Lessons Learnt

Randomised Controlled Trial Feedback

During the trial feedback from the health coaches, research/recruiting staff and clinical stakeholders was collated. Feedback included:

Intervention training

Generally, health coaches were satisfied with the level of training and returned to training materials or communicated with other health coaches if additional support was needed. Health coaches’ backgrounds and experiences in health-related fields provided them with further confidence in carrying out their roles.

There were varied levels of satisfaction with researchers’ training to recruit participants. Support was available throughout the study. However, some staff were unclear on earlier aspects of the study, which affected their approach to recruitment. Training on how the study process aligns with national guidelines would improve this in the future.

Recruitment of women

While some staff members felt that overall participant recruitment was successful, challenges were experienced during the process. One site identified that involving healthcare staff, such as obstetricians and midwives, in informing participants about the importance of the study was beneficial to the recruitment process.

Reported causes of uncertainty among some recruitment staff when screening and recruiting participants were:

• • where the trial screening protocol did not fully align with local guidelines
  • a lack of specific intervention content awareness
  • the appropriateness of weight as a primary outcome for normal range BMI women, and
  • the level of information that could be shared with participants regarding treatment allocation groups.

Health coach delivery

Being part of a randomised control trial felt restrictive and posed additional challenges for some health coaches, such as discomfort around calls being recorded. The disconnect between health coaches and research staff was logistically challenging, but also for understanding project roles, feeling part of the project as a whole and large time zone differences between Europe and Australia.

Participation

Some women reported challenges in completing questionnaires, particularly those measuring diet, which may have led to inaccuracies in the data.

Weighing

The scales were provided to both the control and intervention groups to enable the woman to self-monitor their weight and to support remote collection of trial data. The scales were seen by some as an effective weight management tool. Most women used the scales to regularly weigh themselves and sent their weights to the research team. There was a small number of women who found weighing and/or sending in weights to be distressing because of their weight/weight gain/weight history. Another small number found the process of sharing their weights as inconvenient.

Communicating purpose of the trial and gestational diabetes risk

The understanding women had of their gestational diabetes risk and the reasons for their invitation to participate in the trial were varied. Some participants did not recall being told they were at risk of gestational diabetes, whereas others were aware that factors, such as age and BMI, increased their risk and that was why they were invited to participate in the trial. Some women understood the trial monitored general health, whereas others could specify that outcomes related to gestational diabetes and weight were being examined.

External factors

The COVID-19 pandemic affected researchers’ access to clinical sites and change the study to remote communication modes. Challenges experienced with remote communication modes affected recruitment and, in some cases, retention.