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Trial registered on ANZCTR


Registration number
ACTRN12616000235404
Ethics application status
Approved
Date submitted
16/02/2016
Date registered
22/02/2016
Date last updated
14/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Lifestyle intervention for metabolic syndrome
Scientific title
Lifestyle intervention to reduce potentially avoidable hospital presentations and risk factors for metabolic syndrome: a retrospective evaluation
Secondary ID [1] 288553 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 297661 0
Obesity 297662 0
Hypertension 297663 0
Impaired glucose tolerance 297664 0
Dislipidemia 297665 0
Condition category
Condition code
Metabolic and Endocrine 297849 297849 0 0
Metabolic disorders
Diet and Nutrition 297901 297901 0 0
Obesity
Cardiovascular 297902 297902 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective evaluation of a lifestyle intervention program that has been running at a health service for 2 years.
Intervention group participants would have participated in an 8 week multidisciplinary lifestyle intervention program. The program comprised of 8 once-weekly 2.5 hour group education and exercise sessions with or without an additional 1 hour exercise session per week. The education sessions were based on adult learning principals and were conducted in the health service. Topics changed over time (dependent on staffing), and may have included healthy eating, mental health, making changes, medication management, exercise and GP involvement in the management of health conditions and where to get support in the community. Exercise sessions were conducted in the health service or in the community and included walking, water exercise and local gym exercise.
Intervention code [1] 293932 0
Not applicable
Comparator / control treatment
This retrospective study will match participants with metabolic syndrome who attended the lifestyle intervention program to control participants with metabolic syndrome who were referred to the program but did not attend. Participants will be matched according to age (+/- 5 years) and sex.
Both intervention and control group participants would have received usual care from the health service (e.g. outpatient appointments, medical, nursing and allied health as required) and in the community (e.g. GP care).
Control group
Active

Outcomes
Primary outcome [1] 297372 0
The number of potentially avoidable hospital presentations to the health service per group will be identified by screening central hospital medical records (which cover the 5 hospital sites affiliated with the health service).
Potentially avoidable hospitalisations are admissions to hospital that could have potentially been prevented through the provision of appropriate non-hospital health services. Potentially avoidable presentations to an emergency department are those where the patient: 1) is triaged as a category 4 or 5; 2) did not arrive by ambulance, police or correctional vehicle; and 3) was not admitted to hospital not referred to another hospital or did not die.
Timepoint [1] 297372 0
Hospital records will be screened from the date that a participant was referred to the lifestyle intervention program up until March 1, 2016.
Primary outcome [2] 297373 0
Presence or absence of metabolic syndrome and metabolic syndrome risk factors as defined by the International Diabetes Federation; National Heart, Lung and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and the International Association for the Study of Obesity joint statement will be assessed by screening medical records.
Timepoint [2] 297373 0
Medical records will be screened for information from the date that the participant was referred to the intervention program until March 1, 2016. The most recent medical record data available will be used as the primary endpoint.
Secondary outcome [1] 320863 0
The presence of impaired glucose tolerance (elevated fasting glucose 100mg/dL or more, or on drug therapy for elevated glucose or with a diagnosis of pre-diabetes or diabetes) will be assessed by screening medical records.
Timepoint [1] 320863 0
Medical records will be screened for information from the date that the participant was referred to the intervention program until March 1, 2016. The most recent medical record data available will be used as the primary endpoint.
Secondary outcome [2] 320864 0
The presence of overweight and obesity (elevated waist circumference using population specific definitions or Body Mass Index using World Health Organization definitions) will be assessed by screening hospital medical records.
Timepoint [2] 320864 0
Medical records will be screened for information from the date that the participant was referred to the intervention program until March 1, 2016. The most recent medical record data available will be used as the primary endpoint.
Secondary outcome [3] 320867 0
The presence of dislipidemia (elevated triglycerides 1.7mmol/L or more, or on drug therapy for elevated triglycerides, or reduced HDL cholesterol <1.0mmol/L for males or <1.3mmol/L for females or on drug therapy for reduced HDL cholesterol) will be assessed by screening medical records.
Timepoint [3] 320867 0
Medical records will be screened for information from the date that the participant was referred to the intervention program until March 1, 2016. The most recent medical record data available will be used as the primary endpoint.
Secondary outcome [4] 320872 0
The presence of cardiovascular disease will be assessed by screening medical records for documented diagnosis of cardiovascular diseases.
Timepoint [4] 320872 0
Medical records will be screened for information from the date that the participant was referred to the intervention program until March 1, 2016. The most recent medical record data available will be used as the primary endpoint.
Secondary outcome [5] 320874 0
At the health service, exercise endurance is assessed as part of routine practice, using the 6 minute walk test, before and after the lifestyle intervention program. Therefore, only intervention group participants will have this data available for extraction from their medical records for the retrospective evaluation.
Timepoint [5] 320874 0
Exercise endurance measured on a participants' completion of the lifestyle program (week 8) will be the primary endpoint in this retrospective evaluation.
Secondary outcome [6] 320875 0
Waist circumference (cm) is assessed as part of routine practice at the health service at baseline (week 0) and on completion of the program (week 8) for the participants who complete the lifestyle intervention program. This data will be extracted from medical records for the retrospective evaluation.
Timepoint [6] 320875 0
Waist circumference measured on a participants' completion of the lifestyle program (week 8) will be the primary endpoint in this retrospective evaluation.
Secondary outcome [7] 320876 0
Weight (kg) is assessed as part of routine practice at the health service at baseline (week 0) and on completion of the program (week 8) for the participants who complete the lifestyle intervention program. This data will be extracted from medical records for the retrospective evaluation.
Timepoint [7] 320876 0
Weight measured on a participants' completion of the lifestyle program (week 8) will be the primary endpoint in this retrospective evaluation.
Secondary outcome [8] 320877 0
Presence of hypertension (systolic 130mmHg or more and/or diastolic 85mmHg or more, or on antihypertensive drug therapy in a person with a history of hypertension) will be assessed by screening medical records.
Timepoint [8] 320877 0
Medical records will be screened for information from the date that the participant was referred to the intervention program until March 1, 2016. The most recent medical record data available will be used as the primary endpoint.

