Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000209998
Ethics application status
Approved
Date submitted
22/02/2011
Date registered
24/02/2011
Date last updated
24/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Get Involved, Reach Top Health Pilot Study - A peer education community based healthy lifestyle intervention for men that focuses on physical activity, nutrition, sleep, stress management and reduced waist circumference.
Scientific title
A study to investigate if participation in a structured healthy lifestyle peer-support program can help men adopt a healthier lifestyle and reduce waist circumference.
Secondary ID [1] 259665 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
GIRTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity/overweight 261217 0
Physical activity 261218 0
Diet/nutrition 261219 0
Sedentary behaviour 261220 0
Health self-efficacy 261227 0
Condition category
Condition code
Public Health 259368 259368 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GIRTH: Get Involved Reach Top Health is a healthy lifestyle peer education community based program for men.

The 12-week program focuses on reducing waist circumference (GIRTH) by encouraging healthy eating, increased physical activity, improved sleep habits and stress management. Booklets containing straightforward guidelines and recommendations were developed to affect improvements in each of these four principal lifestyle areas. A self-monitoring tool and explanatory booklet are also included to reinforce the messages and recommendations contained in each of the GIRTH lifestyle booklets.

The GIRTH program was delivered to participants by Men’s Health Co-ordinators (MHCs) trained as peer-educators. In addition to leading groups through a structured 12-week program of peer-support, the MHCs were also responsible for collecting baseline and follow-up data. The peer educators were trained to collect the data measures.

The program was trialled in South Australia, Northern Territory and Victoria between August and December 2010. Participants (men aged 18 years and older) were recruited for the program (and study) at free-to-public seminars held by the MHCs. Participants were randomly assigned to one of two groups: intervention and control.

The intervention group participants received all the GIRTH education materials and took part in a 12-week structured program of peer-support. They were asked to meet once a week for approximately an hour to discuss topics on the four principal components of the program - physical activity, healthy eating, good sleep habits and stress management. Other topics specific to men’s health such as prostate cancer and testicular cancer were also included. The MHCs used strategies such as brainstorming, group problem solving and goal setting to encourage group interaction and to foster self-discovery on health issues.

Pre-and-post test measures were collected at the Enrolment session and during the final program session to enable changes in the parameters measured over the course of the program to be quantified.
Intervention code [1] 258082 0
Behaviour
Intervention code [2] 258084 0
Lifestyle
Comparator / control treatment
The control group participants received all the GIRTH education materials but did not take part in the 12-week structured program of peer support. Pre-and-post test measures for each participant were collected at the Enrolment Session and again after a further 11 weeks.
Control group
Active

Outcomes
Primary outcome [1] 262189 0
Reduced waist circumference.

Will be measured using a standard measuring tape.
Timepoint [1] 262189 0
Baseline and 11 Weeks
Primary outcome [2] 262200 0
Increased health self-efficacy.

Will be measured using the following tools:

1. Coping Self-Efficacy Scale (Chesney, et al, 2006)
2. Self-Efficacy to Regulate Exercise Scale (Bandura, 1997)
3. Self-Efficacy to Regulate Eating Habits Scale (Bandura,1997)
4. Sleep Self-Efficacy Scale (Lacks, 1987)
Timepoint [2] 262200 0
Baseline and 11 Weeks
Secondary outcome [1] 273280 0
Change in other chronic disease risk measures - specifically:

1. Change in cholesterol, triglyceride and blood glucose

The CardioChek PA Analyzer (Polymer Technology Systems, Inc., Indiana USA) testing kit will be used for the blood cholesterol and triglyceride tests. The Optium Xceed Diabetes Monitoring System (Abbott Diabetes Care, Vic. Aust.) will be used to measure blood glucose levels.

2. Change in weight

A digital bathroom scale will be used to measure weight.

3. Change in Body Mass Index (BMI)

Data will be calculated using the Quetelet index (weight in kilograms and height in meters).

4. Change in Hand Grip Strength

Maximal hand grip strength of both hands will be measured using the hydraulic handgrip dynamometer Jamar Grip Dynamometer (JAMAR, Model 5030J1; Sammons Preston Roylan, Bolingbrook, IL).

5. Change in Prostate Symptom

The International Prostate Symptom Score (IPSS) will be used to assess symptoms of the lower urinary tract.

6. Change in Erectile Function

The short form of the International Index of Erectile Dysfunction (IIED 5) will be used to evaluate symptoms for erectile dysfunction.
Timepoint [1] 273280 0
Baseline and 11 weeks
Secondary outcome [2] 273295 0
Changes in behaviour and psychosocial measures - specifically:

1. Changes in nutrition and eating habits, and alcohol consumption.

Will be measured using the Australian Recommended Food Score (ARFS) by Collins et al, 2008.

2. Changes in self-reported physical activities

Will be measured using the International Physical Activity Questionnaire (IPAQ) Short Version

3. Change in general health and well-being

Will be measured using SF-36 Health Status Survey.

