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Trial registered on ANZCTR


Registration number
ACTRN12612001017819
Ethics application status
Approved
Date submitted
18/09/2012
Date registered
20/09/2012
Date last updated
21/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Young Women's Heart Health Study: the effects of a lifestyle intervention on cardiovascular disease risk factors in overweight women aged 18-30 years
Scientific title
The effects of a randomised control trial 12-week multidisciplinary lifestyle intervention on cardiovascular disease risk factors in young Caucasian women aged 18-30 years with abdominal obesity
Secondary ID [1] 281254 0
Nil
Universal Trial Number (UTN)
U1111-1134-7515
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/ obesity 287446 0
Cardiovascular disease risk factors 287473 0
Condition category
Condition code
Cardiovascular 287785 287785 0 0
Other cardiovascular diseases
Diet and Nutrition 287807 287807 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12-week lifestyle intervention comprising of:
(1) Physical activity (3 sessions per week).
a. 2 sessions per week of a 45-60 minute aerobic and strength training circuit/ group class (at 70-85% maximal effort) supervised by an exercise physiologist. The circuit incorporated cycling on a stationary ergometer, walking/jogging on a motorised treadmill, body-mass strength exercises and resistance training using free and machine weights.
b. 1 unsupervised session per week of brisk walking/jogging. Starting with 30 minutes and building to 45 minutes (with structured intervals) by the end of the intervention at an intensity of 70-85% maximal effort.

(2) Nutrition education - one theme (e.g. serving size, dietary fats) was prepared each week by a dietician. Printed information was administered to each participant. An accompanying short explanation (eg. 15 minutes) of this information was provided by the study coordinator (an exercise physiologist).

(3) Cognitive behavioural therapy (1-hour group session per week - delivered by a counsellor).
Intervention code [1] 285720 0
Early detection / Screening
Intervention code [2] 285721 0
Prevention
Intervention code [3] 285722 0
Lifestyle
Comparator / control treatment
Wait-list control group. Control participants maintained their usual lifestyle habits for the 12-weeks. These same participants were eventually exposed to the lifestyle intervention.
Control group
Active

Outcomes
Primary outcome [1] 288007 0
Abdominal obesity as assessed by waist circumference
Timepoint [1] 288007 0
Baseline and at 12 and 24 weeks after intervention commencement. A small sample of participants were also measured at one year after randomisation.
Secondary outcome [1] 299259 0
Blood borne markers of cardiovascular disease risk (fasting glucose, insulin, hsCRP, total cholesterol, HDL-cholesterol, triglycerides) as assessed by the analysis of blood samples.
Timepoint [1] 299259 0
Baseline and at 12 and 24 weeks after intervention commencement. A small sample of participants were also measured at one year after randomisation.
Secondary outcome [2] 299260 0
Anthropometric measures as assessed by height, body mass and hip circumference
Timepoint [2] 299260 0
Baseline and at 12 and 24 weeks after intervention commencement. A small sample of participants were also measured at one year after randomisation.
Secondary outcome [3] 299261 0
Aerobic fitness as assessed by the YMCA submaximal cycle eregometer test
Timepoint [3] 299261 0
Baseline and at 12 and 24 weeks after intervention commencement. A small sample of participants were also measured at one year after randomisation.
Secondary outcome [4] 299262 0
Cardiac function (including measures of heart structure, architecture, haemodynamics and myocardial strain) as assessed by cardiovascular ultrasound imaging
Timepoint [4] 299262 0
Baseline and at 12 and 24 weeks after intervention commencement. A small sample of participants were also measured at one year after randomisation.
Secondary outcome [5] 299263 0
Vascular function (including carotid artery intima-media thickness and brachial artery flow-mediated dilation) as assessed by cardiovascular ultrasound imaging.
Timepoint [5] 299263 0
Baseline and at 12 and 24 weeks after intervention commencement. A small sample of participants were also measured at one year after randomisation.
Secondary outcome [6] 299264 0
Lifestyle information including health status, current physical activity levels, 15D measure of health-related quality-of-life questionnaire (Sintonen & Perkurinen, 1993), Stages-of-change (Marcus et al, 1992), Motives for physical activity (Ryan et al, 1997) and Barriers to physical activity (Garcia et al 1995) were assessed.

