Introducing the revised framework for developing and evaluating complex interventions: A challenge and a resource for nursing research.

This invited discussion paper highlights key updates in the MRC/NIHR's revised framework for the development and evaluation of complex nursing interventions and reflects on the implications for nursing research.

Reprint of: 'A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance'.

The UK Medical Research Council's widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.

Social network interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease.

BACKGROUND: Globally, cardiovascular diseases (CVD, that is, coronary heart (CHD) and circulatory diseases combined) contribute to 31% of all deaths, more than any other cause. In line with guidance in the UK and globally, cardiac rehabilitation programmes are widely offered to people with heart disease, and include psychosocial, educational, health behaviour change, and risk management components. Social support and social network interventions have potential to improve outcomes of these programmes, but whether and how these interventions work is poorly understood.  OBJECTIVES: To assess the effectiveness of social network and social support interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease. The comparator was usual care with no element of social support (i.e. secondary prevention alone or with cardiac rehabilitation).  SEARCH METHODS: We undertook a systematic search of the following databases on 9 August 2022: CENTRAL, MEDLINE, Embase, and the Web of Science. We also searched ClinicalTrials.gov and the WHO ICTRP. We reviewed the reference lists of relevant systematic reviews and included primary studies, and we contacted experts to identify additional studies.  SELECTION CRITERIA: We included randomised controlled trials (RCTs) of social network or social support interventions for people with heart disease. We included studies regardless of their duration of follow-up, and included those reported as full text, published as abstract only, and unpublished data. DATA COLLECTION AND ANALYSIS: Using Covidence, two review authors independently screened all identified titles. We retrieved full-text study reports and publications marked 'included', and two review authors independently screened these, and conducted data extraction. Two authors independently assessed risk of bias, and assessed the certainty of the evidence using GRADE. Primary outcomes were all-cause mortality, cardiovascular-related mortality, all-cause hospital admission, cardiovascular-related hospital admission, and health-related quality of life (HRQoL) measured at > 12 months follow-up.  MAIN RESULTS: We included 54 RCTs (126 publications) reporting data for a total of 11,445 people with heart disease. The median follow-up was seven months and median sample size was 96 participants. Of included study participants, 6414 (56%) were male, and the mean age ranged from 48.6 to 76.3 years. Studies included heart failure (41%), mixed cardiac disease (31%), post-myocardial infarction (13%), post-revascularisation (7%), CHD (7%), and cardiac X syndrome (1%) patients. The median intervention duration was 12 weeks. We identified notable diversity in social network and social support interventions, across what was delivered, how, and by whom.  We assessed risk of bias (RoB) in primary outcomes at > 12 months follow-up as either 'low' (2/15 studies), 'some concerns' (11/15), or 'high' (2/15). 'Some concerns' or 'high' RoB resulted from insufficient detail on blinding of outcome assessors, data missingness, and absence of pre-agreed statistical analysis plans. In particular, HRQoL outcomes were at high RoB. Using the GRADE method, we assessed the certainty of evidence as low or very low across outcomes. Social network or social support interventions had no clear effect on all-cause mortality (risk ratio (RR) 0.75, 95% confidence interval (CI) 0.49 to 1.13, I2 = 40%) or cardiovascular-related mortality (RR 0.85, 95% CI 0.66 to 1.10, I2 = 0%) at > 12 months follow-up. The evidence suggests that social network or social support interventions for heart disease may result in little to no difference in all-cause hospital admission (RR 1.03, 95% CI 0.86 to 1.22, I2 = 0%), or cardiovascular-related hospital admission (RR 0.92, 95% CI 0.77 to 1.10, I2 = 16%), with a low level of certainty. The evidence was very uncertain regarding the impact of social network interventions on HRQoL at > 12 months follow-up (SF-36 physical component score: mean difference (MD) 31.53, 95% CI -28.65 to 91.71, I2 = 100%, 2 trials/comparisons, 166 participants; mental component score MD 30.62, 95% CI -33.88 to 95.13, I2 = 100%, 2 trials/comparisons, 166 participants).  Regarding secondary outcomes, there may be a decrease in both systolic and diastolic blood pressure with social network or social support interventions. There was no evidence of impact found on psychological well-being, smoking, cholesterol, myocardial infarction, revascularisation, return to work/education, social isolation or connectedness, patient satisfaction, or adverse events.  Results of meta-regression did not suggest that the intervention effect was related to risk of bias, intervention type, duration, setting, and delivery mode, population type, study location, participant age, or percentage of male participants.  AUTHORS' CONCLUSIONS: We found no strong evidence for the effectiveness of such interventions, although modest effects were identified in relation to blood pressure. While the data presented in this review are indicative of potential for positive effects, the review also highlights the lack of sufficient evidence to conclusively support such interventions for people with heart disease. Further high-quality, well-reported RCTs are required to fully explore the potential of social support interventions in this context. Future reporting of social network and social support interventions for people with heart disease needs to be significantly clearer, and more effectively theorised, in order to ascertain causal pathways and effect on outcomes.

Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update.

BACKGROUND: The Medical Research Council published the second edition of its framework in 2006 on developing and evaluating complex interventions. Since then, there have been considerable developments in the field of complex intervention research. The objective of this project was to update the framework in the light of these developments. The framework aims to help research teams prioritise research questions and design, and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. METHODS: There were four stages to the update: (1) gap analysis to identify developments in the methods and practice since the previous framework was published; (2) an expert workshop of 36 participants to discuss the topics identified in the gap analysis; (3) an open consultation process to seek comments on a first draft of the new framework; and (4) findings from the previous stages were used to redraft the framework, and final expert review was obtained. The process was overseen by a Scientific Advisory Group representing the range of relevant National Institute for Health Research and Medical Research Council research investments. RESULTS: Key changes to the previous framework include (1) an updated definition of complex interventions, highlighting the dynamic relationship between the intervention and its context; (2) an emphasis on the use of diverse research perspectives: efficacy, effectiveness, theory-based and systems perspectives; (3) a focus on the usefulness of evidence as the basis for determining research perspective and questions; (4) an increased focus on interventions developed outside research teams, for example changes in policy or health services delivery; and (5) the identification of six 'core elements' that should guide all phases of complex intervention research: consider context; develop, refine and test programme theory; engage stakeholders; identify key uncertainties; refine the intervention; and economic considerations. We divide the research process into four phases: development, feasibility, evaluation and implementation. For each phase we provide a concise summary of recent developments, key points to address and signposts to further reading. We also present case studies to illustrate the points being made throughout. LIMITATIONS: The framework aims to help research teams prioritise research questions and design and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. In many of the areas of innovation that we highlight, such as the use of systems approaches, there are still only a few practical examples. We refer to more specific and detailed guidance where available and note where promising approaches require further development. CONCLUSIONS: This new framework incorporates developments in complex intervention research published since the previous edition was written in 2006. As well as taking account of established practice and recent refinements, we draw attention to new approaches and place greater emphasis on economic considerations in complex intervention research. We have introduced a new emphasis on the importance of context and the value of understanding interventions as 'events in systems' that produce effects through interactions with features of the contexts in which they are implemented. The framework adopts a pluralist approach, encouraging researchers and research funders to adopt diverse research perspectives and to select research questions and methods pragmatically, with the aim of providing evidence that is useful to decision-makers. FUTURE WORK: We call for further work to develop relevant methods and provide examples in practice. The use of this framework should be monitored and the move should be made to a more fluid resource in the future, for example a web-based format that can be frequently updated to incorporate new material and links to emerging resources. FUNDING: This project was jointly funded by the Medical Research Council (MRC) and the National Institute for Health Research (Department of Health and Social Care 73514).

Interventions are actions taken to make a change, for example heart surgery, an exercise programme or a smoking ban in public. Interventions are described as complex if they comprise several stages or parts or if the context in which they are delivered is complex. A framework on how to develop and evaluate complex interventions was last published by the Medical Research Council in 2006 (Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and Evaluating Complex Interventions. London: Medical Research Council; 2006). This document describes how the framework has been updated to include advances in research methods and thinking and presents the new framework document. The updating process had four stages: (1) review of the literature to identify areas requiring update; (2) workshop of experts to discuss topics to update; (3) open consultation on a draft of the framework; and (4) writing the framework. The updated framework divides the research process into four phases: development, feasibility, evaluation and implementation. Key updates include: the definition of a complex intervention was changed to include both the content of the intervention and the context in which it is conductedaddition of systems thinking methods: an approach that considers the broader system an intervention sits withinmore emphasis on interventions that are not developed by researchers (e.g. policy changes and health services delivery)emphasis on the usefulness of evidence as the key goal of complex intervention researchidentification of six elements to be addressed throughout the research process: context; theory refinement and testing; stakeholder involvement; identification of key uncertainties; intervention refinement; and economic considerations. The updated framework is intended to help those involved in funding and designing research to consider a range of approaches, questions and methods and to choose the most appropriate. It also aims to help researchers conduct and report research that is as useful as possible to users of research.