Eligibility
Key inclusion criteria
This is a retrospective evaluation. Participants were eligible to participate in the lifestyle intervention program if they were adults (40 to 80 years) with chronic disease risk factors and were able to participate in moderate intensity physical activity.
Participants will be eligible for this retrospective study if they meet the requirements for metabolic syndrome as defined by the International Diabetes Federation; National Heart, Lung and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and the International Association for the Study of Obesity joint statement. Additionally, intervention group participants will need to have attended at least one intervention session.
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not meeting the criteria for a diagnosis of metabolic syndrome.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Primary analysis will provide estimates of between group effects using Incident Rate Ratios (IRR) and 95% confidence intervals (95% CI) to compare the rates of incidences (potentially avoidable hospital presentations, metabolic syndrome risk factors and chronic disease) between groups.
Hazard Ratios (HR) and 95% confidence intervals will be calculated for between group differences in dichotomous outcomes for presence or absence of specific chronic diseases or chronic disease risk factors.
Mean Differences (MD) and 95% CIs will be calculated for continuous outcomes for within group effects for intervention group participants for walking endurance, waist circumference and weight.

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)
VIC
Recruitment hospital [1] 5282 0
Craigieburn Health Service - Craigieburn
Recruitment postcode(s) [1] 12744 0
3064 - Craigieburn

Funding & Sponsors
Funding source category [1] 292900 0
Self funded/Unfunded
Name [1] 292900 0
N/A
Address [1] 292900 0
N/A
Country [1] 292900 0
Primary sponsor type
Hospital
Name
Northern Health
Address
The Northern Hospital, 185 Cooper Street, Epping, Victoria 3076
Country
Australia
Secondary sponsor category [1] 291646 0
None
Name [1] 291646 0
N/A
Address [1] 291646 0
N/A
Country [1] 291646 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294398 0
Northern Health Human Research Ethics Committee
Ethics committee address [1] 294398 0
The Northern Hospital, 185 Cooper Street, Epping, Victoria 3076
Ethics committee country [1] 294398 0
Australia
Date submitted for ethics approval [1] 294398 0
19/11/2015
Approval date [1] 294398 0
05/02/2016
Ethics approval number [1] 294398 0
LR 32.2015

Summary
Brief summary
One quarter of the world’s adults have metabolic syndrome. Lifestyle modification appears to be the key to reduce the risk of heart disease and diabetes in this population but there are no established, replicable program guidelines that can be used by health services to promote healthy lifestyle habits for people with metabolic syndrome. There is also no research to support the effect of such lifestyle programs for people with metabolic syndrome in terms of avoidable hospital presentations.
This retrospective study aims to evaluate the effects of a novel multidisciplinary lifestyle intervention program, embedded in a health service, which aims to empower adults with metabolic syndrome to make behavior changes to reduce metabolic risk factors to prevent progression to chronic disease and reduce associated potentially avoidable hospital presentations. This program has been running at the health service for 2 years. This retrospective study will analyze routinely collected data to evaluate the effectiveness of the program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63594 0
Dr Casey Peiris
Address 63594 0
La Trobe University
Level 5, HS3
Kingsbury Drive
Melbourne, Victoria 3086
Country 63594 0
Australia
Phone 63594 0
+613 94795931
Fax 63594 0
Email 63594 0
C.Peiris@latrobe.edu.au
Contact person for public queries
Name 63595 0
Dr Casey Peiris
Address 63595 0
La Trobe University
Level 5, HS3
Kingsbury Drive
Melbourne, Victoria 3086
Country 63595 0
Australia
Phone 63595 0
+613 94795931
Fax 63595 0
Email 63595 0
C.Peiris@latrobe.edu.au
Contact person for scientific queries
Name 63596 0
Dr Casey Peiris
Address 63596 0
La Trobe University
Level 5, HS3
Kingsbury Drive
Melbourne, Victoria 3086
Country 63596 0
Australia
Phone 63596 0
+613 94795931
Fax 63596 0
Email 63596 0
C.Peiris@latrobe.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