive delivery at population and individual levels. Four key themes emerged: how incentives can address or create inequalities; enhance or diminish intrinsic motivation and wellbeing; have a positive or negative effect on relationships with others within personal networks or health providers; and can impact on health systems and resources by raising awareness and directing service delivery, but may be detrimental to other health care areas. Financial incentives are controversial and generated emotive and oppositional responses. The planning, design and delivery of future incentive interventions should evaluate unexpected consequences to inform the evidence for effectiveness, cost-effectiveness and future implementation.

Funding This report presents independent research commissioned by the NIHR. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the Public Health Research programme or the Department of Health. The views and opinions expressed by the interviewees in this publication are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, MRC, CCF, NETSCC, the Public Health Research programme or the Department of Health. The Nursing Midwifery and Allied Health Professionals Research Unit, the Health Services Research Unit and Health Economics Research Unit are funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorate. Data availability statement Data are available on reasonable request. Access to data can be arranged through the coprincipal investigators of the study: Professor Pat Hoddinott (University of Stirling, p.m.hoddinott@stir.ac.uk) and Dr Stephan Dombrowski (University of New Brunswick, stephan.dombrowski@unb.ca) to discuss data sharing, data requirements and conflicts of interest, in line with any EU and other regulations, including ethics approvals. ; Peer reviewed ; Publisher PDF

© The Author(s) 2021. Published by Oxford University Press on behalf of the Society of Behavioral Medicine. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/ licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. ; Background: Patterns of protective health behaviors, such as handwashing and sanitizing during the COVID-19 pandemic, may be predicted by macro-level variables, such as regulations specified by public health policies. Health behavior patterns may also be predicted by micro-level variables, such as self-regulatory cognitions specified by health behavior models, including the Health Action Process Approach (HAPA). Purpose: This study explored whether strictness of containment and health policies was related to handwashing adherence and whether such associations were mediated by HAPA-specified self-regulatory cognitions. Methods: The study (NCT04367337) was conducted among 1,256 adults from Australia, Canada, China, France, Gambia, Germany, Israel, Italy, Malaysia, Poland, Portugal, Romania, Singapore, and Switzerland. Self-report data on cross-situational handwashing adherence were collected using an online survey at two time points, 4 weeks apart. Values of the index of strictness of containment and health policies, obtained from the Oxford COVID-19 Government Response Tracker database, were retrieved twice for each country (1 week prior to individual data collection). Results: Across countries and time, levels of handwashing adherence and strictness of policies were high. Path analysis indicated that stricter containment and health policies were indirectly related to lower handwashing adherence via lower self-efficacy and self-monitoring. Less strict policies were indirectly related to higher handwashing adherence via higher self-efficacy and self-monitoring. Conclusions: When policies are less strict, exposure to the SARS-CoV-2 ...

International audience ; BACKGROUND: Patterns of protective health behaviors, such as handwashing and sanitizing during the COVID-19 pandemic, may be predicted by macro-level variables, such as regulations specified by public health policies. Health behavior patterns may also be predicted by micro-level variables, such as self-regulatory cognitions specified by health behavior models, including the Health Action Process Approach (HAPA). PURPOSE: This study explored whether strictness of containment and health policies was related to handwashing adherence and whether such associations were mediated by HAPA-specified self-regulatory cognitions.METHODS: The study (NCT04367337) was conducted among 1,256 adults from Australia, Canada, China, France, Gambia, Germany, Israel, Italy, Malaysia, Poland, Portugal, Romania, Singapore, and Switzerland. Self-report data on cross-situational handwashing adherence were collected using an online survey at two time points, 4 weeks apart. Values of the index of strictness of containment and health policies, obtained from the Oxford COVID-19 Government Response Tracker database, were retrieved twice for each country (1 week prior to individual data collection).RESULTS: Across countries and time, levels of handwashing adherence and strictness of policies were high. Path analysis indicated that stricter containment and health policies were indirectly related to lower handwashing adherence via lower self-efficacy and self-monitoring. Less strict policies were indirectly related to higher handwashing adherence via higher self-efficacy and self-monitoring.CONCLUSIONS: When policies are less strict, exposure to the SARS-CoV-2 virus might be higher, triggering more self-regulation and, consequently, more handwashing adherence. Very strict policies may need to be accompanied by enhanced information dissemination or psychosocial interventions to ensure appropriate levels of self-regulation.

International audience ; BACKGROUND: Patterns of protective health behaviors, such as handwashing and sanitizing during the COVID-19 pandemic, may be predicted by macro-level variables, such as regulations specified by public health policies. Health behavior patterns may also be predicted by micro-level variables, such as self-regulatory cognitions specified by health behavior models, including the Health Action Process Approach (HAPA). PURPOSE: This study explored whether strictness of containment and health policies was related to handwashing adherence and whether such associations were mediated by HAPA-specified self-regulatory cognitions.METHODS: The study (NCT04367337) was conducted among 1,256 adults from Australia, Canada, China, France, Gambia, Germany, Israel, Italy, Malaysia, Poland, Portugal, Romania, Singapore, and Switzerland. Self-report data on cross-situational handwashing adherence were collected using an online survey at two time points, 4 weeks apart. Values of the index of strictness of containment and health policies, obtained from the Oxford COVID-19 Government Response Tracker database, were retrieved twice for each country (1 week prior to individual data collection).RESULTS: Across countries and time, levels of handwashing adherence and strictness of policies were high. Path analysis indicated that stricter containment and health policies were indirectly related to lower handwashing adherence via lower self-efficacy and self-monitoring. Less strict policies were indirectly related to higher handwashing adherence via higher self-efficacy and self-monitoring.CONCLUSIONS: When policies are less strict, exposure to the SARS-CoV-2 virus might be higher, triggering more self-regulation and, consequently, more handwashing adherence. Very strict policies may need to be accompanied by enhanced information dissemination or psychosocial interventions to ensure appropriate levels of self-regulation.