Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000827033
Ethics application status
Approved
Date submitted
7/09/2010
Date registered
5/10/2010
Date last updated
22/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Farming fit? Depression and obesity in farm men and women
Scientific title
Study the effect of physical activity on obese/overweight farm men and women on their psychological health and obesity related clinical co-morbidities
Secondary ID [1] 252553 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 258037 0
Insulin resistance 258039 0
Dislipidaemia 258038 0
Hypertension 258040 0
Psychological distress 258036 0
Nutritional assesment in in obese/overweight farm men and women 258041 0
Physical activity assesment in obese/overweight farm men and women 258042 0
Condition category
Condition code
Metabolic and Endocrine 258203 258203 0 0
Diabetes
Mental Health 258202 258202 0 0
Depression
Diet and Nutrition 258204 258204 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical activity program (designed by an exercise physiologist) - to perform at least 3 times a week for a period of six months
1. Walking - 20 minutes
2. Full double squat -20 repetitions 2 sets
3. Forward bend leg kick back - 20 repetitions 2 sets
4. Wall push up - 20 repetitions 2 sets
5. Double heel raise - 20 repetitions 2 sets
6. Chair pushup - 20 repetitions 2 sets
7. Prone alternating side arm lifts - 20 repetitions 2 sets
8. Neutral back -10 repetitions 1 set
9. Double Gastroc step stretch -2 repetitions 1 set
10. Half kneel quad stretch- 2 repetitions 1 set
11. Arm extend neck sidebend - 2 repetitions 1 set
12. Doorway pec stretch - 2 repetitions 1 set

Telephone coaching - all the participants are to be contacted by the research assistant (trained by the exercise physiologist) to coach at once a month for 30 minutes for six month period.
Video - Demostration (exercise) video will be provided to all the participants in the intervention group
Intervention code [1] 257077 0
Lifestyle
Intervention code [2] 257078 0
Behaviour
Comparator / control treatment
Control group -no coached physical activity program
Control group
Active

Outcomes
Primary outcome [1] 259065 0
Improvements in anthropometric meassurements
(Weight, height, waist circumference (WC), hip circumference (HC), Body fat %)
Timepoint [1] 259065 0
Baseline, Final( 6-month)
Primary outcome [2] 259066 0
Improvement in self-rated psychological health meassurements (Deppression Anxiety and Stress Scale (DASS) score)
Timepoint [2] 259066 0
Baseline, 3- month and Final( 6-month)
Primary outcome [3] 259064 0
Improvement in biochemical chemical meassurements
(fasting blood glucose (FBG), Lipid profile, Serum/salivary cortisol)
Timepoint [3] 259064 0
Baseline, Final( 6-month), 3-month additional for salivary cortisol
Secondary outcome [1] 265331 0
Improvement diet( adherence to healthy balanced diet - using dietary recall questionnaire)
Timepoint [1] 265331 0
Baseline, 3- month and Final( 6-month)
Secondary outcome [2] 265332 0
Improvemt of physical activity (adherence to higher physical activty- using physical activity questionnaire)
Timepoint [2] 265332 0
Baseline, 3- month and Final( 6-month)

Eligibility
Key inclusion criteria
Body mass index (BMI) >=25 kg/m2
Rural victorian farmers
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age below 18 years or over 74 years
Not been farming for more than 5 years
Very high level of psychological distress
Participants unable to participate physical activity program due to any other chonic illness

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Convenient sample (initial group of participants in intervention and later recruited group control)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
8/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257520 0
Government body
Name [1] 257520 0
beyondblue -Victorian Centre of Excellence in Depression and Related Disorders (bbVCoE)
Country [1] 257520 0
Australia
Primary sponsor type
Government body
Name
National Centre for Farmer Health
Address
National Centre for Farmer Health
Hamilton Hospital
Western District Health Service
P O Box 283 HAMILTON VIC 3300
Country
Australia
Secondary sponsor category [1] 256752 0
University
Name [1] 256752 0
Deakin University
Address [1] 256752 0
School of Medicine
Faculty of Health Medicine Nursing & Behavioural Sciences
Geelong Campus at Waurn Ponds
Deakin University
Pigdons Road
Geelong VIC 3217 Australia
Country [1] 256752 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259550 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 259550 0
Ethics committee country [1] 259550 0
Australia
Date submitted for ethics approval [1] 259550 0
04/12/2009
Approval date [1] 259550 0
03/02/2010
Ethics approval number [1] 259550 0
DU-HREC/2009/215

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

Contacts
Principal investigator
Name 31564 0
Address 31564 0
Country 31564 0
Phone 31564 0
Fax 31564 0
Email 31564 0
Contact person for public queries
Name 14811 0
Clinical Associate Professor Susan Brumby
Address 14811 0
Director National Centre for Farmer Health
Western District Health Service
P O Box 283
HAMILTON
VIC 3300
Country 14811 0
Australia
Phone 14811 0
61 3 55518460
Fax 14811 0
61 3 55518267
Email 14811 0
Susan.Brumby@wdhs.net
Contact person for scientific queries
Name 5739 0
Dr. Ananda Chandrasekara
Address 5739 0
Research Fellow
National Centre for Farmer Health
Hamilton Hospital
Western District Health Service
P O Box 283 HAMILTON
VIC 3300
Country 5739 0
Australia
Phone 5739 0
61 3 55518575
Fax 5739 0
61 3 55518267
Email 5739 0
anandach@deakin.edu.au

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.