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The effect of pre-pregnancy dietary advice and regular exercise to promote health in women with BMI between 18.5 and 24.9kg/m2, on pregnancy outcomes: the Begin Better 2.0 randomised trial.

The effect of pre-pregnancy dietary advice and regular exercise to promote health in women with BMI between 18.5 and 24.9kg/m2, on pregnancy outcomes: the Begin Better 2.0 randomised trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001470785
Enrollment
163
Registered
2022-11-21
Start date
2023-03-31
Completion date
2026-01-01
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Women of reproductive age have been identified by the WHO as an important target group as they prepare for parenthood, as the time around conception and pregnancy often represents a significant turning point in a woman’s cardiovascular and health trajectory, inducing metabolic changes which contribute to weight gain and poor health. Australian data indicate that 3 in 4 pregnancies are planned, and for women planning pregnancy, ~86% will initiate changes in health behaviours before conception. More than 50% of women attending their general practitioner for pre-conception advice, including information about healthy lifestyle and nutrition. Accessing up-to-date, evidence-based health information in a contemporarily acceptable format during reproductive years presents an unmet opportunity in Australia, to improve the health and well-being of potential parents. 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, • Reduce health care costs and • Provide an evidence-based tool that can be readily scaled up for implementation in the community.

Interventions

Women randomised to the Lifestyle Intervention Group will receive verbal advice based on current RACGP's guideline (2021) on Preventative activities prior to pregnancy. Participants will be offered a one-on-one appointment with the registered Midwife (face-to-face, by phone or virtual) for between 30-60 minutes within the first 4 weeks of the study. Information will be provided to encourage women to stop smoking and use of illicit substances, limit alcohol intake, commence folate supplementatio

Women randomised to the Lifestyle Intervention Group will receive verbal advice based on current RACGP's guideline (2021) on Preventative activities prior to pregnancy. Participants will be offered a one-on-one appointment with the registered Midwife (face-to-face, by phone or virtual) for between 30-60 minutes within the first 4 weeks of the study. 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 optimal pre-conception health. The participants will attend one appointment with a study Dietitian for up to 60 minutes, within the first 4 weeks of the intervention. This appointment will be one-on-one and may be face-to-face, by phone or virtual. This appointment will include an assessment of food frequency questionnaire, as well as comprehensive questions about general health and lifestyle, social and environmental factors, diet history and physical activity habits. Individual health goal setting is also discussed. Behavioural Goals We will encourage and support behavioural strategies to increase physical activity and improve diet. Dietary Goals Dietary advice will be Dietitian prescribed, consistent with current Australian dietary guidelines and the Australian guide to healthy eating. The dietary intervention will be individualised for each woman. Physical Activity Goals Women will be instructed to increase or maintain optimal physical activity by their health coach to meet the recommendations of Australia’s Physical Activity & Sedentary Behaviour Guidelines for Adults. The current guidelines suggest women should aim for 150 to 300 minutes of moderate physical activity per week OR 75 to 150 minutes of vigorous physical activity per week AND Muscle strengthening activities on at least 2 days each week. Health management Strategies will promote ongoing healthy dietary and physical behaviours, and will involve regular ongoing face to face, telephone and SMS health coaching with research staff. Staff are tertiary qualified in the areas of health and nutrition, and will be trained by a clinical psychologist on motivational interviewing principles and techniques. The research staff conducting health coaching are not the same as the Midwife or the Dietitian. 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. Further information about this intervention is available from the trial contact staff named in this registration.

Sponsors

University of Adelaide
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Women with BMI between 18.5 - 24.9 kg/m2 and who are considering pregnancy.

Exclusion criteria

Women with BMI greater than or equal to 25kg/m2; currently pregnant; less than 8 weeks postpartum; inability to provide written informed consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026