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Trial registered on ANZCTR


Registration number
ACTRN12620000597998
Ethics application status
Approved
Date submitted
13/03/2018
Date registered
22/05/2020
Date last updated
22/05/2020
Date data sharing statement initially provided
22/05/2020
Date results information initially provided
22/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
PRE-BABE: Pre-conception weight loss for women above a healthy weight: a pilot randomized controlled trial
Scientific title
Feasibility and acceptability of an online pre-conception weight loss program for women with overweight and obesity? A pilot randomised controlled trial
Secondary ID [1] 294322 0
None
Universal Trial Number (UTN)
Trial acronym
PRE-BABE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight women (BMI>25kg/m2) 307040 0
Condition category
Condition code
Diet and Nutrition 306141 306141 0 0
Obesity
Reproductive Health and Childbirth 306142 306142 0 0
Antenatal care
Reproductive Health and Childbirth 306522 306522 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this trial is to compare the effects of a partial meal replacement diet (Flexi) vs recommended advice both delivered in a clinic setting on pre-conception weight loss, in women with a BMI>25kg/m2 planning a pregnancy within the next 6 to 12 months.

The intervention arm comprises an Australian meal replacement product (details available on the website https://www.impromy.com/flexi-by-impromy/) that will be delivered in a clinic setting targeted for women planning pregnancy. All women will have a baseline and a 5 and 10 week appointment with a dietitian. The baseline and the 10 week appointments last 1 hour and the 5 week appointment 30 minutes.

Women randomised to the intervention arm will be advised to follow the Flexi program for 10 weeks and will receive advice on how to log on plus be given their meal replacements in the clinic. The Flexi program is based on alternate day energy restriction (eg Tuesday, Thursday, and Sunday comprise meal replacements and one healthy meal with protein and Monday, Wednesday, and Friday meal replacements plus salad/vegetables) to allow for one day per week to eat ad libitum ( eg Saturday).

A trained research dietitian will deliver and monitor the dietary intervention. Individual estimated energy requirements will be calculated for all women at study visit 1
based on actual body weight, multiplied by appropriate physical activity levels
and reduced by 25-30% to achieve energy restriction for weight loss. This individualized energy level determines the number of formulated meal replacements and the number of snacks for each woman. As an example women with BMI 25 - 30 are likely to require 2 meal replacements per day and BMI > 30 3 meal replacements per day. Meal replacements
require reconstitution with 250 mL of either skim milk or a dairy-free alternative (unsweetened, calcium-enriched). The 10-week meal replacement diet program selected for this trial uses nutritionally complete meal replacement products. (ImpromyTM, manufactured by Probiotec Pty Ltd., Laverton North, Australia; MR =~1000kJ, 25g protein, 4g fat, 27g carbohydrate, 6g fibre with each containing 25% recommended daily intake for Vitamin A, Thiamin, Riboflavin, Niacin, Folate, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Calcium, Iodine, Iron, Magnesium, Phosphorus and Zinc.)

The total daily macronutrient distribution for the MRP diet shown above was 31% of total energy as carbohydrate, 38% protein and 28% total fat (52% monounsaturated fat and 17% polyunsaturated fat) with the remaining 3% non-soluble fibre. Prescribed snack option for the plan include: fruit, low fat dairy, wholegrains and nut/seed/legume. The number of snacks allocated per day is also tailored to individual energy requirements for weight loss.

Behavioural strategies included in the dietitian visits and the accompanying website include, goal setting, self-monitoring of behaviour and progress, stimulus control (e.g. recognising triggers that prompt unplanned eating), cognitive restructuring (modifying unhelpful thoughts), problem solving, assertiveness, slowing the rate of eating, reinforcing changes and relapse prevention. We will also provide a helpline for the program so women are able to access a dietitian for advice during the 10 weeks. This support will be available via a dedicated email monitored by 3 study team members and a study mobile phone during business hours. The website provides general advice regarding the program and weight loss support plus a virtual consultation which has been informed through the FAQs of the CSIRO pilot trial and has been designed by dietitians Women will also receive a copy of the printed booklet from the Australian Government website regarding healthy weight. http://healthyweight.health.gov.au

We will monitor adherence to the meal replacements by questionnaires, weight measurement at the study visit and a count of supplied products to the participating women
Intervention code [1] 300628 0
Prevention
Intervention code [2] 300629 0
Lifestyle
Comparator / control treatment
Recommended weight loss advice delivered in a clinic setting.

