Nutritional and Culinary Habits to Empower Families (n-CHEF): a feasibility study to increase consumption and home cooking of plant-based foods.

OBJECTIVE: To analyse the feasibility and acceptability of a culinary nutritional intervention aimed at increasing plant-based foods consumption in the context of the Mediterranean diet in parent-child dyads. DESIGN: The Nutritional and Culinary Habits to Empower Families (n-CHEF) is a 9-month feasibility study that included four culinary nutritional workshops (two face to face, two online) led by a chef and a dietitian-nutritionist. These workshops combined cooking with plant-based foods, with nutritional advice and experimental activities. The main outcomes were retention, quality of the intervention (monitoring workshops, acceptability and perceived impact) and changes in dietary and cooking habits. SETTING: Parent-child dyads, Spain. PARTICIPANTS: Parent-child (aged 10-14 years) dyads. RESULTS: Fifteen parent-child dyads were recruited, of which thirteen were retained during the 6-month follow-up. All but one parent-child dyads attended the four workshops. The overall assessment of the workshops was positive, although the online workshops were rated lower than the face to face. In general, parent-child dyads reported benefits in terms of nutrition and cooking aspects. Parents significantly increased their adherence to the Mediterranean diet, but non-significant changes were observed in children. However, children increased their consumption of vegetables and legumes and reduced snacks and ready meals. Parents also changed some of their culinary habits and increased their confidence in cooking at home. CONCLUSIONS: The n-CHEF showed that the culinary nutritional intervention had good levels of recruitment, retention and acceptability among parent-child dyads. In addition, dietary and culinary knowledge and habits can be improved, although further studies are needed to know the long-term effects in larger populations.

Cardiac coherence and medical hypnosis: a feasibility study of a new combined approach for managing preoperative anxiety in patients with breast or gynaecological cancer.

Background: Non-pharmaceutical approaches can help manage preoperative anxiety, but few studies have evaluated psychoeducational programmes, especially for cancer surgery. We assessed the feasibility of the COHErence Cardiaque (COHEC) programme where cardiac coherence and medical hypnosis are combined to manage preoperative anxiety in patients undergoing breast or gynaecological cancer surgical interventions (BGCSI). Methods: Patients undergoing BGCSI were enrolled and followed a daily home programme with cardiac coherence and medical hypnosis sessions, starting 7 days before the procedure. The primary endpoint was optimal patient adherence (i.e. completion of ≥14 sessions). Secondary endpoints were anxiety levels, measured using the Visual Analogue Scale (VAS) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS), satisfaction (EVAN-G), and quality of postoperative recovery (QoR-15). Results: In total, 53 patients [mean age: 55 (34-82) yr] were included; 83.7% had breast cancer and 15.1% had gynaecological cancer. Optimal adherence was achieved by 64.2% (95% confidence interval: 49.8-76.9%) of the intention-to-treat population. Among the 43 patients who completed at least one session, exploratory analysis showed that anxiety on the day before (P=0.02) and the morning of the intervention (P=0.04) was decreased in patients with severe anxiety at baseline (VAS ≥70). The median VAS satisfaction score for the programme was 10 (4-10). Overall, 94% of patients were willing to include the COHEC programme in their daily routine. Conclusions: The implementation of a psychoeducational programme combining cardiac coherence and medical hypnosis is feasible and might potentially help patients undergoing BGCSI to manage preoperative anxiety. A randomised trial is underway to assess the efficacy of the COHEC programme. Clinical trial registration: NCT03981731.

Intraoperative Real-Time Image-Guided Fibular Harvest and Mandibular Reconstruction: A Feasibility Study on Cadaveric Specimens.

