Causal effects of later-eating rhythm on adiposity in children through the comparison of two cohorts in the UK and China: a cross-cohort study.

BACKGROUND: Later-eating rhythm (LER) refers to a later timing, greater energy intake, and higher meal frequency in the evening. The role of childhood LER in obesity development is emerging, but most evidence is cross-sectional. Cross-context comparison allows the improvement of causal inference in observational studies by comparing cohorts with different confounding structures. This method is applied to assess the causal effects of LER on adiposity, by exploring the likelihood of residual confounding due to socioeconomic status. METHODS: In this cross-cohort analysis, we used ongoing birth cohort data from the UK Avon Longitudinal Study of Parents and Children (ALSPAC) established in 1991, and the nationally representative China Health and Nutrition Survey (CHNS) collected in 1989-2011. Children with available data at age 7 years were eligible. We applied indices of inequality for assessing confounding structure by regressing LER/adiposity on the standardised score of socioeconomic status (SES) in each cohort. We used multivariable linear and binary logistic regressions to model cross-sectional and prospective associations between LER at 7 years of age and body-mass index (BMI) at ages 7 and 9 years in both cohorts. Analyses were adjusted by age, sex, ethnicity, residency, and socioeconomic status. We used a p value for the Cochrane Q-test obtained from meta-analysis to test for heterogeneity between cohorts. FINDINGS: We analysed data from 4019 children (2170 [54·0%] female; 1849 [46.0%] male) in ALSPAC and 1749 (788 [45·1%] female; 961 [54.9%] male) in CHNS. The associations between SES and LER or adiposity differed between ALSPAC and CHNS (SES and energy intake for evening main meal: b=1·81 [95% CI 0·81 to 2·81] vs -3·02 [-4·76 to -1·27]; SES and frequency of evening snacks: odds ratio [OR]=0·51 [95% CI 0·41-0·63] vs 5·71 [3·54-9·22]; SES and BMI: b=-0·42 [-0·65 to -0·18] vs 1·29 [0·75 to 1·84]). Positive associations between frequency of evening snacks and BMI were seen in both cross-sectional and longitudinal analyses in both cohorts (mean change of BMI with 1 day increase of consuming evening snacks b=0·09 [0·02 to 0·15]; 0·13 [0·03 to 0·22] kg/m2 per day in ALSPAC, and b=0·11 [-0·07 to 0·28]; 0·30 [0·07 to 0·52] kg/m2 per day in CHNS). No associations were found for energy intake. p values for heterogeneity ranged from 0·107 to 0·932. INTERPRETATION: Both cohorts showed consistent results despite varied dietary cultures and SES patterning of LER or adiposity. Energy intake in the evening or night was not associated with adiposity, whereas evening snacking was. More recent, high-quality cohorts are warranted to enhance the strength of the conclusions. FUNDING: None.

Should left- and right-sided unilateral cleft lip and palate patients be grouped together when reporting the outcomes?

OBJECTIVES: Investigate associations between cleft laterality in patients with non-syndromic unilateral cleft lip and palate (UCLP) and oral-health, dental-arch, speech, audiological, psychological and nasolabial-aesthetic outcomes. METHODS: Secondary data analysis of the outcomes of 5-year-old children with non-syndromic complete UCLP identified from three studies: Cleft Collective (n = 155), Cleft Care UK (CCUK) (n = 266) and Clinical Standards Advisory Group (CSAG) study (n = 238). Outcome measures included occlusal assessment using the 5-year-old's index score, speech intelligibility rating using the CAPS-A Audit tool, audiological assessment using pure tone audiometry, nasolabial aesthetic assessment using the Asher-McDade tool, oral-health assessment using decayed, missing, filled teeth scores and parent-reported outcomes. Logistic regression with adjustment for age, sex and index-of-multiple-deprivation scores were performed. RESULTS: No differences were found in patient-reported outcomes between the left and right clefts in the Cleft Collective study. From the CCUK study, right clefts had poorer speech (n = 236; 95% CI 1.09, 3.42; and P = .03) and hearing outcomes (n = 211; 95% CI 1.03, 3.43; P = .04). In the CSAG study, patients with left clefts were more likely to be teased (n = 213; 95% CI 0.26, 0.85; and P = .01). CONCLUSION: Weak associations between cleft laterality, speech, hearing and psychological outcomes were found, however the findings were inconsistent across the studies. This study contributes to evidence of associations between laterality and outcomes in children born with UCLP.