An app-, web- and social support-based weight loss intervention for adults with obesity: the 'HelpMeDoIt!' feasibility randomised controlled trial.

BACKGROUND: Social support has an important role in successful weight loss. The aim of this study was to assess the feasibility and acceptability of an app-, web- and social support-based intervention in supporting adults with obesity to achieve weight loss. METHODS: The intervention and evaluation methods were tested in a feasibility randomised controlled trial. Adults in the Greater Glasgow and Clyde Health Board area of Scotland with a body mass index ≥ 30 kg/m2 were recruited and randomised 2:1 (intervention to control). The feasibility and acceptability of the intervention and trial methods were assessed against pre-specified progression criteria, via process, economic and outcome evaluation. Three primary outcomes were explored: BMI, diet and physical activity, as well as a number of secondary outcomes. The intervention group had access to the HelpMeDoIt! intervention for 12 months. This encouraged them to (i) set goals, (ii) monitor progress and (iii) harness social support by inviting 'helpers' from their existing social network. The control group received a healthy lifestyle leaflet. RESULTS: One hundred and nine participants were recruited, with 84 participants (77%) followed-up at 12 months. The intervention and trial methods were feasible and acceptable. Participants and helpers were generally positive. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it. Interview data indicated that HelpMeDoIt! promoted social support from existing social networks to support weight loss. This support was often given outside of the app.Outcomes were compared using linear regression models, with randomised group, the baseline measurement of the outcome, age and gender as predictor variables. These analyses were exploratory and underpowered to detect effects. However, all pre-specified primary outcome effects (BMI, diet and physical activity) had wide confidence intervals and were therefore consistent with clinically relevant benefits. Objective physical activity measures perhaps showed most potential (daily step count (p = 0.098; 1187 steps [- 180, 2555])) and sedentary time (p = 0.022; - 60.8 min [- 110.5, - 11.0]). However, these outcomes were poorly completed. CONCLUSIONS: The study demonstrated that a novel social support intervention involving support from participants' close social networks, delivered via app and website, has potential to promote weight loss and is feasible and acceptable. TRIAL REGISTRATION: ISRCTN, ISRCTN85615983. Registered 25 September 2014.

The lifestyle behaviours of young adults with intellectual disabilities as they transition from school to adulthood: A pilot and feasibility study.

BACKGROUND: In the general population, the transition from adolescence to adulthood has been identified as a "high-risk" period for weight gain. There has been no research examining health behaviours over this transition in adults with intellectual disabilities. METHODS/DESIGN: The feasibility of recruitment, retention and relevant health behaviours were measured in 31 adolescents with mild-moderate intellectual disabilities. Anthropometric, objective physical activity, dietary and self-determination measures were collected over a 12-month transitional period from school to adulthood. RESULTS: Key results suggest weight and BMI increased significantly from month 6 to month 12 (p = 0.044 and p = 0.043). Waist circumference increased significantly from baseline to month 12 (p = 0.049), and from month 6 to month 12 (p = 0.03). DISCUSSION: Recruiting and retaining young adults with intellectual disabilities over a 12-month health behaviour study is feasible. The data indicate the transition from school to adulthood may be the start of a high-risk period for weight gain.

Community-based group guided self-help intervention for low mood and stress: randomised controlled trial.

BACKGROUND: To date no studies have explored the effectiveness of written cognitive-behavioural therapy (CBT) resources for low mood and stress delivered via a course of self-help classes in a community setting. Aims To assess the effectiveness of an 8-week community-based CBT self-help group classes on symptoms of depression, anxiety and social function at 6 months (trial registration: ISRCTN86292664). METHOD: In total, 142 participants were randomly allocated to immediate (n = 71) or delayed access to a low-intensity CBT intervention (n = 71). Measures of depression, anxiety and social function were collected at baseline and 6 months. RESULTS: There was a significant improvement for the primary outcome of Patient Health Questionnaire-9 (PHQ-9) score (mean between-group difference: -3.64, 95% CI -6.06 to -1.23; P = 0.004). The percentage of participants reducing their PHQ-9 score between baseline and 6 months by 50% or more was 17.9% for the delayed access group and 43.8% for the immediate access group. Secondary outcomes also improved including anxiety and social function. The intervention was cost neutral. The probabilities of a net benefit at willingness to pay thresholds of £20 000, £25 000 or £30 000 were 0.928, 0.944 and 0.955, respectively. CONCLUSIONS: Low-intensity class-based CBT delivered within a community setting is effective for reducing depression, anxiety and impaired social function at little additional cost. Declaration of interest C.W. is president of British Association for Behavioural & Cognitive Psychotherapies (BABCP) - the lead body for CBT in the UK. He is also author of a range of CBT-based resources available commercially. He is developer of the LLTTF classes evaluated in this study. He receives royalty, and is shareholder and director of a company that commercialises these resources.