BACKGROUND: This study assesses the feasibility of real-time surgical navigation to plan and guide sequential steps during mandible reconstruction on a series of cadaveric specimens. METHODS: An image-guided surgical (IGS) system was designed including customized mandible and fibula fixation devices with navigation reference frames and an accompanied image-guided software. The mandibular and fibular segmental osteotomies were performed using the IGS in all five cadaveric patients. Procedural time and cephalometric measurements were recorded. RESULTS: Five real-time IGS mandibulectomy and fibular reconstruction were successfully performed. The mean Dice score and Hausdorff-95 distance between the planned and actual mandible reconstructions was 0.8 ± 0.08 and 7.29 ± 4.81 mm, respectively. Intercoronoid width, interangle width, and mandible projection differences were 1.15 ± 1.17 mm, 0.9 ± 0.56 mm, and 1.47 ± 1.62 mm, respectively. CONCLUSION: This study presents the first demonstration of a comprehensive image-guided workflow for mandibulectomy and fibular flap reconstruction on cadaveric specimens and resulted in adequate cephalometric accuracy.

Artificial Intelligence Smartphone Application for Detection of Simulated Skin Changes: An In Vivo Pilot Study.

BACKGROUND: The development of artificial intelligence (AI) is rapidly expanding, showing promise in the dermatological field. Skin checks are a resource-heavy challenge that could potentially benefit from AI-tool assistance, particularly if provided in widely available AI solutions. A novel smartphone application(app)-based AI system, "SCAI," was developed and trained to recognize spots in paired images of skin, pursuing identification of new skin lesions. This pilot study aimed to investigate the feasibility of the SCAI-app to identify simulated skin changes in vivo. MATERIALS AND METHODS: The study was conducted in a controlled setting with healthy volunteers and standardized, simulated skin changes (test spots), consisting of customized 3-mm adhesive spots in three colors (black, brown, and red). Each volunteer had a total of eight test spots adhered to four areas on back and legs. The SCAI-app collected smartphone- and template-guided standardized images before and after test spot application, using its backend AI algorithms to identify changes between the paired images. RESULTS: Twenty-four volunteers were included, amounting to a total of 192 test spots. Overall, the detection algorithms identified test spots with a sensitivity of 92.0% (CI: 88.1-95.9) and a specificity of 95.5% (CI: 95.0-96.0). The SCAI-app's positive predictive value was 38.0% (CI: 31.0-44.9), while the negative predictive value was 99.7% (CI: 99.0-100). CONCLUSION: This pilot study showed that SCAI-app could detect simulated skin changes in a controlled in vivo setting. The app's feasibility in a clinical setting with real-life skin lesions remains to be investigated, where the challenge with false positives in particular needs to be addressed.

A feasibility trial of olanzapine for young people with Anorexia Nervosa (OPEN): clinicians' perspectives.

BACKGROUND: The OPEN feasibility trial testing olanzapine in anorexia nervosa (AN) in young people (YP) was not successful due to poor recruitment. This study aims to understand clinicians' views and experiences of using olanzapine in AN and the challenges in implementing the trial in National Health Service (NHS) clinical settings. METHODS: We conducted qualitative interviews with eating disorders (ED) clinicians involved with the study (n = 11). Framework analysis was applied to qualitative data to identify barriers and facilitators to recruitment and study implementation. A web-based semi-structured Qualtrics survey was administered to ED clinicians (n = 24). Findings from the survey were used to corroborate and expand on the information derived from qualitative interviews. RESULTS: Qualitative analysis identified four main themes: (1) Acknowledging Service User (SU) / Family Concerns, (2) Prioritising person-centred care, (3) Limited Service Capacity and (4) Study eligibility criteria. Subthemes are outlined accordingly. Clinicians appeared confident addressing SU concerns around olanzapine in clinical discussions, but timing was critical, and olanzapine was considered one aspect of treatment that needed to align with their holistic approach. Service pressures restricted opportunities for recruitment and the ability to offer regular review. At the same time, some YP were ineligible for the trial, as they were already taking olanzapine, or needed to be prescribed it more promptly than the study procedures allowed. Survey findings underlined confidence in prescribing and informing on olanzapine, the various possible benefits of olanzapine besides weight gain, and the importance of therapeutic alliances and informed consent. Both data sets highlight the need for further evidence on long-term safety, side effects and efficacy of olanzapine use for AN. Where clinical service capacity is at a premium, research implementation is not prioritised, particularly in intensive clinical settings. CONCLUSIONS: Findings provide first-hand insight into individual and systemic challenges with research implementation in the NHS, which need to be considered when designing future clinical research studies. We emphasise a person-centred approach when discussing olanzapine to consider a holistic recovery from AN beyond weight-gain as an isolated outcome for improvement.

