Sarah Roberts

IntroductionA high BMI during and after pregnancy is linked to poor pregnancy outcomes and contributes to long-term maternal obesity, hypertension, and diabetes. Evidence of feasible, effective postnatal interventions is lacking. This randomised controlled trial will assess the feasibility of conducting a future definitive trial to determine effectiveness and cost-effectiveness of lifestyle information and access to Slimming World® (Alfreton, UK) groups for 12 weeks commencing from 8 to 16 weeks postnatally, in relation to supporting longer-term postnatal weight management in women in an ethnically diverse inner city population. Methods/analysis:Women will be recruited from one maternity unit in London. To be eligible, women will be overweight (BMI 25–29.9 kg/m2) or obese (BMI ≥ 30 kg/m2) as identified at their first antenatal contact, or have a normal BMI (18.5–24.9 kg/m2) at booking but gain excessive gestational weight as assessed at 36 weeks gestation. Women will be aged 18 and over, can speak and read English, expecting a single baby, and will not have accessed weight management groups in this pregnancy. Women will be randomly allocated to standard care plus lifestyle information and access to Slimming World® (Alfreton, UK) groups or standard care only. A sample of 130 women is required. Feasibility trial objectives reflect those considered most important inform a decision about undertaking a definitive future trial. These include estimation of impact of lifestyle information and postnatal access to Slimming World® (Alfreton, UK) on maternal weight change between antenatal booking weight and weight at 12 months postbirth, recruitment rate and time to recruitment, retention rate, influence of lifestyle information and Slimming World® (Alfreton, UK) groups on weight management, diet, physical activity, breastfeeding, smoking cessation, alcohol intake, physical and mental health, infant health, and health-related quality of life 6 and 12 months postnatally. An embedded process evaluation will assess acceptability of study processes and procedures to women. Ethics/dissemination:London–Camberwell St Giles Research Ethics Committee, reference: 16/LO/1422. Outcomes will be disseminated in peer-reviewed journals and presentations at national and international conferences. Trial registration:Trial registration number: ISRCTN 39186148. Protocol version number: v7, 13 August 17. Trial sponsor: King’s College London.

Objectives To assess feasibility of a future randomised controlled trial (RCT) of clinical and cost‐effectiveness of lifestyle information and commercial weight management groups to support postnatal weight management to 12 months post‐birth. Design Two‐arm feasibility trial, with nested mixed‐methods process evaluation. Setting Inner‐city unit, south England. Population Women with body mass indices (BMIs) ≥25 kg/m2 at pregnancy booking or normal BMIs (18.5–24.9 kg/m2) identified with excessive gestational weight gain at 36 weeks of gestation. Methods Randomised to standard care plus commercial weight management sessions commencing 8–16 weeks postnatally or standard care only. Main outcomes Feasibility outcomes included assessment of recruitment, retention, acceptability and economic data collation. Primary and secondary end points included difference between groups in weight 12 months postnatally compared with booking (proposed primary outcome for a future trial), diet, physical activity, smoking, alcohol, mental health, infant feeding, NHS resource use. Results In all, 193 women were randomised: 98 intervention and 95 control; only four women had excessive gestational weight gain. A slightly greater weight change was found among intervention women at 12 months, with greatest benefit. Among women attending ten or more weight management sessions. There was >80% follow up to 12 months, low risk of contamination and no group differences in trial completion. Conclusion It was feasible to recruit and retain women with BMIs ≥25 kg/m2 to an intervention to support postnatal weight management; identification of excessive gestational weight gain requires consideration. Economic modelling could inform out‐of‐trial costs and benefits in a future trial. A definitive trial is an important next step. Tweetable abstract A feasibility RCT of postnatal weight support showed women with BMIs ≥25 kg/m2 can be recruited and followed to 12 months postnatally.

Improving management of type 1 diabetes in the UK: the Dose Adjustment For Normal Eating (DAFNE) programme as a research test-bed. A mixed-method analysis of the barriers to and facilitators of successful diabetes self-management, a health economic analysis, a cluster randomised controlled trial of different models of delivery of an educational intervention and the potential of insulin pumps and additional educator input to improve outcomes.