A theory-informed qualitative exploration of social and environmental determinants of physical activity and dietary choices in adolescents with intellectual disabilities in their final year of school.

BACKGROUND: The prevalence of obesity is higher in those with intellectual disabilities than the general population. The aim of the study was to understand the determinants of physical activity and dietary patterns in this population during their final year of school. METHOD: Qualitative data were generated from 10 interviews with adolescents with mild-moderate intellectual disabilities. Data were analysed using deductive thematic analysis, employing Self-Determination Theory as a theoretical framework. RESULTS: Adolescents' environment and social interactions play a pivotal role in influencing physical activity and dietary patterns. Three themes emerged from the analysis: situatedness, motivation and wider environmental influences. CONCLUSIONS: School structure, high self-efficacy and social connectedness facilitate increased physical activity and healthier diet in adolescents with intellectual disabilities. Home life, low self-efficacy and a lack of social connectedness can serve as a barrier to PA and a healthy diet.

A qualitative exploration of participants' experiences of taking part in a walking programme: Perceived benefits, barriers, choices and use of intervention resources.

BACKGROUND: Adults with intellectual disabilities (ID) experience significant inequalities and tend to be more sedentary and less physically active than the wider population. Walking programmes are an effective way to increase physical activity (PA) but have not been used in studies involving adults with intellectual disabilities. METHOD: Nineteen adults with intellectual disabilities participated in semistructured interviews or focus groups exploring their experiences of taking part in a walking programme (Walk Well). Data were coded using thematic analysis. RESULTS: Four overarching themes emerged: perceived benefits of taking part in the programme, perceived drawbacks/ barriers, walking choices and using the Walk Well resources. While there was not a significant increase in walking for all, the participants reported positive experiences of taking part in the programme. Self-monitoring proved difficult for some, particularly reading the daily step count recorded on the pedometer and writing it in the diary. Carers also played an important role in facilitating and preventing behaviour change in adults with intellectual disabilities. CONCLUSION: Additional barriers prevent many adults with intellectual disabilities from participating in PA. Capturing participant experiences provides important information for designing effective and equitable health improvement programmes.

Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.

INTRODUCTION: HelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite 'helpers' from their social circle to help them achieve their goal(s). AIM: To test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals. METHODS AND ANALYSIS: 12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI)> 30 kg/m2 and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual factors influencing the intervention. ETHICS AND DISSEMINATION: The protocol has been approved by the West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108). Findings will be disseminated widely through peer-reviewed publication and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN85615983.

'Moving on and feeling good': a feasibility study to explore the lifestyle behaviours of young adults with intellectual disabilities as they transition from school to adulthood-a study protocol.

BACKGROUND: The transition from adolescence to adulthood is a 'high-risk' period for weight gain in the general population. There is speculation that this may also be a risk period for adults with intellectual disabilities; however, there has been no research which has monitored change in health indicators. Since adults with intellectual disabilities have higher rates of obesity and engage in more sedentary behaviour and less physical activity than the general population, there is a need to understand more about the lifestyle behaviours of this population during the transition to adulthood. This protocol paper will provide details of the moving on and feeling good feasibility study, designed for young people with intellectual disabilities. METHODS/DESIGN: A multi-point recruitment strategy will be used to recruit 30 participants with a mild-moderate level of intellectual disability. The aim of the feasibility study is to examine the feasibility of recruitment, participant retention and the measurement of relevant health behaviour outcomes. The study will assess the feasibility of monitoring weight, diet and physical activity levels in adolescents over a 12-month transitional period from school to adult life. This mixed method study will provide insight into the lives of young people with intellectual disabilities and will examine the use of Walker et al.'s social-ecological approach to promote self-determination specific to lifestyle behaviours, during this transition period. Baseline data will be collected during the final year of school, with follow-up data collection at 6 and 12 months. Anthropometric (weight, height, waist and hip circumference), objective physical activity measures (7-day accelerometer wear) and dietary and choice measures will be collected at each time point to assess the feasibility of measuring diet patterns, food frequency, physical activity and BMI. Furthermore, ten participants will be selected for short semi-structured scoping interviews at baseline and 12-month follow-up, to gain information on psychological, social and environmental factors which might affect behaviour change. DISCUSSION: The outcomes from the feasibility study will aid the development and piloting of a sufficiently powered randomised controlled trial. This would allow us to evaluate the effectiveness and sustainability of a lifestyle behaviour intervention, over a 5-year transition period.

