Inappropriate complementary feeding contributes to child undernutrition, even in food-secure areas. This paradox highlights the need to look beyond food availability and examine the household-level mechanisms that shape everyday feeding decisions in the farming and food-secure settings. The objective of this study was to explore the household dynamics of maternal caregiving and agricultural labour in complementary feeding practices in rural farming communities in Geita.
Phenomenology study design was employed to explore the lived experiences and perceptions of mothers regarding complementary feeding practices.
Rural farming communities in Geita Region, Tanzania.
Mothers of children aged 6–23 months were purposively selected to participate in seven in-depth interviews and two focus group discussions.
In these farming communities, four household-level factors were found to influence complementary feeding practices: maternal responsibility and farming obligations, carrying children and porridge to the farms, limited paternal involvement, fatigue due to prolonged farm work, reliance on elder siblings for childcare and fear of judgement or sanctions for late arrival at the farm. Farming emerged as a cross-cutting theme that intersected all these sub-themes.
Mothers described complementary feeding practices as closely linked to household division of labour, caregiving arrangements and the demands of farming activities that shaped daily routines. These findings suggest the need for context-sensitive strategies that consider intra-household roles and the time constraints associated with subsistence farming.
Clinical psychology interventions for reducing obesity have developed alongside pharmacological and surgical treatments, but usually as interventions for individual patients. Any healthcare intervention rests on a logic model: assumptions that through specific physical and social mechanisms, it will produce certain intended outcomes, provided that conducive background conditions (‘contexts’) exist. Using evidence from the feasibility trial preceding a full randomised controlled trial (RCT), this paper assesses the empirical validity of the initial logic model of a new group-based weight management intervention: PROGROUP, designed for patients with body mass index (BMI) ≥40 kg/m2 or ≥35 kg/m2 with comorbidities. We aimed to test whether:
PROGROUP’s programme components produce the intended outcomes at all, whatever their size and how. The intervention can practicably be implemented (‘delivered’) as designed. How the programme and delivery components affected each other.
Multimethod proof-of-concept study by means of realist evaluation of the initial PROGROUP logic model. We:
Elicited the logic model underlying the intervention design. Compared these assumptions with data from a pre-RCT feasibility study in two English and one Welsh National Health Service (NHS) sites during 2021–2023. Revised the logic model in light of the data, noting how much variation in delivery the programme components (therapeutic mechanisms) could tolerate.
Specialised ambulatory mental health services in the English NHS.
Adults with severe obesity (BMI ≥40 kg/m2 or ≥35 kg/m2 with comorbidities).
Group-building techniques to enhance group members’ adoption of evidence-based methods of behaviour change affecting their dietary behaviour and physical activity.
Qualitative outcomes. What kinds of:
Mechanisms were established and triggered by the attempt to implement PROGROUP (secondary outcome, see objective 1 above). Patient behaviours resulted and whether patients sustained them after the intervention ended (primary outcome; see objective 1 above); and what kinds of context affected that (objectives 2 and 3).
Quantitative measures not used.
The initial logic model assumed that the following sequence of mechanisms would produce weight loss: referral from GP to specialist weight management services; further referral to PROGROUP; preparatory individual consultation; facilitated group sessions produce a group identity; group identity reinforces weight management capability and motivation; further individual consultations adjust for individual circumstances; behaviour change outside the treatment setting, producing weight loss. Contexts necessary for these mechanisms to work included: sufficient catchment population; group size, continuity and membership retention; suitable location; facilitator training; and practical support outside the treatment setting.
The findings suggested revisions to the logic model, but more in the delivery components and contextual assumptions than the core therapeutic mechanisms. There was scope to simplify the referral mechanisms. Different professions could implement the model. A realist evaluation of a pre-RCT feasibility study can be used to make the intervention’s logic model more securely evidence-based, serving as a proof-of-concept test for the intervention. It indicated the conditions under which such group psychological interventions might be more widely used.
Malnutrition is a highly prevalent chronic condition that contributes to higher morbidity and mortality in patients with multiple comorbidities. While positive effects of nutritional therapy in the in-hospital setting have recently been demonstrated, the benefits of long-term nutritional therapy after hospital discharge remain uncertain. Herein, we outline the design and rationale of the EFFORTII trial, the largest nutritional trial to date to assess the effects of continued nutritional support after hospital discharge in medical patients, with particular attention to key design decisions regarding nutritional strategy, patient selection criteria and study endpoints.
The Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery (EFFORTII) is an investigator-initiated, non-commercial randomised controlled trial designed to evaluate whether ongoing, individualised nutritional therapy after hospital discharge—targeted to meet specific energy and protein requirements—offers a cost-effective approach to lowering mortality, minimising complications and maintaining functional status compared with standard care. Eligible participants are adult, chronically ill medical inpatients at risk of malnutrition. Patients in the intervention group receive individualised nutritional therapy delivered by an experienced dietitian through a combination of telemedicine and in-person consultations. The intervention aims to meet personalised nutritional targets, supported by a trained dietitian. Control group patients receive nutritional counselling at discharge, but no structured nutritional management during follow-up. We designed the trial as an event-driven trial with a target of 247 mortality events (primary endpoint), which will be assessed over approximately 5 years until event-driven endpoint is met. The minimum total sample size is at least 802 participants, based on the assumed treatment HR of 0.70. The main trial is enrolling patients across multiple sites in Switzerland. During the trial, additional sites in Spain joined the study, and their data will be analysed using a patient-level pooled approach.
This study involves human participants and was first granted ethical approval by the Ethics Committee Northwest- and Central Switzerland and then by all participating local ethics committees. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed journals and academic conferences.
Allergic rhinoconjunctivitis (ARC) is a highly prevalent immune-mediated condition associated with substantial symptom burden, impaired quality of life and increased healthcare use. Emerging evidence highlights the role of the gut microbiome in immune regulation and allergic disease. Fermented foods may contain live microbes (when unpasteurised or uncooked) and bioactive postbiotic metabolites that can modulate immune responses. Despite growing interest in dietary strategies targeting the microbiome, no randomised controlled trial has compared fermented versus unfermented red cabbage for ARC.
This single-centre, randomised, controlled trial with a sensory-matched, unfermented cabbage comparator investigates the effects of daily consumption of fermented red cabbage for 8 weeks compared with an unfermented red cabbage control in young adults (18–35 years) with ARC. A total of 158 participants will be randomly assigned (1:1). The primary outcome is change in Total Nose and Eye Symptom Score from baseline to week 8. Secondary outcomes include daily symptoms and medication use captured via mobile ecological momentary assessments, quality of life, psychological well-being, gastrointestinal symptoms, systemic inflammatory markers, total IgE, immune cell profile and metagenomic characterisation of stool samples. A nested qualitative component explores participants’ experiences and acceptability of the intervention. Analyses will include mixed-effects models, time-series analyses incorporating daily pollen counts and comprehensive microbiome statistics. Safety outcomes and adverse events will also be assessed.
This study was approved by the Ethics Committee of Charité—Universitätsmedizin Berlin (EA4/043/25) and is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be disseminated through peer-reviewed publications, conference presentations and a lay summary provided to participants. Anonymised datasets and analysis scripts will be made available in public repositories, and metagenomic sequencing data will be deposited in an international sequence archive to ensure transparency and reproducibility.
DRKS00036475.
Findings of previous studies on associations between dairy consumption and metabolic health status were inconsistent. This study aimed to assess the link between consumption of dairy foods and metabolic health status, brain-derived neurotrophic factor (BDNF) and adropin levels in adults.
Cross-sectional.
An observational study in Isfahan, Iran.
Adults (n=527) selected by multistage cluster random sampling. Dietary intakes were assessed via a validated 168-item food frequency questionnaire.
Anthropometric indices, blood pressure and biochemical parameters were assessed. The criteria proposed by Wildman et al were used to categorise participants into metabolically healthy and metabolically unhealthy (MU).
Participants had a mean age of 42.66 years (45.7% women). Moderate consumption of total dairy was, respectively, linked to 58% lower odds of MU (OR T2 vs T1=0.42; 95% CI 0.18 to 0.96), after taking all confounders into account. Participants in the middle versus low tertile of low-fat dairy intake showed 51% marginally lower odds of MU (OR T2 vs T1=0.49; 95% CI 0.22 to 1.08; p=0.08). No significant association was discovered between high-fat dairy intake and MU chance. However, higher total dairy intake was associated with lower odds of hypertension (OR T3 vs T1=0.36; 95% CI: 0.14 to 0.93). No significant associations were observed between dairy intake and BDNF or adropin levels.