How full am I? The effect of rating fullness during eating on food intake, eating speed and relationship with satiety responsiveness.

Modifying eating behaviours may be an effective strategy to limit excess food intake, such as eating slower and mindfully. We hypothesized that regularly rating fullness whilst eating a standard meal in one course would increase post-meal satiety and reduce intake in a subsequent course during the same sitting. A between-subjects design was employed (n = 65; 75% female; mean age = 26.7 (s.d. = 9.5); mean body mass index = 22.4 (s.d. = 3.3)), with three conditions of within-meal visual-analogue-scale ratings: 'Fullness' (rated fullness); 'Taste' (rated pleasantness of taste of food); 'Control' (rated comfort of room). Fasted participants ate a pasta meal (327 kcal) followed by cookies ad libitum. Appetite ratings were measured at baseline, following each course and for 3-h post-meal. Satiety responsiveness was measured using the Adult Eating Behaviour Questionnaire, Intuitive Eating Scale and by calculating the satiety quotient of the pasta course alone and the whole meal. The primary outcomes were fullness ratings post-pasta course [mean (s.d.): Fullness = 67.1 (21.9); Taste = 64.4 (13.7); Control = 60.2 (21.5)] and cookie intake [mean kcal (s.d.): Fullness = 249 (236); Taste = 279 (231); Control = 255 (208)]. Eating speed was included as a secondary, control outcome [mean (s.d.): Fullness = 59.3 (9.0); Taste = 59.2 (17.7); Control = 60.7 (19.6)]. No evidence for a difference in outcomes was identified between conditions (p > 0.05). Future work could involve testing the impact of rating fullness during multiple meals over a longer period. Secondly, this study explored whether levels of satiety responsiveness influenced the impact of the manipulation on outcomes; however only weak evidence for a relationship with eating speed was found. Finally, only a weak relationship was found between the satiety responsiveness measures, suggesting that different aspects of the underlying construct are being captured.

Educational Attainment of Children Born with Unilateral Cleft Lip and Palate in the United Kingdom.

OBJECTIVE: This study evaluated association between functional outcomes in children born with unilateral cleft lip and palate (UCLP) and educational attainment. DESIGN: Cleft Care UK (CCUK) was a United Kingdom (UK) wide cross-sectional study. SETTING: UK Cleft Teams (data collected from all UK sites providing centralized cleft services). PATIENTS, PARTICIPANTS: Five-year olds born with nonsyndromic UCLP (n = 268). MAIN OUTCOME MEASURE(S): National tests for educational attainment Key Stage 1 (KS1) undertaken by children at age 7 were linked to CCUK data to describe differences in educational attainment. Associations between functional outcomes and KS1 results were evaluated using regression analysis. We adjusted for birth month, gender, and an area-based measure of socioeconomic status. RESULTS: Data were available for 205 children with UCLP. These children scored lower than national average (NA) scores across all subject areas, with a 0.62 lower score observed in the Average Point Score (APS; P = .01). There was association between being in a lower category for a cleft related outcomes and poorer KS1 results, with a trend for poorer attainment with higher numbers of poor functional outcomes. Those with 3 or more poor outcomes had a -2.26 (-3.55 to -0.97) lower APS compared to those with 0 to 1 poor outcomes. CONCLUSIONS: Children born with UCLP have poorer educational attainment at age 7 across all subject areas though differences were modest. Children with poor functional outcomes at age 5 had worse educational outcomes age 7. Improvements in functional outcomes could enhance educational outcomes.

Disease trajectories, place and mode of death in people with head and neck cancer: Findings from the 'Head and Neck 5000' population-based prospective clinical cohort study.

