Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001528246
Ethics application status
Approved
Date submitted
9/09/2018
Date registered
12/09/2018
Date last updated
12/06/2019
Date data sharing statement initially provided
19/02/2019
Date results information initially provided
12/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a healthy lifestyle program for women with a history of pre-eclampsia: Be Healthe for your Heart
Scientific title
A randomised controlled trial to determine the feasibility of a translatable eHealth healthy lifestyle intervention for women with a history of pre-eclampsia: Be Healthe for your Heart Study
Secondary ID [1] 295967 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BH4YH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-eclampsia
309477 0
Cardiovascular disease 309478 0
Condition category
Condition code
Reproductive Health and Childbirth 308311 308311 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 308312 308312 0 0
Coronary heart disease
Cardiovascular 308423 308423 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention phase will run for 3-months. Once enrolled in the study, participants will be randomly allocated into 2 groups: 1) Be Healthe for your Heart lifestyle eHealth intervention; 2) control group. The requirements for each group are as follows:

Be Healthe for your Heart (Group 1):
-Participants will be provided with access to online resources developed by the program related to healthy eating, physical activity, weight management and stress management via the Be Healthe for your Heart webpage for 3-months. Participants will can access the website as often as they choose but will be encouraged to log-in once per week.
-Participants will receive weekly newsletter emails which will summarise the information given by the program resources related to a specific health behaviour topic.
-Lifestyle recommendations will be consistent with the National Heart Foundation’s Eating for Heart Health Position Statement and Australia’s Physical Activity and Sedentary Behaviour Guidelines for Adults (18-64 years) and Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults, Adolescents and Children in Australia.
-Participants will be asked to complete an initial 'screening tool' to evaluate their current eating behaviours, physical activity levels, body weight and stress. They will receive individualised automated (generated by the website) feedback based their responses to the screening tool questions. The feedback provided will be based on a scoring system that compares current health behaviours to program recommendations.
-The participants will be able select pre-specified goals for the duration of the study related to healthy eating, physical activity, stress management and weight management on the program website.
-Participants will be able to monitor their progress towards their health behaviour goals and will be provided with automated feedback on their progress throughout the 3-months.
-The study will also objectively measure the participants’ use of the intervention components by recording their website logins, website page visits and number of email newsletters opened.
Intervention code [1] 312296 0
Lifestyle
Intervention code [2] 312297 0
Behaviour
Comparator / control treatment
Control (Group 2):
•Participants will be sent an email with a web-link to the National Heart Foundation website to access all available online information.
Control group
Active

Outcomes
Primary outcome [1] 307291 0
Program acceptability measured using a questionnaire designed specifically by the study
Timepoint [1] 307291 0
3 months
Primary outcome [2] 307388 0
Resource efficiency will be logged weekly by the project manager using Excel spreadsheets which will record the budget, resources and time required to implement the study
Timepoint [2] 307388 0
Continuous for the duration of the study (3 months)
Secondary outcome [1] 351394 0
Weight (kg) measured on a digital scale
Timepoint [1] 351394 0
Baseline and 3 months
Secondary outcome [2] 351397 0
Systolic and Diastolic Blood pressure measured using a automatic sphygmomanometer
Timepoint [2] 351397 0
Baseline and 3 months
Secondary outcome [3] 351399 0
Physical activity measured using the International Physical Activity Questionnaire (IPAQ) (short-form)
Timepoint [3] 351399 0
Baseline and 3 months
Secondary outcome [4] 351400 0
Time spent sitting will measured using The Doman-Specific Sitting Questionnaire (adapted version)
Timepoint [4] 351400 0
Baseline and 3 months
Secondary outcome [5] 351401 0
Dietary intake measured using the Australian Eating Survey
Timepoint [5] 351401 0
Baseline and 3 months
Secondary outcome [6] 351402 0
Stress, depression and anxiety will be measured using the Depression, Anxiety and Stress Scale
Timepoint [6] 351402 0
Baseline and 3 months
Secondary outcome [7] 351772 0
Fasting blood samples will assayed for total cholesterol
Timepoint [7] 351772 0
Baseline and 3 months
Secondary outcome [8] 351773 0
Fasting blood samples will assayed for high-density lipoprotein cholesterol (HDL-C)
Timepoint [8] 351773 0
Baseline and 3 months
Secondary outcome [9] 351774 0
Fasting blood samples will assayed for low-density lipoprotein cholesterol (LDL-C)
Timepoint [9] 351774 0
Baseline and 3 months
Secondary outcome [10] 351775 0
Fasting blood samples will assayed for triglycerides
Timepoint [10] 351775 0
Baseline and 3 months
Secondary outcome [11] 351776 0
Fasting blood samples will assayed for glucose
Timepoint [11] 351776 0
Baseline and 3 months
Secondary outcome [12] 351777 0
Fasting blood samples will assayed for insulin
Timepoint [12] 351777 0
Baseline and 3 months
Secondary outcome [13] 351778 0
Life quality and satisfaction will be measured using The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form
Timepoint [13] 351778 0
Baseline and 3 months
Secondary outcome [14] 351779 0
Life quality and satisfaction will be measured using The Satisfaction with Life Scale
Timepoint [14] 351779 0
Baseline and 3 months
Secondary outcome [15] 351783 0
Cardiovascular disease risk measured using the Framingham Full Cardiovascular Disease 30-year risk score (includes risk of hard CVD or coronary insufficiency, angina pectoris, transient ischemic attack, intermittent claudication or congestive heart failure)
Timepoint [15] 351783 0
Baseline and 3 months
Secondary outcome [16] 351784 0
Body mass will measured using bioelectrical impedance
Timepoint [16] 351784 0
Baseline and 3 months
Secondary outcome [17] 351785 0
Visceral fat will measured using bioelectrical impedance
Timepoint [17] 351785 0
Baseline and 3 months
Secondary outcome [18] 351786 0
Percentage body fat will measured using bioelectrical impedance
Timepoint [18] 351786 0
Baseline and 3 months

