RecruitingACTRN12621000128897

The effect of pre-pregnancy dietary advice and regular exercise in women with overweight or obesity on pregnancy outcomes: the BEGIN BETTER randomised trial.


Sponsor

University of Adelaide

Enrollment

864 participants

Start Date

Jun 29, 2021

Study Type

Interventional

Conditions

Summary

In Australia, at least half of women aged 18 to 45 are overweight or obese. Women who are overweight or obese are at increased risk of some pregnancy complications. Babies of women who are overweight or obese are more likely to have birth weight above 4kg, which can put them at increased risk of childhood obesity. Our aim is to conduct a randomised trial of a dietary & lifestyle intervention prior to conception • To improve maternal nutrition, physical activity and healthy behaviours and • To evaluate the impact on maternal, newborn and child health outcomes. Our hypotheses are that this innovative public health approach will • Improve health outcomes for women, and their babies and children, who are otherwise at risk of chronic metabolic disease • Reduce health care costs and • Provide an evidence-based tool that can be readily scaled up for implementation in the community.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

The months before becoming pregnant are one of the most overlooked windows of opportunity to improve the health of both mother and baby. For women who are overweight or obese — at least half of Australian women of reproductive age — excess weight significantly increases the risk of pregnancy complications such as gestational diabetes and having a larger-than-average baby, which in turn raises that child's risk of obesity later in life. This study (the BEGIN BETTER trial) is testing whether a structured dietary and lifestyle program delivered before conception can improve pregnancy outcomes for these women. Participants receive personalised advice on healthy eating and physical activity, with the goal of improving their health before they fall pregnant. Women with a BMI of 25 kg/m² or higher who are considering pregnancy in the coming months may be eligible. You must be at least 18 years old and not currently pregnant (or less than 8 weeks postpartum). Women with a BMI under 25, those who cannot provide written consent, and those who are already pregnant are not eligible. This is a community-based trial that could help demonstrate a practical, scalable way to improve health outcomes for thousands of Australian families.

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

Women randomised to the Lifestyle Intervention Group will receive written and verbal advice based on current RACGP's guideline on Preventative activities prior to pregnancy from a registered midwife a

Women randomised to the Lifestyle Intervention Group will receive written and verbal advice based on current RACGP's guideline on Preventative activities prior to pregnancy from a registered midwife at the trial entry appointment, in which information will be provided to encourage women to stop smoking and use of illicit substances, limit alcohol intake, commence folate supplementation, and ensure immunisations (particularly rubella) and cervical cytology are current, consistent with best clinical practice. The comprehensive dietitian prescribed intervention will combine dietary, exercise and behavioural strategies to promote weight loss. Behavioural Goals We will encourage and support behavioural strategies to increase physical activity and improve diet. Dietary and Weight Loss Goals Dietary advice will be dietitian prescribed, consistent with current Australian guidelines, and designed to encourage weight loss. The dietary intervention will be individualised for each woman. Physical Activity Goals Women will be instructed to increase physical activity by their health coach to meet the recommendations of Australia’s Physical Activity & Sedentary Behaviour Guidelines for Adults. Weight Loss Maintenance Strategies will promote ongoing healthy dietary and physical behaviours, and will involve regular ongoing face to face, telephone and SMS contact with research staff. Adherence to diet and physical activity advice will be assessed by food frequency and physical activity questionnaires at the commencement and completion of the intervention period. Details intentionally brief to protect contamination of the control group. Further information about this intervention is available from the trial contact staff named in this registration.


Locations(3)

Womens and Childrens Hospital - North Adelaide

SA, Australia

Lyell McEwin Hospital - Elizabeth Vale

SA, Australia

Flinders Medical Centre - Bedford Park

SA, Australia

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ACTRN12621000128897