Healthy Habits in Pregnancy and Beyond pilot RCT
Research type
Research Study
Full title
The ’Healthy Habits in Pregnancy and Beyond’ (HHIPBe) pilot randomised controlled trial. Delivery of a habit-based lifestyle intervention to overweight or obese pregnant women on the Island of Ireland: a study exploring the feasibility and acceptability of integrating the intervention into existing antenatal care pathways, compared with usual care.
IRAS ID
266602
Contact name
Michelle McKinley
Contact email
Sponsor organisation
Queen's University Belfast
Duration of Study in the UK
2 years, 7 months, 25 days
Research summary
Research Summary
More than 50% of pregnant women are considered overweight or obese when they present for antenatal care. Overweight and obesity in pregnancy is associated with complications and poorer health outcomes for mothers and their babies, as well as risk for excessive gestational weight gain and postpartum weight retention, increasing the likelihood of long-term obesity for these women. There is also evidence that excess maternal weight and weight gain in pregnancy is associated with obesity in the offspring from early childhood through to adolescence. There is an urgent need for simple, effective interventions targeting lifestyle which can be delivered during routine healthcare.
The aim of this study is to assess if a brief weight management intervention for pregnant women with overweight and obesity (body mass index between 25.0 & <38.0 kg/m2), is feasible and acceptable to deliver within existing antenatal care pathways across four geographical locations in Northern Ireland and the Republic of Ireland.
This study is a two-arm pilot randomised controlled trial. Healthcare staff in four partner sites will be trained in introducing the study to the target sample and in the intervention. Twenty women will be individually and equally randomised to control and intervention groups to complete the study within each site.
Women randomised to the intervention group will receive a brief intervention to encourage the development of ten healthy habits in relation to diet, physical activity and weight management, plus their local routine antenatal care. The intervention will be delivered by a designated midwife at each site or a member of the research team, and is aimed to be integrated into appointments already attended by women as part of routine antenatal care. Women randomised to the control group will receive their local routine antenatal care.
Summary of Results
Why did we start? (the need for the research, how the intervention is novel but unproven, designed to prevent and cure illness and/or the reason why the work was commissioned)
In Northern Ireland (NI) and the Republic of Ireland (ROI), more than half of pregnant women have overweight or obesity at their first routine antenatal appointment, usually when they are around 12 weeks pregnant. If a mother has overweight during pregnancy, or gains too much weight during pregnancy, it can mean there are increased risks for the health of mum and baby, for example, by increasing the chance of needing a caesarean section.
There is currently limited support given to women who have overweight or obese at the start of pregnancy in NI or the ROI. We need to address the gap in healthy lifestyle advice suitable for pregnant women with something that is simple, yet based on scientific evidence. ‘Ten Top Tips for a Healthy Weight’ (10TT) is a leaflet which includes 10 healthy eating and activity habits and has been shown in scientific research to help overweight adults manage their weight over the long-term. The leaflet is unique as it is based on habit-formation which means it builds on the idea of repeating something over and over until it becomes ‘second nature’. This makes it an attractive option for use during pregnancy but first it needed to be adapted in line with pregnancy-specific health advice.
This research aimed to adapt the 10TT materials to make them suitable for pregnancy (so becoming the 'Healthy Habits In Pregnancy and Beyond' (HHIPBe) intervention), and then to do a small study to test if it was possible to incorporate the adapted intervention into routine antenatal care and see if it was acceptable to pregnant women.
- What did we do? (Methods, including any infrastructure above and beyond staff) In NI and the ROI, researchers tested the delivery of the HHIPBe brief, habit-based weight management intervention for pregnant women with overweight and obesity in early pregnancy. The HHIPBe feasibility study was designed to take place in four maternity units: two in NI (Altnagelvin Maternity Unit (Derry/Londonderry); Royal Jubilee Maternity Hospital (Belfast)); and two in ROI (Sligo University Hospital (Sligo); and Our Lady of Lourdes (Drogheda)). Participants in the study were allocated by chance to receive either the HHIPBe intervention (a 15–20-minute conversation with health professional, supported by a leaflet, logbook and app, plus routine antenatal care) or the control group (routine antenatal care). Women were followed up during their pregnancy and 6 weeks after having their baby to see how they found the intervention.
- What answer did we get? (Findings)
Overall, the HHIPBe intervention was acceptable to pregnant women living with overweight and obesity. Data supports positive trends in the adoption of healthy behaviours during pregnancy, continuing into the early postpartum period. All women in the intervention group thought the programme should be offered to other pregnant women. All participants would take part in the study again and would recommend the study to other pregnant women. Many women felt that the study should be offered to all pregnant women, regardless of weight status.Despite significant variation across the hospital sites in how antenatal care us delivered, (such as booking appointments, scans and appointment structures), this work revealed that it was possible to implement the intervention and it was feasible and acceptable to clinical staff. Feedback from health care professionals suggests that they valued the training and support for having weight management discussions provided as part of the HHIPBe study and that it enhanced their knowledge, skills and confidence for discussing weight appropriately.
- What should be done now? (Practice/Policy Implications/Recommendations) We have shown that HHIPBe is acceptable to pregnant women and to healthcare staff. The next steps will be to refine HHIPBe based on suggestions from women and healthcare staff and then do a large study to see if it helps women with positive habit formation in relation to eating well, being active and healthy weight management in pregnancy and beyond.
REC name
HSC REC A
REC reference
19/NI/0192
Date of REC Opinion
6 Dec 2019
REC opinion
Further Information Favourable Opinion