BACKGROUND: Few large studies describe initial disease trajectories and subsequent mortality in people with head and neck cancer. This is a necessary first step to identify the need for palliative care and associated services. AIM: To analyse data from the Head and Neck 5000 study to present mortality, place and mode of death within 12 months of diagnosis. DESIGN: Prospective cohort study. PARTICIPANTS: In total, 5402 people with a new diagnosis of head and neck cancer were recruited from 76 cancer centres in the United Kingdom between April 2011 and December 2014. RESULTS: Initially, 161/5402 (3%) and 5241/5402 (97%) of participants were treated with 'non-curative' and 'curative' intent, respectively. Within 12 months, 109/161 (68%) in the 'non-curative' group died compared with 482/5241 (9%) in the 'curative' group. Catastrophic bleed was the terminal event for 10.4% and 9.8% of people in 'non-curative' and 'curative' groups, respectively; terminal airway obstruction was recorded for 7.5% and 6.3% of people in the same corresponding groups. Similar proportions of people in both groups died in a hospice (22.9% 'non-curative'; 23.5% 'curative') and 45.7% of the 'curative' group died in hospital. CONCLUSION: In addition to those with incurable head and neck cancer, there is a small but significant 'curative' subgroup of people who may have palliative needs shortly following diagnosis. Given the high mortality, risk of acute catastrophic event and frequent hospital death, clarifying the level and timing of palliative care services engagement would help provide assurance as to whether palliative care needs are being met.

Outcome Measures in UCLP: The Modified 5-Year-Olds'-Index-Development and Reliability.

OBJECTIVE: Can we reliably discriminate severity within the existing categories of the 5-Year-Olds' Index? DESIGN: Retrospective method comparison and development study. SETTING: School of Oral and Dental Science, University of Bristol. METHODS: Dental study models of 5-year-olds with unilateral cleft lip and palate (UCLP) were collected from the archives of 2 national cleft surveys (n = 351). One hundred randomly selected models were ranked to construct the modified 5-Year-Olds' Index and also scored using a visual analogue scale (VAS). Reliability testing was performed on 51 study models. Visual analogue scale scores were used to aid statistical analysis and investigate the reliability of a VAS for outcome measurement. The modified 5-Year-Olds' Index was then applied to 198 study models of 5-year-olds with UCLP. RESULTS: The modified 5-Year-Olds' Index showed excellent intra and interexaminer agreement (intraclass correlation > 0.94) and good discrimination of severity. When applied to the Cleft Care UK participants (n = 198), the modified 5-Year-Olds' Index showed good discrimination of severity within the better categories (groups 1-3) of the 5-Year-Olds' Index. Visual analogue Scale scores resulted in unacceptable variation between measurements. CONCLUSIONS: The new modified 5-Year-Olds' Index is a reliable method of assessing outcomes at 5 years of age and showed improved discriminatory power between the "better" outcome categories than the original 5-Year-Olds' Index. A VAS was found to be unsuitable for assessing outcome at 5 years of age for children with UCLP.

Squamous cell carcinoma of the nasal cavity: A descriptive analysis of cases from the head and neck 5000 study.

OBJECTIVES: This paper aims to provide contemporary epidemiological data on squamous cell carcinoma (SCC) of the nasal cavity, which represents a rare type of head and neck cancer. DESIGN, SETTING & PARTICIPANTS: A descriptive analysis of people with nasal cavity SCC treated with curative intent from the Head and Neck 5000 study; a multicentre clinical cohort study of people from the UK with head and neck cancer. People with tumours of the nasopharynx, paranasal sinuses and other sub-sites of the head and neck were excluded. MAIN OUTCOME MEASURES: Demographic data and treatment details are presented for all participants. The main outcomes were overall survival and survival according to categories of characteristics (eg, smoker vs non-smoker); these were explored using Kaplan-Meier plots. RESULTS: Thirty people with nasal cavity SCC were included in the study, of which most were male (67%) and current or ex-smokers (70%). The majority (70%) presented with early-stage (T1/2, N0) tumours. Cervical lymph node metastases at presentation were rare, occurring in only one person. Nine people died during the follow-up period (30%). Worse survival outcomes were seen in people with moderate or severe co-morbidities. CONCLUSIONS: This paper provides epidemiological data on nasal cavity SCC in the UK. Patterns of disease and survival outcomes are described, identifying high-risk groups. Further studies should explore whether primary treatment modality alters survival.

Health benefits of electrically-assisted cycling: a systematic review.

