Abstract
BackgroundMany pregnant women gain excess weight during pregnancy which increases the health risks to the mother and her baby. Interventions to prevent excess weight gain need to be given to the whole population to prevent excess weight gain. The aim of this study was to assess the effectiveness of a simple and brief intervention embedded withinroutine antenatal care to prevent excessive gestation weight gain.MethodsSix hundred and ten pregnant women (between 10-14 weeks gestation), aged ≥18 years with a body mass index (BMI) ≥18.5 kg/m2, planned to receive community midwife led care or shared care at the time of recruitment are eligible to take part in the study. Women will be recruited from four maternity centres in England. Community midwives complete a short training module before delivering the intervention. In the intervention, midwives weigh women, set maximum weight limits for weight gain at each antenatal appointment and ask women to monitor their weight at home. Themaximum weight limit is adjusted by the midwife at each antenatal appointment if women have exceeded their maximum weight gain limit set at their previous appointment. The intervention will be compared with usual antenatal care. The primary outcome is the proportion of women per group who exceed the Institute of Medicine guidelines for gestational weight gain at 38 weeks of pregnancy according to their early pregnancy BMI category.DiscussionThe proposed trial will test a brief intervention comprising regular weighing, target setting and monitoring ofweight during pregnancy that can be delivered at scale as part of routine antenatal care. Using the professional expertise of community midwives, but without specialist training in weight management, the intervention will incur minimal additionalhealthcare costs, and if effective at reducing excess weight gain, is likely to be very cost effective. Trial registrationCurrent controlled trials ISRCTN67427351. Date assigned 29/10/2014.
Highlights
Many pregnant women gain excess weight during pregnancy which increases the health risks to the mother and her baby
The Institute of Medicine (IOM) recommend that women with a healthy, overweight and obese pre pregnancy body mass index (BMI) should gain between 11.5–16 kg, 7– 11.5 kg and 5–9 kg respectively
Feasibility work: Preventing Obesity in Pregnancy Study (POPS) In preparation for this phase III trial we conducted a feasibility Randomised Controlled Trial (RCT) with 76 pregnant women randomised to usual antenatal care only or usual antenatal care plus an intervention involving community midwives setting targets for healthy weight gain, regular weighing and providing feedback on progress
Summary
To assess the effectiveness of a brief intervention to encourage healthy weight gain during pregnancy. We will assess whether midwives delivered advice according to the protocol in the intervention group and did not contaminate the trial in the usual care group by asking women in a questionnaire about the advice given by their community midwife about weight control, eating, and physical activity. This is not a trial about giving lifestyle advice so midwives will not be asked to refrain from offering usual advice about diet and exercise early in pregnancy This trial is testing the addition to usual care of an intervention where midwives set targets for healthy weight gain, weigh women and encourage women to monitor their weight to ensure they stay on target, and give feedback on every visit for antenatal care. All the hospitals involved in this research have ethically reviewed and approved the protocol
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