Title: Feasibility and acceptability of a brief routine weight management intervention for postnatal women embedded within the national child immunisation programme in primary care: randomised controlled trial and nested qualitative study
Funder: Department of Health and Social Care

Abstract: Studies have reported that among women who have a healthy BMI prior to pregnancy 30% are overweight one year after giving birth. Of women who are overweight prior to conception, 44% are obese 1 year after giving birth, while 97% of women who are obese prior to pregnancy remain so at 1 year postnatally. On average women gain about 14-15kg during pregnancy and at 1 year after birth 5-9kg is retained. Postnatal weight retention can significantly increase the risk of later obesity and is associated with chronic diseases indicating the need to develop interventions to help women lose weight after giving birth. Reviews show that most trials in this population include small samples and/or evaluate intensive weight loss interventions. These types of interventions cannot be offered to all of the 820,000 women who give birth every year, 520,500 of whom are overweight/obese. Instead, we propose test a simple intervention for maternal weight management into the national child immunisation programme so, if it is feasible, and eventually effective, it can be rolled out to every woman giving birth at little extra cost to the NHS and no cost to women, thereby reaching even the most disadvantaged communities. We will assess the feasibility of an intervention focused on promoting self-monitoring of postnatal weight and signposting to a online weight management programme by practice nurses as part of the child immunisation programme. In this feasibility cluster RCT 80 women will be recruited from 10 practices (clusters) to test recruitment, acceptability and trial procedures. Every 2 weeks Birmingham Women’s Hospital will complete searches of women who are at least 4 weeks post birth registered at participating practices and send a study invitation to them. Interested women will be visited to collect baseline data. Women must be aged 18 years or more, given birth at least 4 weeks previously and not yet attended the first immunisation, with a BMI 25 kg/m2 or more at baseline. In the 1st year babies are immunised at 2, 3, 4 and 12 months of age; we plan to embed the intervention within these pre-existing contacts. This study will run over the first 3 immunisation appointments (2, 3, & 4 months). The intervention occurs when women attend their practice to have their child immunised and involves a brief intervention to encourage regular weighing to promote self-management of weight and a recommendation to enrol in a proven effective online weight management programme (POWeR). Women will be asked to weigh themselves weekly and record this on a record card attached to the child health ‘red book’ or on the online programme. Women will be advised to aim for 0.5-1kg weight loss p/w until achieving their pre-pregnant weight and within the healthy range. At each child immunisation visit the nurse will weigh them to assess progress against this goal. We know that someone who is regularly weighed is more likely to stay focussed on their weight loss. Nurses will not provide any lifestyle counselling; their role is simply to provide regular external accountability and to signpost women to the online weight loss programme, for weight loss support. The comparator group will receive a healthy lifestyle leaflet. Follow up will be at 3 months post baseline. Women and nurses will be interviewed to ascertain their views of the intervention. The primary outcome will be the feasibility of a subsequent phase III trial based on pre-specified progression criteria.

Lay abstract: After the birth of their baby, many women find it hard to lose the weight they have gained during pregnancy. It is estimated that on average women gain about 14-15 kg during pregnancy and at 1 year after birth 5-9 kg is retained. This extra weight increases the risk of developing diseases in later life. Many women would like support to lose weight at this time. So far, research to find the best treatment has tested intensive weight loss programmes in small groups of women. This type of treatment cannot be offered to all of the 820,000 women who give birth every year, of which 520,500 are overweight or obese. It would be too expensive to do this and many women find it hard to attend extra visits with health professionals at a time when their mind is focused on their baby. We plan to test a simple online intervention for women that could be offered to women as part of the national child immunisation programme. If it works, this treatment could easily be adopted in the NHS. In the first instance we will conduct a feasibility study involving 80 women to test the study processes and whether the intervention is acceptable to women. To do this, women who have given birth at least 4 weeks ago will be identified by the hospital where they gave birth and sent a study invitation letter. Interested women will be visited at home to measure their weight and collect information about them at the start of the study and allocated to the intervention or the comparison group. Women must be aged 18 or more and have given birth at least 4 weeks previously and be overweight when recruited. In the 1st year babies are immunised four times, at 2, 3, 4 and 12 months of age. This study will run over the first three of these immunisation appointments. When women attend the practice for their baby to be immunised, the nurses will encourage women to monitor their weight weekly and record this on a record card that will be attached to their child’s ‘red book’. Women will also be encouraged to sign up to an online weight loss programme and advised to aim to lose 0.5-1kg per week. So that women know their weight is important, they will be advised that at each child immunisation the nurse will weigh them again to assess their progress. We know that someone who is regularly weighed is more likely to stay focused on their weight loss. Nurses will NOT provide any lifestyle counselling; their role is simply to provide regular monitoring for weight loss and to encourage women to use an online weight loss programme. In this feasibility study, weight will be measured again 3 months after women start the study (after the 4 month immunisation visit). Women and nurses will be interviewed about their views of the intervention to get their feedback as well. . If this first study goes well and we meet some rules about acceptability which are set up at the start of the first study, we will plan a much bigger trial over 1 year, to see if the intervention is effective in helping women lose weight soon after having a baby. Feedback from 6 members of a pregnancy public involvement group has already been incorporated in to the design and focus of this proposal. This study will take 18 months to complete.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;METABOLIC AND ENDOCRINE;ORAL AND GASTROINTESTINAL;STROKE