Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000115730
Ethics application status
Not yet submitted
Date submitted
22/01/2013
Date registered
31/01/2013
Date last updated
31/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of a home based 'Healthy Living' program in improving the dietary and exercise behaviours of people living with severe and enduring mental health conditions.
Scientific title
The effectiveness of a home based individually tailored program for promoting healthier dietary and exercise behaviours in people with mental health conditions living at a Mental Health Community Care Unit.
Secondary ID [1] 281812 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Healthy Living Program - CCU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Illness 288159 0
Obesity 288160 0
Metabolic Syndrome 288161 0
Condition category
Condition code
Mental Health 288523 288523 0 0
Schizophrenia
Mental Health 288524 288524 0 0
Psychosis and personality disorders
Diet and Nutrition 288525 288525 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will include 6 x 1 hour face to face counselling and education sessions with an Occupational Therapist that will be focussed on assisting participants to develop and follow through on their own lifestyle goals through use of the ’12 weeks to a Healthier Life’ planner (Swap it don’t Stop it, Australian Government, 2011).

The number and frequency of sessions with the Occupational Therapists will be reduced over the 12 week program (6 visits in total). However, participants will also receive weekly phone calls and daily texts to remind them to wear their pedometers and monitor their 'step' goals.

Clinicians and NGO support workers will work alongside consumers in between each session wit the Occupational Therapist to follow through on strategies identified.

Physical activity goals will focus on: 1) replacing sedentary leisure activities with more active leisure activities and 2) performing more incidental and structured physical activity like walking during every day activities.

Dietary goals will focus on 1) replacing the intake of foods high in saturated fat, added sugar, sodium and alcohol with healthier lower energy options and 2) providing guidance on appropriate quantities of each food group based on the Australian Guide to Healthy Eating.

Strategies will be individualised and although primarily home based may include referrals to established group exercise programs and or sessions with a dietician. Group education sessions will be run for clinical staff and NGO support workers to ensure long term support for participants in lifestyle goals.
Intervention code [1] 286361 0
Rehabilitation
Intervention code [2] 286395 0
Lifestyle
Comparator / control treatment
This is a descriptive study, there is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288681 0
Dietary intake and eating patterns will be through a validated Dietary Questionnaire for Epidemiological Studies (formally Food Frequency Questionnaire) from the Cancer Council Victoria. Qualitative assessment of change in dietary behaviour will be analysed based on comparison to the food groups from the revised Australian Guide to Healthy Eating.
Timepoint [1] 288681 0
At commencement and 12 weeks.
Primary outcome [2] 288682 0
Anthropometric Measures:

Including height, weight, waist and hip circumference, body composition (fat mass and fat free mass) (using air displacement plethysmography [the BOD POD]

The BOD POD body composition test measures body density and calculates fat and fat-free mass very accurately. It has a fast test time (2 minutes inside BOD POD and about 5 minutes total test time) and it is safe, non-invasive, and ideally suited for frequent testing. For this test participants will be required to wear a pair of swimming trunks and cap to compress hair and skin for the most accurate measurements. It involves sitting for two minutes in a small chamber with a Perspex window allowing you to easily see outside. The unit has an internal emergency button that participants can press to deactivate the chamber door if need be.

The machine is also in a secure, private room and one of the researchers will be operating the machine during the test at all times. Participants will be supported by Extended Care Team Clinicians to attend the University to have these measures done.

As food and fluid intake can make a difference to body weight, and hydration status impacts on the BODPOD, the BOD POD assessment will be done within the first hour of waking and before the participant has breakfast.

