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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
A lifestyle intervention to prevent gestational weight gain: will it effect infant obesity?
Scientific title
Evaluating the effectiveness of a dietary and lifestyle intervention in reducing excessive gestational weight gain in obese pregnant women, and determining the effect on infant obesity.
Secondary ID [1] 293876 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Excessive Gestational Weight Gain 306343 0
Maternal Obesity 306593 0
Pregnancy 306722 0
Condition category
Condition code
Diet and Nutrition 305431 305431 0 0
Reproductive Health and Childbirth 305822 305822 0 0
Antenatal care

Study type
Description of intervention(s) / exposure
Clients that have consented to participate will be randomly allocated to the Intervention or the Control group. There will be 282 participants in each group.
Women randomised to the Intervention group will complete questionnaires including questions from the NSW Population Health Survey (2105), 24h food recall, an Active Australia Questionnaire and Edinburgh Depression scale.
Initial dietetic consultations for each of the participants is educational and advice based, and lasts for 45 approximately minutes. This is with a senior clinical dietitian with more than 10 years experience. It includes the rational for the concern over excessive gestational weight gain. It is personalised and involves information on culturally appropriate meal planning, healthy weight gain targets during pregnancy, nutritional requirements for pregnancy, strategies to limit sugar and saturated fat consumption, and how to approach non–hungry eating. Participants will be given exercise-related advice, specifically on the importance of how to incorporate 30-45min of moderate-intensity physical activity into their day. Moderate intensity means being able to hold a conversation while exercising without being short of breath, such as brisk walking, swimming or yoga/pilates. This will be provided by the dietitian and or midwife. Individualised dietary and exercise advice will be tailored by identifying gaps in the participant's dietary knowledge and exercise regimen, and optimised by providing appropriate advice to address these issues during initial and review consultations as required.
Participants in the Intervention group will also receive regular monthly follow-up consultations with a midwife and dietitian until 28 weeks gestation, biweekly consultations from 28-36 weeks gestation, and weekly consultations until delivery. Review consultations are approximately 30 minutes. Should Participants not attend these consultations, they will be contacted by the Senior Clinical Dietitian or Midwife for a telephone consultation. Dietary and exercise will be review and discussed during face to face consultations or telephone interactions and once again will be tailored to the needs of the individual participant and their personal circumstances. During these consultations, participants can ask for advice, and clarify any issues with eating or exercise behaviours. Adherence to the program will be monitored via a food diary, using a 24h recall, GWG and clinic attendance.
Participants will also receive fortnightly SMS messages in between face to face or telephone consultations, encouraging healthy eating and appropriate physical activity.
Postpartum follow up includes a 15-30min telephone call by the dietitian at 3m postpartum, reinforcing dietary and lifestyle advice, targeting weight loss goals, and revisiting healthy eating and exercise strategies. This will culminate at 26 weeks post-partum, in participants attending WH or their Early Childhood Centres, or being telephoned for maternal and infant weight and referral to transition to Get Healthy NSW for continuity of care.
Intervention code [1] 300141 0
Intervention code [2] 300645 0
Treatment: Other
Intervention code [3] 300646 0
Comparator / control treatment
Women randomised to the control group will complete questionnaires including questions from the NSW Population Health Survey (2105), 24h food recall, an Active Australia Questionnaire and Edinburgh Depression scale. These participants will receive standard dietary and lifestyle advice as per Antenatal Care Clinical Practice Guidelines (Australian Department of Health, 2017) and will receive regularly scheduled visits with their prenatal care providers which typically involve monthly visits until 28wk gestation, biweekly for 28-36wk gestation and weekly until delivery and at 6w postpartum.
Control group

Primary outcome [1] 304616 0
Gestational Weight Gain. This is the maternal weight when the client attends her first clinic appointment at "Booking-in" minus the weight at the final clinic appointment or weight in the deliver suite if available. This will be determined by electronic weight scales.
Timepoint [1] 304616 0
At final clinic visit prior to delivery
Primary outcome [2] 304617 0
Newborn birth weight-for-age centile using the World Health Organisation Child Growth standards. Newborn birth weight will be determined from hospital records.
Timepoint [2] 304617 0
Within 24h of birth
Secondary outcome [1] 342556 0
Incidence of gestational diabetes mellitus as assessed using hospital records
Timepoint [1] 342556 0
This outcome is measured at "booking-in" when attending the first clinic visit via a random blood glucose and via routine screening at 24-28weeks gestation via a 75g Oral Glucose Tolerance Test.
Secondary outcome [2] 342557 0
Maternal weight which will be determined from electronic weight scales
Timepoint [2] 342557 0
6 months post-partum
Secondary outcome [3] 342558 0
Infant weight-for-age centile using World Health Organisation Child Growth standards. Infant weight will be determined using electronic scales or records from Clinical Nurse Consultant Child and family Health records.
Timepoint [3] 342558 0
6 months post-partum