Although olanzapine, an atypical antipsychotic medication, is commonly used in eating disorder services across the world, it is not currently recommended by clinical guidelines in the United Kingdom. We interviewed clinicians working in eating disorder services that took part in a research study looking at olanzapine for young people with anorexia nervosa (AN), and published a survey asking clinicians about their experiences with and views on using olanzapine for AN. The lack of official long-term evidence concerned both clinicians and services users (SU)s. Many clinicians suggested that people with AN might be fearful of weight-gain as a side effect from olanzapine and therefore declined to take part in the study. Having a good relationship built on trust and consistency was deemed very important by clinicians to talk about medication and to provide good health care that focuses on the needs of SUs. Clinicians explained that it was a challenge to introduce the study to SUs in their day-to-day work, as mental health services are increasingly overburdened. Clinicians were also clear that SUs should only be prescribed olanzapine within the study if it was at the right time for them and fitted their treatment pathway.

Feasibility Study of Nivolumab in Combination with Carboplatin Plus Paclitaxel and Concurrent Thoracic Radiation in Patients with Untreated Unresectable Locally Advanced Non-Small Cell Lung Cancer.

Despite advancements in diagnosing and treating non-small cell lung cancer (NSCLC), the prognosis remains poor. Immune checkpoint inhibitors have shown promise in enhancing survival rates. Therefore, this study aimed to investigate the safety of nivolumab administration with concurrent chemoradiation therapy (CCRT) in patients with unresectable locally advanced NSCLC. Twelve patients with unresectable locally advanced NSCLC at Kansai Medical University Hospital and Izumi City General Medical Center were enrolled from May 2018 to September 2020. They received nivolumab (360 mg) tri-weekly twice, weekly carboplatin (AUC 2 min × mg/mL) and paclitaxel (40 mg/m2) for 6 weeks, and thoracic radiotherapy (60 Gy/30 fractions), followed by maintenance nivolumab therapy (360 mg, tri-weekly) for 6 months. The primary endpoint was incidence of dose-limiting toxicities (DLTs), and the secondary endpoints included safety, response rate, progression-free survival (PFS), overall survival (OS), 2-year survival rate, and treatment completion rate. Three patients completed the protocol. Nine discontinued due directly to interstitial pneumonia (three) and pneumonia (one). Ten patients (83.3%) experienced a grade 3 or higher event, of which three (25%) experienced a grade 4 or higher event, and of these, one (8.3%) experienced a grade 5 event. Three patients experienced DLTs. Concurrent nivolumab with CCRT was tolerated in unresectable locally advanced NSCLC, which offers potential treatment benefits.

Feasibility of a person-centred multidimensional interdisciplinary rehabilitation programme in community-dwelling people with dementia: a randomised controlled pilot trial.

BACKGROUND: A team-based, individualised rehabilitation approach may be required to meet the complex needs of people with dementia. This randomised controlled pilot trial evaluated the feasibility of a person-centred multidimensional interdisciplinary rehabilitation programme for community-dwelling older people with dementia and their informal primary caregivers. METHODS: Participants with dementia were randomised to an intervention group (n = 31, mean age (SD) 78.4 (6.0) years) or usual care (n = 30, mean age 79.0 (7.1)). The rehabilitation programme consisted of a 20-week rehabilitation period containing assessments and interventions based on each individual's goals, and group-based physical exercise plus social interaction twice a week for 16 weeks at a rehabilitation unit. After 5 and 14 months, the interdisciplinary team followed up participants over two four-week periods. For both groups, dates of deaths and decision to move to nursing home over three years, as well as interventions for the relevant periods, were collected. Blinded assessors measured physical functions, physical activity, activities of daily living, cognitive functions, nutritional status, and neuropsychiatric symptoms at baseline and at 5, 12, 24, and 36 months. RESULTS: Participants in the intervention group received a mean of 70.7 (20.1) interventions during the 20-week rehabilitation period, delivered by all ten team professions. The corresponding figures for the control group were 5.8 (5.9). In the intervention group, all but one participated in rehabilitation planning, including goal setting, and attendance in the exercise and social interaction groups was 74.8%. None of the adverse events (n = 19) led to any manifest injury or disease. Cox proportional hazard regression showed a non-significant lower relative risk (HR = 0.620, 95% CI 0.27-1.44) in favour of the intervention for moving to nursing home or mortality during the 36-month follow-up period. Linear mixed-effect models showed non-significant but potentially clinically meaningful between-group differences in gait, physical activity, and neuropsychological symptoms in favour of the intervention. CONCLUSIONS: The rehabilitation programme seems feasible among community-dwelling older people with dementia. The overall results merit proceeding to a future definitive randomised controlled trial, exploring effects and cost-effectiveness. One could consider to conduct the programme earlier in the course of dementia, adding cognitive training and a control attention activity. TRIAL REGISTRATION: The study protocol, ISRCTN59155421 , was registered online 4/11/2015.