BACKGROUND: Electrically assisted bicycles (e-bikes) have been highlighted as a method of active travel that could overcome some of the commonly reported barriers to cycle commuting. The objective of this systematic review was to assess the health benefits associated with e-cycling. METHOD: A systematic literature review of studies examining physical activity, cardiorespiratory, metabolic and psychological outcomes associated with e-cycling. Where possible these outcomes were compared to those from conventional cycling and walking. Seven electronic databases, clinical trial registers, grey literature and reference lists were searched up to November 2017. Hand searching occurred until June 2018. Experimental or observational studies examining the impact of e-cycling on physical activity and/or health outcomes of interest were included. E-bikes used must have pedals and require pedalling for electric assistance to be provided. RESULTS: Seventeen studies (11 acute experiments, 6 longitudinal interventions) were identified involving a total of 300 participants. There was moderate evidence that e-cycling provided physical activity of at least moderate intensity, which was lower than the intensity elicited during conventional cycling, but higher than that during walking. There was also moderate evidence that e-cycling can improve cardiorespiratory fitness in physically inactive individuals. Evidence of the impact of e-cycling on metabolic and psychological health outcomes was inconclusive. Longitudinal evidence was compromised by weak study design and quality. CONCLUSION: E-cycling can contribute to meeting physical activity recommendations and increasing physical fitness. As such, e-bikes offer a potential alternative to conventional cycling. Future research should examine the long-term health impacts of e-cycling using rigorous research designs.

Using neuroimaging to investigate the impact of Mandolean® training in young people with obesity: a pilot randomised controlled trial.

BACKGROUND: Slowing eating rate using the Mandolean® previously helped obese adolescents to self-select smaller portion sizes, with no reduction in satiety, and enhanced ghrelin suppression. The objective of this pilot, randomised trial was to investigate the neural response to food cues following Mandolean® training using functional Magnetic Resonance Imaging (fMRI), and measures of ghrelin, PYY, glucose and self-reported appetite. METHOD: Twenty-four obese adolescents (11-18 years; BMI ≥ 95th centile) were randomised (but stratified by age and gender) to receive six-months of standard care in an obesity clinic, or standard care plus short-term Mandolean® training. Two fMRI sessions were conducted: at baseline and post-intervention. These sessions were structured as an oral glucose tolerance test, with food cue-reactivity fMRI, cannulation for blood samples, and appetite ratings taken at baseline, 30 (no fMRI), 60 and 90 min post-glucose. As this was a pilot trial, a conservative approach to the statistical analysis of the behavioural data used Cliff's delta as a non-parametric measure of effect size between groups. fMRI data was analysed using non-parametric permutation analysis (RANDOMISE, FSL). RESULTS: Following Mandolean® training: (i) relatively less activation was seen in brain regions associated with food cue reactivity after glucose consumption compared to standard care group; (ii) 22% reduction in self-selected portion size was found with no reduction in post-meal satiety. However, usage of the Mandolean® by the young people involved was variable and considerably less than planned at the outset (on average, 28 meals with the Mandolean® over six-months). CONCLUSION: This pilot trial provides preliminary evidence that Mandolean® training may be associated with changes in how food cues in the environment are processed, supporting previous studies showing a reduction in portion size with no reduction in satiety. In this regard, the study supports targeting eating behaviour in weight-management interventions in young people. However, given the variable usage of the Mandolean® during the trial, further work is required to design more engaging interventions reducing eating speed. TRIAL REGISTRATION: ISRCTN, ISRCTN84202126 , retrospectively registered 22/02/2018.

Which index should be used to measure primary surgical outcome for unilateral cleft lip and palate patients?

OBJECTIVE: To determine the optimal dentoalveolar measure to assess unilateral cleft lip and palate (UCLP) patient plaster models. DESIGN: The models of 34 patients with UCLP taken at 5, 10, and 15-20 years of age were scored by two examiners on two separate occasions using five indices: the 5 Year Olds' (5YO), GOSLON, Modified Huddart/Bodenham (MHB), EUROCRAN, and Overjet. Reliability, validity, and ease of use were recorded for each index/examiner. SETTING: All models were scored in either Bristol Dental Hospital or Derriford Hospital, Plymouth, United Kingdom by senior orthodontic clinicians. RESULTS: Highest overall reliability was seen with MHB (Kappa = 0.56-0.97). Predictive validity was similar for MHB, GOSLON, and 5YO with a 50-65 per cent prediction of final outcome from 5 and 10 years. EUROCRAN palatal index showed no clear predictive validity (Spearman's correlation = 0.20-0.21). Agreement to the gold standard 5YO score at the 5-year age group was high for MHB (Kappa = 0.83) and moderate for GOSLON (Kappa = 0.59). Agreement to the gold standard GOSLON score at 10 years was highest for 5YO (Kappa = 0.69), followed by Overjet (Kappa = 0.59) and MHB (Kappa = 0.46). Time to score 34 models per index (minutes): GOSLON (13.4) < Overjet (13.6) < 5YO (19.4) < EUROCRAN (24.8) < MHB (27.4). CONCLUSION: As an outcome measure of UCLP models, only MHB and 5YO indices can be recommended for use at 5 years of age and GOSLON at 10 years of age.

