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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

12/11/2021

Date data sharing statement initially provided

22/05/2020

Date results 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]

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)

Condition category

Condition code

Diet and Nutrition

Obesity

Reproductive Health and Childbirth

Antenatal care

Reproductive Health and Childbirth

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]

Prevention

Intervention code [2]

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]

Change in weight (in kg) between week 0 and week 10
Measured in person using identical digital scales

Timepoint [1]

Weight in kg at completion of the 10 week program

Primary outcome [2]

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]

At the completion of the 10 week program

Secondary outcome [1]

Weight (kg) in first trimester (if pregnant within 12 months post intervention). Measured at hospital booking visit using digital scales.

Timepoint [1]

First trimester hospital booking visit - 12 weeks gestation

Secondary outcome [2]

Waist circumference (cm) measured in person at study visits using SOP

Timepoint [2]

At completion of the 10 week program

Secondary outcome [3]

Weight at 12 months (kg) measured in person at study visit using digital scales

Timepoint [3]

12 months after completion of the program

Secondary outcome [4]

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]

12 months after completion of the program

Secondary outcome [5]

Gestational diabetes

Timepoint [5]

Assessed after birth by access to electronic medical record and perinatal data

Secondary outcome [6]

Birthweight

Timepoint [6]

Assessed at birth using digital scales as per normal clinical practice

Secondary outcome [7]

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]

Measured at 5 and 10 weeks

Secondary outcome [8]

Birthlength

Timepoint [8]

Assessed in first 6 hours of life as per routine clinical practice

Secondary outcome [9]

Birth head circumference

Timepoint [9]

Measured day 1 and collected from medical record

Secondary outcome [10]

Nursery admission

Timepoint [10]

After delivery and before discharge home - collected from medical record

Secondary outcome [11]

Gestational hypertension

Timepoint [11]

Assessed at birth by linkage to pregnancy medical record

Secondary outcome [12]

Gestation at delivery

Timepoint [12]

Assessed at birth through routine perinatal data collection and access to medical record

Secondary outcome [13]

Mode of delivery

Timepoint [13]

Type of delivery assessed at birth through medical record (routine perinatal data collection)

Secondary outcome [14]

Feasibility - Recruitment rate

Timepoint [14]

At trial completion of 12 month follow up of 50 women

Secondary outcome [15]

Delivery of program as intended

Timepoint [15]

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

Sex

Females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

Actual

14/06/2018

Date of last participant enrolment

Anticipated

Actual

18/12/2019

Date of last data collection

Anticipated

18/12/2020

Actual

21/12/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment postcode(s) [1]

2006 - The University Of Sydney

Recruitment postcode(s) [2]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

Charles Perkins Centre
Research and Education Hub D17
The University of Sydney, NSW, 2006

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Impromy

Address

83 Cherry Lane, Laverton North VIC 3026.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Ethics & Governance Office | Royal Prince Alfred Hospital

Ethics committee address [1]

Suite 210A, 100 Carillon Ave. Newtown NSW 2042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/12/2017

Approval date [1]

08/03/2018

Ethics approval number [1]

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

Dr Adrienne Gordon

Address

University of Sydney, Charles Perkins Centre
Research and Education Hub D17
The University of Sydney | NSW | 2006

Country

Australia

Phone

+61405816782

Fax

[email protected]

Contact person for public queries

Name

Rachelle Sau-Harvey

Address

Charles Perkins Centre
Research and Education Hub D17
The University of Sydney | NSW | 2006

Country

Australia

Phone

+61 402 856 864

Fax

[email protected]

Contact person for scientific queries

Name

Adrienne Gordon

Address

Charles Perkins Centre
Research and Education Hub D17
The University of Sydney | NSW | 2006

Country

Australia

Phone

+61405816782

Fax

[email protected]

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 [email protected], principal investigator contact details [email protected] - telephone 02 9515 8248

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6529	Ethical approval					374716-(Uploaded-22-01-2020-08-36-11)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

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Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A pilot randomized controlled trial of a partial meal replacement preconception weight loss program for women with overweight and obesity.	2021	https://dx.doi.org/10.3390/nu13093200

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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