Moderate consumption of total and low-fat dairy was associated with lower odds of being metabolically unhealthy in Iranian adults, but high-fat dairy intake was not. Hypertension was less common among individuals with higher dairy intake. No association was found between dairy intake and serum levels of BDNF or adropin.
This study aimed to assess the association between lipid accumulation product (LAP) index, a novel index combining waist circumference (WC) and triglyceride levels, and anthropometric indices, metabolic factors and hepatic function markers in obese subjects with non-alcoholic fatty liver disease (NAFLD).
Cross-sectional study.
Specialised and subspecialised outpatient clinics of Tabriz University of Medical Sciences.
Overall, 232 adult patients with obesity and ultrasound-proven NAFLD were included in the present study.
Anthropometric measurements (body weight, height and waist and hip circumferences) were measured, and serum levels of glucose, lipid profile, ferritin and liver enzymes were assessed subsequent to an overnight fasting.
Mild and Moderate NAFLD were found in 43.5% and 48.2% of the participants, respectively. LAP index markedly increased with higher grades of steatosis, showing values of 63.72±22.26, 84.57±44.96 and 112.14±56.97 for healthy, grade I and grade II groups, respectively (p
In conclusion, the LAP index was not only associated with anthropometric indices, metabolic parameters and hepatic function markers, but also increased in line with higher grades of liver steatosis in NAFLD.
To assess the sex-specific status of dietary diversity (DD) and its associated factors among older men and women (aged ≥60 years) in Bangladesh.
A nationally representative cross-sectional survey was conducted in 2018–2019 on food security, nutrition and health of older adults of both sexes.
Data were collected from 82 clusters (rural 57, non-slum urban 15 and slum 10) from all eight administrative divisions of Bangladesh.
A total of 4817 participants aged ≥60 years (2482 men and 2335 women) were enrolled.
A list-based (24-item) recall method was employed, and the items were later aggregated into 10 food groups. The outcome variable was the prevalence of inadequate DD, defined as consumption of less than 5 food groups out of 10.
Men and women had mean DD scores of 4.33±1.6 and 4.13±1.7, respectively. Women had a higher prevalence of inadequate DD than men (61.2% vs 56.3%, p=0.028). Among the food groups, women consumed significantly less fish and eggs than men (fish: 50.96% vs 57.76%, p=0.002; eggs: 17.13% vs 22.10%, p=0.004). Poor education, rural dwellings, living in homes with fewer individuals and living in food-insecure households were associated with inadequate DD in both sexes. Furthermore, among men, older age and not being currently married, and among women, lower age and living in households with middle wealth status were associated with inadequate DD.
The study found that older women consume relatively less diverse diets than men, and several sociodemographic factors influence inadequate DD among older adults of both sexes in Bangladesh. These factors should be considered while developing policies and programmes to promote equitable access to a diversified diet and improve geriatric health and nutritional outcomes.
Maternal dietary practices are vital for improving maternal and neonatal outcomes. However, comprehensive information about optimal dietary practices among pregnant women is limited in Ethiopia. Therefore, this systematic review and meta-analysis aimed to determine the pooled prevalence of optimal dietary practices and its associated factors among pregnant women in Ethiopia.
A systematic review and meta-analysis of observational studies was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
PubMed, EMBASE, Web of Science, Scopus, African Journals Online and Cochrane Library were searched for studies published in English before 25 March 2024.
Observational studies reporting the prevalence of optimal dietary practices and/or associated factors among pregnant women in Ethiopia were included.
Data were independently extracted by two reviewers, and the quality of the included studies was evaluated using the Newcastle–Ottawa Scale adapted for cross-sectional research. Review Manager V.5.4.1 and STATA V.14 software were used for data synthesis and statistical analysis. A random-effects and/or fixed-effects model was employed to calculate pooled ORs and 95% CIs to determine the correlation between dependent and independent factors. We checked heterogeneity using the I² statistic and conducted subgroup analysis to explore the source of heterogeneity among the included studies. Funnel plots and Egger’s regression test were used to determine publication bias.