Are photographs a suitable alternative to dental study casts when assessing primary surgical outcome in children born with unilateral cleft lip and palate?

OBJECTIVE: To compare the use of the 5-year-olds' index on both dental study casts and intraoral photographs when measuring primary surgical outcome for children born with unilateral cleft lip and palate (UCLP). DESIGN: A cross-sectional study. SETTING: Models and photographs collected from cleft units across the UK as part of the CCUK (Cleft Care UK) study were scored by two clinicians at the School of Oral and Dental Sciences, Bristol, UK. PARTICIPANTS: Five-year-old children born with UCLP as part of the CCUK study. One hundred and ninety-eight had dental study casts available and 49 had intraoral photographs available. METHODS: The records of both groups, that is study casts (n = 198) and photographs (n = 49) were scored using the 5-year-olds' index on two occasions by two examiners. RESULTS: Reliability of scoring is reduced for intraoral photographs compared with dental study casts. Using weighted Kappa the inter-rater reliability for dental study casts was 0.72 to 0.77 and the inter-rater reliability for intraoral photographs was 0.52 to 0.59. LIMITATIONS: The photographs and study casts were not matched for each individual and were collected by a number of different clinicians in each unit, both of which will have had an effect on the quality and consistency of the final records. CONCLUSIONS: Dental study casts provide more reliable results and thus still represent the gold standard when assessing primary surgical outcome in cleft care using the 5-year-olds' index.

Perceptions of team members working in cleft services in the United kingdom: a pilot study.

BACKGROUND: Cleft care provision in the United Kingdom has been centralized over the past 15 years to improve outcomes for children born with cleft lip and palate. However, to date, there have been no investigations to examine how well these multidisciplinary teams are performing. METHODS: In this pilot study, a cross-sectional questionnaire surveyed members of all health care specialties working to provide cleft care in 11 services across the United Kingdom. Team members were asked to complete the Team Work Assessment (TWA) to investigate perceptions of team working in cleft services. The TWA comprises 55 items measuring seven constructs: team foundation, function, performance and skills, team climate and atmosphere, team leadership, and team identity; individual constructs were also aggregated to provide an overall TWA score. Items were measured using five-point Likert-type scales and were converted into percentage agreement for analysis. RESULTS: Responses were received from members of every cleft team. Ninety-nine of 138 cleft team questionnaires (71.7%) were returned and analyzed. The median (interquartile range) percentage of maximum possible score across teams was 75.5% (70.8, 88.2) for the sum of all items. Team performance and team identity were viewed most positively, with 82.0% (75.0, 88.2) and 88.4% (82.2, 91.4), respectively. Team foundation and leadership were viewed least positively with 79.0% (72.6, 84.6) and 76.6% (70.6, 85.4), respectively. CONCLUSIONS: Cleft team members perceive that their teams work well, but there are variations in response according to construct.

Establishing a large prospective clinical cohort in people with head and neck cancer as a biomedical resource: head and neck 5000.

BACKGROUND: Head and neck cancer is an important cause of ill health. Survival appears to be improving but the reasons for this are unclear. They could include evolving aetiology, modifications in care, improvements in treatment or changes in lifestyle behaviour. Observational studies are required to explore survival trends and identify outcome predictors. METHODS: We are identifying people with a new diagnosis of head and neck cancer. We obtain consent that includes agreement to collect longitudinal data, store samples and record linkage. Prior to treatment we give participants three questionnaires on health and lifestyle, quality of life and sexual history. We collect blood and saliva samples, complete a clinical data capture form and request a formalin fixed tissue sample. At four and twelve months we complete further data capture forms and send participants further quality of life questionnaires. DISCUSSION: This large clinical cohort of people with head and neck cancer brings together clinical data, patient-reported outcomes and biological samples in a single co-ordinated resource for translational and prognostic research.

