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Engaging women with obesity in health-related studies during preconception is challenging. Limited data exists relating to their participation. The aim of this study is to explore the experiences and opinions of women participating in a weight-related, preconception trial. This is an explanatory sequential (quan-QUAL) mixed-methods Study Within A Trial, embedded in the GetGutsy randomized controlled trial (ISRCTN11295995). Screened participants completed an online survey of eight questions (single or multiple choice and Likert scale) on recruitment, motivations and opinions on study activities. Participants with abdominal obesity (waist circumference ≥ 80 cm) were invited to a subsequent semi-structured, online focus group (n = 2, 9 participants) that was transcribed and analyzed using inductive thematic analysis, with a pragmatic epistemological approach. The survey (n = 102) showed the main research participation motivations were supporting health research (n = 38, 37.3%) and wanting health screening (n = 30, 29.4%). Most participants were recruited via email (n = 35, 34.7%) or social media (n = 15, 14.7%). In the FGs, participants valued flexibility, convenience and. research methods that aligned with their lifestyles. Participants had an expanded view of health that considered emotional well-being and balance alongside more traditional medical assessments. Clinical trialists should consider well-being, addressing the interconnectedness of health and incorporate a variety of research activities to engage women of reproductive age with obesity.

Background Individual differences in children eating behaviours have been linked with childhood overweight and obesity. The determinants of childhood eating behaviours are influenced by a complex combination of hereditary and ecological factors. This study examines if key ecological predictors of childhood overweight; maternal socio-economic status (SES), children’s screen time, and childcare arrangements, are associated with eating behaviours in children aged 5-years-old. Methods This is secondary, cross-sectional analysis of the ROLO (Randomized COntrol Trial of LOw glycemic diet in pregnancy) study, using data from the 5-year follow-up (n = 306). Weight, height, and body mass index (BMI) were obtained from mothers and children at the 5-year follow-up. Children’s BMI z-scores were calculated. SES was determined using maternal education level and neighborhood deprivation score. Information on children’s screen time and childcare arrangements were collected using lifestyle questionnaires. Children’s eating behaviours were measured using the Children’s Eating Behaviour Questionnaire (CEBQ). Multiple linear regression, adjusted for potential confounders, assessed associations between maternal SES, screen time and children’s eating behaviours. One-way ANOVA, independent sample t-tests and Spearman’s correlation examined childcare exposure and children’s eating behaviour. Results Mothers in the lowest SES group had higher BMI and were younger than those in the highest SES group (p = p = 0.03 respectively). In adjusted analysis, the lowest SES group was associated with a 0.463-point higher mean score for ‘Desire to Drink’ (95% CI = 0.054,0.870, p = 0.027) and higher ‘Slowness to Eat’ (B = 0.388, 95% CI = 0.044,0.733, p = 0.027) when compared with the highest SES group. Screen time (hours) was associated with higher ‘Food Fussiness’ (B = 0.032, 95% CI = 0.014,0.051, p = 0.001). Those who attended childcare had higher scores for ‘Desire to Drink’(p = 0.046). No relationship was observed between longer duration (years) spent in childcare and eating behaviours. Conclusions In this cohort, the ecological factors examined had an influence on children’s eating behaviours aged 5-years-old. Our results illustrate the complexity of the relationship between the child’s environment, eating behaviour and children’s body composition. Being aware of the ecological factors that impact the development of eating behaviours, in the pre-school years is vital to promote optimal childhood appetitive traits, thus reducing the risk of issues with excess adiposity long-term.