Eligibility
Key inclusion criteria
-Diagnosis of pre-eclampsia within the past 4 years
-Access to an electronic device (e.g. computer, smart-phone, tablet) with internet and email access
-Able to attend assessments at the University of Newcastle Callaghan campus, interested in improving eating habits, physical activity levels and managing their body weight and stress levels
-Completed post-partum check-up at 6 weeks with doctor with no further follow-up required
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-Currently or recently (<3 months post-partum) pregnant; planning to become pregnant within the next 3 months
-Currently or planning to participate in another healthy lifestyle program
-Diagnosed with type-1 diabetes
-Non-English speaking
-Unable to provide the contact details of their General Practitioner

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)
A researcher that is not a primary investigator of the study will prepare the concealed envelopes and distribute them following the completion of baseline assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence was generated by a computer-based random number algorithm producing individual group allocation in block lengths of six and stratified by time since pre-eclampsia.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be measured through the series of objective measures and questionnaires as outlined above. All analyses will be performed using STATA. Data will be presented as mean (SD) or median (IQR) for continuous variables and counts (percentages) for categorical variables. Changes in impact on absolute cardiovascular risk score, cardiovascular risk markers and lifestyle health behaviours will be determined, and differences between groups. Analysis for the efficacy outcomes will be conducted on an intention-to-treat basis (all participants who were randomized to groups and completed baseline assessments) and for completers only (those who provided data at 3-months). The effect of treatment on the efficacy outcomes will be assessed using linear mixed models. The efficacy outcome will be the outcome in the model, time (baseline, 3-months) and treatment group (intervention, control) as predictors, and group × time as an interaction term. The p-value of the interaction term will be used to determine the statistical significance of any difference between treatment groups in the change from baseline. Effect sizes will be calculated using the equation: Cohen’s d = (M1 change score - M2 change score)/SDpooled (change scores).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/11/2018
Actual
12/02/2019
Date of last participant enrolment
Anticipated
22/03/2019
Actual
19/04/2019
Date of last data collection
Anticipated
22/07/2019
Actual
Sample size
Target
90
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300563 0
Charities/Societies/Foundations
Name [1] 300563 0
National Heart Foundation Vanguard Grant
Country [1] 300563 0
Australia
Funding source category [2] 300565 0
Charities/Societies/Foundations
Name [2] 300565 0
Foundation for High Blood Pressure Research
Country [2] 300565 0
Australia
Primary sponsor type
Individual
Name
Dr Melinda Hutchesson
Address
Hunter Building
University Drive
University of Newcastle
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 300048 0
Individual
Name [1] 300048 0
Professor Clare Collins
Address [1] 300048 0
University of Newcastle
ATC 310
Advance Technology Centre
University Drive
Callaghan NSW 2308
Country [1] 300048 0
Australia
Secondary sponsor category [2] 300050 0
Individual
Name [2] 300050 0
Professor Robin Callister
Address [2] 300050 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University Of Newcastle
Callaghan, NSW 2308
Country [2] 300050 0
Australia
Secondary sponsor category [3] 300051 0
Individual
Name [3] 300051 0
Dr Felicity Parks
Address [3] 300051 0
Maternity & Gynaecology
John Hunter Hospital, Locked Bag 1, Hunter Region Mail Centre NSW 2310
Country [3] 300051 0
Australia
Secondary sponsor category [4] 300052 0
Individual
Name [4] 300052 0
Dr Linda Campbell
Address [4] 300052 0
Priority Research Centre for GrowUpWell
University Drive
The University of Newcastle
Callaghan
NSW 2308
Country [4] 300052 0
Australia
Secondary sponsor category [5] 300053 0
Individual
Name [5] 300053 0
Dr Lisa Vincze
Address [5] 300053 0
School of Allied Health Sciences
G02 Clinical Sciences 1, Level 1.04
Gold Coast campus
Griffith University QLD 4222
Country [5] 300053 0
Australia
Secondary sponsor category [6] 300054 0
Individual
Name [6] 300054 0
Dr Vanessa Shrewsbury
Address [6] 300054 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University of Newcastle
Callaghan
NSW 2308
Country [6] 300054 0
Australia
Secondary sponsor category [7] 300055 0
Individual
Name [7] 300055 0
Miss Rachael Taylor
Address [7] 300055 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University of Newcastle
Callaghan
NSW 2308
Country [7] 300055 0
Australia
Secondary sponsor category [8] 300056 0
Individual
Name [8] 300056 0
Ms Nicole Bennett
Address [8] 300056 0
Maternity & Gynaecology
John Hunter Hospital, Locked Bag 1, Hunter Region Mail Centre NSW 2310
Country [8] 300056 0
Australia
Secondary sponsor category [9] 300057 0
Individual
Name [9] 300057 0
Ms Therese Finnegan
Address [9] 300057 0
Maternity & Gynaecology
John Hunter Hopsital, Locked Bag 1, Hunter Region Mail Centre, Nsw 2310
Country [9] 300057 0
Australia
Secondary sponsor category [10] 301808 0
Individual
Name [10] 301808 0
Grace Perrot
Address [10] 301808 0
ATC Building Priority Research Centre for Physical Activity and Nutrition University Drive The University of Newcastle Callaghan NSW 2308
Country [10] 301808 0
Australia
Secondary sponsor category [11] 301809 0
Individual
Name [11] 301809 0
Maxime Gelens
Address [11] 301809 0
ATC Building Priority Research Centre for Physical Activity and Nutrition University Drive The University of Newcastle Callaghan NSW 2308
Country [11] 301809 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301355 0
Hunter New England Local Health District, Hunter New England Human Research Ethics Committee
Ethics committee address [1] 301355 0
Locked Bag 1 HRMC, Hunter Region MC, NSW 2310
Ethics committee country [1] 301355 0
Australia
Date submitted for ethics approval [1] 301355 0
30/08/2018
Approval date [1] 301355 0
05/10/2018
Ethics approval number [1] 301355 0
18/09/19/4.09