Centralization of services for children born with orofacial clefts in the United kingdom: a cross-sectional survey.

Objective : To examine current provision of cleft lip and/or palate services in the U.K. and compliance with recommendations made by the Clinical Standards Advisory Group (CSAG) in 1998. Design : Cross-sectional questionnaire survey. Setting : All 11 services within the U.K. providing care for children born with a cleft lip and palate. Participants : Members from each healthcare specialty in each U.K. cleft team. Interventions : Self-administered postal questionnaires enquired about the provision of cleft services. Data were collected about the overall cleft service, team coordination, hearing, orthodontics, pediatric dentistry, primary cleft surgery, psychology, restorative dentistry, secondary surgery, specialist cleft nursing, and speech and language therapy. Results : Questionnaires were returned from members of 130/150 cleft teams (87%) and these showed that U.K. cleft services have been restructured to 11 centralized services with 17 primary operative sites and 61 peripheral sites. All services provide care through a multidisciplinary (MDT) model, but the composition of each team varies. Primary cleft surgery and orthodontics were the only specialties that were represented in all cleft teams. Specialties may be represented in a team but their attendance at MDT clinics is variable. Only one team met all of the CSAG recommendations. Conclusions : Our survey shows that cleft services have centralized over the last 10 years, and an MDT model of care has been adopted. Further research is needed to show how this has influenced outcomes and to see whether some models of centralized care are associated with better outcomes.

Associations between body mass index and episodic memory for recent eating, mindful eating, and cognitive distraction: A cross-sectional study.

Objectives: Eating while distracted has been associated with a higher body mass index (BMI), whereas mindful eating and episodic memory for recent eating have shown the opposite pattern. This pre-registered, global study (https://osf.io/rdjzk) compared the relative association between these variables (and four "positive controls": restraint, disinhibition, emotional eating, plate clearing) and self-reported BMI. The timing of data collection (April-May 2020) during the SARS-CoV-2 pandemic enabled an investigation of the impact of stay-at-home restrictions imposed on the UK population on the measures of eating behavior. Methods: An online survey was completed, including: (i) demographic data (e.g., self-reported BMI), (ii) Likert ratings assessing episodic memory for recent eating, mindful eating, cognitive distraction, restrained eating, emotional eating, disinhibition and plate clearing over the last 12 months and the last 7 days (during the first UK COVID-19 lockdown), and (iii) the Mindful Eating Questionnaire (MEQ). Results: A large adult sample participated (N = 846; mean (SD) age = 33.0 (14.3) years; mean (SD) BMI = 24.6 (5.6) kg/m2). Mindful eating (MEQ-total score) was associated with a lower self-reported BMI (ß = -0.12; 95% CI = -0.20, -0.04; p = 0.004), whereas disinhibited eating was associated with a higher self-reported BMI (ß = 0.30; 95% CI = 0.21, 0.38; p < 0.001). In UK participants (n = 520), consistent changes in eating behavior during lockdown were not found. For those that did experience change, decreases were reported in; emotional eating, disinhibited eating, focusing on taste during a meal (a measure of mindful eating), and using a smart phone while eating. Conclusions: These findings provide evidence in a large global sample for associations between BMI and (i) mindful eating, and (ii) disinhibited eating. Future research should evaluate whether mindful eating demonstrates a prospective association with body weight and should consider mechanisms of action.

Daily Duration of Eating for Children and Adolescents: A Systematic Review and Meta-Analysis.

