Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000341022
Ethics application status
Approved
Date submitted
22/04/2010
Date registered
28/04/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lifestyle Management of Weight and Heart Disease Risk Factors in General Practice Patients
Scientific title
Piloting a structured comprehensive lifestyle program ,CLIP ,delivered via telephone on weight loss and lipid profile in overweight and obese general practice patients.
Secondary ID [1] 251650 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 257114 0
Condition category
Condition code
Cardiovascular 257266 257266 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CLIP handbook will be posted to the participant ,plus telephone coaching will be provided by the National Heart Foundation Healthy Heart Information call centre staff alongside usual general practitioner (GP)care.The coaching and introduction for each participant will take approximately 20 or 30 minutes. They will be contacted by a CLIP trained coach for an introduction to the program and will be subsequently supported by them by telephone every 2 weeks for 12 weeks.
Intervention code [1] 256368 0
Lifestyle
Comparator / control treatment
Lifescripts resources are based on weight,nutrition and healthy lifestyle.It will be posted to the participant in week 1 to be used at the participants discretion over the 12 weeks of the study.Lifescripts is a national initiative, being implemented through local divisions of general practice.
Control group
Active

Outcomes
Primary outcome [1] 258183 0
A reduction in weight .The volunteers will be weighed at week 1 and the again at week 12.
Timepoint [1] 258183 0
week 1 and week 12
Primary outcome [2] 258184 0
A reduction in low density lipoprotein (LDL) cholesterol.This will be measured by obtaining a fasting blood sample by trained nursing staff at week 1 and again at week 12.
Timepoint [2] 258184 0
week 1 and week 12
Secondary outcome [1] 264010 0
Questionnaires on health wellbeing and exercise will be used to identify key patient characteristics, barriers and facilitators of successful short term dietary and exercise compliance. The questionnaires will take approximately 30 minutes to complete at week 1 and week 12.
Timepoint [1] 264010 0
week 1 and week 12

Eligibility
Key inclusion criteria
Age 30-55 years, Body Mass Index between 26 and 40 kg/m2
or a waist circumference greater than 102cm for men and greater than 88cm for women.Have at least one additional cardiovascular or diabetes risk factor including family history of cardiovascular disease or type 2 diabetes, family history of premature heart disease or hypercholesterolemia.
Walk independently and able to perform physical activity without pain.
No personal history of cardiac abnormalities.
Contactable by telephone
Able to tolerate particular foods such as fish and whole grains.
Minimum age
30 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Reported medical treatment which GP indicates necessitates preclusion from study.Type 1 Diabetes .Lipid lowering medication ,for example Lipitor or Zocor.
Concurrent use of medications which may be adversely affected by the intervention for example Warfarin.
Existing chronic diseases like diabetes, ischemic heart disease and asthma.
Women who are pregnant or breastfeeding
Patients who have a terminal illness ,cancer.
Patients deemed by their GP as not able to comply with the requirements of the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256780 0
Government body
Name [1] 256780 0
Commonwealth Scientific Industrial Research Organisation
Country [1] 256780 0
Australia
Funding source category [2] 256876 0
Government body
Name [2] 256876 0
Commonwealth Scientific Industrial Research Organisation
Country [2] 256876 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation
Address
Gate 13,Kintore Ave
Adelaide BC SA 5000
Country
Australia
Secondary sponsor category [1] 256056 0
None
Name [1] 256056 0
None
Address [1] 256056 0
Nil
Country [1] 256056 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31026 0
Address 31026 0
Country 31026 0
Phone 31026 0
Fax 31026 0
Email 31026 0
Contact person for public queries
Name 14273 0
Associate Professor Manny Noakes
Address 14273 0
Gate 13,Kintore Ave
Adelaide SA 5000
Country 14273 0
Australia
Phone 14273 0
+61 08 83038827
Fax 14273 0
Email 14273 0
[email protected]
Contact person for scientific queries
Name 5201 0
Associate Professor Manny Noakes
Address 5201 0
Gate 13,Kintore Ave
Adelaide SA 5000
Country 5201 0
Australia
Phone 5201 0
+61 08 83038827
Fax 5201 0
Email 5201 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.