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Background: Untreated heterozygous familial hypercholesterolaemia (FH) causes high low-density lipoprotein cholesterol (LDL-C) levels and increased cardiovascular disease (CVD) risk. Despite pharmacological treatment, many treated individuals remain at higher CVD risk than non-affected individuals. This may be due to LDL-C targets not being met and presence of other CVD risk factors. Adhering to dietary and physical activity (PA) recommendations developed for individuals with FH may further reduce CVD risk. However, there is insufficient research to support the efficacy of adhering to these guidelines on LDL-C and other CVD risk factors. The need for studies to investigate the effectiveness of nutrition and PA interventions in the FH population has been widely recognised and recommended. This paper describes the protocol of a pilot, randomised controlled trial designed to evaluate the feasibility and acceptability of a specifically developed nutrition and PA intervention aimed at improving the dietary intakes and PA levels of families with FH. Methods: A two-arm randomised waitlist-controlled pilot trial will be conducted across three National Health Service (NHS) sites in England, UK. Twenty-four young people with FH, aged 10–18 years, and their affected parent, will be recruited and randomly assigned to the intervention or waitlist and usual care control. The primary aim is to provide evidence for the feasibility and acceptability of delivering the intervention, explored quantitatively (rates of recruitment, retention and outcome measure completeness) and qualitatively (qualitative interviews). The secondary aim is to provide evidence for the potential efficacy of the intervention on dietary intake, PA, sedentary time, body composition, CVD risk factors and quality of life determined at baseline and endpoint assessments. The intervention will involve an hour-long consultation with a dietitian at baseline and four follow-up contacts across the 12-week intervention. It has been specifically developed for use with individuals with FH and incorporates behavioural change techniques to target identified enablers and barriers to adherence in this population. Discussion: This trial will estimate the feasibility and acceptability of the nutrition and PA intervention delivered to young people and parents with FH. If appropriate, this study can be used to inform the design of an adequately powered definitive trial. Trial registration: ISRCTN, ISRCTN24880714. Registered 07/06/2018, http://www.isrctn.com/ISRCTN24880714. [ABSTRACT FROM AUTHOR]

Background: Interventions promoting physical activity by General Practitioners (GPs) lack a strong evidence base. Recruiting participants to trials in primary care is challenging. We investigated the feasibility of (i) delivering three interventions to promote physical activity in inactive participants and (ii) different methods of participant recruitment and randomised allocation., Methods: We recruited general practices from Devon, Bristol and Coventry. We used a 2-by-2 factorial design for participant recruitment and randomisation. Recruitment strategies were either opportunistic (approaching patients attending their GP surgery) or systematic (selecting patients from practice lists and approaching them by letter). Randomisation strategies were either individual or by practice cluster. Feasibility outcomes included time taken to recruit the target number of participants within each practice. Participants were randomly allocated to one of three interventions: (i) written advice (control); (ii) brief GP advice (written advice plus GP advice on physical activity), and (iii) brief GP advice plus a pedometer to self-monitor physical activity during the trial. Participants allocated to written advice or brief advice each received a sealed pedometer to record their physical activity, and were instructed not to unseal the pedometer before the scheduled day of data collection. Participant level outcomes were reported descriptively and included the mean number of pedometer steps over a 7-day period, and European Quality of Life (EuroQoL)-5 dimensions (EQ-5D) scores, recorded at 12 weeks' follow-up., Results: We recruited 24 practices (12 using each recruitment method; 18 randomising by cluster, 6 randomising by individual participant), encompassing 131 participants. Opportunistic recruitment was associated with less time to target recruitment compared with systematic (mean difference (days) -54.9, 95% confidence interval (CI) -103.6; -6.2) but with greater loss to follow up (28.8% versus. 6.9%; mean difference 21.9% (95% CI 9.6%; 34.1%)). There were differences in the socio-demographic characteristics of participants according to recruitment method. There was no clear pattern of change in participant level outcomes from baseline to 12 weeks across the three arms., Conclusions: Delivering and trialling GP-led interventions to promote physical activity is feasible, but trial design influences time to participant recruitment, participant withdrawal, and possibly, the socio-demographic characteristics of participants., Trial Registration Number: ISRCTN73725618.

