Postnatal depressive symptoms mediate the relation between prenatal role overload and responsiveness among first-time mothers.

BACKGROUND: This study examined the association between prenatal role overload and maternal responsiveness, with postnatal depressive symptoms as a mediator. METHODS: Participants were 127 first-time mothers in Hong Kong (M = 32.8, SD = 4.0). Participants completed data collection for self-report on prenatal role overload (Time 1) in the third trimester of pregnancy, postnatal depressive symptoms (Time 2) at 4-month postpartum and maternal responsiveness (Time 3) at 9-month postpartum. The hypothesised mediation model was tested with the Hayes PROCESS macro (model 4). RESULTS: Time 1 prenatal role overload was not directly predictive of later responsiveness (B = -0.06, p = .270). However, the indirect effect of Time 2 postnatal depressive symptoms in the association between Time 1 prenatal role overload and Time 3 responsiveness was significant (unstandardised effect = -0.03, 95% Bootstrapping CI = [-0.081, -0.001]; standardised effect = -0.06, 95% Bootstrapping CI = [-0.152, -0.002]). CONCLUSION: Findings highlighted that more attention is required to the support provided to first-time expectant mothers to prevent role overload, and that intervention for postnatal depressive symptoms may focus on role overload. The findings also highlighted that postnatal depressive symptoms could be a promising way to increase maternal responsiveness.

Beyond intention: Predicting children's COVID-19 vaccine uptake using the theory of planned behavior.

This prospective study tested if parental factors from the theory of planned behavior (TPB) predicted children's uptake of the COVID-19 vaccine and examined whether parents' intention to vaccinate children against COVID-19 would mediate such associations. Participants were 852 Hong Kong parents of 1076 children aged 5-12. At Time 1, parents reported on items measuring the TPB predictors (i.e. attitudes, subjective norms, and perceived behavioral control) and intention. At Time 2 (approximately 4 months after Time 1), parents reported whether their children had received the COVID-19 vaccine. Attitudes, perceived behavioral control, and intention predicted children's actual uptake of the COVID-19 vaccine. Intention mediated the relations between two TPB predictors, namely attitudes and subjective norms, and children's COVID-19 vaccination uptake. The TPB is considered a useful framework in the development of future COVID-19 vaccine programs for children to promote parents' intention and the subsequent uptake of the COVID-19 vaccine among children.

Children's Daily Living Routine Mediates the Relations Between Parent-Child Relationships and Child Adjustment Problems During School Suspension in Hong Kong.

Young children's adjustment problems were found to be prevalent during the COVID-19 pandemic. Such adjustment problems may be dependent on children's relationships with their parents and children's daily living routine in the family during the pandemic-related school suspension period. This study examines how children's routine mediated the associations between parent-child relationships and child adjustment problems during the fifth wave of the COVID-19 pandemic in Hong Kong, when schools were suspended. The study collected data from 937 parents (87.8% mothers) of children aged 5-12 (M = 7.35 years, SD = 2.09; 50.5% girls). Parents reported on parent-child relationships, children's daily living routine, and child adjustment problems in an online survey. Our findings from structural equation modeling indicate that parent-child closeness was negatively related to child adjustment problems, whereas conflict was positively related to child adjustment problems. Children's routine mediated the associations between parent-child relationships (i.e., closeness and conflict) and child externalizing problems. However, children's routine did not mediate the associations between parent-child relationships (i.e., closeness and conflict) and child internalizing problems. The findings show that parents should be helped to establish routine, especially in difficult times when young children experience turbulence in their daily life, so as to reduce their adjustment problems, in particular of an externalizing nature.

Children infected vs. uninfected with COVID-19: Differences in parent reports of the use of mobile phones to calm children, routines, parent-child relationship, and developmental outcomes.