Psychological consequences of childhood obesity: psychiatric comorbidity and prevention.

Childhood obesity is one of the most serious public health challenges of the 21st century with far-reaching and enduring adverse consequences for health outcomes. Over 42 million children <5 years worldwide are estimated to be overweight (OW) or obese (OB), and if current trends continue, then an estimated 70 million children will be OW or OB by 2025. The purpose of this review was to focus on psychiatric, psychological, and psychosocial consequences of childhood obesity (OBy) to include a broad range of international studies. The aim was to establish what has recently changed in relation to the common psychological consequences associated with childhood OBy. A systematic search was conducted in MEDLINE, Web of Science, and the Cochrane Library for articles presenting information on the identification or prevention of psychiatric morbidity in childhood obesity. Relevant data were extracted and narratively reviewed. Findings established childhood OW/OBy was negatively associated with psychological comorbidities, such as depression, poorer perceived lower scores on health-related quality of life, emotional and behavioral disorders, and self-esteem during childhood. Evidence related to the association between attention-deficit/hyperactivity disorder (ADHD) and OBy remains unconvincing because of various findings from studies. OW children were more likely to experience multiple associated psychosocial problems than their healthy-weight peers, which may be adversely influenced by OBy stigma, teasing, and bullying. OBy stigma, teasing, and bullying are pervasive and can have serious consequences for emotional and physical health and performance. It remains unclear as to whether psychiatric disorders and psychological problems are a cause or a consequence of childhood obesity or whether common factors promote both obesity and psychiatric disturbances in susceptible children and adolescents. A cohesive and strategic approach to tackle this current obesity epidemic is necessary to combat this increasing trend which is compromising the health and well-being of the young generation and seriously impinging on resources and economic costs.

Process evaluation of the Walk Well study: a cluster-randomised controlled trial of a community based walking programme for adults with intellectual disabilities.

BACKGROUND: Walking interventions can be effective in encouraging sedentary populations to become more active; however, limited research has explored the effectiveness of walking interventions for adults with intellectual disabilities. This process evaluation explored the delivery of a community based walking intervention for adults with intellectual disabilities. METHODS: Walk Well was a single-blind cluster randomised controlled trial of a 12-week physical activity consultation-led walking intervention. 102 participants were randomised to the Walk Well intervention or a waiting list control group. Participants in the intervention group received three physical activity consultations with a walking advisor at baseline, 6 & 12-weeks. They were encouraged to use a pedometer to set goals and monitor their daily step count. Primary outcome was change in daily step count at 12-weeks. Process evaluation measures included qualitative interviews with key stakeholders (n = 6) and quantifiable data collected as part of the intervention. Additional process data were extracted from a sub-set of qualitative interviews with participants and carers (n = 20). Data were analysed for process information related to context, recruitment and retention, reach, implementation, and fidelity. RESULTS: Walk Well was not effective in significantly increasing levels of physical activity. The process evaluation did, however, highlight several important areas for consideration in future studies, including: a successful recruitment and retention strategy reaching a representative sample of adults with intellectual disabilities in the community; feasible and (for most) enjoyable methods of engaging adults with intellectual disabilities in activities to support behaviour change; potential need for greater intervention duration and frequency of contact; advantages and disadvantages of using pedometers as a behaviour change tool; the need for strategies which engage carers in supporting participants; and the complex issue of 'freedom of choice' in relation to lifestyle behaviours and study participation. CONCLUSIONS: Walking interventions for adults with intellectual disabilities can be feasibly delivered in the community in relation to reach, recruitment, retention and intervention fidelity. More intensive intervention methods need to be explored as well as strategies to engage and motivate carers in their support of participants. TRIAL REGISTRATION: Current Controlled Trials ISRCTN50494254 (3(rd) April 2012).