A total of 22 studies with 10 915 participants were included in the review. The pooled prevalence of optimal dietary practice was 35.83% (95% CI 28.35 to 43.32). The overall study’s quality was high, and we detected significant publication bias (Egger’s test, p value=0.001). Monthly income ≥5000 ETB/90 US$) (pooled OR (OR=2.56, 95% CI 1.12 to 5.88), formal education (OR=2.74; 95% CI 1.22 to 6.16), good dietary knowledge (OR=4.1; 95% CI 3.19 to 5.25), ownership of radio/television (OR: 5.64, 95% CI 2.05 to 15.52), favourable attitude (OR=3.90, 95% CI 3.05 to 4.99) and food security (OR: 4.48; 95% CI 3.03 to 6.61), urban residency (OR=6.25, 95% CI 4.06 to 9.63), family size
Only one in three pregnant women in Ethiopia practises optimal dietary behaviours. Several modifiable individual and sociodemographic factors influence dietary practices. Interventions focusing on improving nutrition knowledge, enhancing attitudes, expanding access to media-based nutrition information and strengthening antenatal nutrition education, particularly for rural and less educated women, may improve dietary practices and pregnancy outcomes.
CRD42024542652.
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a leading chronic liver disorder closely linked to diabetes mellitus (DM) and its cardiovascular and renal complications. Early identification of diabetes risk in this population is essential for timely intervention.
To develop machine learning (ML) models to predict diabetes risk in individuals with MASLD and to identify key predictive factors using a nationally representative dataset.
Data from 6310 MASLD participants (2007–2018) were analysed and classified into DM and non-DM groups. Feature selection was performed using Random Forest, Least Absolute Shrinkage and Selection Operator and Support Vector Machine Recursive Feature Elimination. Based on selected features, nine ML models were developed. Model performance was evaluated using accuracy, sensitivity, area under the curve, F1 score, Rank Score and Brier Score. SHapley Additive exPlanations (SHAP) were used for interpretability.
Eight key variables (age, urinary albumin (Ualb), total cholesterol (TC), lipid accumulation product (LAP), urinary creatinine, white blood cell count, uric acid and Visceral Adiposity Index) were identified and used for model construction. Among nine algorithms, the Light Gradient Boosting Machine (LightGBM) model showed superior predictive performance. SHAP analysis revealed that Ualb, age, TC and LAP were the most influential predictors.
Our ML-based model effectively identifies individuals with MASLD at high risk for developing DM. The LightGBM algorithm outperformed other models in both accuracy and interpretability. Key predictors such as Ualb and LAP highlight the importance of renal and metabolic markers in early diabetes risk prediction, offering a new approach for individualised intervention and clinical decision-making.
Personalised nutrition that incorporates genetic results into dietary interventions holds significant potential to optimise weight management and metabolic outcomes. While traditional calorie-restricted diets remain effective, emerging evidence suggests that variations in macronutrient distribution may offer additional benefits. Genetic variants help explain interindividual differences in dietary responses, with certain alleles showing enhanced weight loss and metabolic improvements with specific macronutrient distributions. However, comprehensive reviews of randomised controlled trials (RCTs) examining genotype-based dietary effects, particularly those focusing on macronutrient distribution metabolic pathway interactions, are lacking, limiting the development of robust evidence-based guidelines for nutrigenetic counselling. This systematic review aims to assess the influence of genetic variants on weight loss outcome in adults in response to varying macronutrient distribution diets (eg, low-fat, low-carbohydrate, high-protein diets) using evidence from RCTs.
We will systematically review RCTs examining weight loss outcomes of macronutrient-varied diets in adults with genotype stratifications to risk and protective allele. Multiple databases, PubMed, Cochrane Library, Scopus, Science Direct and Google Scholar, will be used. Reviewers will screen studies, extract data on study characteristics, weight loss, metabolic marker outcomes and genetic data, and assess the risk of bias using the Cochrane Risk of Bias Tool 2.0 tool.
