Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001470785
Ethics application status
Approved
Date submitted
13/10/2022
Date registered
21/11/2022
Date last updated
21/11/2022
Date data sharing statement initially provided
21/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 307440 0
None
Universal Trial Number (UTN)
U1111-1283-7980
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preconception Health 326807 0
Condition category
Condition code
Reproductive Health and Childbirth 324024 324024 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323884 0
Lifestyle
Intervention code [2] 323885 0
Behaviour
Comparator / control treatment
Women randomised to the Educational Control 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. This information is the same as for the Intervention group. Women will receive limited information about a healthy diet and exercise prior to pregnancy.
Changes in diet and physical activity will be assessed by by food frequency and physical activity questionnaires at the commencement of study participation and 6 months later.
Control group
Active

Outcomes
Primary outcome [1] 331813 0
The primary outcome is birth weight z-score. Birth weight will be measured by the attending midwife using digital scales as per usual practice across maternity units in Australia. This birth weight will be converted to a z score using population birth weight means and standard deviations for infant sex and gestational age.
Timepoint [1] 331813 0
At birth of infant, for women who achieve pregnancy during study participation and follow up.
Secondary outcome [1] 411254 0
Body weight: Weight (kilograms) will be measured by study staff using calibrated scales or self-reported by study participants..
Timepoint [1] 411254 0
Weight will be measured at appointments by study staff (or self-reported by study participants when not possible) at the time of trial entry (TE), 6 months after trial entry, at conception, 28 and 36 wk gestation, and post-natally (6wk, 6mo, 18mo). In addition, body weight will be self-reported bi-monthly after TE until a pregnancy is reported, or in the absence of a pregnancy, until 2.5 years after enrollment.
Secondary outcome [2] 411255 0
Maternal anthropometric assessment: This includes skin-fold thickness of biceps, triceps, subscapular, suprailiac, abdominal and thigh skinfold sites using skinfold calipers, and body circumference measurement of abdomen, hips, thigh and upper arm using a measuring tape.
Timepoint [2] 411255 0
Skin fold thickness and circumferences will be measured by study staff at appointments at the time of trial entry, 6 months after trial entry and 36 wk gestation.
Secondary outcome [3] 411256 0
Blood pressure will be measured using a digital blood pressure monitor.
Timepoint [3] 411256 0
Trial entry, completion of the 6 month intervention/participation period, and at 28 and 36wks pregnancy.
Secondary outcome [4] 411257 0
Pre-conception health questionnaire: Women will complete a study questionnaire, designed specifically for this study, asking about pre-conception and early pregnancy health including pregnancy loss, previous diabetes or other health conditions, use of assisted reproductive technologies (ART) and time to conceive (TTC).
Timepoint [4] 411257 0
Trial entry, completion of the 6 month intervention/participation period, and at 28 and 36wks pregnancy
Secondary outcome [5] 411258 0
Maternal diet: Harvard Semi-quantitative Food Frequency Questionnaire

Timepoint [5] 411258 0
Measured at trial entry, 6 months after trial entry and at 28 and 36 weeks of pregnancy for women who become pregnant.
Secondary outcome [6] 411259 0
Maternal physical activity: SQUASH Questionnaire

Timepoint [6] 411259 0
Measured at trial entry, 6 months after trial entry and at 28 and 36 weeks of pregnancy for women who become pregnant.
Secondary outcome [7] 411260 0
Maternal health and wellbeing: SF12 Quality of Life Questionnaire

.
Timepoint [7] 411260 0
Measured at trial entry, 6 months after trial entry and at 28 and 36 weeks of pregnancy for women who become pregnant.
Secondary outcome [8] 415295 0
Maternal depression, anxiety and stress: DASS21 Questionnaire
Timepoint [8] 415295 0
Measured at trial entry, 6 months after trial entry and at 28 and 36 weeks of pregnancy for women who become pregnant.
Secondary outcome [9] 415296 0
Post natal mental health: Edinburgh Postnatal Depression Scale (EPDS)
Timepoint [9] 415296 0
Measured post-natally at 6weeks, 6 months and 18 months
Secondary outcome [10] 415297 0
Gestational weight gain: Gestational weight gain will be the difference between the most recent pre-pregnancy weight and weight at 36 weeks of gestation. These records may be recorded following review of medical records or as reported by participants.
Timepoint [10] 415297 0
Pre- or early pregnancy weight, 36 weeks gestation.
Secondary outcome [11] 415298 0
Pregnancy hypertension and pre-eclampsia: blood pressure will be measured using a digital blood pressure monitor. A systolic blood pressure greater than or equal to 140 mm Hg and / or diastolic greater than or equal to 90 mm Hg.