Time-limited eating is a dietary intervention whereby eating is limited to a specific window of time during the day. The usual eating windows of adults, and how these can be manipulated for dietary interventions, is well documented. However, there is a paucity of data on eating windows of young people, the manipulation of which may be a useful intervention for reducing obesity. This paper reviewed the existing literature on the eating windows of children and adolescents, aged 5-18 years, plus clock times of first and last intakes and variations by subgroup. Two databases (Medline and Embase) were searched for eligible papers published between February 2013 and February 2023, with forward searching of the citation network of included studies on Web of Science. Articles were screened, and data extracted, in duplicate by two independent reviewers. Ten studies were included, with both observational and experimental designs. Narrative synthesis showed large variations in eating windows with average values ranging from 9.7 h to 16.4 h. Meta-analysis, of five studies, showed a pooled mean daily eating window of 11.3 h (95% CI 11.0, 11.7). Large variations in eating windows exist across different study populations; however, the pooled data suggest that it may be possible to design time-limited eating interventions in paediatric populations aimed at reducing eating windows. Further high-quality research, investigating eating windows and subsequent associations with health outcomes, is needed.

Association between 6-thioguanine nucleotide levels and preventing production of antibodies to infliximab in patients with inflammatory bowel disease.

OBJECTIVE: Combination therapy with infliximab and a thiopurine has been shown to be more effective than monotherapy in patients with inflammatory bowel disease (IBD). The therapeutic efficacy of thiopurines is correlated with 6-thioguanine (6-TGN) levels between 235 and 450 pmol/8×108 erythrocytes. The primary aim of the study was to investigate the association between 6-TGN levels and inhibition prevention of the production of antibodies to infliximab (ATI). DESIGN: We performed a retrospective review of the medical records of patients being treated with infliximab for IBD at University Hospitals Bristol NHS Foundation Trust. Demographic and biochemical data were extracted, alongside thiopurine metabolite levels, trough levels of infliximab and the presence of ATI. χ2 tests were used to investigate the association between 6-TGN levels and prevention of ATI. Logistic regression was used to compare the odds of prevented ATI between those with a 6-TGN level between 235 and 450 pmol/8×108 erythrocytes, those with a 6-TGN level outside of this range, and the baseline group who were on infliximab monotherapy. RESULTS: Data were extracted for 100 patients. Six of 32 patients with a 6-TGN level between 235 and 450 pmol/8×108 erythrocytes developed ATI (18.8%) compared with 14 out of 22 (63.6%) patients with a 6-TGN outside of this range and 32 out of 46 (69.6%) patients on monotherapy (p=0.001). The OR (95% CI) for prevented ATI in those with a 6-TGN between 235 and 450 pmol/8×108 erythrocytes compared with a 6-TGN outside of this range was 7.6 (2.2, 26.3) (p=0.001) and compared with monotherapy was 9.9 (3.3, 29.4) (p=0.001). CONCLUSION: 6-TGN levels between 235 and 450 pmol/8×108 erythrocytes prevented production of ATI. This supports therapeutic drug monitoring to help guide treatment and maximise the beneficial effects of combination therapy for patients with IBD.

''I felt marvellous e-cycling. If I had long hair I would have flicked it": a qualitative investigation of the factors associated with e-cycling engagement among adults with type 2 diabetes.

Background: Physical activity (PA) is a key component in the management of type 2 diabetes. However, this population have low rates of PA engagement. Electrically assisted cycling has been identified as a means through which to increase PA by incorporating activity into daily life, while overcoming some of the barriers to conventional cycling. The determinants of e-cycling among people living with chronic disease are largely unknown. The aim of this research was to explore the determinants of e-cycling among individuals with type 2 diabetes using the Theoretical Domains Framework (TDF) and the Capability, Opportunity and Motivation for Behaviour change model (COM-B). This information is important for determining the suitability of future e-cycling initiatives and, if appropriate, inform future e-cycling interventions. Method: One-to-one semi structured interviews were conducted with 16 participants from the e-cycling arm of a pilot randomised controlled trial between September 2019 and April 2020. The TDF was used to develop the interview guide. The framework method of analysis was used, incorporating both deductive and inductive reasoning. A conceptual model of the factors that influence e-cycling in this population was created. Results: The most commonly reported TDF domains were skills, knowledge, belief about capabilities, belief about consequences and environmental context and resources. Specifically, e-bike training facilitated e-cycling engagement by providing participants with the skills, knowledge, and confidence needed to ride the e-bike and ride on the road. In addition, the enjoyment of e-cycling was a key facilitator to engagement. Participants engaged in e-cycling to improve their health rather than for environmental reasons. Most barriers to e-cycling related to the natural or physical environment. Conclusion: This study provides insight into the personal, social, and environmental factors associated with e-cycling in this population. The findings of this study can be used to develop a more refined e-cycling intervention targeting the factors identified as influencing e-cycling engagement. In addition, this information will help in the selection of mechanistic outcome measures for evaluation.

