MELK study: an observational study on human milk composition and infant health determinants during the first year of life in a Dutch cohort

Introduction
Human milk plays a crucial role in infants’ nutrition and immunity, with its composition being influenced by different factors. The role of maternal diet on human milk fatty acid composition, especially eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is well studied. Higher fish intake is associated with higher DHA levels in human milk, while fewer associations have been reported for EPA. Yet, maternal diet’s impact on human milk composition for other nutrients is understudied, and variations in sampling protocols and study quality hinder definitive conclusions on its overall impact. Ethnicity may also impact milk composition, with different dietary habits intertwined with different genetic backgrounds, but also here research lacks standardised protocols. Our study aims to investigate maternal diet, ethnicity, and their association with human milk composition, along with their potential short-term associations with infant health and development, through detailed dietary assessment and by recruiting participants from diverse backgrounds. Understanding these associations could inform the development of tailored nutritional guidelines for mothers and infants, ultimately promoting optimal health and well-being for both. The study design, with its strict sampling procedure, can guide and inspire future studies.

Methods and analysis
We will conduct an observational study involving 120 healthy mothers from three ethnic backgrounds (Chinese, Caucasian and Turkish), exclusively breastfeeding their 2-month-old infants. We will collect human milk samples at two time points and assess maternal dietary intake over 4 days. Additionally, we will collect data on various maternal and child characteristics, including maternal stress, socioeconomic status and health, and infant feeding, sleeping, crying, gastrointestinal health and developmental status.

Ethics and dissemination
The study has been approved by the Medical Ethical Committee Oost-Nederland (NL79447.091.21), and all participants provided written informed consent before entering the study. Findings will be widely disseminated at international conferences and meetings including the annual Nutrition & Growth conference, ESPGHAN, and through publication in scientific peer-reviewed journals.

Trial registration number
ISRCTN registry (ISRCTN35735283).

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Psychological stress-induced local immune response to food antigens increases pain signaling across the gut in mice

We recently showed that a bacterial infection can break oral tolerance to food and lead to IgE-dependent mast cell activation and food-induced abdominal pain, which could constitute an important pathogenic mechanism in post-infectious irritable bowel syndrome (IBS). Here, we investigated whether similar immune mechanisms in response to psychological stress lead to food-evoked pain signaling, and thus potentially explain the pathophysiology in a larger group of patients with IBS.

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Combination Drug Therapy May Better Alleviate PTSD Symptoms Than SSRIs Alone

Currently, the only medications approved by the US Food and Drug Administration for posttraumatic stress disorder (PTSD) are the selective serotonin reuptake inhibitors (SSRIs) sertraline and paroxetine. But a 2022 meta-analysis of drugs used for PTSD found that about 40% of patients don’t benefit from SSRIs. However, those living with PTSD who took a combination of sertraline and the antipsychotic brexpiprazole showed greater improvements in symptoms than those who took sertraline with a placebo.

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Resilience-promoting social networks among unpaid dementia caregivers: protocol for a mixed-methods, 2-year exploratory study

Introduction
Unpaid caregivers of people living with dementia often experience lower levels of perceived life satisfaction and higher rates of depression and anxiety compared with those caring for individuals without Alzheimer’s disease or related dementias. While research on unpaid caregiver well-being and satisfaction has primarily focused on the characteristics of people living with dementia and their dyadic relationships, it has not adequately explored the role of social networks in supporting unpaid caregiver well-being. In this study, we aim to fill this gap by taking an egocentric social network approach to understand the multiple dimensions of social relations among unpaid caregivers of people living with Alzheimer’s disease or related dementia.

Methods and analysis
We will conduct a mixed-method, 2-year exploratory study that involves a structured survey-based telephone interview in year 1 and semistructured interviews in year 2 with caregivers of PLWD recruited through community and healthcare partners. Participants will participate in 1 60-min interview in year 1 (n=100) and a 45–60 min semistructured interview in year 2 (n=75). Eligibility for caregivers includes being an unpaid caregiver, aged 40 years or older, residing and providing care in Arizona or Nevada. The survey consists of questions about caregiver and care recipient demographics, caregiver background, caregiver stress, resilience, well-being and egocentric social network data. Network composition attributes, such as tie strength, the function of the relationship and reliance on network members, will also be assessed. In year 2, qualitative semistructured interviews will supplement these quantitative measures to understand network selection, perceived network changes over time and network strength.