Timepoint [11] 415298 0
Usual antenatal care includes blood pressure measurement at all antenatal visits to screen for hypertensive disorders of pregnancy. Study staff will measure blood pressure at 36 wks.
Secondary outcome [12] 415299 0
Gestational diabetes: a positive oral glucose tolerance test (OGTT) as per current SA Perinatal Practice Guidelines. Usual antenatal care includes screening for gestational diabetes at 28 weeks gestation.
Timepoint [12] 415299 0
28 wks gestation
Secondary outcome [13] 415300 0
Pregnancy outcome: Antepartum haemorrhage. These data are obtained from hospital medical records as recorded by clinical staff.
Timepoint [13] 415300 0
Records will be reviewed following birth, after hospital discharge.
Secondary outcome [14] 415301 0
Pregnancy outcome: Onset of labour. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.
Timepoint [14] 415301 0
Records will be reviewed following birth, after hospital discharge.
Secondary outcome [15] 415302 0
Pregnancy outcome: Caesarean section. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff
Timepoint [15] 415302 0
Records will be reviewed following birth, after hospital discharge.
Secondary outcome [16] 415303 0
Pregnancy outcome: Postpartum haemorrhage. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.

Timepoint [16] 415303 0
Records will be reviewed following birth, after hospital discharge.
Secondary outcome [17] 415304 0
Pregnancy outcome: Perineal trauma. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.
Timepoint [17] 415304 0
Records will be reviewed following birth, after hospital discharge.
Secondary outcome [18] 415305 0
Pregnancy outcome: Wound infection. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.
Timepoint [18] 415305 0
Records will be reviewed following birth, after hospital discharge.
Secondary outcome [19] 415306 0
Pregnancy outcome: Endometritis. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.

Timepoint [19] 415306 0
Records will be reviewed following birth, after hospital discharge.
Secondary outcome [20] 415307 0
Pregnancy outcome: Maternal death. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.
Timepoint [20] 415307 0
Records will be reviewed following birth, after hospital discharge.
Secondary outcome [21] 415308 0
Neonatal outcomes: Preterm birth (<37 weeks). Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.
Timepoint [21] 415308 0
Records will be reviewed following birth, after hospital discharge.
Secondary outcome [22] 415309 0
Neonatal outcomes: Mortality or infant death. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.
Timepoint [22] 415309 0
Pregnancy and birth outcomes measured at birth and postpartum outcomes measured up to 6 weeks postnatal.
Secondary outcome [23] 415310 0
Neonatal outcomes: Birth weight. To be categorised as greater than 4.0kg, between 2.5-4.0kg, less than 2.5kg, and/or large for gestational age (>90th centile for age and sex), small for gestational age (less than the 10th centile for age and sex) or appropriately grown for gestational age (AGA, between the 10th and 90th centile for age and sex). Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.
Timepoint [23] 415310 0
Recorded at birth.
Secondary outcome [24] 415311 0
Neonatal outcomes: Hypoglycaemia. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.

Timepoint [24] 415311 0
Pregnancy and birth outcomes measured at birth and postpartum outcomes measured up to 6 weeks postnatal.
Secondary outcome [25] 415312 0
Neonatal outcomes: Nursery admission. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.

Timepoint [25] 415312 0
Pregnancy and birth outcomes measured at birth and postpartum outcomes measured up to 6 weeks postnatal.
Secondary outcome [26] 415313 0
Neonatal outcomes: Neonatal jaundice requiring phototherapy. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.
Timepoint [26] 415313 0
Pregnancy and birth outcomes measured at birth and postpartum outcomes measured up to 6 weeks postnatal.
Secondary outcome [27] 415314 0
Neonatal outcomes: Birth trauma. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff.