Children were suggested to be at lower risk of developing the severe form of the COVID-19. However, children infected with COVID-19 may be more likely to experience biopsychosocial stressors associated with the pandemic and display poorer developmental outcomes. The current study is among the first to compare children infected and uninfected with COVID-19 on outcomes related to parents' use of mobile phones to calm children, routines, parent-child relationship, externalizing and internalizing problems, prosocial behavior, gratitude, and happiness. A total of 1,187 parents (88.6% mothers) of children aged 5 to 12 completed an online survey between April 2022 and May 2022 when schools were suspended during the 5th wave of resurgence in Hong Kong. Our findings showed no substantial differences in various psychological, social, emotional, and behavioral outcomes between infected and uninfected children. Our findings can be used to educate parents to reduce their fear and anxieties associated with their children's COVID-19 infection. Our findings also suggested that support during the pandemic should be provided to children and families regardless of whether children have been infected with COVID-19.

Child aggression and parenting behavior: Understanding the child-driven effects with parents' emotion regulation as a moderator.

The present study examined the longitudinal relations between child aggression and coercive parenting behaviors and the moderating role of parental emotion regulation strategies in these relations. The sample of this study were 168 children (88 girls; Mage = 60.97 months, SD = 5.51) and their parents recruited from five kindergartens. At Time 1 (T1), parents reported their own use of coercive parenting behaviors (i.e., physical coercion and psychological control) and emotion regulation strategies (i.e., suppression and reappraisal). A coloring task was administered to assess the child's aggression at the child's kindergarten. At Time 2 (T2; approximately 6 months later), mothers and fathers again reported their coercive parenting behaviors. Results indicate that suppression served as a moderator in the relations between child aggression and mothers' coercive parenting behavior. Specifically, (a) T1 child aggression was not directly predictive of T2 coercive parenting behaviors; (b) child overt aggression at T1 was associated with increased coercive parenting behaviors at T2 among mothers reporting higher use of suppression and was associated with decreased coercive parenting behaviors at T2 among mothers reporting lower use of suppression; (c) T1 child covert aggression was associated with increased T2 psychological control among mothers with more use of suppression and was associated with decreased psychological control among mothers reporting lower use of suppression. Reappraisal was not a moderator in the relations between child aggression and coercive parenting behaviors. These results shed light on the relations between child aggression and coercive parenting behavior as a function of parents' emotion regulation strategy. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Parental scaffolding and children's math ability: The type of activities matters.

A growing body of research has shown that parent-child math activities predict children's math competence. However, observational studies are limited. This study investigated maternal and paternal scaffolding behaviours in three types of parent-child math activities (i.e., worksheet, game and application activities) and their associations with children's formal and informal math abilities. Ninety-six 5-6-year-olds participated in this study with their mothers and fathers. All children completed three activities with their mothers and three comparable activities with their fathers. Parental scaffolding was coded for each parent-child dyadic activity. Children's formal and informal math abilities were tested individually using the Test of Early Mathematics Ability. Results showed that both mothers' and fathers' scaffolding in application activities significantly predicted their children's formal math ability even after controlling for background variables and their scaffoldings in the other two types of math activities. The findings highlight the importance of parent-child application activities in children's math learning.

Moral obligation to follow anti-COVID-19 measures strengthens the mental health cost of pandemic burnout.

BACKGROUND: It has been observed that people become gradually exhausted by receiving COVID-19-related information and adhering to the corresponding preventive measures as the pandemic unfolds. This phenomenon is known as pandemic burnout. Emerging evidence shows that pandemic burnout is related to poor mental health. This study extended the trendy topic by examining the idea that moral obligation, a crucial motivation driving people to follow the preventive measures, would amplify the mental health cost of pandemic burnout. METHODS: Participants were 937 Hong Kong citizens (88 % females, 62.4 % aged 31-40 years). They participated in a cross-sectional online survey reporting on pandemic burnout, moral obligation, and mental health problems (i.e., depressive symptoms, anxiety, and stress). RESULTS: Findings of moderation model analyses showed that higher levels of pandemic burnout and moral obligation were related to more mental health problems. Importantly, the "pandemic burnout-mental health problems" links were moderated by moral obligation, with those who felt more morally obliged to follow the measures reporting poorer mental health than those who felt less morally obliged to do so. LIMITATIONS: The cross-sectional design of the study may constrain the evidence about the directions and causality of the relationships. Participants were only recruited from Hong Kong and females were over-represented, thus limiting the generalizability of the findings. CONCLUSIONS: People who experience pandemic burnout while feeling more morally obliged to follow the anti-COVID-19 measures are at greater risk of mental health problems. They might need more mental health support from medical professionals.

