Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000138088
Ethics application status
Not yet submitted
Date submitted
26/01/2010
Date registered
10/02/2010
Date last updated
10/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Brief interventions for promoting physical activity, healthy eating, and weight management in primary care and workplace settings
Scientific title
Brief interventions for promoting physical activity, healthy eating, and weight management in primary care and workplace settings
Secondary ID [1] 1360 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 256678 0
Nutrition 256730 0
Weight Management 256731 0
Obesity 256732 0
Cardiovascular Risk 256733 0
Condition category
Condition code
Public Health 256835 256835 0 0
Health promotion/education
Cardiovascular 256885 256885 0 0
Other cardiovascular diseases
Diet and Nutrition 256886 256886 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants recruited and screened by cardiovascular disease (CVD) risk assessment in primary care settings will be randomised either to a family-based intensive intervention to increase physical activity and healthy eating. This will be delivered at home and will involve five one hour sessions aimed at educating and informing the family on ways to improve physical activity levels and encourage healthy eating.They will occur at a time which suits the family involved.Sessions will be conducted by a health professional/nurse who has been trained specifically for this programme. Alternatively they will receive just a brief motivational interview (approximately 15 minutes) with their General Practitioner (GP) at their primary care clinic on healthy lifestyle and the benefits of healthy eating and including physical activity in daily life to improve health outcomes .

In the workplace randomisation will be by workplace. Either a CVD risk assessment followed by a health promotion programme or a CVD risk assessment followed by a one off motivational interview. Workplace intervention involves educational sessions on physical activity and nutrition,suggestions on changes which can be made to diet or excersise to improve health,and workplace challenges to encourage healthy lifestyles. One off motivational/counselling session(approximately 15 minutes) will be conducted by a work place health professional and will provide advice on how to improve lifestyle by becoming physically active and eating a healthy diet. CVD Risk Assessment involves blood pressure testing, blood testing for sugar levels and lipids,height and weight measurement, and assessment of family demographic and historical information.
Intervention code [1] 255909 0
Lifestyle
Comparator / control treatment
Control conditions are the participants who receive a cardiovascular (CVD) risk assessment and only one off advice to improve lifestlye.
Control group
Active

Outcomes
Primary outcome [1] 257700 0
Physical activity. Phyical activity will be assessed by the New Zealand (NZ) Physical Activity questionnaire short-form (NZPAC-SF).This measures moderate and vigorous physical activity across a variety of domains which are accumulated to give weekly total minutes of vigorous and moderate physical activity.Minutes of toal weighted physical activity (vigorous minutes count for double) over one (the previous) week, will be the main outcome measure for physical activity.
Timepoint [1] 257700 0
baseline, 3 and 12 months
Primary outcome [2] 257701 0
Weight. For weight the main outcome measure will be the change in Body mass index (BMI).
Timepoint [2] 257701 0
baseline, 3 and 12 months
Primary outcome [3] 257702 0
Healthy eating behaviours. Healthy eating outcomes will be a change in frequency of
1.Breakfast eating
2.Sugary drinks consumed
3.Fast fod or takeaway meals eaten
4.Number of fruit and vegetables eaten
Each measure will be self report from the previous week
Timepoint [3] 257702 0
baseline, 3 and 12 months
Secondary outcome [1] 263046 0
Other modifiable cardiovascular risk factors (Blood pressure (BP), blood lipids). Cardiovascular risk score is a secondary outcome measure. This is defined as the change in the 5 year risk of a cardiovascular event as defined by the Framingham equation.
Timepoint [1] 263046 0
baseline, 3 and 12 months

Eligibility
Key inclusion criteria
Risk of cardiovascular event over the next five years >= 10%
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have received primary care counseling and screening for CVD and/or lifestyle in the past two years

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)
Randomisation at primary cares settings is patient by patient and primary care clinics will receive advice on randomisation after participant reaches inclusion criteria. Eligible consenting patients in the primary care setting will receive notification of programme they have been randomly selected into, by a sealed envelope.