Improving the quality of the NHS workforce through values and competency-based selection.

Robust selection processes are essential to ensure the best and most appropriate candidates for nursing, midwifery and allied health professional (NMAHP) positions are appointed, and subsequently enhance patient care. This article reports on a study that explored interviewers' and interviewees' experiences of using values and competency-based interview (VCBI) methods for NMAHPs. Results suggest that this resource could have a positive effect on the quality of the NMAHP workforce, and therefore on patient care. This method of selection could be used in other practice areas in health care, and refinement of the resource should focus on supporting interview panels to develop their VCBI skills and experience.

Effectiveness of a walking programme to support adults with intellectual disabilities to increase physical activity: walk well cluster-randomised controlled trial.

BACKGROUND: Programs to change health behaviours have been identified as one way to reduce health inequalities experienced by disadvantaged groups. The objective of this study was to examine the effectiveness of a behaviour change programme to increase walking and reduce sedentary behaviour of adults with intellectual disabilities. METHODS: We used a cluster randomised controlled design and recruited participants over 18 years old and not regularly involved in physical activity from intellectual disabilities community-based organisations. Assessments were carried out blind to allocation. Clusters of participants were randomly allocated to the Walk Well program or a 12-week waiting list control. Walk Well consisted of three face-to-face physical activity consultations incorporating behaviour change techniques, written resources for participants and carers, and an individualised, structured walking programme. The primary outcome measured with accelerometers was change in mean step count per day between baseline and 12 weeks. Secondary outcomes included percentage time per day sedentary and in moderate-vigorous physical activity (MVPA), body mass index (BMI), and subjective well being. RESULTS: One hundred two participants in 50 clusters were randomised. 82 (80.4%) participants completed the primary outcome. 66.7% of participants lived in the most deprived quintile on the Scottish Index of Multiple Deprivation. At baseline, participants walked 4780 (standard deviation 2432) steps per day, spent 65.5% (standard deviation 10.9) of time sedentary and 59% percent had a body mass in the obesity range. After the walking programme, the difference between mean counts of the Walk Well and control group was 69.5 steps per day [95% confidence interval (CI) -1054 to 1193.3]. There were no significant between group differences in percentage time sedentary 1.6% (95% CI -2.984 to 6.102), percentage time in MVPA 0.3% (95% CI -0.7 to 1.3), BMI -0.2 kg/m(2) (95% CI -0.8 to 0.4) or subjective well-being 0.3 (95% CI -0.9 to 1.5). CONCLUSIONS: This is the first published trial of a walking program for adults with intellectual disabilities. Positively changing physical activity and sedentary behaviours may require more intensive programmes or upstream approaches to address the multiple social disadvantages experienced by adults with intellectual disabilities. Since participants spent the majority of their time sedentary, home-based programmes to reduce sitting time may be a viable health improvement approach. TRIAL REGISTRATION: Current Controlled Trials ISRCTN50494254.

A community-based pilot randomised controlled study of life skills classes for individuals with low mood and depression.

BACKGROUND: Cognitive behavioural therapy (CBT) is recommended for the treatment of depression and anxiety. However, access is limited. Low-intensity approaches such as guided CBT self-help (bibliotherapy) can increase access to treatment and is recommended by UK guidelines. No previous research has explored the provision of group-based guidance/support for a bibliotherapy approach for depression and anxiety in community settings. The objective was to carry out a pilot study of a group guided self-help intervention, using community based recruitment methods. METHOD: A randomised controlled trial comparing an 8 week CBT group guided self-help intervention to usual care. Recruitment and the delivery of the intervention were carried out in Glasgow and Derry/Londonderry in partnership with national depression charities. Fifty-three people were randomised, however we refer only to the forty-six participants who provided baseline data: 16 males and 30 females, aged 16 or over, with a PHQ-9 score of ≥ 5, were recruited from the community. The mean age of the sample was 43.7 (sd = 13) and 93.5% of participants had suffered from low mood for a year or more. RESULTS: There was effective recruitment, randomisation, uptake and adherence with 21 Immediate Access (IA) and 25 Delayed Access Control (DAC) participants. The intervention was highly acceptable to participants attending on average 4.46 of the 8 sessions (sd 3.06), 65.2% attended more than half of all sessions. The mean satisfaction on the Client Satisfaction Questionnaire was 28 out of 32 (sd 4.8). The provisional results in the pilot suggest the intervention may improve both anxiety and depression. At three months, data collection was achieved from 74% of participants. The trial successfully provided estimates of the sample size needed for the future planned trial. CONCLUSIONS: Low-intensity group-based classes may offer an alternative method of managing depression and anxiety and warrant further research. TRIAL REGISTRATION: Current Controlled Trials ISRCTN84893887 . Registered 3 November 2011.

