Lifestyle information and commercial weight management groups to support maternal postnatal weight management and positive lifestyle behaviour: the SWAN feasibility randomised controlled trial

Abstract

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.

Barriers and facilitators to uptake and retention of inner-city ethnically diverse women in a postnatal weight management intervention: a mixed-methods process evaluation within a feasibility trial in England

“…Social opportunity (including within the programme; eg social support, supportive leader and outside; eg, family and friends) was the dominant driver of retention, with psychological capability also important (highest retention when there was self-monitoring and feedback on behaviour). A recently completed feasibility randomised controlled trial of access to SW in a postnatal population 15 presented data on recruitment, retention and other feasibility outcomes, which were supportive of progression to a definitive trial. This paper reports results from the mixed-methods process evaluation of the study, the objective being to use the COM-B to examine the barriers and facilitators to uptake and retention of women allocated to the intervention.…”

“…Responders at 6 months were invited to complete a further questionnaire at 12 months postbirth. The 6- and 12-month questionnaires, which included measures of dietary intake, mental and physical health and lifestyle behaviours (reported elsewhere) 15 , also assessed attendance at SW. This included uptake (asking if they attended any sessions and, if so, age of their baby when attending their first session); and retention (how many sessions attended in total; if they stayed for the whole session or just got weighed).…”

“…Barriers and facilitators to study participation were considered separately to those that relate to the intervention and are reported elsewhere. 15 …”

Financial Incentives for Preventing Postpartum return to Smoking (FIPPS): study protocol for a three-arm randomised controlled trial

“…These measures are: Age Ethnicity Highest educational qualification Occupation Gestation Level of cigarette consumption before pregnancy Expired CO level in ppm Parity (i.e. number of previous pregnancies that have gone beyond 24 weeks) Assessment of any smoking in the home and of whether partner smokes Length of time since last smoking (months/weeks) Self-efficacy: rating of ‘How confident are you that you will continue not to smoke at least until your baby’s first birthday?’ (not at all confident, slightly confident, moderately confident, very confident, extremely confident) [ 30 ] Depression: Edinburgh Postnatal Depression Scale [ 31 ] (for the item ‘The thought of harming myself has occurred to me ’ , if women respond ‘Yes, quite often’ or ‘sometimes’, they will be referred to their health visitor, family nurse partnership or GP) Breastfeeding intent [ 32 ] Alcohol consumption: Alcohol Use Disorders Identification-Consumption (AUDIT-C) test [ 33 , 34 ] Use of support for smoking cessation beyond what is provided in the trial Whether they recruited a significant other supporter (SOS) during their pregnancy Use of nicotine replacement therapy (NRT) in the last week and main types of NRT used Use of heat-not-burn products in the last week Use of e-cigarettes in the last week …”

Financial Incentives for Preventing Postpartum Return to Smoking (Fipps): Study Protocol for a Three-Arm Randomised Controlled Trial

“…• Breastfeeding intent [31] • Alcohol consumption: Alcohol Use Disorders Identification-Consumption (AUDIT-C) test [32,33] • Use of support for smoking cessation beyond what is provided in the trial.…”