Diet was assessed by a 3-day food recall and the Foodworks Program
Timepoint [6] 299264 0
Baseline and at 12 and 24 weeks after intervention commencement. A small sample of participants were also measured at one year after randomisation.
Secondary outcome [7] 299265 0
Vascular function as assessed by blood pressure using an automatic sphygmomanometer
Timepoint [7] 299265 0
Baseline and at 12 and 24 weeks after intervention commencement. A small sample of participants were also measured at one year after randomisation.

Eligibility
Key inclusion criteria
Abdominal obesity (defined as: waist circumference greater than or equal to 80cm), Caucasian, sedentary (defined as: physical activity less than 210 minutes per week)
Minimum age
18 Years
Maximum age
30 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or breast-feeding; smoker; diagnosed with: polycystic ovarian syndrome, type 1 diabetes mellitus, gestational diabetes, thyroid abnormalities, cardiovascular disease, heart arrhythmia and liver or kidney disease; taking medications that could confound exercise response

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation: Participants were randomly allocated to either the intervention or control group by coin-tossing by an individual not associated with the study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Wait-list control group
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286027 0
University
Name [1] 286027 0
Australian Catholic University
Address [1] 286027 0
Australian Catholic University
School of Exercise Science
115 Victoria Parade
Fitzroy
VICTORIA, 3065
Country [1] 286027 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Australian Catholic University
School of Exercise Science
115 Victoria Parade
Fitzroy
VICTORIA, 3065
Country
Australia
Secondary sponsor category [1] 284841 0
None
Name [1] 284841 0
Address [1] 284841 0
Country [1] 284841 0
Other collaborator category [1] 277077 0
University
Name [1] 277077 0
University of Avignon
Address [1] 277077 0
Laboratory of Cardiovascular Pharmacology
University of Avignon
33 Louis Pasteur Street
AVIGNON, 84000
Country [1] 277077 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288076 0
Australian Catholic University Research Ethics Committee
Ethics committee address [1] 288076 0
Australian Catholic University
Research Services
115 Victoria Parade
Fitzroy
VICTORIA, 3065
Ethics committee country [1] 288076 0
Australia
Date submitted for ethics approval [1] 288076 0
Approval date [1] 288076 0
18/12/2009
Ethics approval number [1] 288076 0
v2009-91

Summary
Brief summary
The Young Women’s Heart Health Study aims to assess the influence and sustainability of a 12-week multidisciplinary lifestyle intervention - comprising of physical activity, nutrition education and cognitive behavioural therapy - on cardiovascular disease risk factors in young inactive Caucasian women aged 18 to 30 years who have abdominal obesity. Cardio-metabolic markers analysed at baseline, post-intervention and 3-months post intervention will include: waist circumference, BMI, blood pressure, aerobic fitness, triglycerides, fasting glucose, HOMA-IR, total cholesterol, hsCRP HDL-cholesterol, cardiac structure and function, myocardial strain, vascular endothelial function and arterial intima-media thickness. It is hypothesised that the lifestyle intervention will reduce abdominal obesity and improve cardio-metabolic markers. The outcome of this work aspires to advance the understanding of heart health in young women.
Trial website
Trial related presentations / publications
Poster Presentation: Heart Foundation Conference, Melbourne, March 2011

Podium Presentation: Be Active - International Congress on Physical Activity and Public Health, Sydney, October 2012
Public notes

Contacts
Principal investigator
Name 34728 0
Address 34728 0
Country 34728 0
Phone 34728 0
Fax 34728 0
Email 34728 0
Contact person for public queries
Name 17975 0
Bianca Share
Address 17975 0
Australian Catholic University
School of Exercise Science
115 Victoria Parade, Fitzroy
VICTORIA, 3065
Country 17975 0
Australia
Phone 17975 0
+61 3 9953 3538
Fax 17975 0
Email 17975 0
bianca.share@acu.edu.au
Contact person for scientific queries
Name 8903 0
Bianca Share
Address 8903 0
Australian Catholic University
School of Exercise Science
115 Victoria Parade, Fitzroy
VICTORIA, 3065
Country 8903 0
Australia
Phone 8903 0
+61 3 9953 3538
Fax 8903 0
Email 8903 0
bianca.share@acu.edu.au

No information has been provided regarding IPD availability
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 – basic reporting
Results – plain English summary