Timepoint [27] 415314 0
Pregnancy and birth outcomes measured at birth and postpartum outcomes measured up to 6 weeks postnatal.
Secondary outcome [28] 415315 0
Neonatal outcomes: Shoulder dystocia. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff
Timepoint [28] 415315 0
Pregnancy and birth outcomes measured at birth and postpartum outcomes measured up to 6 weeks postnatal.
Secondary outcome [29] 415316 0
Neonatal outcomes: Serious neonatal morbidity: including seizures and neonatal encephalopathy. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff
Timepoint [29] 415316 0
Pregnancy and birth outcomes measured at birth and postpartum outcomes measured up to 6 weeks postnatal.
Secondary outcome [30] 415317 0
Neonatal outcomes: Feeding practices. Labour and birth outcomes and complications are routinely recorded in Australian maternity units. These data are obtained from hospital medical records as recorded by clinical staff
Timepoint [30] 415317 0
Pregnancy and birth outcomes measured at birth and postpartum outcomes measured up to 6 weeks postnatal.
Secondary outcome [31] 415318 0
Hospital admissions. These data are obtained from hospital medical records as recorded by clinical staff.
Timepoint [31] 415318 0
Timepoint includes any time during pregnancy and up to 6 weeks post-natal.
Secondary outcome [32] 415319 0
Please note this is not a composite and all outcomes will be measured separately.
Maternal biomarkers of adipoinsular axis function: these will be assessed from blood samples including Insulin (µIU/ml), Adiponectin (µg/mL) and Leptin (ng/mL).
Timepoint [32] 415319 0
Blood samples will be collected from women at trial entry and 6 months after trial entry.
Secondary outcome [33] 415919 0
Please note this is not a composite and all outcomes will be measured separately.
Maternal biomarkers of cardiometabolic risk : these will be assessed from blood samples including fasting and non-fasting glucose (mmol/L), Glycated haemoglobin (HbA1c; mmol/mol), total cholesterol (mmol/L), HDL(mmol/L), LDL(mmol/L), triglycerides (mmol/L), non esterified fatty acids (NEFA; mmol/L), C reactive protein (CRP; mg/L), and inflammatory cytokines ( GMCSF (pg/mL), IFN-gamma (pg/mL), TNF-a (pg/mL), IL-1ß (pg/mL), IL-2 (pg/mL),IL-4 (pg/mL), IL-5 (pg/mL), IL-6 (pg/mL), IL-8 (pg/mL)).
Timepoint [33] 415919 0
Blood samples will be collected from women at trial entry and 6 months after trial entry.
Secondary outcome [34] 415920 0
Please note this is not a composite and all outcomes will be measured separately.
Infant growth: Infant length (cm) and weight (kg), anthropometric assessments (including skin-fold thickness of biceps, triceps, subscapular, suprailiac, abdominal and thigh skinfold sites using skinfold calipers, in mm) and body circumferences (measurement of chest, abdomen, head, and mid upper arm, in cm) will be measured.
Timepoint [34] 415920 0
These outcomes will be measured when child is 6 months of age
Secondary outcome [35] 415921 0
Please note this is not a composite and all outcomes will be measured separately.
Infant development: Assessments related to infant development include specific questionnaires completed by the mother; Infant feeding practices, Ages and Stages Questionnaire relevant to infants at 6 months of age, and age appropriate physical activity questionnaires (Movement Behaviour Questionnaire for babies, MBQ-B, Trost, 2022) . Blood pressure will also be measured, by oscillometric blood pressure monitor.
Timepoint [35] 415921 0
These outcomes will be measured when infant is 6 months of age
Secondary outcome [36] 415923 0
Please note this is not a composite and all outcomes will be measured separately.
Child growth: Child height (cm) and weight (kg), anthropometric assessments (including skin-fold thickness of biceps, triceps, subscapular, suprailiac, abdominal and thigh skinfold sites using skinfold calipers, in mm) and body circumferences (measurement of chest, abdomen, head, and mid upper arm, in cm) will be measured.
Timepoint [36] 415923 0
These outcomes will be measured when child is 18 months of age
Secondary outcome [37] 415924 0
Please note this is not a composite and all outcomes will be measured separately.
Child development: Assessments include specific questionnaires completed by the mother relating to child feeding practices, Ages and Stages Questionnaire relevant to 18 months of age, and age appropriate physical activity questionnaires (Movement Behaviour Questionnaire for children, MBQ-C, Trost, 2022) . Blood pressure will also be measured, by oscillometric blood pressure monitor.
Timepoint [37] 415924 0
These outcomes will be measured when child is 18 months of age