Participants allocated to control arm will be advised on the Australian dietary guidelines for healthy eating and receive advice as per existing RANZCOG and Preventative Activities for General Practice professional college guidelines. They will receive a brochure on the healthy weight guide http://healthyweight.health.gov.au and be informed about the NSW Get Healthy Program https://www.gethealthynsw.com.au/
Control group
Active

Outcomes
Primary outcome [1] 305157 0
Change in weight (in kg) between week 0 and week 10
Measured in person using identical digital scales
Timepoint [1] 305157 0
Weight in kg at completion of the 10 week program
Primary outcome [2] 306646 0
Acceptability

Both arms: Study specific questions on whether the program worked for them, would they recommend to other women planning pregnancy, did they feel supported.. Australian online eating survey at baseline and 4 weeks post completion of the program.
Timepoint [2] 306646 0
At the completion of the 10 week program
Secondary outcome [1] 344359 0
Weight (kg) in first trimester (if pregnant within 12 months post intervention). Measured at hospital booking visit using digital scales.
Timepoint [1] 344359 0
First trimester hospital booking visit - 12 weeks gestation
Secondary outcome [2] 354768 0
Waist circumference (cm) measured in person at study visits using SOP
Timepoint [2] 354768 0
At completion of the 10 week program
Secondary outcome [3] 354769 0
Weight at 12 months (kg) measured in person at study visit using digital scales
Timepoint [3] 354769 0
12 months after completion of the program
Secondary outcome [4] 354770 0
Pregnant within 12 months of completion (%) - participant reported on follow up questionnaire then once booked into antenatal care confirmed by routinely collected data via the hospital system
Timepoint [4] 354770 0
12 months after completion of the program
Secondary outcome [5] 354771 0
Gestational diabetes
Timepoint [5] 354771 0
Assessed after birth by access to electronic medical record and perinatal data
Secondary outcome [6] 354774 0
Birthweight
Timepoint [6] 354774 0
Assessed at birth using digital scales as per normal clinical practice
Secondary outcome [7] 379016 0
Compliance

Intervention arm: adherence to Flexi program assessed by number of meal replacements used reported at study visits.
Control arm: Whether signed up to NSW free Get Healthy in Control Arm.
Timepoint [7] 379016 0
Measured at 5 and 10 weeks
Secondary outcome [8] 379178 0
Birthlength
Timepoint [8] 379178 0
Assessed in first 6 hours of life as per routine clinical practice
Secondary outcome [9] 379179 0
Birth head circumference
Timepoint [9] 379179 0
Measured day 1 and collected from medical record
Secondary outcome [10] 379180 0
Nursery admission
Timepoint [10] 379180 0
After delivery and before discharge home - collected from medical record
Secondary outcome [11] 379181 0
Gestational hypertension
Timepoint [11] 379181 0
Assessed at birth by linkage to pregnancy medical record
Secondary outcome [12] 379182 0
Gestation at delivery
Timepoint [12] 379182 0
Assessed at birth through routine perinatal data collection and access to medical record
Secondary outcome [13] 379183 0
Mode of delivery
Timepoint [13] 379183 0
Type of delivery assessed at birth through medical record (routine perinatal data collection)
Secondary outcome [14] 379235 0
Feasibility - Recruitment rate
Timepoint [14] 379235 0
At trial completion of 12 month follow up of 50 women
Secondary outcome [15] 381768 0
Delivery of program as intended
Timepoint [15] 381768 0
Evaluation survey to participants - sent by email within a month after completion of the 10 week program

Eligibility
Key inclusion criteria
– Women with a BMI greater than or equal to 25kg/m2;
– Aged >/= 18 - 40 years;
– Willing to attend CPA RPA clinic on 3 occasions;
– Willing to follow a weight loss dietary protocol for 10 weeks
– Has been weight stable (i.e. less than 3 kg weight loss) for the past 2 months.
Minimum age
18 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
– Significant pre-existing, diagnosed medical condition that may prevent them from participating in the study, including but not limited to: Kidney disease or renal impairment; Gall bladder disorders or stones; Liver disease (e.g. cirrhosis); severe cardiovascular disease where rapid weight loss is contraindicated eg Cardiac arrhythmia, congenital heart disease; Malabsorptive Gastrointestinal disease (including celiac, Crohns disease);
– History of bariatric surgery;
– Severe depression;
– Cancer (unless benign or non-progressive skin cancer);
– Type 1 or type 2 diabetes.
– Regular use of medications prescribed by a medical practitioner that are deemed unsuitable for this trial – as determined by the appointed study physician during screening process;
– A food allergy/intolerance to, or not willing to consume, the foods prescribed in the protocol;
– A person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table of variable blocks created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Delivery of the intervention is not blinded however the data analyst will be blinded to allocation of intervention or control program.
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
This is a pilot study of a dietary intervention using meal replacements to assess acceptability and feasibility of this weight loss program for women with overweight or obesity planning pregnancy and to determine weight loss between intervention and control arms to inform sample size calculation for a larger trial focused on pregnancy and newborn outcomes

