Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000414213
Ethics application status
Approved
Date submitted
15/02/2018
Date registered
21/03/2018
Date last updated
12/10/2021
Date data sharing statement initially provided
26/02/2020
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
None
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
Obesity
Reproductive Health and Childbirth 305822 305822 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
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
Lifestyle
Intervention code [2] 300645 0
Treatment: Other
Intervention code [3] 300646 0
Behaviour
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
Active

Outcomes
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

Eligibility
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
Sex
Females
Can healthy volunteers participate?
No
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
Prevention
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
Parallel
Other design features
Single Centre Two Arm Randomised Controlled Trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
31/12/2021
Actual
6/02/2020
Date of last data collection
Anticipated
31/12/2022
Actual
6/02/2020
Sample size
Target
564
Accrual to date
Final
440
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9868 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 18657 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 298499 0
Hospital
Name [1] 298499 0
Department of Women's and Newborn Health, Westmead Hospital
Country [1] 298499 0
Australia
Primary sponsor type
Hospital
Name
Women's and Newborn Health, Westmead Hospital
Address
Westmead Hospital
Corner of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 297639 0
None
Name [1] 297639 0
Address [1] 297639 0
Country [1] 297639 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299481 0
Western Sydney Local Health District HREC
Ethics committee address [1] 299481 0
Ethics committee country [1] 299481 0
Australia
Date submitted for ethics approval [1] 299481 0
18/01/2017
Approval date [1] 299481 0
12/05/2017
Ethics approval number [1] 299481 0
HREC/17/WMEAD/16

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 80554 0
+61 02 8890 8434
Fax 80554 0
+61 02 8890 5198
Email 80554 0
Caron.blumenthal@health.nsw.gov.au
Contact person for public queries
Name 80555 0
Caron Blumenthal
Address 80555 0
Women's and Newborn Health
Westmead Hospital
Corner of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country 80555 0
Australia
Phone 80555 0
+61 2 8890 8434
Fax 80555 0
+61 2 8890 5198
Email 80555 0
Caron.blumenthal@health.nsw.gov.au
Contact person for scientific queries
Name 80556 0
Caron Blumenthal
Address 80556 0
Women's and Newborn Health
Westmead Hospital
Corner of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country 80556 0
Australia
Phone 80556 0
+61 2 8890 8434
Fax 80556 0
+61 2 8890 5198
Email 80556 0
Caron.blumenthal@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.