Eligibility
Key inclusion criteria
Women with BMI between 18.5 - 24.9 kg/m2 and who are considering pregnancy.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Online randomisation system that will confirm eligibility and allocate treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation schedule with balanced variable block sizes prepared by statistician not involved with recruitment, conduct of the trial or data collection.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A pre-specified data analysis plan will be published prior to any analyses being undertaken. Analyses will be conducted using SAS v(current) (Cary, NC, US) using standard analytical methods relevant to RCTs.
Analysis will be by intention to treat, women will be analysed in the groups to which they have been assigned.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2023
Actual
Date of last participant enrolment
Anticipated
1/01/2026
Actual
Date of last data collection
Anticipated
1/01/2028
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22623 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 22624 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [3] 22625 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 37897 0
5006 - North Adelaide
Recruitment postcode(s) [2] 37899 0
5042 - Bedford Park
Recruitment postcode(s) [3] 37898 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 312339 0
Government body
Name [1] 312339 0
NHMRC Investigator Grant
Country [1] 312339 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Women's and Children's Hospital
72 King William Rd,
North Adelaide,
Adelaide 5005
South Australia
Country
Australia
Secondary sponsor category [1] 313168 0
None
Name [1] 313168 0
Address [1] 313168 0
Country [1] 313168 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311162 0
Womens and Childrens Health Network (WCHN) Human Research Ethics Committee (HREC)
Ethics committee address [1] 311162 0
Level 2, Zone E/Samuel Way Building,
Women’s and Children’s Hospital (WCH) Campus
Ethics committee country [1] 311162 0
Australia
Date submitted for ethics approval [1] 311162 0
13/07/2022
Approval date [1] 311162 0
31/08/2022
Ethics approval number [1] 311162 0
2022/HRE00182

Summary
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.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120166 0
Prof Jodie Dodd
Address 120166 0
The University of Adelaide and The Women's and Children's Hospital
72 King William St,
North Adelaide SA 5006
Country 120166 0
Australia
Phone 120166 0
+61 881617615
Fax 120166 0
Email 120166 0
jodie.dodd@adelaide.edu.au
Contact person for public queries
Name 120167 0
Dr Megan Mitchell
Address 120167 0
The University of Adelaide and The Women's and Children's Hospital
72 King William St,
North Adelaide SA 5006
Country 120167 0
Australia
Phone 120167 0
+61 883131389
Fax 120167 0
+61881617652
Email 120167 0
megan.mitchell@adelaide.edu.au
Contact person for scientific queries
Name 120168 0
Prof Jodie Dodd
Address 120168 0
The University of Adelaide and The Women's and Children's Hospital
72 King William St,
North Adelaide SA 5006
Country 120168 0
Australia
Phone 120168 0
+61 881617615
Fax 120168 0
+61881617652
Email 120168 0
jodie.dodd@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data, including all data underlying published results, may be shared following researcher requests to the chief investigator for consideration on an individual basis.
When will data be available (start and end dates)?
Data will be available following publication of the results and analyses to be conducted by the primary research team. No end date to availability planned.
Available to whom?
Researchers who provide a methodologically sound proposal in writing for consideration on case-by-case basis at the discretion of chief investigator and the trial steering committee.
Available for what types of analyses?
To achieve the aims of methodologically sound proposals as approved by the chief investigator and the trial steering committee.
How or where can data be obtained?
The de-identified data will be made available electronically in a format compatible to both parties. Data will be password protected.
Contact principal investigator, Jodie Dodd (jodie.dodd@adelaide.edu.au )


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.