Ethics and dissemination
The Arizona State Institutional Review Board (00018191) approved this study. All participants will receive electronic informed consent documents to review and sign. During the initial interview, participants will be asked if they have any questions about the informed consent documents. We will confirm that participants have completed the required consent form before the start of any research activity. The findings of this study will be disseminated through peer-reviewed journal articles, academic and community presentations, and community-focused publications targeting caregivers.

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Acceptance and commitment therapy for mild traumatic brain injury (ACTion-mTBI): a quasiexperimental feasibility study

Objectives
This study aimed to determine the feasibility of recruiting, implementing and delivering an acceptance and commitment therapy (ACT) intervention for mild traumatic brain injury (mTBI) (ACTion-mTBI) within a multidisciplinary outpatient mTBI rehabilitation services. The study also aimed to conduct a preliminary investigation of group differences between ACTion-mTBI and an equivalent cognitive behavioural therapy (CBT) intervention on various outcome measures and psychological treatment targets.

Design
A two-arm quasiexperimental feasibility study.

Setting
Five mTBI rehabilitation clinics throughout New Zealand.

Intervention
Psychologists working in mTBI rehabilitation clinics throughout New Zealand were trained to deliver ACTion-mTBI or CBT. Eligible participants were assigned to either of these interventions based on the psychologist available at the clinic they were referred to. ACTion-mTBI is a five sessions intervention that incorporates all six components of the ACT model. The CBT intervention is an equivalent intervention and incorporating all four components of the CBT model. Both interventions are adapted for an mTBI context.

Primary outcome measures
The primary outcomes were related to the feasibility of ACTion-mTBI. This included recruitment, retention and treatment adherence of participants, study procedure and fidelity of treatment delivery.

Secondary outcome measures
To explore group differences between ACTion-mTBI and CBT on functional disability, postconcussion symptoms, mental health, valued living and psychological flexibility.

Results
The intervention proved feasible to implement with community-based mTBI rehabilitation services. Attrition rates were comparable between the two psychological interventions and fidelity to the treatments was high. At post-treatment, when covarying pretreatment scores, ACTion-mTBI had a significantly greater improvement in functional disability than CBT (moderate effect). ACTion-mTBI also had a significantly greater reduction in postconcussion symptoms, anxiety and stress. Promisingly, significant improvements in psychological flexibility was also found post-treatment. There were no group differences on depressive symptoms and valued living.

Conclusion
We conclude that a full clinical trial of ACTion-mTBI for individuals with mTBI is feasible and warranted.

Trial registration number
ACTRN1262100059482.

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Cluster analysis of post-COVID-19 physical and mental health outcomes 3-6 months after SARS-CoV-2 infection: results of the French Prospective ALCOVID Cohort Study

Objectives
This study aims to characterise the diversity of post-COVID-19 physical and mental health outcomes, known as the post-COVID-19 condition (PCC), and the determining factors 3–6 months after acute SARS-CoV-2 infection.

Design
This is a prospective cohort study.

Setting
This study took place at the European Hospital of Marseille, France.

Participants
Participants include patients with acute COVID-19 treated as inpatients or outpatients.

Interventions
Interventions include face-to-face assessment of physical and mental health symptoms.

Main outcome measures
Main outcome measures include symptom scores and scales, as well as paraclinical elements (thoracic CT scan, pulmonary functional tests). Multiple component analysis was used to identify clinical phenotypic clusters of PCC patients, as well as their initial comorbidity groups. A multinomial regression model was used to evaluate the association between the initial comorbidities and disease severity with PCC phenotype.

Results
A total of 210 patients agreed to participate, of which 157 (75%) reported at least one symptom at the 3–6 months visit; mostly asthenia, dyspnoea, psychiatric disorders such as anxiety, depression, post-traumatic stress disorder and cognitive disorders. Four PCC clusters were recognised: (1) paucisymptomatic PCC (n=82, 39%); (2) physical sequelae PCC (n=39, 18.6%), (3) pre-existing pulmonary comorbidities PCC (n=29, 13.8%); and (4) functional somatic and/or mental symptoms PCC (n=60, 28.6%). In addition to their PCC symptoms, the patients in these clusters differed in terms of their demographic characteristics (sex), comorbidities and severity of COVID-19.

