Project description:ObjectivesTo examine care home resident and staff perceptions of the acceptability of participating in a feasibility trial evaluating nutritional interventions in the treatment of malnutrition.DesignExploratory qualitative methodology was used to gather descriptions of resident and staff perceptions of trial procedures, using semi-structured interviews with residents and focus groups with staff. The interviews were used to explore individual perceptions of the acceptability of the assigned intervention and the outcomes measured. Focus groups were used to explore staff experiences of trial participation and perspectives of nutritional support interventions.SettingThe study was embedded within a cluster randomised feasibility trial, which randomised six care homes to provide standard care (SC), food-based (FB) intervention or oral nutritional supplement (ONS) intervention to residents with, or at risk of, malnutrition.ParticipantsResidents in the trial with capacity to consent (n=7) formed the sampling frame for inclusion. Four agreed to be approached by the researcher and to take part in the individual interviews. All were women, representing two arms of the trial (ONS and SC). Twelve staff participated in six focus groups, one at each care home. All participants were women, representing all three arms of the trial.ResultsMajor themes that emerged from both interviews and focus groups included the perceived acceptability of trial involvement, the value of residents completing participant-reported outcome measures and the challenges associated with outcomes measurement in this setting. Themes that emerged from the focus groups alone, included the importance of individualising an intervention, and the perceived value of FB and ONS interventions and dietetic input.ConclusionsResidents and staff perceived involvement in a trial evaluating nutritional interventions to be acceptable, although the challenges associated with research in this setting were acknowledged. Resident preferences were highlighted by staff as an important consideration when implementing a nutrition support plan.Trial registration numberISRCTN38047922.

Project description:IntroductionOn average women retain 5 to 9 kg 1 year after giving birth which can increase the risk of later obesity and chronic diseases. Some previous trials in this population have been effective in reducing weight, but are too intensive and costly to deliver at scale. There is a need for low-cost interventions to facilitate weight loss in this population.Methods and analysisThe primary aim is to assess the feasibility of delivering a weight management intervention for overweight/obese postnatal women within child immunisation appointments. We will conduct a randomised controlled cluster feasibility trial with a nested qualitative study to assess study recruitment and acceptability of the intervention. General practitioner practice (cluster) will be the unit of randomisation, with practices randomised to offer usual care plus the intervention or usual care only. Eighty women will be recruited. The intervention group will be offered brief support that encourages self-management of weight when attending child immunisation appointments. Practice nurses will encourage women to weigh themselves weekly and record this, and to make healthy lifestyle choices through using an online weight management programme. Women will be advised to aim for 0.5 to 1 kg/week weight loss. At each child immunisation the nurse will assess progress by weighing women. The comparator group will receive a healthy lifestyle leaflet. Data on weight, body fat, depression, anxiety, body image, eating behaviours and physical activity will be collected at baseline and follow-up. Women and nurses will be interviewed to ascertain their views about the intervention. The decision to proceed to the phase III trial will be based on prespecified stop-go criteria.Ethics and disseminationData will be stored securely at the University of Birmingham. Results will be disseminated through academic publications and presentations and will inform a possible phase III trial. The National Research Ethics Committee approved the study protocol.Trial registration numberISRCTN12209332.

Project description:ObjectiveTo explore the views of UK-based recipients of Morita Therapy (MT) on the acceptability of MT.DesignQualitative study nested within a pilot randomised controlled trial of MT (a Japanese psychological therapy largely unknown in the UK) versus treatment as usual, using post-treatment semistructured interviews analysed with a framework approach.Setting and participantsParticipants who received MT as part of the Morita Trial, recruited for the trial from General Practice record searches in Devon, UK. Data from 16 participants were purposively sampled for analysis.ResultsWe identified five themes which, together, form a model of how different participants viewed and experienced MT. Overall, MT was perceived as acceptable by many participants who emphasised the value of the approach, often in comparison to other treatments they had tried. These participants highlighted how accepting and allowing difficulties as natural phenomena and shifting attention from symptoms to external factors had facilitated symptom reduction and a sense of empowerment. We found that how participants understood and related to the principles of MT, in light of their expectations of treatment, was significantly tied to the extent to which MT was perceived as acceptable. Our findings also highlighted the distinction between MT in principle and practice, with participants noting challenges of engaging with the process of therapy such as fear and discomfort around rest, needing sufficient support from the therapist and others, and the commitment of treatment.ConclusionsPeople in the UK can accept the premise of MT, and consider the approach beneficial and novel. Therefore, proceeding to a large-scale trial of MT is appropriate with minor modifications to our clinical protocol. Participants' expectations and understandings of treatment play a key role in acceptability, and future research may investigate these potential moderators of acceptability in MT.Trial registration numbercISRCTN17544090; Pre-results.

