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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
Date results information initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
The PLAN Project: Pregnancy Lifestyle Activity and Nutrition: effectiveness of maternal lifestyle intervention commenced before 10 weeks gestation, in normal, overweight and obese mothers on maternal behaviours and infant's adiposity.
Scientific title
A randomised controlled trial investigating whether a maternal lifestyle intervention with behaviour change intervention commencing before 10 weeks gestation and consolidation phase to end of pregnancy, compared to usual clinical care, optimizes maternal lifestyle behaviour and reduces offspring adiposity.
Secondary ID [1] 287412 0
Universal Trial Number (UTN)
Trial acronym
PLAN Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 296118 0
Condition category
Condition code
Diet and Nutrition 296379 296379 0 0

Study type
Description of intervention(s) / exposure
The Pregnancy Lifestyle Activity Nutrition (PLAN) intervention is a 12-week program in early gestation, starting before 10 weeks gestation, which includes a web based application with a weight tracker, diet, physical activity and psychological modules. Accompanying the web-based programme, participants will have access to a one on one session with a dietitian/research nurse, and follow up with personalised, automated SMS follow up on SMART goal. SMART stands for Specific Measurable Attainable Realistic Time-Based. The SMART goal is decided on in consultation with the dietician. Following the end of the 12 week intervention period, the individual continues to have access to the web-site App and SMS SMART goal follow up until the end of pregnancy.

In further detail, the intervention includes:
1. Delivery of gestational weight gain guidelines according to the Institute of Medicine (The web-based application customised for this study provides a real-time feedback of a mother’s weight synchronized to her stage of pregnancy. It plots the individual’s weight against an individualized optimal weight gain based on guidelines. Immediate feedback is given when weight is entered. According to level of adherence to guidelines, escalating support will be given in the form of SMS reminders, telephone or face to face visits);
2. Web based delivery of Dietary education (on low glycemic index, low saturated fat, increased omega-3 fatty acid, increased fibre), cognitive behavioural materials to encourage goal setting, self-monitoring and problem solving and physical activity guidelines;
3. One private session with a trained research assistant who will deliver tailored feedback on dietary intake and accelerometry with personalized diet and exercise plans, and SMART goal setting. (This occurs at approximately week 2 of the intervention and the duration is approximately 45-60 minutes.)
4. Automated follow SMS targeted to the individual’s SMART goal stipulated in the one on one session.

The web based intervention provides a combination of written material and interactive activities such as quizzes. The participants are progressively given access to the material with 3 modules delivered every week. Participants are given email reminders to enter weight twice a week and also emails to inform them that new modules are available.

Strategies to monitor adherence will include evidence of frequency of weight logging on the web based application.
Intervention code [1] 292764 0
Intervention code [2] 293712 0
Comparator / control treatment
Standard obstetric clinical care
Control group

Primary outcome [1] 296024 0
Gestational weight gain in kg between start of intervention and to end of 12 weeks intervention
Timepoint [1] 296024 0
Measured between start of intervention to end of 12 week intervention.
Primary outcome [2] 296025 0
Neonatal and infant body fat percentage measured using the Cosmed PeaPod, a non-invasive assessment that uses air-displacement plethysmography.
Timepoint [2] 296025 0
Primary outcome [3] 298324 0
Rate of gestational weight gain during pregnancy in kg/week.
Timepoint [3] 298324 0
At enrolment and 36 weeks gestation
Secondary outcome [1] 317275 0
DNA methylation assessed on DNA extracted from cord blood
Timepoint [1] 317275 0
Secondary outcome [2] 323848 0
Glucose tolerance as ascertained by routine oral glucose tolerance test at 28 weeks gestation
Timepoint [2] 323848 0
28 weeks gestation

Key inclusion criteria
Pregnant women who are recruited at <10 weeks gestation and have a pre-pregnancy BMI of >20, or BMI >18 in high-risk ethnic groups.
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria
Women with a current diagnosis of a serious pre-existing medical condition (e.g. type 1 or 2 diabetes, psychosis, eating disorder, thyroid condition or on medication for Polycystic Ovarian Syndrome)
Multiple births