Key inclusion criteria
Age > 18y
Pre-pregnancy BMI > 27.5
Gestational age between 10 and 18wk
Own a smartphone with SMS capability
Have internet access
Have sufficient skill in the English language to read text messages
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria
Prior diagnosis of Gestational Diabetes
Prior diagnosis of Type 1 Diabetes
Patients with self- reported major health or psychiatric disorders

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person determining if a subject is eligible for inclusion in the trial is unaware, when that decision is made, to which group the person will be allocated. Allocation is concealed in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a block size of 16. Blocks are then randomly chosen to determine patients assignment into the groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Single Centre Two Arm Randomised Controlled Trial
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Statistical analyses will be performed using SPSS version 20 (SPSS Inc, Chicago, USA). To determine differences between groups, normally distributed data will be analysed using Students t tests, and nonparametric data analysed with the Mann-Whitney U test. Differences will be considered statistically significant at p<0.05.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 9868 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 18657 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 298499 0
Name [1] 298499 0
Department of Women's and Newborn Health, Westmead Hospital
Address [1] 298499 0
Westmead Hospital
Corner of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country [1] 298499 0
Primary sponsor type
Women's and Newborn Health, Westmead Hospital
Westmead Hospital
Corner of Hawkesbury and Darcy Rd
Westmead NSW 2145
Secondary sponsor category [1] 297639 0
Name [1] 297639 0
Address [1] 297639 0
Country [1] 297639 0

Ethics approval
Ethics application status
Ethics committee name [1] 299481 0
Western Sydney Local Health District HREC
Ethics committee address [1] 299481 0
Research Office, Level 2, REN Building
Westmead Hospital
Hawkesbury & Darcy Rds
Westmead NSW 2145
Ethics committee country [1] 299481 0
Date submitted for ethics approval [1] 299481 0
Approval date [1] 299481 0
Ethics approval number [1] 299481 0

Brief summary
Overweight and obesity are major global public health issues identified to contribute to disease burden by increasing the risk of diabetes and cardiovascular disease and their associated complications. Over half the adult female Australian population are classified as being overweight or obese with women of reproductive age having one of the highest rates of weight gain in Australia.
At Westmead Hospital in 2014/15, 42.7% of the 5600 women who gave birth there were overweight or obese, approximately 50% had excessive gestational weight gain (GWG) and over 400 developed gestational diabetes.
There are a number of well documented adverse outcomes associated with excessive weight gain and overweight and obesity during pregnancy and these risks increase with increasing BMI. Furthermore, growing evidence indicates the fetus of an overweight mother on an unhealthy diet is ‘programmed’ via epigenetics to lifelong obesity and ill-health. Interventions to prevent childhood obesity must begin during pregnancy.
Women who are able to keep their gestational weight gain to within the recommended limits, whether obese or of normal weight, show significantly reduced rates of foetal and maternal complications.
Due to the frequency of contact of health professions during the antenatal period, it is an ideal time to take the opportunity to intervene and make changes that mothers perceive will optimise the outcome for themselves and their offspring.
A recent Cochrane review (2015), indicated that intense diet and exercise can reduce the risk of excessive GWG, with some studies reporting 5kg lower GWG, and a significant reduction in macrosomia, which has obvious implications for neonatal adiposity.
Furthermore, it has been shown that the use of SMS text messaging are effective in promoting weight loss and appropriate GWG.
We hypothesize that an early and intense dietary and lifestyle intervention, i.e. utilising frequent patient contact via mobile phone technology and face-to-face support, will reduce GWG, GDM, post-partum weight retention and infant adiposity, compared to standard antenatal care.

Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 80554 0
Dr Caron Blumenthal
Address 80554 0
Women's and Newborn Health
Westmead Hospital
Corner of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country 80554 0
Phone 80554 0
+61 02 8890 8434
Fax 80554 0
+61 02 8890 5198
Email 80554 0
Contact person for public queries
Name 80555 0
Dr Caron Blumenthal
Address 80555 0
Women's and Newborn Health
Westmead Hospital
Corner of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country 80555 0
Phone 80555 0
+61 2 8890 8434
Fax 80555 0
+61 2 8890 5198
Email 80555 0
Contact person for scientific queries
Name 80556 0
Dr Caron Blumenthal
Address 80556 0
Women's and Newborn Health
Westmead Hospital
Corner of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country 80556 0
Phone 80556 0
+61 2 8890 8434
Fax 80556 0
+61 2 8890 5198
Email 80556 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results