Mothers' and fathers' stress and severity of depressive symptoms during the COVID-19 pandemic: actor-partner effects with parental negative emotions as a moderator.

BACKGROUND: In the face of the coronavirus disease 2019 (COVID-19) pandemic, families with young children are bombarded with new challenges and stressors. This study examined the additive and interactive effects of parental stress and negative emotions during COVID-19 on parents' severity of depressive symptoms. METHODS: Participants were 221 Chinese families involving maritally intact mothers and fathers of preschool-aged children. DISCUSSION: Path analysis indicated that mothers' parental stress interacted with their negative emotions, such that their stress was related to their severity of depressive symptoms only when negative emotions were high. By comparison, fathers' stress and negative emotions were additively associated with their severity of depressive symptoms. Supporting the cumulative risk model, parental stress during COVID-19 and negative emotions were linked to parents' severity of depressive symptoms additively or interactively, depending on the gender of the parent. These findings inform practitioners about the relevance of parents' stress and negative emotions to their severity of depressive symptoms during the pandemic.

Oral glucose tolerance testing at 1 h and 2 h: relationship with glucose and cardiometabolic parameters and agreement for pre-diabetes diagnosis in patients with morbid obesity.

BACKGROUND: One hour plasma glucose concentration (1hPG) during an oral glucose tolerance test (OGTT) may be an alternative to 2-h plasma glucose concentration (2hPG) in the identification of individuals at increased risk of hyperglycaemia, although its role is not fully understood. AIM: We aim to investigate the relationship of these measures with other glucose parameters, as well as their relationship with cardiometabolic risk markers and the level of agreement for prediabetes mellitus diagnosis, in a sample of patients with morbid obesity. METHODS: We retrospectively evaluated 656 patients with morbid obesity without diagnosed diabetes. To define prediabetes with 2hPG, 2022 American Diabetes Association guidelines criteria were used, while for 1hPG, glucose ≥ 155 mg/dL was considered. Cohen's Kappa coefficient was used to assess the agreement between both measures of prediabetes mellitus diagnosis. RESULTS: A Cohen's Kappa coefficient of 0.405 (p < 0.001) was obtained. The 1hPG were positively correlated with homeostatic model assessment for insulin resistance (HOMA-IR) (ρ = 0.281, p < 0.001), fasting plasma glucose (FPG) (ρ = 0.581, p < 0.001), glycated haemoglobin (Hb1AC) (ρ = 0.347, p < 0.001) and were negatively correlated with homeostatic model assessment for cell-ß function (HOMA-ß) (ρ = -0.092, p = 0.018). 2hPG were also correlated with the same parameters, except for HOMA-ß. CONCLUSION: A fair agreement between 1 and 2hPG was verified. 1hPG criteria may be a useful indicator of ß-cell dysfunction and insulin resistance in patients with morbid obesity without diabetes diagnosis.

Letter to the editor: Backdrop context of the study "Intention to vaccinate young children against COVID-19: a large-scale survey of Hong Kong parents".

The current letter provides the backdrop context of the study "Intention to vaccinate young children against COVID-19: a large-scale survey of Hong Kong parents" conducted when the COVID-19 vaccination was first made available to young children in Hong Kong during the fifth wave of the outbreak. The study was conducted to examine parents' intention for informing the development of an effective child COVID-19 vaccine program because parents were speculated to have low intention to vaccinate their children against COVID-19.

Intention to vaccinate young children against COVID-19: A large-scale survey of Hong Kong parents.