Background Increasing numbers of UK women have overweight or obese body mass index scores when they become pregnant, or gain excessive weight in pregnancy, increasing their risk of adverse outcomes. Failure to manage postnatal weight is linked to smoking, non-healthy dietary choices, lack of regular exercise and poorer longer-term health. Women living in areas of higher social deprivation are more likely to experience weight management problems postnatally. Objectives The objectives were to assess the feasibility of conducting a definitive randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of lifestyle information and access to a commercial weight management group focusing on self-monitoring, goal-setting and motivation to achieve dietary change commencing 8–16 weeks postnatally to achieve and maintain weight management and positive lifestyle behaviour. Design The design was a randomised two-arm feasibility trial with a nested mixed-methods process evaluation. Setting The setting was a single centre in an inner city setting in the south of England. Participants Participants were women with body mass index scores of ˃ 25 kg/m2 at antenatal ‘booking’ and women with normal body mass index scores (18.0–24.9 kg/m2) at antenatal booking who developed excessive gestational weight gain as assessed at 36 weeks’ gestation. Main outcome measures Recruitment, retention, acceptability of trial processes and identification of relevant economic data were the feasibility objectives. The proposed primary outcome was difference between groups in weight at 12 months postnatally, expressed as percentage weight change and weight loss from antenatal booking. Other proposed outcomes included assessment of diet, physical activity, smoking, alcohol consumption, body image, maternal esteem, mental health, infant feeding and NHS costs. Results Most objectives were achieved. A total of 193 women were recruited, 98 allocated to the intervention arm and 95 to the control arm. High follow-up rates (˃ 80%) were achieved to 12 months. There was an 8.8% difference in weight loss at 12 months between women allocated to the intervention arm and women allocated to the control arm (13.0% vs. 4.2%, respectively; p = 0.062); 47% of women in the intervention arm attended at least one weight management session, with low risk of contamination between arms. The greatest benefit was among women who attended ≥ 10 sessions. Barriers to attending sessions included capability, opportunity and motivation issues. Data collection tools were appropriate to support economic evaluation in a definitive trial, and economic modelling is feasible to quantify resource impacts and outcomes not directly measurable within a trial. Limitations The trial recruited from only one site. It was not possible to recruit women with normal body mass index scores who developed excessive pregnancy weight gain. Conclusions It was feasible to recruit and retain women with overweight or obese body mass index scores at antenatal booking to a trial comparing postnatal weight management plus standard care with standard care only and collect relevant data to assess outcomes. Approaches to recruit women with normal body mass index scores who gain excessive gestational weight need to be considered. Commercial weight management groups could support women’s weight management as assessed at 12 months postnatally, with probable greater benefit from attending ≥ 10 sessions. Process evaluation findings highlighted the importance of providing more information about the intervention on trial allocation, extended duration of time to commence sessions following birth and extended number of sessions offered to enhance uptake and retention. Results support the conduct of a future randomised controlled trial.

Background: Increasing numbers of UK women have overweight or obese BMIs when they become pregnant, or gain excessive weight in pregnancy, increasing their risk of adverse outcomes. Failure to manage postnatal weight is linked to smoking, non-healthy dietary choices, lack of regular exercise, and poorer longer-term health. Women living in areas of higher social deprivation are more likely to experience weight management problems postnatally. Objectives: To assess feasibility of conducting a definitive RCT to determine effectiveness of lifestyle information and access to a commercial weight management group focusing on self-monitoring, goal setting and motivation to achieve dietary change commencing 8 to 16 weeks postnatally to achieve and maintain weight management and positive lifestyle behaviours. Design: A randomised two arm feasibility trial, with a nested mixed-methods process evaluation. Setting: A single centre in an inner city setting in the south of England Participants: Women with BMIs>25kg/m2 at antenatal booking and women with normal BMIs (18.5kg/m2) at antenatal booking who developed excessive gestational weight gain as assessed at 36 weeks gestation. Feasibility objectives: Recruitment, retention, acceptability of study processes and identification of relevant economic data. The proposed primary outcome was difference between groups in weight 12 months postnatally, expressed as % weight change and weight loss from antenatal booking. Other proposed outcomes included assessment of diet, physical activity, smoking, alcohol, body image, maternal esteem, mental health, infant feeding and NHS costs. Results: Most objectives were achieved. 193 women were recruited, 98 allocated to the intervention and 95 to the control. High follow up rates (>80%) were achieved to 12 months. A possible 8.8% benefit in weight change at 12 months compared with booking BMI was found among intervention women, compared with control (4.2% compared to 13.0% p=0.062) , 47% of whom attended at least one weight management session, with low risk of contamination between groups. Greatest benefit was among women who attended 10+ sessions. Barriers to attending sessions included opportunity, capability and motivation issues. Data collection tools were appropriate to support economic evaluation in a definitive trial, and economic modelling is feasible to quantify resource impacts and outcomes not directly measurable within a trial. Limitations: The study only recruited from one site. It was not possible to recruit women with normal BMIs who developed excessive pregnancy weight gain. Conclusion: It was feasible to recruit and retain women with overweight or obese BMIs at pregnancy commencement to a trial of postnatal weight management plus standard care compared to standard care only, and collect relevant data to assess outcomes. Approaches to recruit women with normal BMIs who gain excessive gestational weight need to be considered. Commercial weight management groups could support women’s weight management as assessed at 12 months postnatally, with likely greater benefit from attending 10+ sessions. Process evaluation findings highlighted importance of providing more information about the intervention on study allocation, extended duration of time to commence sessions following birth, and extended number of sessions offered to enhance uptake and retention. Future work: Results support the conduct of a future effectiveness RCT.