For the surface anthropometry, participants will have eight skinfolds measurements taken with steel calipers in duplicate by a highly qualified anthropometrist. This procedure involves a double skinfold of skin lifted before the calipers are applied and the measurement taken. This process is quick and painless but some minor discomfort may be felt as the caliper branches are applied. The ultrasound device will measure body fat at the same sites as the surface anthropometry calipers. A hand held probe will measure the depth of surface fat at the same eight skinfold sites. This is painless, quick and non-invasive.
Timepoint [2] 288682 0
At commencement and 12 weeks.
Copies of participants standard metabolic monitoring forms will be collected a further 3 months after the program to monitor longer term weight changes and BMI.
Primary outcome [3] 288717 0
The International Physical Activity Questionnaire (IPAQ) will be used to measure changes in Excercise Behaviours. Physical activity will also be objectively assessed using a record of daily steps using a pedometer from both targeted exercise and incidental activity.
Timepoint [3] 288717 0
At commencement and 12 weeks
Secondary outcome [1] 300750 0
The self-efficacy for exercise scale (SEE) is a 13-item instrument listing common reasons for preventing participation in exercise. The scale has previously been tested for reliability and validity, with exercise self efficacy found to be significantly correlated to future participation in exercise.
Timepoint [1] 300750 0
At commencement and 12 weeks.
Secondary outcome [2] 300751 0
Physical Fitness will be assessment using the 6 minute walk test (6MWT). The 6 minute walk test (6MWT) provides a simple and valid indicator of patient functional capacity that has been associated with better QOL and disease prognosis. No encouragement will be given to the participants during the walking test so to maximise its reliability.
Timepoint [2] 300751 0
At commencement and 12 weeks.
Secondary outcome [3] 300753 0
The COPM is an outcome measure that is used to detect change in a participant’s perception of occupational performance over time. This tool will be administered via 30 minute semi-structured interview (pre and post intervention) and the participant will be asked to identify any activities that are difficult to perform across the areas of self-care, work and leisure. The COPM is standardised and has excellent validity and reliability, and has been found to be responsive to clinically important change.
Timepoint [3] 300753 0
At commencement and 12 weeks.
Secondary outcome [4] 300754 0
The Mental Health Inventory is a measure that is standard practice and a measure of general psychological distress and well-being. The MHI contains 38 items and summary scores derived from it include a global Mental Health Index score, psychological distress and wellbeing scores and six sub-scale scores representing anxiety, depression, loss of behavioural or emotional control, general positive affect, emotional ties and life satisfaction.
Timepoint [4] 300754 0
At commencement and 12 weeks.
Secondary outcome [5] 300755 0
Pathology: Fasting Blood Glucose, Cholesterol, LDL, HDL, Triglycerides
Timepoint [5] 300755 0
At commencement and 12 weeks

Eligibility
Key inclusion criteria
All residents residing at the Mountain Creek Community Care Unit (Sunshine Coast, Queensland) within 2 months of the study commencing.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil exclusion creiteria

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)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be two-tailed with a significance level of a = 0.05. Data will be assessed for normality and analysed using either parametric or nonparametric statistics, as appropriate. Summary statistics will be obtained to describe the demographic and clinical profiles of the intervention groups at baseline and 3 months. The effect of interventions on the outcome variables will be assessed by comparing the change scores for the participants with repeated measures mixed models and effect size analyses. All models will adjust for any other important confounders that are shown to exist.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/03/2013
Actual
Date of last participant enrolment
Anticipated
30/04/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 6213 0
4557 - Mountain Creek

Funding & Sponsors
Funding source category [1] 286607 0
Charities/Societies/Foundations
Name [1] 286607 0
Wishlist - Sunshine Coast Health Foundation
Country [1] 286607 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast Hospital and Health Service - Mental Health Service
Address
Extended Care Team
6 Lady Musgrave Drive
Mountain Creek
QLD 4557
Country
Australia
Secondary sponsor category [1] 285394 0
University
Name [1] 285394 0
School of Health and Sport Science
University of the Sunshine Coast
Address [1] 285394 0
Building T
University of the Sunshine Coast
Maroochydore
QLD 4558
Country [1] 285394 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288681 0
Metro North HHS - The Prince Charles Hospital
Ethics committee address [1] 288681 0
Ethics committee country [1] 288681 0
Australia
Date submitted for ethics approval [1] 288681 0
31/01/2013
Approval date [1] 288681 0
Ethics approval number [1] 288681 0
EC000168

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

Contacts
Principal investigator
Name 37210 0
Ms Elise Hampton
Address 37210 0
Occupational Therapist
Extended Care Team - Community Initiatives
6 Lady Musgrave Drive
Mountain Creek
QLD 4557
Country 37210 0
Australia
Phone 37210 0
+61 (7) 5452 4444
Fax 37210 0
+61 (7) 5452 4400
Email 37210 0
[email protected]
Contact person for public queries
Name 37211 0
Elise Hampton
Address 37211 0
Occupational Therapist
Extended Care Team - Community Initiatives
6 Lady Musgrave Drive
Mountain Creek
QLD 4557
Country 37211 0
Australia
Phone 37211 0
+61 (7) 5452 4444
Fax 37211 0
+61 (7) 5452 4400
Email 37211 0
[email protected]
Contact person for scientific queries
Name 37212 0
Marion Gray
Address 37212 0
Head of Dicipline - Occupational Therapy
School of Health and Sports Science
Health and Sports Centre
Building T
University of the Sunshine Coast
Maroochydore
QLD 4558
Country 37212 0
Australia
Phone 37212 0
+61 (7) 5456 5127
Fax 37212 0
Email 37212 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.