Objective: To investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression presenting in primary care., Design: Pragmatic, multicentre, two arm parallel randomised controlled trial., Setting: General practices in Bristol and Exeter., Participants: 361 adults aged 18-69 who had recently consulted their general practitioner with symptoms of depression. All those randomised had a diagnosis of an episode of depression as assessed by the clinical interview schedule-revised and a Beck depression inventory score of 14 or more., Interventions: In addition to usual care, intervention participants were offered up to three face to face sessions and 10 telephone calls with a trained physical activity facilitator over eight months. The intervention was based on theory and aimed to provide individually tailored support and encouragement to engage in physical activity., Main Outcome Measures: The primary outcome was self reported symptoms of depression, assessed with the Beck depression inventory at four months post-randomisation. Secondary outcomes included use of antidepressants and physical activity at the four, eight, and 12 month follow-up points, and symptoms of depression at eight and 12 month follow-up., Results: There was no evidence that participants offered the physical activity intervention reported improvement in mood by the four month follow-up point compared with those in the usual care group; adjusted between group difference in mean Beck depression inventory score -0.54 (95% confidence interval -3.06 to 1.99; P=0.68). Similarly, there was no evidence that the intervention group reported a change in mood by the eight and 12 month follow-up points. Nor was there evidence that the intervention reduced antidepressant use compared with usual care (adjusted odds ratio 0.63, 95% confidence interval 0.19 to 2.06; P=0.44) over the duration of the trial. However, participants allocated to the intervention group reported more physical activity during the follow-up period than those allocated to the usual care group (adjusted odds ratio 2.27, 95% confidence interval 1.32 to 3.89; P=0.003)., Conclusions: The addition of a facilitated physical activity intervention to usual care did not improve depression outcome or reduce use of antidepressants compared with usual care alone., Trial Registration: Current Controlled Trials ISRCTN16900744.

Objectives: Chronic wounds such as diabetic foot and venous leg ulcers are a major burden for health services. Our programme was developed to explore the psychological and behavioural factors that may influence both the incidence of chronic wounds and their progression. The present article focuses on two particular aspects of the programme: patient knowledge of diabetic foot ulceration and factors influencing foot-related behaviour in patients with and without foot ulcers; and patient and podiatrist perspectives of consultations for diabetic foot ulcers., Methods: Two independent qualitative studies were undertaken: one with diabetic patients without a history of ulceration; and the other with diabetic patients with active ulceration and podiatrists treating these patients., Results: We found that patients may find it difficult understanding the rationale underlying prevention and treatment of foot ulcers; ulcerated patients may find it difficult to engage in the management of their foot ulcer outside consultations; and some podiatrists feel frustrated and unsupported in their attempts at empowering and building partnerships with patients., Conclusion: Patient and practitioner factors may contribute to the effective implementation of clinical guidelines regarding education, partnership building and shared decision-making. These findings are discussed in relation to patient education, partnership building and shared decision-making as recommended in NICE guidelines.

Objective: According to the common-sense model of illness behaviour, illness representations are directly related to coping and, via coping, to adaptive or maladaptive outcomes. However, it may be more appropriate to conceptualize coping by assessing what patients actually do - i.e., their coping behaviours - rather than what they say they do in coping scales - i.e., their coping cognitions. The aim of this study was to examine the relationships between illness representations and the relative importance of coping cognitions and coping behaviours in the context of the management of type 2 diabetes., Design: The relationship between illness representations and coping variables was explored within a prospective design., Methods: The illness representations of 134 patients were assessed with the IPQ-R (Moss-Morris et al., 2002) along with coping cognitions and coping behaviours (medication, physical activity, diet)., Results: Illness representations predicted coping cognitions and coping behaviours but coping cognitions did not mediate the relationships between illness representations and coping behaviours., Conclusion: The results demonstrate that illness representations are direct predictors of both coping cognitions and coping behaviours in patients with type 2 diabetes. In addition, coping cognitions and coping behaviours appear to be distinct mechanisms that operate independently. The findings suggest that rather than manipulating patients' coping cognitions to improve patients' health behaviours it may be beneficial to focus on their beliefs about diabetes.