Telephone Counseling for Children Recovering from Tonsil Surgery-A Randomized Controlled Feasibility Study.

BACKGROUND: Even though children after tonsil surgery experience pain and other limitations in their daily lives, nursing care is transferred to parents after tonsil surgery, and they might need some kind of support. The aim of the study was to test the design of a randomized controlled trial intended to evaluate a nurse-led telephone follow-up after tonsil surgery on postoperative symptoms and quality of life. METHODS: Of the seventeen children aged 3-17 years scheduled to tonsil surgery, nine were randomized to the intervention group and eight to the control group using a randomization list. The parents in the intervention group were contacted by telephone on days 1, 3, 5, and 10 postoperatively for counseling by a nurse. The instruments Postoperative Recovery in Children (PRiC) and the health-related quality of life instrument (EQ-5 D-Y) were used to evaluate postoperative symptoms and quality of life, respectively. RESULTS: Eight participants in the intervention group reported throat pain compared to five participants in the control group on the operation day and four days after, possibly due to an uneven distribution of the type of surgery between the study groups. The parents appreciated the telephone counseling, and there were no unplanned revisits in the intervention group. However, it was difficult to recruit participants and the assessment tools were not always fully completed. CONCLUSIONS: No explicit conclusions can be drawn from this feasibility study due to the low number of participants and the study design needs adjustments.

Older adults' experiences of being screened for fall risk in a clinical setting: a focus group study.

PURPOSE: There is a need for further research on older adults' experiences of fall risk screening to improve health communication strategies. The purpose of this study was to describe and explore older adults' experiences of being screened for risk of an injurious fall, using the first-time injurious falls (FIF) screening tool. METHODS: A qualitative study with five focus group interviews was carried out including 17 older adults (11 women and six men, with a mean age of 77.4 years) who were recruited from two primary healthcare rehabilitation clinics in Sweden. Data were analyzed using reflexive thematic analysis. RESULTS: The analysis generated one overarching theme, "Screening for fall risk promotes engagement by raising older adults' awareness of their own abilities", and four categories; "Screening may motivate to take action but can also create a false sense of security", "Self-sufficiency is affected by the screening result and level of control over the environment", "Easy-to-perform and helps to facilitate a discussion with the healthcare professional" and "Ideas of how FIF tool could be used in healthcare". CONCLUSION: Older adults considered screening for fall risk to be meaningful insofar as it raises awareness of their own abilities and motivates them to prevent falls. On the other hand, a low fall risk could create a false sense of security, and lack of control over environmental factors related to fall risk could negatively impact their sense of self-sufficiency. They emphasized the need to receive support from healthcare providers and to be involved in care decisions if the screening indicates a high fall risk.

Feasibility of a noninvasive heart failure telemonitoring system: A mixed methods study.