Can physical activity interventions for adults with type 2 diabetes be translated into practice settings? A systematic review using the RE-AIM framework.

Despite the strong evidence base for the efficacy of physical activity in the management of type 2 diabetes, a limited number of physical activity interventions have been translated and evaluated in everyday practice. This systematic review aimed to report the findings of studies in which an intervention, containing physical activity promotion as a component, has been delivered within routine diabetes care. A comprehensive search was conducted for articles reporting process data relating to components of the RE-AIM (Reach, Effectiveness, Adoption, Implementation and/or Maintenance) framework. Twelve studies met the selection criteria. Of the nine studies which measured physical activity as an outcome, eight reported an increase in physical activity levels, five of which were significant. Tailoring recruitment, resources and intervention delivery to the target population played a positive role, in addition to the use of external organisations and staff training. Many interventions were of short duration and lacked long-term follow-up data. Findings revealed limited and inconsistent reporting of useful process data.

A systematic review of physical activity and sedentary behavior intervention studies in youth with type 1 diabetes: study characteristics, intervention design, and efficacy.

OBJECTIVE: To systematically review physical activity and/or sedentary behavior intervention studies for youth with type 1 diabetes. METHODS: Several databases were searched for articles reporting on randomized-controlled trials (RCTs) in youth (<18 yr) with type 1 diabetes. Data was extracted and bias assessed to evaluate study characteristics, intervention design, and efficacy of interventions on physical activity and health. Where sufficient data were available meta-analyses of health outcomes [for hemoglobin A1c (HbA1c)] were performed. Weighted mean differences (WMD) were calculated using fixed and random effect models. RESULTS: The literature search identified 12/2397 full-text articles reporting on 11 studies. Two interventions were wholly unsupervised and only one was based on behavior change theory with no studies exploring changes in behavior processes. Nine interventions aimed to improve fitness or physical activity, two aimed to improve health, and none aimed at changing sedentary behavior. Eight interventions improved physical activity and/or fitness. At least one beneficial effect on health was found in each intervention group apart from two studies where no changes were found. Meta-analysis of 10 studies showed the interventions have a significant beneficial reduction of HbA1c (%), indicating an improvement in glycemic control [WMD, -0.85% (95% CI, -1.45 to -0.25%)]. There were insufficient data to pool other health outcome data. CONCLUSIONS: Few RCTs explored the efficacy of unsupervised theory-based physical activity and/or sedentary behavior interventions in youth with type 1 diabetes. Limited reporting made comparison of findings challenging. There was an overall significant beneficial effect of physical activity on HbA1c.

Walk Well: a randomised controlled trial of a walking intervention for adults with intellectual disabilities: study protocol.

BACKGROUND: Walking interventions have been shown to have a positive impact on physical activity (PA) levels, health and wellbeing for adult and older adult populations. There has been very little work carried out to explore the effectiveness of walking interventions for adults with intellectual disabilities. This paper will provide details of the Walk Well intervention, designed for adults with intellectual disabilities, and a randomised controlled trial (RCT) to test its effectiveness. METHODS/DESIGN: This study will adopt a RCT design, with participants allocated to the walking intervention group or a waiting list control group. The intervention consists of three PA consultations (baseline, six weeks and 12 weeks) and an individualised 12 week walking programme.A range of measures will be completed by participants at baseline, post intervention (three months from baseline) and at follow up (three months post intervention and six months from baseline). All outcome measures will be collected by a researcher who will be blinded to the study groups. The primary outcome will be steps walked per day, measured using accelerometers. Secondary outcome measures will include time spent in PA per day (across various intensity levels), time spent in sedentary behaviour per day, quality of life, self-efficacy and anthropometric measures to monitor weight change. DISCUSSION: Since there are currently no published RCTs of walking interventions for adults with intellectual disabilities, this RCT will examine if a walking intervention can successfully increase PA, health and wellbeing of adults with intellectual disabilities. TRIAL REGISTRATION ISRCTN: ISRCTN50494254.