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Intensive weight loss intervention versus usual care in adults with obesity: a protocol for the LightCARE randomised clinical trial

Por: Larsen · S. C. · Heitmann · B. L. · Wane · S. · Wielsoe · S. · Lindschou · J. · Jakobsen · J. C. · Engstrom · J. · Specht · I. O. · Christiansen · A.-K. L. · Jensen · A. K. G. · Nyvold Bojsen-Moller · K. · Bandholm · T. · Overbeck · G. · Kousgaard · M. B. · Albury · C. · Reventlow · S
Introduction

Total diet replacements (TDRs) and weight loss medications (WLMs) have proven effective in producing substantial weight loss for individuals with obesity. Evidence is lacking on whether combining these treatments is effective and cost-effective in primary care for adults with obesity class I (body mass index (BMI) 30–34.9) or uncomplicated obesity class II or higher (BMI≥35 without obesity-related disease).

Methods and analysis

LightCARE is a 2-year 1:1 randomised, parallel-group, clinical superiority trial with blinded outcome assessment evaluating the benefits and harms of an intensive weight loss (IWL) intervention compared with usual care for adults with obesity in Denmark and the UK. The trial will include 400 participants aged 18–60 years with obesity class I or uncomplicated obesity class II or higher. The IWL programme aims to achieve and maintain a weight loss of ≥20% through a flexible and individualised combination of TDR, behavioural support, including physical activity and sleep guidance, and WLM if needed and will continue for 2 years. The control group will receive usual care offered in each country, typically consisting of brief behavioural support for weight loss. The primary outcome is body weight 2 years after randomisation. Secondary outcomes will include the proportion of participants achieving ≥20% weight loss, Short-Form-36 Mental Component Score, 4-m gait speed and Metabolic Syndrome Severity-Z score. Serious adverse events, the incidence of eating disorders and bone mineral density will be evaluated as safety outcomes. We will also examine the cost-effectiveness of the intervention, within the trial and in the longer term through modelling. We will conduct a process evaluation to inform any future implementation.

Ethics and dissemination

Ethical approval was granted in Denmark (December 2023, H-23051332) and the UK (August 2024, 24/SC/0210). Findings from the trial will be disseminated through peer-reviewed journals and scientific conferences.

Trial registration number

NCT06321432.

Beyond Survival: Unveiling Psychological and Social Adaptation After Visceral Transplantation

ABSTRACT

Aim

To explore the meaning of adaptation after visceral transplantation in terms of patient experiences, symptoms, self-efficacy, transplant-specific and mental well-being.

Design

A convergent parallel mixed-methods study, consisting of interviews and generic as well as transplant-specific questionnaires. Results were integrated using meta-inference.

Methods

The study comprises a population of 17 visceral transplant recipients in Scandinavia, 12 women and 5 men with a mean age of 40.6 years (range 19–63 years) and an average follow-up of 9.4 years (range 0–25 years). Data were collected between May 2023 and January 2024 through open-ended in-depth interviews with 12 participants and analysed in accordance with phenomenological hermeneutics. Questionnaires from all 17 participants were analysed to measure transplant-specific well-being, symptoms, self-efficacy as well as anxiety and depressive symptoms.

Results

Being a visceral transplant recipient is a dynamic and life-long adaptation process that comprises two distinct yet interconnected trajectories: coherence and endurance. Coherence involves the person's ability to make sense of their situation and find meaning despite the challenges and adversity of the chronic condition. In contrast, endurance involves a person's capacity to withstand hardship and endure unpleasant or difficult experiences. Both trajectories interact dynamically, influencing and reinforcing each other. Resilience based on coherence enabled acceptance and adjustment. Conversely, uncertainty, resignation and feeling unsupported resulted in a lack of acceptance, manifested as resistance. The challenge involved in adaptation was demonstrated by 47% showing borderline elevated or elevated levels of anxiety and 18% reporting symptoms of depression. Self-efficacy varied considerably.

Conclusion

The meaning of adaptation after visceral transplantation in terms of experiences, symptoms, transplant-specific and mental well-being is balancing between coherence and endurance facilitated by acceptance and hampered by resistance. The uncertainty inherent in being a visceral transplant recipient may lead to heightened self-rated anxiety symptoms and diminished self-efficacy.

Implications for the Profession and/or Patient Care

What problem did the study adress?

This study adresses the challenges involved in being a visceral transplant recipient and adapting to life after a visceral transplantation.

What were the main findings?

Reporting Method

COREQ checklist (consolidated criteria for reporting qualitative research).