All eligible RCTs will first be summarised in structured tables describing study characteristics, macronutrient distribution and genetic variants and will be analysed with narrative synthesis. For quantitative analysis, interventions will be grouped into three predefined diet types (high-protein, low to moderate carbohydrate and low-fat diet). Because heterogeneity across diet categories is expected, pooled effects will be estimated separately within each diet subgroup using random-effects meta-analysis, expressed as mean differences in weight change (kg). Within each subgroup, and when at least 10 studies or data are available, random-effects meta-regression will be used to examine potential moderators, including intervention duration, physical activity and ancestry. Heterogeneity will be evaluated using I2 and 2, and publication bias assessed when feasible. Evidence certainty will be graded using Grading of Recommendations Assessment, Development and Evaluation.
Ethical approval is not required for this protocol as it involves the analysis of data from primary studies. The findings will be disseminated through publication in peer-reviewed journals. Any enquiries regarding research integrity of this protocol may be directed to the Head of the Doctoral Program in Medical Health and Sciences, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada via the institutional email address s3fk@ugm.ac.id, as the responsible academic authority for research integrity.
CRD420251050587.
To assess nutrition-related knowledge, attitudes and practices among pregnant women, and identify socioeconomic and healthcare determinants.
A cross-sectional study on maternal nutrition during pregnancy.
Pregnant women attending primary healthcare centres in the south of Tehran from December 2022 to March 2024.
1535 pregnant women of all ages living in the south of Tehran (both Iranian and non-Iranian).
Pregnant women were systematically selected from primary healthcare centres. Data were collected via validated questionnaires and electronic health records. Statistical analyses included multivariate logistic regression (adjusted ORs (aORs) with 95% CIs) and generalised linear mixed models.
The findings revealed that a majority of pregnant women (83.3%; 95% CI 81.2% to 85.3%) exhibited low levels of nutritional knowledge (scores below 12), whereas 14% demonstrated moderate knowledge (scores between 12 and 17), and only 2.7% (95% CI 1.9% to 3.8%) possessed high nutritional knowledge (scores above 18). In terms of attitudes, 36.9% of respondents expressed positive views toward nutrition, with higher education significantly associated with positive attitudes (aOR=1.8; 95% CI 1.3 to 2.5, comparing higher vs lower education levels). Dietary variety was consistently reported by 65.4% of participants, while 8.5% lacked dietary variety. Statistically significant associations were observed between educational attainment, socioeconomic status and nutrition-related practices (p
As a cross-sectional study, these findings highlight substantial gaps in nutrition knowledge among pregnant women in Tehran, with socioeconomic status and education playing crucial roles in shaping dietary behaviours. Improving nutritional education through healthcare interventions is essential for enhancing maternal and fetal health outcomes.
To examine the associations between food-related behaviours and nutrient intake on nutritional status among clients undergoing Community-Based Treatment and Rehabilitation (CBTaR) in Kelantan, Malaysia.
Cross-sectional analytical study.
Seven CBTaR centres (n=7) across the state of Kelantan, Malaysia.
A total of 393 adult clients (aged 18 years and above) enrolled in CBTaR programmes between June and December 2022 were selected through stratified random sampling.
The primary outcome was nutritional status, assessed using body mass index. Secondary outcomes included nutrient intake (macronutrients and micronutrients) and food-related behaviours (emotional eating, external eating, restrained eating and food addiction), measured through Bahasa Malaysia validated questionnaires and 24-hour dietary recalls. All variables were introduced into the structural equation modelling to examine the associations among these variables and their association with nutritional status.
The results revealed that food-related behaviour was significantly associated with the nutrient intake (β=–0.524, p≤0.001). Additionally, the drug use profile significantly determined the food-related behaviour (β=–0.129, p=0.006) and nutritional status (β=–0.134, p=0.007). Nutrient intake was found to be a significant predictor of nutritional status (β=–0.213, p≤0.001). Sociodemographic and drug use profiles were significantly correlated with nutritional outcomes through behavioural and dietary associations. Importance-performance map analysis identified nutrient intake as the most impactful variable, highlighting the need for urgent intervention (R2=0.272).
This study highlights that nutrient intake is a significant predictor associated with food-related behaviours on nutritional status among individuals with substance use disorder. Integrating nutrition counselling and behavioural interventions into CBTaR services may improve recovery and long-term health outcomes.
This study examined the effects of food accessibility on eating habits, home eating environment and anthropometrics among rural parent-child dyads.
