None listed
Conditions
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.
Interventions
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 Hear
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.
Sponsors
Dr Melinda Hutchesson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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
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
Outcome results
None listed