4. Change in perceived stress

Will be measured using the Perceived Stress Scale.

5. Change in risks of sleep apnoea

Will be measured using the Berlin Questionnaire.
Timepoint [2] 273295 0
Baseline and 11 weeks

Eligibility
Key inclusion criteria
1. Men aged 18 years and older
2. Willing and able to give written informed consent
3. Willing and able to attend the 12 weekly GIRTH sessions
4. Willing and able to complete the questionnaire.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any medical condition that prevents/interferes with regular physical activity and/or participation in the weekly peer education sessions

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were recruited at free-to-public seminars where the GIRTH program and pilot study was explained. Interested audience members signed the Expression of Interest Form.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were then invited to attend an Enrolment Session the following week. On arrival (at the Enrolment Session), the name of each participant was recorded on an Attendance Sheet. Each line on the attendance sheet had a pre-assigned unique code number. As such, once the code number had been allocated to a participant, it became that participant's code number for the duration of the program. A duplicate of each assigned code number was placed in a box and then numbers were drawn to allocate participants into intervention and control groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N.B. While the study was designed for participants to be randomly assigned to intervention and control groups, the recommended randomisation protocols were not always followed, resulting in the self-selection by some participants to one or other group.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
174
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3629 0
5051
Recruitment postcode(s) [2] 3630 0
3193
Recruitment postcode(s) [3] 3631 0
3150
Recruitment postcode(s) [4] 3632 0
3207
Recruitment postcode(s) [5] 3633 0
3002
Recruitment postcode(s) [6] 3634 0
3018
Recruitment postcode(s) [7] 3635 0
3218
Recruitment postcode(s) [8] 3636 0
0850
Recruitment postcode(s) [9] 3637 0
0871

Funding & Sponsors
Funding source category [1] 258545 0
University
Name [1] 258545 0
The University of Adelaide - Freemasons Foundation Centre for Men's Health
Country [1] 258545 0
Australia
Funding source category [2] 258546 0
Charities/Societies/Foundations
Name [2] 258546 0
The Freemason Foundation Inc.
Country [2] 258546 0
Australia
Funding source category [3] 258547 0
Government body
Name [3] 258547 0
SA Heath (South Australia Department of Health)
Country [3] 258547 0
Australia
Primary sponsor type
University
Name
The University of Adelaide - Freemasons Foundation Centre for Men's Health
Address
School of Medicine
P.O. Box 498
The University of Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 257697 0
None
Name [1] 257697 0
Address [1] 257697 0
Country [1] 257697 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260515 0
Research Ethics Committee - Royal Adelaide Hospital
Ethics committee address [1] 260515 0
Royal Adelaide Hospital
North Terrace
ADELAIDE SA 5000
Ethics committee country [1] 260515 0
Australia
Date submitted for ethics approval [1] 260515 0
29/06/2010
Approval date [1] 260515 0
06/07/2010
Ethics approval number [1] 260515 0
RAH PROTOCOL NO: 100706.

Summary
Brief summary
There is a significant body of clinical evidence to support the assertion that if men adopt a healthier lifestyle, they experience improvements in health outcomes including: reduced chronic
disease risks (i.e. reduced: waist circumference, weight, BMI, blood pressure, cholesterol, blood glucose); reduced urological symptoms (i.e. erectile dysfunction, urinary symptoms); and
improved psycho-social welfare (i.e. reduced depression/anxiety, improved sleep and perceived
quality of life).

There is less evidence, however, about how to engage and support men in a community setting to adopt and sustain the necessary lifestyle changes – this is our central
focus.

The theoretical basis for the GIRTH program is the Social Cognitive Theory (SCT) and its construct of self-efficacy. The peer-support program has been constructed around a chronic disease self-management (CDSM) framework to promote participants’ self-efficacy in relation to physical activity, nutrition, sleep habits and stress management. Self-management skills are infused at every step of the program to ensure that positive changes are sustainable.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32249 0
Address 32249 0
Country 32249 0
Phone 32249 0
Fax 32249 0
Email 32249 0
Contact person for public queries
Name 15496 0
Dr Vanessa Glennon
Address 15496 0
Freemasons Foundation Centre for Men's Health
Grand Lodge
254 North Terrace
The University of Adelaide
SA 5005
Country 15496 0
Australia
Phone 15496 0
+61 8 8313 0514
Fax 15496 0
+61 8 8313 0355
Email 15496 0
[email protected]
Contact person for scientific queries
Name 6424 0
Dr Vanessa Glennon
Address 6424 0
Freemasons Foundation Centre for Men's Health
Grand Lodge
254 North Terrace
The University of Adelaide
SA 5005
Country 6424 0
Australia
Phone 6424 0
+61 8 8313 0514
Fax 6424 0
+61 8 8313 0355
Email 6424 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.