COVID-19 vaccines (Sinovac and Pfizer/BioNTech) have recently been approved for Hong Kong children. Understanding parental intentions to vaccinate children against COVID-19 is important to the development of an effective COVID-19 vaccine campaign. From a large-scale, geographically representative dataset in Hong Kong (N = 11,141), we examined parents' intentions to vaccinate their children against COVID-19 under three conditions: (1) no policy restrictions, (2) vaccination rate considered for school resumption, and (3) more choices of vaccine. Results showed that levels of vaccine hesitancy in Hong Kong parents are high. Hong Kong parents' intention to vaccinate their children was highest when there were more vaccines to choose from, followed by when vaccination rate was considered to resume school, and when there was no policy restrictions. Finally, Hong Kong parents with higher education backgrounds and family income were less willing to vaccinate their children. Together, these findings indicate that effective vaccines campaign should consider the characteristics and preferences of parents who have little intention to vaccinate within a specific social context.

Why do Hong Kong parents have low intention to vaccinate their children against COVID-19? testing health belief model and theory of planned behavior in a large-scale survey.

COVID-19 vaccines have been authorized for use in children in some societies. Parents' intention to vaccinate their children is context-specific. Drawing upon health belief model (HBM) and theory of planned behavior (TPB), this study contributed to a timely topic by examining the extent to which parents intended to vaccinate their children and its associated factors in Hong Kong, where the government announced children as young as five could take COVID-19 vaccines starting from 21 January 2022. A large-scale, online survey was conducted among 11,141 Hong Kong parents (86% mothers) of children aged 5-12 (N = 14,468, 49.5% girls). They reported on measures that assessed HBM constructs (i.e., perceived susceptibility, perceived severity, perceived benefits, perceived barriers, and cues to action), TPB constructs (i.e., attitudes, subjective norms, and perceived behavioral control), and their intention to vaccinate each of their children. Results of descriptive statistics showed that Hong Kong parents' intention to vaccinate their children was very low (1.55 out of 5.00). Multilevel regression showed that after controlling for parents' and children's demographic variables (e.g., sex and age), parents' intention to vaccinate their children was higher if parents had higher levels of perceived susceptibility, perceived benefits, positive attitudes, and subjective norms and if they had lower levels of perceived barriers. Positive attitudes were the strongest correlate of parents' intention. These findings have important implications for public health by informing which factors authorities should address in order to boost Hong Kong parents' intention to vaccinate their children.

Statin Therapy Among Bariatric Patients: The Impact on Metabolic Outcomes and Diabetes Status.

INTRODUCTION: Statin therapy is associated with an increased risk of developing diabetes. Among bariatric patients, the influence of this therapy on various metabolic outcomes, such as diabetes status and its remission, is largely unknown. METHODS: This was a retrospective study of 1710 patients who underwent bariatric surgery at our hospital between January/2010 and June/2017. We compared patients with and without statin therapy at baseline, 12 and 24 months after surgery regarding statin use and its impact on several clinical and analytical parameters. Multiple linear regression was performed, adjusting differences for age, sex, surgery type, antidiabetic drugs at baseline, hypertension at baseline, LDL cholesterol ˃ 130 mg/dL, weight variation one year after surgery, and age of obesity onset. RESULTS: The overall prevalence of statin use was 20.2% before, 13.6% 12 months after surgery, and 15.0% 24 months after surgery. There was a larger reduction in fasting glucose and HbA1c at 12 and 24 months after surgery among statin-treated patients, with the opposite trend for weight reduction and BMI. Statin-treated patients with diabetes had lower diabetes remission rates (45.3 vs 68.5%) 12 months after surgery, with the highest reduction in HbA1c (1.3±1.3 vs -1.1±1.2%; p=0.042), fasting glucose (-40.8±48.8 vs -30.9±41.6 mg/dL; p=0.028), and insulin (-21.7±28.2 vs -13.4±14.2 mIU/L; p=0.039). The proportion of new-onset cases of diabetes was equal between statin-treated vs non-treated individuals at 12 months (1.9%) and 24 months (1.0%) after surgery. CONCLUSION: Bariatric surgery seems to lead to diabetes remission more frequently in patients not treated with statins. A larger reduction was observed in fasting glucose and HbA1c among statin-treated patients. Statin did not contribute to an increased proportion of new-onset diabetes after surgery.