IntroductionBehavioural interventions in early life appear to show some effect in reducing childhood overweight and obesity. However, uncertainty remains regarding their overall effectiveness, and whether effectiveness differs among key subgroups. These evidence gaps have prompted an increase in very early childhood obesity prevention trials worldwide. Combining the individual participant data (IPD) from these trials will enhance statistical power to determine overall effectiveness and enable examination of intervention-covariate interactions. We present a protocol for a systematic review with IPD meta-analysis to evaluate the effectiveness of obesity prevention interventions commencing antenatally or in the first year after birth, and to explore whether there are differential effects among key subgroups.Methods and analysisSystematic searches of Medline, Embase, CENTRAL, CINAHL, PsycInfo, and trial registries for all ongoing and completed randomised controlled trials evaluating behavioural interventions for the prevention of early childhood obesity have been completed up to March 2020 and will be updated annually to include additional trials. Eligible trialists will be asked to share their IPD; if unavailable, aggregate data will be used where possible. An IPD meta-analysis and a nested prospective meta-analysis (PMA) will be performed using methodologies recommended by the Cochrane Collaboration. The primary outcome will be body mass index (BMI) z-score at age 24 +/- 6 months using World Health Organisation Growth Standards, and effect differences will be explored among pre-specified individual and trial-level subgroups. Secondary outcomes include other child weight-related measures, infant feeding, dietary intake, physical activity, sedentary behaviours, sleep, parenting measures and adverse events.Ethics and disseminationApproved by The University of Sydney Human Research Ethics Committee (2020/273) and Flinders University Social and Behavioural Research Ethics Committee (project no. HREC CIA2133-1). Results will be relevant to clinicians, child health services, researchers, policy-makers and families, and will be disseminated via publications, presentations, and media releases.RegistrationProspectively registered on PROSPERO: CRD42020177408STRENGTHS AND LIMITATIONS OF THIS STUDYThis will be the largest individual participant data (IPD) meta-analysis evaluating behavioural interventions for the prevention of early childhood obesity to date, and will provide the most reliable and precise estimates of early intervention effects to inform future decision-making.IPD meta-analysis methodology will enable unprecedented exploration of important individual and trial-level characteristics that may be associated with childhood obesity or that may be effect modifiers.The proposed innovative methodologies are feasible and have been successfully piloted by members of our group.It may not be possible to obtain IPD from all eligible trials; in this instance, aggregate data will be used where available, and sensitivity analyses will be conducted to assess inclusion bias.Outcome measures may be collected and reported differently across included trials, potentially increasing imprecision; however, we will harmonise available data where possible, and encourage those planning or conducting ongoing trials to collect common core outcomes following prospective meta-analysis methodology.

This project is funded by the European Union Commission Horizon 2020 grant entitled `Implementation Action to Prevent Diabetes From Bump 2 Baby (IMPACT DIABETES B2B)' under grant agreement 847984, with collaborative National Health and Medical Research Council, Australia cofunding under grant number APP1194234. The project is sponsored by the University College Dublin. The funders and the sponsor have no role in the design of the study; the collection, analysis, and interpretation of the data; or writing of the manuscript or decision to publish. Financial audits are carried out by the European Union Commission., Background: Gestational diabetes (GDM) impacts 8–18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translation gap remains around delivering implementable interventions with adequate population penetration and participation. Impact Diabetes Bump2Baby is an implementation project of an evidence-based system of care for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomised controlled trial investigating the effectiveness of a mHealth coaching programme in pregnancy and postpartum for women at high risk of developing GDM. Methods: Eight hundred women will be recruited in early pregnancy from 4 clinical sites within Ireland, the UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled from 12 to 24 weeks’ gestation and randomised on a 1:1 basis into the intervention or control arm. Alongside usual care, the intervention involves mHealth coaching via a smartphone application, which uses a combination of synchronous and asynchronous video and text messaging, and allows for personalised support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from early pregnancy until 12 months postpartum. The primary outcome will be a difference in maternal body mass index (BMI) of 0.8 kg/m2 at 12 months postpartum. Secondary maternal and infant outcomes include the development of GDM, gestational weight gain, pregnancy outcomes, improvements in diet, physical activity, sleep, and neonatal weight and infant growth patterns. The 5-year project is funded by the EU Commission Horizon 2020 and the Australian National Health and Medical Research Council. Ethical approval has been received. Discussion: Previous interventions have not moved beyond tightly controlled efficacy trials into routine service delivery. This project aims to provide evidence-based, sustainable support that could be incorporated into usual care for women during pregnancy and postpartum. This study will contribute evidence to inform the early prevention of non-communicable diseases like obesity and diabetes in mothers and the next generation., European Union Commission Horizon 2020 grant entitled 'Implementation Action to Prevent Diabetes From Bump 2 Baby (IMPACT DIABETES B2B)' 847984, National Health and Medical Research Council of Australia APP1194234, University College Dublin, European Commission