Conclusions
The four identified PCC clusters corresponded to distinct and coherent clinical and paraclinical entities, making it possible to consider adapted and personalised prognosis and therapeutic interventions.

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Effects of manual osteopathic interventions on psychometric and psychophysiological indicators of anxiety, depression and stress in adults: a systematic review and meta-analysis of randomised controlled trials

Objectives
To evaluate whether osteopathic and related manual interventions improve adult mental health (depression, anxiety, stress) and psychophysiological measures (eg, heart rate variability, skin conductance).

Design
Systematic review and meta-analysis of randomised controlled trials (RCTs).

Data sources
PubMed, MEDLINE (Ovid), Scopus, Cochrane, and AMED, searched through September 2024.

Eligibility criteria
English-language RCTs with ≥30 participants investigating osteopathic or related manual therapies (eg, myofascial release, high-velocity low-amplitude thrusts) delivered by qualified practitioners, compared with no treatment or sham, and reporting immediate postintervention mental health or psychophysiological outcomes.

Data extraction and synthesis
Full-text screening, risk-of-bias assessment and data extraction were conducted independently by multiple reviewers using a standardised Joanna Briggs Institute (JBI) Extraction Form. Risk of bias was assessed using the JBI Critical Appraisal Checklist. For meta-analyses, Hedges’ g (with 95% CIs) was calculated from postintervention means and SD. Random-effects models accounted for heterogeneity, and prediction intervals were calculated to assess uncertainty in effect estimates.

Results
20 RCTs were included. Osteopathic interventions reduced depression (Hedges’ g=–0.47, 95% CI: –0.86 to –0.09, p=0.02) and increased skin conductance (Hedges’ g=0.67, 95% CI: 0.00 to 1.34, p=0.05). Depression improvements were greater in pain populations (Hedges’ g=–0.61, 95% CI: –1.06 to –0.17, p=0.01). However, wide prediction intervals and moderate heterogeneity indicate uncertainty in true effect sizes, and limited studies and sample sizes restrict assessment of publication bias.

Conclusions
Osteopathic and related manual therapies may reduce depression and influence certain psychophysiological markers, particularly in pain populations, but uncertainty and heterogeneity limit confidence. More rigorous, larger, and longitudinal RCTs are needed.

Trial registration number
This meta-analysis was not formally registered, though the protocol and search strategy can be found at Open Science Framework, registration identification: https://osf.io/jrtpx/.

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Diabetes beliefs, perceived risk and health behaviours: an embedded mixed-methods analysis from the Richmond Stress and Sugar Study

Introduction
Efforts to increase engagement with diabetes prevention programmes largely focus on increasing diabetes awareness, with the logic that risk knowledge will motivate behaviour change. However, the salience of perceived risk as it relates to diabetes prevention is contested. The goal of this cross-sectional, embedded mixed-methods study was to examine the relationships between perceived risk, diabetes beliefs and prevention behaviours among adults at elevated risk of type 2 diabetes.

Methods
Data come from the Richmond Stress and Sugar Study (n=125). Diabetes beliefs (ie, internal, chance, powerful others) were assessed using the Multidimensional Health Locus of Control. Preventive behaviours (eg, changing diet, exercise, tobacco, alcohol) were measured by self-report. Perceived risk of developing diabetes was measured using a probability scale (0%–100%). Logistic and Poisson regression models quantified the relationships between beliefs, behaviours and perceived risk. Qualitative themes regarding challenges and facilitators to preventive behaviours were abstracted from open-ended questions and summarised using content analysis.

Results
Perceived risk of developing diabetes was low (median: 35% likelihood) and only 10% of participants had ever attended a prevention class. None of the diabetes belief domains were significantly associated with either engagement in preventive behaviours or perceived diabetes risk. Perceived diabetes risk was not associated with engagement in preventive behaviours; however, having a family history of diabetes was strongly related to perceived risk (OR: 3.35, 95% CI: 1.42 to 7.86). Qualitative facilitators and barriers of preventive behaviours reflected psychosocial factors (eg, determination, stress, preferences) and resources (eg, social support, time, overall health).

Conclusions
Perceptions of risk and health beliefs are not correlated with engagement in preventive behaviours among adults at clinically elevated risk of diabetes. Awareness campaigns may benefit from incorporating family health history information. Diabetes prevention programmes should address barriers beyond health beliefs to promote engagement in behaviour change.

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