RecruitingACTRN12623001228673

Delivering optimal weight gain guidance and support to pregnant women study

Delivering Optimal weighT gain advice to pregnant women (DOT): a case study to achieve healthy weight gain


Sponsor

University of Otago

Enrollment

200 participants

Start Date

Mar 27, 2024

Study Type

Interventional

Conditions

Summary

Healthy weight gain in pregnancy is difficult to achieve despite clinical guidelines. Irrespective of pre-pregnancy weight, excess weight gain in pregnancy is common and it increases the risk of adverse outcomes such as gestational diabetes, weight retention after pregnancy and large for gestational age babies. Furthermore, individual costs, healthcare costs and societal costs are increased, and the impact is greater for wahine (women) Maori and Pacific women compared with NZ European women. Easily accessible and affordable interventions are needed to support pregnant women achieve their recommended weight gain in pregnancy, and thereby improve health outcomes for mothers and babies. In Northland (Te Tai Tokerau), Aotearoa New Zealand, there is a community initiated impetus to address concerns about the increasing number of women developing gestational diabetes. This case study follows our small successful midwife-delivered optimal weight gain in pregnancy intervention feasibility study in Southland, Aotearoa New Zealand, and our Activation grant project (HRC 20/974), which facilitated engagement and wider consultation with the Northland community, We plan to conduct a case study to examine the acceptability, accessibility and impact of our pragmatic Lead Maternity Carer (LMC) midwife-delivered weight gain in pregnancy management tool in a real world setting (Northland, Aotearoa New Zealand), and understand the factors that influenced implementation and delivery of the intervention, specifically its workability and integration into practice.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Gaining too much weight during pregnancy is very common, regardless of what you weigh before becoming pregnant. This can increase the risk of gestational diabetes, having a larger-than-expected baby, and difficulty losing weight after birth. This study is testing a practical, midwife-delivered program to help pregnant women in the Northland region of New Zealand achieve healthy weight gain throughout their pregnancy. The program is delivered by your Lead Maternity Carer (LMC) midwife through regular check-ins, using a weight gain management tool developed and tested in an earlier feasibility study. The goal is to understand how well this kind of intervention can work in the real world and whether it fits naturally into existing midwifery care. You may be eligible if you are pregnant, aged 18 or older, registered with a midwife before 15 weeks of pregnancy, live in the Northland area of New Zealand, and do not have pre-existing diabetes or a condition requiring specialist dietary care. This research is particularly focused on supporting Maori and Pacific women, who are disproportionately affected by gestational diabetes.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention will be delivered during and as part of antenatal care. There will be one additional antenatal appointment and the duration of this appointment will be 30-45 minutes. There will be tw

The intervention will be delivered during and as part of antenatal care. There will be one additional antenatal appointment and the duration of this appointment will be 30-45 minutes. There will be two further intervention sessions which can be either added to a usual antenatal appointment or be a separate appointment. Whether these two further intervention sessions are added to a usual antenatal appointment or are a separate appointment will depend on what is decided by the participant and her Lead Maternity Carer (LMC) midwife. These two further intervention sessions will each be about 15-30 minutes duration. The intervention appointments will take place at the place where the routine antenatal appointments occur, which is usually at the LMC midwife's practice rooms or the pregnant participant's home. The first intervention visit will take place before 15 weeks gestation and this will be after the first registration antenatal visit. The intervention will consist of the LMC midwife asking some contextual lifestyle questions (see protocol) such as are there any dietary restrictions such as nut free or lactose free, how many people are in the household, who mostly purchase the household food, who mostly cooks household meals. There are also eight questions about eating habits using a modified validated questionnaire (STC:Diet). The response to these questions guides which part of the participant's eating habits to focus on and prompts further detailed questions to enable a goal setting process. Three realistic achievable lifestyle goals will be determined by the participant and her LMC midwife followed by a discussion as to how these could be achieved. Appropriate written resources will be provided or recommended by the LMC midwife. The second intervention session will take place about 3-4 weeks after the first intervention appointment. The purpose of this second intervention session is to check on progress with achieving the lifestyle goals and revise or establish new goals as indicated, and to provide further guidance and support. The third intervention session will take place about 3-4 weeks after the second intervention session. The purpose of this third intervention session is the same as that for the second intervention visit. The participating LMC midwives will attend a 5-hour training programme. The overarching goal of the training programme is to update skills and knowledge to enable the delivery of the intervention to enable healthy weight gain in pregnancy. There will be 1-hour of required pre-reading and self-reflection prior to attending a 2-hour training session via zoom. The topics in this zoom session will include the background to the study, a summary of the importance of healthy gestational weight gain, the principles of good food choice, an explanation of the intervention tool, including a brief dietary assessment and goal setting. This will be followed by a further 2-hour in person session, which will include a brief recap of the the intervention tool (brief dietary assessment and goal setting), an explanation and demonstration of the study processes including informed consent, data collection and recording and clinical measurements, followed by three case studies. The two 2-hour sessions will be delivered by the two study co-principle investigators and two dietitians working in the study area. The training materials are study specific. It is intended that the training programme is delivered over a one month period, and that the the training programme is completed within 6-weeks of a participating LMC midwife enrolling her first pregnant participant into the study. Adherence to the intervention by participants will be monitored by LMC midwives through assessment of goal achievement. Setting and progress with goal achievement will be recorded as part of data collection. Information at each of the three intervention visits such as answers to the brief dietary assessment, recording of participant goals and completion of clinical measures will be recorded electronically and reviewed monthly as part of routine data downloads for data checking. An Assistant Research Fellow will also communicate with participating LMC midwives regularly to support them with their study participation and implementation of the intervention.


Locations(1)

Northland (Te Tai Tokerau), New Zealand

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ACTRN12623001228673