Patient or Public Contribution

No Patient or Public Contribution was organised.

Undergoing Orthopaedic Day Surgery: What Factors Are Associated With patients' Feeling of Safety and Their Recovery?

ABSTRACT

Aim

The study aimed to examine factors associated with the perceived feeling of safety and postoperative recovery in patients who have undergone orthopaedic day surgery under regional anaesthesia.

Design

The design was quantitative, descriptive, and cross-sectional. The study participants comprised a consecutive sample (n = 209) of patients who underwent orthopaedic day surgery under regional anaesthesia.

Methods

A questionnaire was sent to the home addresses of the study population approximately 3 weeks postoperatively. The questionnaire included the Feeling Safe During Surgery Scale (FSS), the Swedish version of the post-discharge surgical recovery scale (S-PSR), and questions concerning background variables. Multivariate regression models were used to examine the association of different variables with both feeling safe and postoperative recovery.

Results

The only factor associated with the feeling of safety was preoperative anxiety; higher levels of preoperative anxiety were associated with lower levels of perceived safety during surgery. The factors associated with postoperative recovery were the recovery process itself and the patient's feeling of safety. Higher levels of postoperative anxiety were associated with a lower level of postoperative recovery. Higher levels of perceived safety during surgery were associated with higher postoperative recovery.

Conclusion

The perceived feeling of safety in the perioperative period could not be explained by factors such as age, gender, or level of education. Based on the results of this study, postoperative recovery was associated with the perceived feeling of safety in the perioperative period. Anxiety in the perioperative period was associated with patients' perceived feeling of safety and their postoperative recovery. Thus, this study's results emphasise the importance of ensuring that people undergoing surgery feel safe to promote their recovery. Based on previous research, the nurse–patient relationship seems to be an important part of making patients feel safe, which ultimately affects their recovery.

Implications for the Profession/and or Patient Care

This study examines the association between perceived feeling of safety in the perioperative period and patients' postoperative recovery after undergoing orthopaedic day surgery under regional anaesthesia. Previous research has shown that the nurse–patient relationship and patients' possibilities to participate in their care are important for them to feel safe. This study further emphasises the importance of fostering relationships in the perioperative period and making patients an active part in decision-making, as it may positively impact their recovery. Creating a feeling of safety for the patient should be prioritised, as it benefits their perioperative experience and postoperative recovery.

Reporting Method

This research is reported in accordance with the STROBE guidelines.

Patient or Public Contribution

No patient or public contribution.

Parents' perceptions of care quality at child health centres: A cross‐sectional study from Sweden

Abstract

Aim

To examine parents' perceptions of care quality at child health centres. Specific objectives were to examine parents' perceptions of the care received and the subjective importance of such care. Furthermore, to examine the relationship between parents' sociodemographic characteristics and the perceptions of care quality.

Design

A cross-sectional study.

Methods

A random sample of parents of children born in Sweden in 2021 participated. Data were collected by the QPP-CHC questionnaire and analysed using descriptive and analytical statistics.

Results

The response rate was 19.4%. The targeted sample size of 210 participants was reached as 584 parents responded to the questionnaire. Parents' overall ratings of care quality at child health centres indicated optimal quality with mean values >3. However, various potential improvements areas were identified as needing additional information. These included dental care (m = 2.82), allergy prevention (m = 2.25), breastfeeding (m = 2.97), sleep (m = 2.83), the child's behaviour (m = 2.47) and the child's crying (m = 2.47). Also, parents rated suboptimal quality regarding that the care was based on healthcare routines rather than parental preferences and needs (m = 2.86). Parents born outside of the Nordic countries rated higher care quality than those born in the Nordic countries, as well as parents with a non-academic education.

Conclusion

Parents want information based on their preferences and needs. Parent's perceptions of areas for improvement are new and important knowledge for registered nurses at child health centres.

Implications for the Profession and/or Patient Care

The findings indicate that parents feel that insufficient attention is given to areas of care that they perceive as important. Parents' perspectives on the care quality at child health centres is an important component of quality work and might lead to improvements in the care quality at child health centres.

Reporting Method

The Strengthening the Reporting of Observational Studies (STROBE) checklist for cross-sectional studies was used to guide reporting.

Implications for policy and practice

The findings of this study suggests that parents feel that insufficient attention is given to areas of care that they perceive as important. Parents' perspectives on the care quality at child health centres provides important knowledge which can guide further development of care quality at child health centres. The findings indicate that a family-centred approach that integrates relational and routine-oriented nursing can be a way to ensure that the care is based on parents' preferences and needs.

No patient or public contribution.

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