Emotional Regulation in Mothers and Fathers and Relations to Aggression in Hong Kong Preschool Children.

This study explored the associations among emotional regulation in mothers and fathers and preschool children's physical and relational aggression using a Hong Kong Chinese sample. This study also explored whether child gender would moderate the association between parental emotional regulation strategies and children's physical and relational aggression. Participants were 168 children aged 4-6 years. Parents reported on their own emotional regulation approaches and kindergarten class teachers rated children's aggression 6 months later. Path analyses showed that higher levels of reappraisal and lower levels of suppression by mothers was associated with higher levels of child relational aggression. There were no significant associations among fathers' emotional regulation and children's aggression. Results from multi-group analysis showed that there were no significant moderation of the associations by child gender. Results highlight the importance of mothers' emotional regulation in child aggression and suggest that the maladaptive consequences of emotional suppression are culturally relative.

Hong Kong Children's School Readiness in Times of COVID-19: The Contributions of Parent Perceived Social Support, Parent Competency, and Time Spent With Children.

School readiness is an important but challenging issue of child development, especially during COVID-19 when most of the traditional offline activities that could promote school readiness (e.g., on-site visit) have been canceled. There is a gap between the knowledge needed to promote children's school readiness in times of pandemic and the limited understanding of this topic so far. This gap could be particularly concerning in the social contexts where examinations are stressed and educational competition is high (e.g., Hong Kong). In this study, we examined how well children were ready for primary school, the extent to which parent perceived social support was related to children's school readiness, and whether parent competence and their time spent with children would moderate the said link. A cross-sectional design survey with total population sampling (supplemented with convenience sampling) was conducted. Massive e-mails were sent to all kindergartens in Hong Kong inviting them to join the study by distributing the survey link to the parents of their K3 students. A total of 643 Hong Kong parents whose children were about to transition to primary school (87.1% mother) participated, answering measures specifically designed for this study online about how well they thought their children were ready for school, their competence to help with children's school transition, and how much time they spent with children. Data were analyzed with PROCESS macro (model 3) in SPSS. The results found that most parents considered that their children were not fully ready for school, especially in terms of academic skills, self-management, and mental preparation. Furthermore, moderation analyses showed that after controlling for a number of demographic variables, parent perceived social support was positively related to better school readiness in children and this link was jointly moderated by parent competence and time spent with children. Specifically, children were rated most ready when parent perceived stronger social support, felt more competent, and spent more time with children. By contrast, the link between perceived social support and children's school readiness was insignificant for parent who felt more competent but spent less time with children. Implications of how to enhance children's school readiness are discussed.

Coparenting and Parental Involvement During School Transition Among Chinese Mothers and Fathers: Children's School Liking as a Moderator.

Parental involvement is a vital social resource that helps children to deal with different challenges in their learning and development in the transition period and may be a strong determinant of children's outcomes. While the role of fathers has been increasingly recognized, there has been a lack of studies examining the predictive role of mother and fathers' coparenting to parental involvement and child readiness outcomes. The purpose of this study is to examine the longitudinal association between coparenting behavior and parental involvement for parents with children in the transition to primary school in a Chinese context, and test whether children's school liking moderated these associations. Using stratified random sampling, 324 children (M age=70.57months, female=51%) and their parents from 10 kindergartens in Hong Kong participated in the study. Both mothers and fathers provided information about their spouse's coparenting behavior at Time 1 (the final year of kindergarten), and their parental involvement at home and school at Time 1 and 2 (the first year of primary school). Children's school liking was assessed by puppet interview at Time 1. Results indicated that maternal cooperation was positively associated with paternal involvement at home and in school, and paternal cooperation was positively associated with maternal involvement at home. Children's school liking moderated the longitudinal associations between coparenting behavior (Time 1) and parental involvement (Time 2). Specifically, mothers of children with high levels of school liking were involved more in school when they perceived more cooperation from the spouse. Fathers of children with low levels of school liking were less involved in school when they perceived more cooperation, while involved more at home and in school when they perceived more triangulation from the spouse. Additionally, fathers perceiving more triangulation decreased their home involvement when the child reported high levels of school liking. Findings of this study revealed that coparenting, children's school liking, and parental gender might be important to understanding parental involvement during school transition.