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10375 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 22052 0
2006 - The University Of Sydney
Recruitment postcode(s) [2] 22053 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 298967 0
University
Name [1] 298967 0
The University of Sydney
Address [1] 298967 0
Charles Perkins Centre
Research and Education Hub D17
The University of Sydney, NSW, 2006

Country [1] 298967 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Impromy
Address
83 Cherry Lane, Laverton North VIC 3026.
Country
Australia
Secondary sponsor category [1] 298189 0
None
Name [1] 298189 0
None
Address [1] 298189 0
None
Country [1] 298189 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299900 0
Research Ethics & Governance Office | Royal Prince Alfred Hospital
Ethics committee address [1] 299900 0
Suite 210A, 100 Carillon Ave. Newtown NSW 2042
Ethics committee country [1] 299900 0
Australia
Date submitted for ethics approval [1] 299900 0
11/12/2017
Approval date [1] 299900 0
08/03/2018
Ethics approval number [1] 299900 0

Summary
Brief summary
BACKGROUND: High preconception BMI is the single most important modifiable risk factor for adverse perinatal outcomes and offspring obesity. Trials to limit weight gain during pregnancy have not lived up to the promise of reducing this burden. There is increasing recognition that targeting obesity before pregnancy might improve outcomes for mother and baby. However, there are no current guidelines to suggest which preconception health programs and interventions are of benefit to women above a healthy weight and their infants. Thus, there is urgent need to establish the effectiveness of preconception weight loss, in order to improving short and long-term maternal and child health.

AIM: To assess the feasibility and acceptability of a 10 week online weight loss program in women with a BMI >25 kg/m2 who are planning pregnancy.

Intervention: Women will be randomly allocated to one of the following programs for 10 weeks:
1. An online weight loss program
2. Recommended weight loss advice delivered in a clinic setting

RECRUITMENT: recruitment will occur over the next 6 months. Eligible women will be recruited from the RPA pregnancy planning clinic, Charles Perkins Centre.

OUTCOMES: Weight loss: Measured in kilograms at 10 weeks
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81922 0
Dr Adrienne Gordon
Address 81922 0
University of Sydney, Charles Perkins Centre
Research and Education Hub D17
The University of Sydney | NSW | 2006
Country 81922 0
Australia
Phone 81922 0
+61405816782
Fax 81922 0
Email 81922 0
adrienne.gordon@sydney.edu.au
Contact person for public queries
Name 81923 0
Dr Adrienne Gordon
Address 81923 0
Charles Perkins Centre
Research and Education Hub D17
The University of Sydney | NSW | 2006
Country 81923 0
Australia
Phone 81923 0
+61405816782
Fax 81923 0
Email 81923 0
adrienne.gordon@sydney.edu.au
Contact person for scientific queries
Name 81924 0
Dr Adrienne Gordon
Address 81924 0
Charles Perkins Centre
Research and Education Hub D17
The University of Sydney | NSW | 2006
Country 81924 0
Australia
Phone 81924 0
+61405816782
Fax 81924 0
Email 81924 0
adrienne.gordon@sydney.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?
Demographic and outcome data
When will data be available (start and end dates)?
Week 10 outcome data available from March 2020 for 10 years
12 month follow up data available from Feb 2021, with no end date determined
Available to whom?
Following request to study team available to other researchers
Available for what types of analyses?
Systematic review
IPD
How or where can data be obtained?
By contacting study team - study specific email is cpc.baby1000@sydney.edu.au, principal investigator contact details adrienne.gordon@sydney.edu.au - telephone 02 9515 8248
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6529 0
Ethical approval
Citation [1] 6529 0
Link [1] 6529 0
Email [1] 6529 0
Other [1] 6529 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 6545 0
Conference abstract
Citation/DOI/link/details [1] 6545 0
Results – basic reporting
Results – plain English summary