Objective: The aim of this study was to examine the feasibility of a noninvasive telemonitoring system used by heart failure patients and nurses in a pilot program of the Heart Hospital unit in Tampere, Finland. Methods: This cross-sectional observational study used a mixed methods design. Quantitative data were collected with one self-generated questionnaire for patients, and qualitative data were collected with a questionnaire for patients and semi-structured focus group interviews for patients and nurses. The questionnaire was sent to 47 patients who were in the pilot program, and 29 patients (61.7%) responded. Purposefully selected 8 patients and 8 nurses attended the interviews. We used descriptive statistics to assess the quantitative data from the questionnaire and inductive thematic analysis to identify themes deriving from the focus group interviews. We categorized the themes into facilitators and barriers to telemonitoring. Results: Both the quantitative and qualitative data show that the telemonitoring system is easy to use, supports self-care and self-monitoring, and increases the feeling of safety. The chat tool of the system facilitated communication. The patients and nurses considered the system reliable despite some technical problems. The focus group interviews addressed technical challenges, nurses' increased workload, and patients' engagement with daily follow-up as possible barriers to telemonitoring. Conclusions: The noninvasive heart failure telemonitoring system used in the pilot program is feasible. We found facilitators and barriers to telemonitoring that should be considered when developing the noninvasive telemonitoring of heart failure in the future.

Positive Impact of UV Photography on Individual Sun Protection: A Swiss Feasibility Study.

Objectives: This study evaluates the feasibility and impact of conveying personalized sun protection message supported by a UV photograph of the face in Switzerland. Methods: 440 adults from 14 private and public sites associated with high sun exposure received a skin cancer prevention intervention composed of a facial UV-filtered photograph and individual counselling by a trained registered nurse. Pre-/post intervention surveys assessed sun protection of participants, their skin cancer risk and reasons for behavioural change. Results: The range of facial UV spots' count per individual was very broad (0-590) and mainly determined by phototype, followed by age. Three months after the intervention, 61% of participants positively changed their sun protection habit both during leisure and at work. Use of all sun protection means increased. No factor could be specifically associated to that propension for change. The individualized message was perceived as the main motivation for change. Conclusion: Personalized sun protection messages supported by a facial UV photograph led to significant favourable behavioural change in a highly sun-exposed population of adults.

Feasibility of a Dutch post-discharge parenting intervention (TOP program) for moderate preterm born infants.

BACKGROUND AND AIM: Moderate preterm (MP) birth is associated with an increased risk of developmental problems. However, post-discharge support for this group is scarce. The aim of this study was to evaluate the feasibility of a post-discharge parenting program (TOP program) for MP infants. Three feasibility dimensions were evaluated (1) recruitment capability and compliance, (2) intervention acceptability, and (3) limited efficacy testing. METHODS: A group of MP infants with a gestational age (GA) between 320/7-346/7 weeks and their parents received six home visits by a TOP interventionist until 6 months corrected age (CA). A pre-posttest intervention design with quantitative and qualitative measures was used. Recruitment capability and compliance, acceptability, and satisfaction with the intervention were evaluated using a questionnaire, checklists, interviews, and a focus group. Infant socio-emotional development, parental distress, self-efficacy, and reflective functioning were measured with questionnaires. Observation measurements were used for infant motor development and parental sensitivity. RESULTS: Thirty-two families completed the six home visits. The satisfaction rate (scale 0-10) was remarkably high (Mean 9.4, range: 8-10). Parents reported that the program was suitable, enhanced their understanding of their infants' developmental needs, and increased their self-efficacy. The infants showed age-appropriate motor and socio-emotional development post-intervention. Parental self-efficacy, reflective functioning, and sensitivity improved from pre to post intervention, with small to large effect sizes. CONCLUSION: The study demonstrated high compliance, acceptability, and satisfaction with the TOP program for MP infants with promising infant and parent outcomes. This study contributes to the preparatory work prior to a larger scale evaluation and dissemination.

A stakeholder-involved adaptation of pathways and resources for engagement and participation (PREP) material with young adults with complex disability in Australia: an implementation feasibility study.