Background Gestational diabetes mellitus (GDM) is an increasingly prevalent risk factor for type 2 diabetes. We evaluated the effectiveness of a group-based lifestyle modification program in mothers with prior GDM within their first postnatal year. Methods and Findings In this study, 573 women were randomised to either the intervention (n = 284) or usual care (n = 289). At baseline, 10% had impaired glucose tolerance and 2% impaired fasting glucose. The diabetes prevention intervention comprised one individual session, five group sessions, and two telephone sessions. Primary outcomes were changes in diabetes risk factors (weight, waist circumference, and fasting blood glucose), and secondary outcomes included achievement of lifestyle modification goals and changes in depression score and cardiovascular disease risk factors. The mean changes (intention-to-treat [ITT] analysis) over 12 mo were as follows: −0.23 kg body weight in intervention group (95% CI −0.89, 0.43) compared with +0.72 kg in usual care group (95% CI 0.09, 1.35) (change difference −0.95 kg, 95% CI −1.87, −0.04; group by treatment interaction p = 0.04); −2.24 cm waist measurement in intervention group (95% CI −3.01, −1.42) compared with −1.74 cm in usual care group (95% CI −2.52, −0.96) (change difference −0.50 cm, 95% CI −1.63, 0.63; group by treatment interaction p = 0.389); and +0.18 mmol/l fasting blood glucose in intervention group (95% CI 0.11, 0.24) compared with +0.22 mmol/l in usual care group (95% CI 0.16, 0.29) (change difference −0.05 mmol/l, 95% CI −0.14, 0.05; group by treatment interaction p = 0.331). Only 10% of women attended all sessions, 53% attended one individual and at least one group session, and 34% attended no sessions. Loss to follow-up was 27% and 21% for the intervention and control groups, respectively, primarily due to subsequent pregnancies. Study limitations include low exposure to the full intervention and glucose metabolism profiles being near normal at baseline. Conclusions Although a 1-kg weight difference has the potential to be significant for reducing diabetes risk, the level of engagement during the first postnatal year was low. Further research is needed to improve engagement, including participant involvement in study design; it is potentially more effective to implement annual diabetes screening until women develop prediabetes before offering an intervention. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12610000338066, Sharleen O'Reilly and colleagues investigate the effectiveness of a diabetes prevention program for reducing weight, waist circumference and fasting glucose measurements for women who have had gestational diabetes., Author Summary Why Was This Study Done? Women who have had gestational diabetes are much more likely to develop type 2 diabetes. Although many diabetes prevention programs for people over the age of 50 exist, few are tailored to the needs of young mothers who have had gestational diabetes. On the assumption that offering prevention earlier is beneficial, researchers developed and tested a diabetes prevention program for women who had gestational diabetes; women participated in the program during their first year after giving birth. What Did the Researchers Do and Find? The researchers enrolled 573 women in a one-year study: 284 women were assigned to the diabetes prevention program (one individual session and five group sessions over a three-month period, followed by telephone calls at six and nine months), and 289 were assigned to the control group (usual postnatal care). After one year, the average changes for women in the diabetes prevention program were a 0.23-kg decrease in weight, a 2.24-cm decrease in waist circumference, and a 0.18-mmol/l increase in fasting blood glucose, while the average changes for women in the control group were a 0.72-kg increase in weight, a 1.74-cm decrease in waist circumference, and a 0.22-mmol/l increase in fasting blood glucose. The between-group difference in weight change was 0.95 kg. The number of women who attended the diabetes prevention program was lower than anticipated—10% attended all sessions, and 53% attended the individual session plus at least one group session; about a quarter of women did not complete the study, mainly due to becoming pregnant again. What Do These Findings Mean? These findings suggest that although a diabetes prevention program designed for women who have had gestational diabetes can prevent weight gain over 12 months, getting women to engage with the program was challenging, so it would not be sustainable in routine health services. The women who participated in the study had low diabetes risk profiles (only one in ten had impaired glucose tolerance), and most diabetes prevention guidelines would not categorise them as being at sufficiently high risk for participation in a diabetes prevention program. For diabetes prevention programs in women who have had gestational diabetes, further research is required on the process of engagement and lifestyle interventions at other time points, including participant involvement in the design of interventions. Australian clinical guidelines stipulate that women who have had gestational diabetes should be screened annually for diabetes. One option for management would be to wait until they develop prediabetes before offering a diabetes prevention program, which may prove more effective because their children will be older and women may be easier to engage in improving their health.