This secondary data analysis utilised baseline and post-intervention data from a mindful eating intervention trial. Parents completed an online survey assessing their sociodemographics, height, weight, eating habits, food resource management behaviours, child feeding attitudes and practices, home eating environment and household food insecurity. Trained data collectors measured children’s height, weight, percent body fat and skin carotenoids at childcare centres. Using Geographic Information System tools, food accessibility was estimated by linking participants’ zip codes to Zip Code Tabulation Areas.
A total of 154 rural parent-child dyads from low-income households were successfully recruited from 26 Head Start childcare centres in the USA. The children’s mean age was 47.16 months (SD=6.56) while parents averaged 32.68 years old (SD=8.00). About one-third of the parents were single and nearly a third had an annual family income below US$20 000. Additionally, 44.2% of parents were unemployed and over half only had an education level of high school or below. Mixed-effect models revealed that at baseline, limited access to full-service restaurants and greater access to limited-service restaurants were related to higher BMI z-scores (p=0.021, 0.040) and percent body fat (p=0.020, 0.032) in children. Longitudinal analyses using pre-post intervention data indicated that parents’ increases in fibre intake from baseline to post-intervention were correlated with less access to limited-service restaurants (p=0.034), while their improved food resource management behaviours over time were associated with greater access to grocery stores/supermarkets (p=0.043) after accounting for other types of food access. Additionally, more access to convenience stores was associated with increases in perceived parental weight (p=0.027) over time.
These findings suggest that food accessibility influences both dietary behaviours and health outcomes, with grocery stores and full-service restaurants having positive impacts, while limited-service restaurants and convenience stores have detrimental effects.
The clinical trial associated with the study’s data is registered at ClinicalTrials.gov under the identifier NCT05780008 on 27 February 2023.
Despite global commitments to eliminate malnutrition, over half the world’s population remains affected. Multisectoral nutrition interventions targeting both proximate and distal causes of malnutrition are essential across the lifespan. Yet, current data collection lacks comprehensive nutrition intervention coverage measures, risking inaccuracies in tracking progress. The One Nutrition Coverage Survey (ONCS) aims to test new and refined coverage measurement methods, assess coverage equity and guide integration into large-scale household surveys.
The ONCS will be a cross-sectional, population-representative household survey conducted in four districts of Bangladesh (Rangpur, Sylhet, Dhaka and Khulna), selected for their geographic spread and urban–rural balance. A stratified multistage sampling approach will be used to select enumeration areas, and a total of approximately 3280 households randomly selected within each EA will be included in the survey. The survey will interview women of reproductive age (15–49 years), caregivers of children (0–9 years), adolescents (10–19 years) and pregnant women, collecting data on multisectoral nutrition interventions relevant to these groups. It will use both existing and new measures, while also capturing monetary and non-monetary costs for survey design to implementation. Data will be analysed to assess coverage, co-coverage and equity by sociodemographic characteristics, as well as the feasibility, accuracy and costs of the survey approach.
The study protocol and instruments were reviewed and approved by the International Centre for Diarrhoeal Disease Research, Bangladesh’s (icddr,b) Ethical Review Board in Bangladesh and the International Food Policy Research Institute’s Institutional Review Board in Washington, DC, USA. Adults provided signed informed consent and adolescents their assent. Findings will be shared through peer-reviewed publications, conferences and presentations in Bangladesh with key stakeholders. This study will yield new tools, methods and evidence for measuring multisectoral nutrition intervention coverage, applicable to other low-income and middle-income countries. Learnings from ONCS will enhance data collection aligned with national strategies, helping governments improve coverage assessments, inform decisions and strengthen programme monitoring.
Systemic sclerosis (SSc) is an autoimmune disorder causing progressive fibrosis of internal organs and skin, leading to increased thickness and rigidity. It frequently results in malnutrition, which can decrease survival rates and physical performance, while also imposing financial burdens on healthcare systems and society. Multimodal nutritional interventions may encompass various approaches, including nutritional counselling, consumption of oral nutritional supplements and disease-specific dietary regimens based on nutritional needs. The present clinical trial is designed to examine the effectiveness of multimodal nutritional intervention on nutritional status, quality of life, food intake, body composition and fatigue in patients with SSc.