PURPOSE: Pathways and Resources for Engagement and Participation (PREP) is an intervention to optimise individuals' participation by building problem-solving capacity and addressing environmental barriers. We investigated the feasibility of implementing PREP with young adults (18-30 years) with complex disability in Australia. MATERIALS AND METHODS: Explanatory sequential mixed methods study in three stages. (i) PREP materials were collaboratively adapted by the research team and consumer research partners. (ii) Steps 1 and 2 of PREP (YA Supplement) were completed with three young adults with disability, and preliminary feasibility explored using qualitative methods. (iii) The feasibility of implementing adapted materials was examined using quantitative and qualitative methods involving four young adults with disability, six support people and two service providers. RESULTS: Stage 1: PREP Young Adults Supplement (PREP (YA Supplement)) for use alongside PREP was developed. Stages 2 and 3: findings indicated PREP (YA Supplement) was acceptable, appropriate and feasible. Three themes were identified: setting and achieving goals were associated with challenges and benefits; finding the right time to implement the program was necessary; and PREP (YA Supplement) drives a shift to a participation-focused approach. CONCLUSION: PREP delivered alongside PREP (YA Supplement) appears feasible with Australian young adults with complex disability.

A novel supplement for the evidence-based Pathways and Resources for Engagement and Participation (PREP) intervention has been developed to enhance participation in life situations for young adults with disability in an Australian context (PREP Young Adult Supplement).Setting participation goals may be a substantial shift for young adults with disability and rehabilitation professionals, and involves considering attendance at, and involvement in, life situations.Implementation of PREP/PREP Young Adult Supplement is inherently flexible and can be adapted to suit the needs, preferences and circumstances of the participant.

A plant-based diet is feasible in patients with Crohn's disease.

BACKGROUND: Incorporating plant-based diets as a supplement to medical treatment may have a beneficial impact on patients with Crohn's disease, however, research with intervention studies is required. OBJECTIVE: To investigate the feasibility of a plant-based diet intervention. Secondly, the purpose was to investigate whether such diet may reduce disease activity and enhance quality of life. MATERIALS AND METHODS: This study was designed as a single arm feasibility study. Outpatients with Crohn's disease in biological therapy were guided over twelve weeks towards a dietary lifestyle change. OUTCOME MEASURES: Feasibility concerning recruitment, retention rate and compliance. Secondary outcomes were measures of patient reported outcome questionnaires (PROMS). Paired t-tests were used to examine changes in CO2 emissions, anthropology, biomarkers, and patient-reported data. Δ-values were used to investigate difference between dietary intake and requirements. Linear regression analyses examined the association between biomarkers and PROMS. RESULTS: In total, 15 participants completed the intervention with easy recruitment and a retention rate at 87.6%. A clinically positive tendency was seen towards improved symptom scores for disease (HBI; p=0.028 and IBDQ; p=0.006) but not for fatigue (IBD-F; p = 0.097), although none of these were statistically significant. Adverse effects were decreased protein intake (p=0.069) and slightly reduced muscle mass. It remains unclear to what extent the intervention contributed to the improved self-reported effects although perception of disease activity was improved. CONCLUSION: This study demonstrates that it is possible to retain patients following a plant-based diet. However, the dietary change required ongoing dietetic support with a focus on anti-inflammatory agents and the still unattainable protein requirements.

Move&Connect-Caregivers: A virtual group intervention for caregivers of youth experiencing persisting symptoms after concussion.

Caregivers play a critical role in supporting youth experiencing persisting symptoms after concussion (PSAC). However, there are limited empirically validated interventions tailored to the specific needs of caregivers, such as improving concussion knowledge and supporting psychosocial wellbeing. This study aims to describe the development of a virtual group intervention for caregivers of youth experiencing PSAC, Move&Connect-Caregivers (M&C-C), and examine its feasibility. Nine mothers participated across two M&C-C groups. Feasibility metrics and semi-structured interviews were collected and analyzed using descriptive and qualitative content analysis. Results suggest that M&C-C is a feasible intervention. By merging social support, concussion psychoeducation, and active skill building, M&C-C is meaningful for caregivers supporting their children experiencing PSAC.

Caring for Families of Patients With Acquired Brain Injury Early During Hospitalization: A Feasibility Study of the SAFIR© Intervention.