Adequate magnesium level as an associated factor of pre-diabetes and diabetes mellitus remission in patients with obesity submitted to bariatric surgery.

Bariatric surgery (BS) can lead to remission of type 2 diabetes mellitus (T2DM), however, the evidence on the influence of preoperative serum magnesium levels on this reversal is scarce. To study the influence of preoperative serum magnesium levels on the pre-T2DM and T2DM remission one year after BS. Retrospective study carried out among 1656 patients with obesity who underwent BS in the Centro Hospitalar Universitário São João. T2DM and pre-T2DM remission were defined as being normal glycaemic measures of at least one year's after BS and without pharmacological therapy. To assess the association between preoperative serum magnesium levels and pre- and T2DM remission, logistic regression models, crude and adjusted for sex, age and body mass index were computed. Patients with normoglycaemia presented hypomagnesaemia less often than those patients with pre-T2DM and T2DM (17.0% vs. 21.3% vs. 39.9%) (p < 0.001). One year after BS, 62.9% of patients with pre-T2DM or T2DM before BS showed remission. Adequate magnesium levels were positively associated with T2DM and pre-T2DM remission, one year after BS (OR 1.79; 95% CI 1.34-2.38), independently of sex, age, and body mass index. Adequate preoperative serum magnesium levels showed to be an important clinical parameter for pre-T2DM and T2DM remission.

Beta Cell Function as a Baseline Predictor of Weight Loss After Bariatric Surgery.

Background: Obesity is a multifactorial disease, which is strongly associated to other metabolic disorders. Bariatric surgery is the most effective treatment of morbid obesity. The role of beta cell function in weight loss after bariatric surgery is uncertain. Aim: To evaluate the association between beta cell function and percentage of total body weight loss (TBWL%) 1, 2, 3, and 4 years after bariatric surgery in patients with morbid obesity. Methods: Retrospective longitudinal study in patients with morbid obesity followed in our center between January 2010 and July 2018. Patients were excluded if they had diabetes at baseline or missing data on the needed parameters. We evaluated baseline Homeostatic Model Assessment of IR, Homeostatic Model Assessment of ß-cell function (HOMA-beta), Quantitative Insulin Sensitivity Check Index, and Matsuda and DeFronzo index, and TBWL% at years 1 to 4. Linear regression models were used to evaluate the association of indexes of insulin resistance with TBWL% (unadjusted and adjusted for age, sex, BMI, and type of surgery). Results: There were 1,561 patients included in this analysis. HOMA-beta was negatively associated with TBWL% at second, third, and fourth years post-surgery (ß = -1.04 [-1.82 to -0.26], p<0.01; ß = -1.16 [-2.13 to -0.19], p=0.02; ß = -1.29 [-2.64 to 0.06], p=0.061, respectively). This was not observed in the first year post-surgery nor for the other indexes. Glycemia at baseline was positively associated to EWL% at second and third years post-surgery. Conclusion: ß-cell function at baseline seems to be associated to long-term weight loss, explicitly after the first year post bariatric surgery. This might be a helpful predictor of weight loss in clinical practice.

Secondary Hyperparathyroidism Among Bariatric Patients: Unraveling the Prevalence of an Overlooked Foe.

