Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000725369
Ethics application status
Approved
Date submitted
30/10/2015
Date registered
18/05/2017
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Date results information initially provided
4/03/2019
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
nil
Universal Trial Number (UTN)
U1111-1171-9320
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
Obesity

Intervention/exposure
Study type
Interventional
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
Lifestyle
Intervention code [2] 293712 0
Prevention
Comparator / control treatment
Standard obstetric clinical care
Control group
Active

Outcomes
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
Birth
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
Birth
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

Eligibility
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
Sex
Females
Can healthy volunteers participate?
Yes
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
Prevention
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
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/12/2015
Date of last participant enrolment
Anticipated
Actual
6/04/2017
Date of last data collection
Anticipated
6/02/2018
Actual
17/01/2018
Sample size
Target
80
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
WA
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] 10641 0
6008 - Subiaco
Recruitment postcode(s) [2] 10237 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 291979 0
Charities/Societies/Foundations
Name [1] 291979 0
Telethon Kids Institute
Country [1] 291979 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Telethon Kids Institute
Address
100 Roberts Road
Subiaco, WA, 6008
Country
Australia
Secondary sponsor category [1] 295306 0
None
Name [1] 295306 0
Address [1] 295306 0
Country [1] 295306 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 293471 0
30/07/2015
Approval date [1] 293471 0
16/10/2015
Ethics approval number [1] 293471 0
1525
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
Australia
Date submitted for ethics approval [2] 295051 0
30/03/2016
Approval date [2] 295051 0
13/04/2016
Ethics approval number [2] 295051 0
873

Summary
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

Contacts
Principal investigator
Name 60062 0
A/Prof Rae-Chi Huang
Address 60062 0
Telethon Kids Institute
100 Roberts Road
Subiaco WA 6008
Australia
Country 60062 0
Australia
Phone 60062 0
+610894897924
Fax 60062 0
Email 60062 0
rae-chi.huang@telethonkids.org.au
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
Australia
Country 60063 0
Australia
Phone 60063 0
+610894897924
Fax 60063 0
Email 60063 0
rae-chi.huang@telethonkids.org.au
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
Australia
Country 60064 0
Australia
Phone 60064 0
+610894897924
Fax 60064 0
Email 60064 0
rae-chi.huang@telethonkids.org.au

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 369251-(Uploaded-01-03-2019-18-44-06)-Basic results summary.docx
Plain language summaryNo This lifestyle intervention used a web-based app t... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating engagement in a digital and dietetic intervention promoting healthy weight gain in pregnancy: Mixed methods study.2020https://dx.doi.org/10.2196/17845
N.B. These documents automatically identified may not have been verified by the study sponsor.