This study aimed to assess the feasibility of a complex family nursing intervention (SAFIR©) designed to support families of patients with acquired brain injuries during the early phase of hospitalization, using a one-group pre- and post-test design with a one-month follow-up. Family members participated in four family meetings. Quantitative data were collected using an intervention protocol checklist and questionnaires. Qualitative data were gathered through semi-structured interviews, written open-ended questions, and note-taking. Feasibility outcomes revealed a family recruitment rate of 15.4% and a retention rate of 100%. Protocol adherence ranged from 94% in Phase 1 to 78% in Phase 3. Our results indicated that the intervention was meaningful and suitable for family members (n=7), healthcare provider (n=1), and nursing managers (n=6). From a sustainability perspective, our findings suggest the need to formally involve the entire inter-professional team in the intervention. Further evaluation of the intervention is warranted through a large-scale experimental.

Neural Conversational Agent for Weight Loss Counseling: Protocol for an Implementation and Feasibility Study.

BACKGROUND: Obesity is a common, serious and costly chronic disease. Current clinical practice guidelines recommend that providers augment the longitudinal care of people living with obesity with consistent support for the development of self-efficacy and motivation to modify their lifestyle behaviors. Lifestyle behavior change aligns with the goals of motivational interviewing (MI), a client-centered yet directive counseling modality. However, training health care providers to be proficient in MI is expensive and time-consuming, resulting in a lack of trained counselors and limiting the widespread adoption of MI in clinical practice. Artificial intelligence (AI) counselors accessible via the internet can help circumvent these barriers. OBJECTIVE: The primary objective is to explore the feasibility of conducting unscripted MI-consistent counseling using Neural Agent for Obesity Motivational Interviewing (NAOMI), a large language model (LLM)-based web app for weight loss counseling. The secondary objectives are to test the acceptability and usability of NAOMI's counseling and examine its ability to shift motivational precursors in a sample of patients with overweight and obesity recruited from primary care clinics. METHODS: NAOMI will be developed based on recent advances in deep learning in four stages. In stages 1 and 2, NAOMI will be implemented using an open-source foundation LLM and (1) few-shot learning based on a prompt with task-specific instructions and (2) domain adaptation strategy based on fine-tuning LLM using a large corpus of general psychotherapy and MI treatment transcripts. In stages 3 and 4, we will refine the best of these 2 approaches. Each NAOMI version will be evaluated using a mixed methods approach in which 10 adults (18-65 years) meeting the criteria for overweight or obesity (25.0≥BMI≤39.9) interact with NAOMI and provide feedback. NAOMI's fidelity to the MI framework will be assessed using the Motivational Interviewing Treatment Integrity scale. Participants' general perceptions of AI conversational agents and NAOMI specifically will be assessed via Pre- and Post-Interaction Questionnaires. Motivational precursors, such as participants' confidence, importance, and readiness for changing lifestyle behaviors (eg, diet and activity), will be measured before and after the interaction, and 1 week later. A qualitative analysis of changes in the measures of perceptions of AI agents and counselors and motivational precursors will be performed. Participants will rate NAOMI's usability and empathic skills post interaction via questionnaire-based assessments along with providing feedback about their experience with NAOMI via a qualitative interview. RESULTS: NAOMI (version 1.0) has been developed. Participant recruitment will commence in September 2024. Data collection activities are expected to conclude in May 2025. CONCLUSIONS: If proven effective, LLM-based counseling agents can become a cost-effective approach for addressing the obesity epidemic at a public health level. They can also have a broad, transformative impact on the delivery of MI and other psychotherapeutic treatment modalities extending their reach and broadening access. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/60361.

The frail-LESS (LEss sitting and sarcopenia in frail older adults) remote intervention to improve sarcopenia and maintain independent living via reductions in sedentary behaviour: findings from a randomised controlled feasibility trial.