INTRODUCTION: Bariatric surgery (BS) is the most effective therapeutic approach to obesity. It is associated with great gastrointestinal anatomic changes, predisposing the patients to altered nutrient absorption that impacts phosphocalcium metabolism. This study aimed to clarify the prevalence of secondary hyperparathyroidism (SHPT) and its predictors in patients submitted to BS. METHODS: Retrospective study of 1431 patients who underwent metabolic surgery between January 2010 and June 2017 and who were followed for at least 1 year. We compared the clinical and biochemical characteristics of patients with and without secondary hyperparathyroidism (considering SHPT a PTH ˃ 69 pg/mL). Two different analyses were performed: (1) paired analysis of participants before and 1 year after surgery (N = 441); (2) Cross sectional analysis of participants submitted to bariatric surgery before (N = 441), 1 year after (N = 1431) and 4 years after surgery (N = 333). Multiple logistic regression models were used to evaluate possible predictors of SHPT after BS. RESULTS: The overall prevalence of SHPT was 24.9% before surgery, 11.2% 1 year after surgery and 21.3% 4 years after surgery. Patients submitted to LAGB had the highest prevalence of SHPT 1 year after surgery (19.4%; vs RYGB, 12.8%, vs SG, 5.3%). Four years after surgery, RYGB had the highest prevalence of SHPT (27.0%), followed by LAGB (13.2%) and SG (6.9%). Higher body mass index and age, decreased levels of vitamin D and RYGB seem to be independent predictors of SHPT 1 year after surgery. The only independent predictor of SHPT 4 years after surgery was RYGB. CONCLUSION: The prevalence of SHPT is higher before and 4 years after BS than 1 year after surgery. This fact raises some questions about the efficacy of the implemented follow-up plans of vitamin D supplementation on the long term, mainly among patients submitted to RYGB.

Gut microbiota changes after metabolic surgery in adult diabetic patients with mild obesity: a randomised controlled trial.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) surgery is one of the most efficient procedures for the treatment of obesity, also improving metabolic and inflammatory status, in patients with mild obesity. The underlying mechanisms have not been fully understood, but gut microbiota is hypothesized to play a key role. Our aim was to evaluate the association between gut microbiota changes and anthropometric, metabolic and inflammatory profiles after metabolic surgery compared with medical therapy, in type 2 diabetic (T2DM) adults with mild obesity (BMI 30-35 kg/m2). METHODS: DM2 was an open-label, randomised controlled clinical trial (RCT: ISRCTN53984585) with 2 arms: (i) surgical, and (ii) medical. The main outcome was gut microbiota changes after: metabolic surgery (Roux-en-Y gastric bypass-RYGB) versus standard medical therapy. Secondary outcomes included anthropometric, metabolic and inflammatory profiles. Clinical visits, blood workup, and stool samples were collected at baseline and months (M)1, 3, 6, 12. Gut microbiota was profiled using 16S rRNA targeted sequencing. RESULTS: Twenty patients were included: 10 in surgical and 10 in medical arm. Anthropometric and metabolic comparative analysis favoured RYGB over medical arm. At M12, the percentage of weight loss was 25.5 vs. 4.9% (p < 0.001) and HbA1c was 6.2 vs. 7.7% (p < 0.001) respectively. We observed a continuous increase of genus richness after RYGB up until M12. In the medical arm, genus richness ended-up being significantly lower at M12. Composition analysis indicated significant changes of the overall microbial ecosystem (permanova p = 0.004, [R2 = 0.17]) during the follow-up period after RYGB. There was a strong association between improvement of anthropometric/metabolic/inflammatory biomarkers and increase in microbial richness and Proteobacterial lineages. CONCLUSIONS: This was the first RCT studying composite clinical, analytic, and microbiome changes in T2DM patients with class 1 obesity after RYGB versus standard medical therapy. The remarkable phenotypic improvement after surgery occurred concomitantly with changes in the gut microbiome, but at a lower level. TRIAL REGISTRATION: ISRCTN53984585.