The Role of the Mediterranean Diet in Breast Cancer Survivorship: A Systematic Review and Meta-Analysis of Observational Studies and Randomised Controlled Trials.

Female breast cancer is the most frequently diagnosed cancer. The long-term survival rates for this disease have increased; however, the unique demand for high-quality healthcare to improve breast-cancer survivorship are commonly unmet. The Mediterranean diet (MD) is associated with reduced breast-cancer risk and various health-related benefits in the general population, but its effect on breast-cancer survivors remains uncertain. The objective of this systematic review and meta-analysis was to assess current evidence from randomised controlled trials (RCTs) and observational studies (cohort, cross-sectional and case-control) regarding the effect of the MD on survival, quality of life (QoL) and health-related outcomes in female breast-cancer survivors. MEDLINE, EMBASE, Web of Science and the Cochrane library were searched for studies published before and including April 2022. Two reviewers independently screened the literature and completed the data extraction and risk-of-bias assessment. Eleven studies (fifteen reports) were included, including two RCTs, four cohort and five cross-sectional studies. The meta-analysis of the cohort studies showed strong evidence of an inverse association between high adherence to the MD and all-cause mortality (hazard ratio (HR) 0.78, 95% confidence interval (CI) 0.66-0.93, I2: 0%, Grading of Recommendations Assessment, Development and Evaluation (GRADE) = low certainty of evidence) and non-breast-cancer mortality (HR 0.67, 95% CI 0.50-0.90, I2: 0%, GRADE = very low certainty of evidence). The associations between high adherence to the MD and QoL and health-related parameters were not consistent. These findings highlight the potential of adherence to the MD to reduce the risk of mortality. Future research with better study designs, as well as more consistent measurements of QoL and MD adherence, taking into account changes in MD adherence over time and population subgroups, is needed to provide more robust evidence on the survival, QoL and health-related outcomes in BC survivors.

Electrically assisted cycling for individuals with type 2 diabetes mellitus: a pilot randomized controlled trial.

BACKGROUND: Type 2 diabetes mellitus (T2DM) and its associated complications puts considerable strain on healthcare systems. With the global incidence of T2DM increasing, effective disease management is essential. Physical activity (PA) is a key component of T2DM management; however, rates of PA engagement are low in this population. Developing effective and sustainable interventions that encourage PA is a high priority. Electrically assisted bicycles are becoming increasingly popular and may increase PA in healthy adults. This study aimed to provide evidence of the feasibility of conducting a randomized controlled trial to evaluate the efficacy of an e-cycling intervention to increase PA and improve health in individuals with T2DM. METHODS: A parallel-group two-arm randomized, waitlist-controlled pilot study was conducted. Individuals were randomized to either an e-bike intervention or standard care. The intervention incorporated two one-to-one e-bike skills training and behavioural counselling sessions delivered by a community-based cycling charity, followed by a 12-week e-bike loan with two further sessions with the instructors. Feasibility was assessed via measures related to recruitment, retention and intervention implementation. Post-intervention interviews with instructors and participants explored the acceptability of the study procedures and intervention. Clinical, physiological and behavioural outcomes were collected at baseline and post-intervention to evaluate the intervention's potential. RESULTS: Forty participants (Mage = 57) were randomized, of which 34 were recruited from primary care practices. Thirty-five participants were retained in the trial. The intervention was conducted with high fidelity (> 80% content delivered). E-bike training provided participants with the skills, knowledge and confidence needed to e-bike independently. Instructors reported being more confident delivering the skills training than behavioural counselling, despite acknowledging its importance. The study procedures were found to be acceptable to participants. Between-group differences in change during the intervention were indicative of the interventions potential for improving glucose control, health-related quality of life and cardiorespiratory fitness. Increases in overall device measured moderate-to-vigorous PA behaviour following the intervention were found, and there was evidence that this population self-selected to e-cycle at a moderate intensity. CONCLUSIONS: The study's recruitment, retention, acceptability and potential efficacy support the development of a definitive trial subject to identified refinements. TRIAL REGISTRATION: ISRCTN, ISRCTN67421464 . Registered 17/12/2018.