This is a parallel, randomised, placebo-controlled clinical trial that will investigate the impacts of multimodal nutritional interventions in SSc patients. 46 qualified SSc participants will be chosen at random and given multimodal nutritional intervention or dietary recommendations for a period of 8 weeks. The primary outcomes of this study are changes in nutritional status and quality of life. The secondary outcomes include changes in body composition, fatigue, body weight, body mass index and calf circumference. Statistical analysis will be conducted using the SPSS software (Version 24).
The current trial received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICINE.REC.1403.345). The findings will be submitted to international, peer-reviewed publications and presented at national and international conferences.
IRCT20220208053971N4.
Obesity is a prevalent multifactorial disease worldwide that has become a major public health concern. Excess adiposity poses a health risk because it is related to several chronic diseases, which impact the person’s quality of life and present a greater risk of mortality. This study presents a protocol to evaluate the effectiveness of the Energy2MOB programme (Improvement of Obesity) in reducing body weight (between 5%–10%) in adults with obesity with a multicomponent group intervention of food education and physical activity.
Randomised clinical trial with two groups (control and intervention) of 1 year, which includes people from the Berguedà health region between 18 and 65 years old with grade II overweight (body mass index (BMI) between 27–30 kg/m2) or obesity (BMI between 30–40 kg/m2). Accepting an alpha risk of 0.05 and a statistical power >0.8 in a bilateral contrast, 68 subjects in each group are needed to detect a difference equal to or >2.5 kg.
The protocol was approved by the Ethics Committee of the University Institute for Research in Primary Care (IDIAP Jordi Gol) with the CEIm code: 24/303-P. The IDIAPJGol CEIm complies with the standards of Good Clinical Practice and with the current legislation that regulates its operation. The protocol complies with the ethical principles of the Declaration of Helsinki and applicable data protection regulations. All participants will provide written informed consent before participating. The dissemination plan includes presenting the results at national and international scientific conferences, publication in peer-reviewed journals, and sharing a plain-language summary with all participants through their primary care centres. Key findings will also be shared with local health authorities and community health professionals to inform future interventions on obesity prevention and management.
This study compared the reliability of two metabolic cart systems, Vyntus CPX and Vmax Encore 29N, to measure whole-body energy metabolism by indirect calorimetry (IC) in individuals with type 2 diabetes (T2D).
Randomised, prospective, crossover study.
Single-centre study conducted in the clinical research centre of the German Diabetes Study (GDS).
Five participants (3 men, 2 women, mean age 49±6 years, body mass index (BMI) 32.62±4.2 kg/m²) with T2D completed the study protocol. Eligibility requires existing participation in GDS and availability for four consecutive study days.
Participants underwent four IC measurements per day on four consecutive days, totalling 16 measurements per device. On each study day, two measurements with both devices, Vyntus CPX and Vmax Encore 29N, were performed in randomised order. Postcalorimetric gas calibration with normalisation was applied after each measurement.
Reliability of respiratory quotient (RQ) and resting energy expenditure (REE), as assessed from the coefficient of variation (CV) and 95% CIs.
Device comparison showed minor differences in CV (95% CI) for carbon dioxide production (VCO2) (3.5% vs 5.3%; 95% CI –8.2% to 8.0%), oxygen consumption (VO2) (3.4% vs 5.7%; 95% CI –9.3% to 8.2%), RQ (3.6% vs 2.3%; 95% CI –3.5% to 3.7%) and REE (3.1% vs 5.6%; 95% CI –8.4% to 7.8%). Postcalorimetric calibration did not consistently affect RQ or REE.
Vyntus CPX provides reliable IC measurements comparable to Vmax Encore 29N and may serve as a suitable replacement in clinical settings.
ClinicalTrials.gov identifier: NCT01055093.
Infant feeding practices in the first 2 years of life are linked to long-term weight trajectories. Despite the importance of obesity prevention interventions, there are no randomised controlled trials (RCTs) evaluating early childhood education and care (ECEC) and primary caregiver-targeted interventions on child weight and feeding outcomes.
To assess the efficacy of an 18-month digital health intervention (Tiny Bites) delivered to ECEC services and primary caregivers of children aged 4 to ≤12 months on child age-adjusted and sex-adjusted body mass index-for-age z-score (zBMI) relative to usual care control in the Hunter New England (HNE) region of New South Wales, Australia.