Randomisation by treatment in workplaces is by workplace to overcome contamination concerns.Following CVD risk assessment, one work place will receive an intervention as mentioned in Description of Intervention, while the second workplace will receive motivational interview as in Description of Intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number sequence is computer generated - this sequence is translated into allocation in primary care setting. This is delivered to the primary care clnic in sealed envelop.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment outside Australia
Country [1] 2441 0
New Zealand
State/province [1] 2441 0
Auckland

Funding & Sponsors
Funding source category [1] 256405 0
Government body
Name [1] 256405 0
Health Research Council of New Zealand(NZ)
Country [1] 256405 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Grant Schofield Ph.D.
Professor of Public Health
Director, Centre for Physical Activity and Nutrition Research
AUT University
Private Bag 92006
Auckland
Country
New Zealand
Secondary sponsor category [1] 251712 0
University
Name [1] 251712 0
The University of Auckland
Address [1] 251712 0
The University of Auckland
Private Bag 92019
Auckland
Country [1] 251712 0
New Zealand
Other collaborator category [1] 1077 0
Commercial sector/Industry
Name [1] 1077 0
Vitalityworks Ltd
Address [1] 1077 0
Level 1, 3 Byron Avenue, Takapuna, Auckland 0622
Country [1] 1077 0
New Zealand
Other collaborator category [2] 1078 0
Commercial sector/Industry
Name [2] 1078 0
Harbour Health
Address [2] 1078 0
PO Box 302-163, North Harbour, Auckland
(Post code not applicable, PO Box)
Country [2] 1078 0
New Zealand
Other collaborator category [3] 1079 0
Commercial sector/Industry
Name [3] 1079 0
Heath WEST
Address [3] 1079 0
PO Box 104-098, Lincoln North, Auckland
(Post code not applicable, PO Box)
Country [3] 1079 0
New Zealand
Other collaborator category [4] 1080 0
Commercial sector/Industry
Name [4] 1080 0
Waiora Health Care
Address [4] 1080 0
Level 1 56 Lincoln Rd, Waitakere City 0610
Country [4] 1080 0
New Zealand
Other collaborator category [5] 1081 0
Commercial sector/Industry
Name [5] 1081 0
West Fono Health Trust
Address [5] 1081 0
411 Great North Rd, Henderson, Auckland,0650
Country [5] 1081 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258462 0
National Health Ethics Committee
Ethics committee address [1] 258462 0
Ethics committee country [1] 258462 0
New Zealand
Date submitted for ethics approval [1] 258462 0
19/02/2010
Approval date [1] 258462 0
Ethics approval number [1] 258462 0

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

Contacts
Principal investigator
Name 30768 0
Address 30768 0
Country 30768 0
Phone 30768 0
Fax 30768 0
Email 30768 0
Contact person for public queries
Name 14015 0
Grant Schofield Ph.D.
Address 14015 0
Professor of Public Health
Director, Centre for Physical Activity and Nutrition Research
AUT University
Private Bag 92006
Auckland
Country 14015 0
New Zealand
Phone 14015 0
+6499219169
Fax 14015 0
+6499219160
Email 14015 0
[email protected]
Contact person for scientific queries
Name 4943 0
Grant Schofield Ph.D.
Address 4943 0
Professor of Public Health
Director, Centre for Physical Activity and Nutrition Research
AUT University
Private Bag 92006
Auckland
Country 4943 0
New Zealand
Phone 4943 0
+6499219169
Fax 4943 0
+6499219160
Email 4943 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
SourceTitleYear of PublicationDOI
EmbaseFamily-centered brief intervention for reducing obesity and cardiovascular disease risk: A randomized controlled trial.2016https://dx.doi.org/10.1002/oby.21602
N.B. These documents automatically identified may not have been verified by the study sponsor.