Summary
Brief summary
The aim of the research is to evaluate the feasibility and preliminary efficacy of a 3-month eHealth intervention for women (aged 18-45 years) with a history of pre-eclampsia (within 4 years of diagnosis). Participants (n=90) will be randomly allocated to the intervention (Be Healthe for your Heart) or the control group. Be Healthe for your Heart supports participants to make changes to key lifestyle behaviours associated with cardiovascular risk, using evidence-based behaviour change techniques (e.g. self-monitoring, goal setting). The Be Healthe for your Heart program resources are tailored to women of childbearing age and delivered via website and email newsletters. Outcomes will be measured at baseline and 3-months, including the Framingham Cardiovascular Disease 30-year risk score, cardiovascular disease risk markers (BMI, waist circumference, blood pressure, biochemical markers), lifestyle risk factors (dietary intake, physical activity, stress levels) and general health and well-being. Intervention acceptability will be evaluated using objective usage data and intervention participant feedback via a process evaluation questionnaire.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86722 0
Dr Melinda Hutchesson
Address 86722 0
Hunter Building
University Drive
University of Newcastle
Callaghan NSW 2308
Country 86722 0
Australia
Phone 86722 0
+61 2 49215405
Fax 86722 0
Email 86722 0
[email protected]
Contact person for public queries
Name 86723 0
Dr Melinda Hutchesson
Address 86723 0
Hunter Building
University Drive
University of Newcastle
Callaghan NSW 2308
Country 86723 0
Australia
Phone 86723 0
+61 2 49215405
Fax 86723 0
Email 86723 0
[email protected]
Contact person for scientific queries
Name 86724 0
Dr Melinda Hutchesson
Address 86724 0
Hunter Building
University Drive
University of Newcastle
Callaghan NSW 2308
Country 86724 0
Australia
Phone 86724 0
+61 2 49215405
Fax 86724 0
Email 86724 0
[email protected]

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


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
SourceTitleYear of PublicationDOI
EmbaseBe healthe for your heart: A pilot randomized controlled trial evaluating a web-based behavioral intervention to improve the cardiovascular health of women with a history of preeclampsia.2020https://dx.doi.org/10.3390/ijerph17165779
EmbaseBe Healthe for Your Heart: Protocol for a Pilot Randomized Controlled Trial Evaluating a Web-Based Behavioral Intervention to Improve the Cardiovascular Health of Women With a History of Preeclampsia.2019https://dx.doi.org/10.3389/fcvm.2019.00144
N.B. These documents automatically identified may not have been verified by the study sponsor.