This type 1 hybrid cluster RCT will include up to 60 ECEC services and 540 children/caregiver dyads. The intervention supports ECEC services and caregivers to deliver recommended responsive feeding practices to infants. ECEC services will receive access to an online assessment platform, training and resources, and implementation support. Primary caregivers will receive text messages, monthly e-newsletters, online links and direct communication from ECEC services. We will assess the impact on child zBMI at 18-month follow-up. Secondary outcomes include duration of consuming any breastmilk, child diet and caregiver responsive feeding practices. We will also assess ECEC policy and practice implementation related to targeted feeding practices, programme cost effectiveness, adverse effects and engagement with the programme (ECECs and caregivers). For the primary outcome, between-group differences will be assessed for paired data using two-level hierarchical linear regression models.
Ethics approval has been provided by HNE Human Research Ethics Committee (HREC) (2023/ETH01158), Deakin University (2024-202) and University of Newcastle HREC (R-2024-0039). Trial results will be submitted for publication in peer-reviewed journals, presented at scientific conferences locally and internationally and to relevant practice stakeholders.
ACTRN12624000576527.
Optimal nutrition during early childhood is crucial for psychosomatic development and for preventing diet-related diseases. However, evidence from Poland highlights significant deviations from recommended dietary practices. The previous Polish Infants and Toddler Nutritional Study conducted in 2016 (PITNUTS 2016) revealed imbalances in nutrient intake among children aged 5–36 months. The aim of this study (PITNUTS 2024) is to assess the diet and nutritional status of infants and children aged 5–72 months, providing a broader understanding of eating behaviours across critical stages of growth and development and allowing evaluation of how dietary practices changed in recent years.
This cross-sectional study will recruit a nationally representative sample of Polish infants and children aged 5 to 72 months using stratified random sampling. Survey interviews will be conducted with parents or legal guardians as proxy reporters for the children. Dietary practices will be evaluated through validated qualitative and quantitative dietary assessments, ensuring a comprehensive evaluation of food consumption and energy and nutrient intake. Dietary data will be collected using the 3 day food record and the survey questionnaire, including a food frequency questionnaire (FFQ). Daily energy and nutrient intake will be compared with national dietary standards and WHO guidelines. Dietary patterns will be derived based on the FFQ data. Nutritional status will be assessed based on measured anthropometric parameters. Energy, macro- and micronutrient intake as well as dietary patterns identified among children will be associated with nutritional status, including body mass index z-score and body weight status.
The study has been approved by the ethics board of the Institute of Mother and Child. Written informed consent was obtained from all participants’ parents or legal guardians before the interviews began. The results from this study will be presented at scientific conferences and published in peer-reviewed journals, contributing to nutrition policies in Poland and informing educational materials and dietary consultation services.
NCT06417151, results.
Diets high in ultraprocessed food (UPF) are associated with poor health outcomes and weight gain. Healthcare workers are particularly at risk of consuming diets high in UPF due to erratic work patterns, high stress and limited access to fresh food at work. Despite this, no interventions to date have specifically targeted a reduction in UPF intake in healthcare workers.
This article describes the development and content of a 6-month behavioural support intervention targeting a reduction in UPF intake in UK healthcare workers. The intervention was offered to all participants who took part in the UltraProcessed versus minimally processed Diets following UK dietAry guidance on healTh outcomEs trial—a two-stage study in which Stage 1 was a controlled-feeding crossover randomised controlled trial of provided UPF versus minimally processed food (MPF) diets (published previously) and was completed before the start of Stage 2. Stage 2, reported here, aimed to support participants to reduce their UPF consumption, increase MPF and increase physical activity in real-world settings. The intervention was developed using the behaviour change wheel framework, which systematically links behavioural diagnoses to intervention functions, incorporating the capability, opportunity and motivation model for behaviour change. It included tailored one-to-one and group support sessions, bespoke digital and print resources and a mobile-optimised website. The detailed description is intended to support future replication and adaptation. The acceptability and feasibility of the intervention will be assessed using quantitative and qualitative data in a future paper.
Sheffield Research Ethics Committee approved the trial (22/YH/0281). Findings will be disseminated through peer-reviewed publications, conference presentations and summaries shared with participants and stakeholders.