Project description:BackgroundThe prevalence of obesity in women continues to rise and pregnancy is a high-risk time for excessive weight gain. The period after childbirth represents an opportunity to offer women support to manage their weight. The primary aim here was to investigate the acceptability and feasibility of delivering a self-management intervention to postnatal women to support weight loss, embedded within the national child immunisation programme.MethodsThe research involved a randomised controlled cluster feasibility trial. Data were collected at baseline and 3 months later. Twenty-eight postnatal women living with overweight or obesity were recruited via Birmingham Women Hospital or general practices. Babies are routinely immunised at 2, 3 and 4 months of age; the intervention was embedded within these appointments. The intervention involved brief motivation/support by practice nurses to encourage participants to make healthier lifestyle choices through self-monitoring of weight and signposting to an online weight management programme, when they attended their practice to have their child immunised. The role of the nurse was to provide external accountability for weight loss. Participants were asked to weigh themselves weekly and record this on a record card or using the online programme. The weight goal was for participants to lose 0.5 to 1 kg per week. Usual care received a healthy lifestyle leaflet. The primary outcome was the feasibility of a phase III trial to test the subsequent effectiveness of the intervention, as assessed against three stop-go traffic light criteria (recruitment, adherence to regular self-weighing and registration with an online weight management programme).ResultsThe traffic light stop-go criteria results were red for recruitment (28/80, 35% of target), amber for registration with the online weight loss programme (9/16, 56%) and green for adherence to weekly self-weighing (10/16, 63%). Nurses delivered the intervention with high fidelity.DiscussionWhilst participants and nurses followed the trial protocol well and adherence to self-weighing was acceptable, recruitment was challenging and there is scope to improve engagement with the online weight management programme component of the intervention.Trial registrationISRCTN 12209332 . Registration date is 04/12/18.

Project description:BackgroundIntegrated mental health care models that provide rapid access to video consultations with mental health specialists for primary care patients are a promising short-term, low-threshold treatment option and may reduce waiting times for specialist care. This qualitative study, nested within a randomized feasibility trial, aimed to explore participants' views on this type of care model, its influence on the lived experience of patients, and barriers and facilitators for its delivery.MethodsIn five primary care practices, 50 adults with depression and/or anxiety were randomly assigned to either an integrated care model (maximum of five video consultations with a mental health specialist) or usual care (primary care or another treatment option). Prior to obtaining the trial results, interviews were held with participants who had received video consultations. Interviews were transcribed and analysed thematically.ResultsTwenty of the 23 patients who received video consultations participated in the interviews. Patients engaged well with the care model and reported positive effects on their most pressing needs, while denying safety concerns. Generally, they perceived the usability of video consultations as high, and temporary connectivity failures were not considered a substantial barrier. We identified two key mechanisms of impacts on the patients' lived experience: fast access to specialist mental healthcare and the emerging rapport with the specialist. In particular, patients with no prior mental healthcare experience indicated that familiarity with the primary practice and their physician as a gatekeeper were important facilitators of proactive treatment.ConclusionsFrom the patients' perspective, mental health care models integrating video consultations with mental health specialists into primary care are linked to positive lived experiences. Our findings imply that primary care physicians should promote their role as gatekeepers to (1) actively engage patients, (2) apply integrated care models to provide a familiar and safe environment for conducting mental health care video consultations, and (3) be able to regularly assess whether certain patients need in-person services. Scaling up such models may be worthwhile in real-world service settings, where primary care physicians are faced with high workloads and limited specialist services.Trial registrationDRKS00015812.

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