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Written informed consent will be obtained before participating in an enrolment appointment. Each participating pregnant woman will be assigned a unique study number and randomly allocated to control or intervention.
Allocation is undertaken by a computer generated algorithm prespecified on RedCap which is stored on servers at a central administration site. After enrolment, the research assistant accesses the computer generated allocation to group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be computer-generated (varying size of permuted blocks) and stratified by body mass index (BMI).
The randomisation will be produced by an independent party
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 1 / Phase 2
Type of endpoint(s)
Statistical methods / analysis
The primary clinical outcomes will be assessed on an “intention-to-treat” basis.
Differences in gestational weight gain in kg between control and intervention group between start and end of intervention and total gestational weight gain will be assessed with linear regression.
Differences between control and intervention group for outcomes in the infant of fat mass, and anthropometry will be assessed by linear mixed modelling adjusted for baseline and covariates (including sex and ethnicity of the infant).
Based on the maternal primary outcome, we require 333 per group to detect a 1.0 kg weight difference between groups (80% power, 0.05 level) . Allowing for a 20% dropout, a total sample size of 800 (400 per group) is required. The feasibility study involves a target of 40 in each group, total 80.

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] 4300 0
Joondalup Health Campus - Joondalup
Recruitment hospital [2] 4436 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 10237 0
6027 - Joondalup
Recruitment postcode(s) [2] 10641 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 291979 0
Name [1] 291979 0
Telethon Kids Institute
Address [1] 291979 0
100 Roberts Road
Subiaco, WA, 6008
Country [1] 291979 0
Primary sponsor type
Telethon Kids Institute
100 Roberts Road
Subiaco, WA, 6008
Secondary sponsor category [1] 295306 0
Name [1] 295306 0
Address [1] 295306 0
Country [1] 295306 0

Ethics approval
Ethics application status
Ethics committee name [1] 293471 0
Joondalup Health Campus Human Research Ethics Committee
Ethics committee address [1] 293471 0
Grand Blvd & Shenton Ave
Joondalup, WA, 6027
Ethics committee country [1] 293471 0
Date submitted for ethics approval [1] 293471 0
Approval date [1] 293471 0
Ethics approval number [1] 293471 0
Ethics committee name [2] 295051 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [2] 295051 0
12 Salvado Road
Subiaco, WA, 6008
Ethics committee country [2] 295051 0
Date submitted for ethics approval [2] 295051 0
Approval date [2] 295051 0
Ethics approval number [2] 295051 0

Brief summary
This RCT will test whether a lifestyle intervention in early pregnancy optimizes gestational weight gain and reduces offspring adiposity. The intervention will use smart phone web based applications to deliver diet, physical activity and well being advice to overweight or obese pregnant women in early pregnancy (commenced prior t0 10 weeks gestation) to optimise their gestational weight gain (weight gain during the course of the pregnancy) within the recommended medical guidelines.

The project will then follow up to assess neonatal and infant outcomes in relation to fat percentage and anthropometry.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 60062 0
A/Prof Rae-Chi Huang
Address 60062 0
Telethon Kids Institute
100 Roberts Road
Subiaco WA 6008
Country 60062 0
Phone 60062 0
Fax 60062 0
Email 60062 0
Contact person for public queries
Name 60063 0
A/Prof Rae-Chi Huang
Address 60063 0
Telethon Kids Institute
100 Roberts Road
Subiaco WA 6008
Country 60063 0
Phone 60063 0
Fax 60063 0
Email 60063 0
Contact person for scientific queries
Name 60064 0
A/Prof Rae-Chi Huang
Address 60064 0
Telethon Kids Institute
100 Roberts Road
Subiaco WA 6008
Country 60064 0
Phone 60064 0
Fax 60064 0
Email 60064 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?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – plain English summary
This lifestyle intervention used a web-based app to deliver an intervention that started between 8 to 11 weeks gestation. While it did not alter gestational weight gain, feasibility of early recruitment was observed and some differences were noted with respect to secondary outcomes such as diet and mental health.