BACKGROUND: Sarcopenia leads to functional disability, dependence in activities of daily living (ADL), and is a key contributor to frailty. Reducing and breaking up sedentary time is associated with improved sarcopenia and frailty-related outcomes. The aim of this study was to determine the feasibility of delivering and evaluating a remote sedentary behaviour intervention to improve sarcopenia and independent living in older adults with frailty. METHODS: A two-arm randomised controlled feasibility trial was conducted with a target of 60 older adults (mean age 74 ± 6 years) with very mild or mild frailty. Participants were randomised to the Frail-LESS (LEss Sitting and Sarcopenia in Frail older adults) intervention or usual care control group for six months. The intervention included tailored feedback on sitting, standing and stepping; an education workbook that included goal setting and action planning; one-to-one health coaching; peer support; and a wearable device to self-monitor sedentary behaviour. Participant recruitment (percentage of eligible individuals recruited), retention and data completion rates were used to assess trial feasibility. Acceptability of the trial was explored through interviews and safety was evaluated via unplanned healthcare utilisation and number of falls. Sitting, standing, stepping and sarcopenia were measured to evaluate potential intervention effects. RESULTS: Sixty participants were recruited. Recruitment and retention rates were 72% and 83%, respectively. Completion rates for outcome measures ranged from 70 to 100%. The trial was safe (< 1 fall per participant on average at each timepoint) and trial procedures were acceptable. Descriptive analysis (mean ± SD) showed that daily sitting was 25.1 ± 82.1 min/day lower in the intervention group, and 6.4 ± 60.5 min/day higher in the control group, at 6 months compared with baseline. Hand grip strength and sit-to-stand score were improved by 1.3 ± 2.4 kg and 0.7 ± 1.0, respectively, in the intervention group. CONCLUSIONS: This study demonstrates the feasibility and safety of delivering and evaluating a remote intervention to reduce and break up sitting in older adults with frailty. The intervention showed evidence towards reducing daily sitting and improving sarcopenia, supporting its evaluation in a definitive randomised controlled trial. TRIAL REGISTRATION: ISRCTN registry (registration number: ISRCTN17158017). Registered 6th August 2021.

Brief intervention protocol by telephone delivered by nurses to patients with harmful alcohol use in primary health care: A feasibility trial.

AIM: The aim of this study is to examine the feasibility of a brief intervention protocol by telephone performed by nurses in primary health care facilities. METHODS: A nonrandomized single-arm feasibility study was performed. The proposed intervention of this study is the Brief Intervention carried out by the nurse delivered by telephone, synchronously with alcohol users. The brief intervention is a motivational approach based on the FRAMES model, with its components being: Feedback, Responsibility, Advice, Menu of options, Empathy and Self-efficacy. To assess the feasibility of the protocol, we evaluated the procedure for enrolling participants, the acceptability of the protocol to participants, the satisfaction of the participants, convenience and treatment continuity. The quantitative data analysis was carried out in the R software, using descriptive statistics, categorical variables were reported by frequencies and percentages. For continuous variables, medians, means, standard deviations and range values were computed. RESULTS: We followed the participants (n = 165) from baseline (T0) until 3 months (T1) and 6 months (T2) after the brief intervention. The partial effect suggests a reduction in alcohol consumption, and statistically significant differences were observed from baseline before the BI, with a decrease of 0.66 points in AUDIT scores at T1. Among the patients who completed the 3-month follow-up, 48 % reported a positive experience of receiving the brief intervention by the nurses, and 44 % reported a decrease in alcohol consumption. CONCLUSIONS: Brief intervention delivered by telephone was considered feasible and acceptable by primary health care patients, and they perceived improvement in their alcohol consumption after receiving the BI performed by nurses.

Key considerations for digital decentralised clinical trials from a feasibility study assessing pacing interventions for long COVID.

Post COVID-19 condition or long COVID is highly prevalent and often debilitating, with key symptoms including fatigue, breathlessness, and brain fog. There is currently a lack of evidence-based treatments for this highly complex syndrome. There is a need for clinical trial platforms to rapidly evaluate nonpharmacological treatments to support affected individuals with symptom management. We co-produced a mixed methods feasibility study to evaluate a multi-arm digital decentralised clinical trial (DCT) platform to assess non-pharmacological interventions for Long COVID, using pacing interventions as an exemplar. The study demonstrated that the platform was able to successfully e-consent participants, randomise them into one of four intervention arms, capture baseline data, and capture outcomes relevant to a health economic evaluation. The study also highlighted several challenges, including difficulties with recruitment, imposter participants, and high attrition rates. We highlight how these challenges can potentially be mitigated to make a fully powered DCT more feasible.