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Trial registered on ANZCTR


Registration number
ACTRN12611000695909
Ethics application status
Approved
Date submitted
22/09/2009
Date registered
7/07/2011
Date last updated
7/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Strength TRaining ONGoing (STRONG) Study: A behavioural intervention for the adoption and maintenance of physical activity in people with type 2 diabetes
Scientific title
A behavioural intervention for the adoption and maintenance of physical activity in people with type 2 diabetes
Secondary ID [1] 262542 0
Nil
Universal Trial Number (UTN)
Trial acronym
The STRONG Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 243859 0
Overweight 243860 0
Obesity 243861 0
Condition category
Condition code
Public Health 239817 239817 0 0
Health promotion/education
Metabolic and Endocrine 268364 268364 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will complete two (2) one hour group (4-12 people) strength training sessions per week (the "Lift For Life" strength training program), supervised by a physical trainer, for 6 months. A third unsupervised session is encouraged after 2 months.
This study will evaluate the effectiveness of using behavioural strategies for improving adherence and maintenance to the Lift for Life strength training program (Enhanced L4L) for older adults with T2DM compared with the Standard L4L program. It will also follow-up participants 6 months later to determine the extent to which the changes in behaviour can be maintained.
This approach will draw on conceptual frameworks of the Social Cognitive Theory and the Transtheoretical Model of behaviour change by incorporating well-established behaviour modification strategies, including self-monitoring, goal-setting and incentives. Over the intervention period (8 months), participants assigned to the Enhanced L4L group will receive: an initial 30 minute interview; weekly self-monitoring; six instructional newsletters (both print-based and/or web-based); 8 telephone calls; and motivational prizes/rewards. Interviews and telephone calls will be conducted by a Psychology-qualified research assistant.
Anthropometric measures including circumferences and functional testing will be conducted at baseline, 2, 4, 6 and 12 months. Strength training adherence (number of strength training sessions performed), Glycated haemoglobin (HbA1c), physical activity and 3 repeat maximum (3RM) strength test, diet, general health, and blood pressure will be assessed at baseline, 6 and 12 months.
Intervention code [1] 241131 0
Lifestyle
Intervention code [2] 241328 0
Behaviour
Comparator / control treatment
This is a comparison trial. All particpants are part of the exercise program but half are also receiving behavioural intervention (the "treatment"). This consists of
Control group
Active

Outcomes
Primary outcome [1] 240577 0
The Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity survey will be used to assess adherence and maintenance with repect to the strength training exercise. This instrument has been specifically designed for use among older adults and has been found to be reliable and valid, and sensitive to change.
Timepoint [1] 240577 0
Baseline, 6 months & 12 months
Primary outcome [2] 240578 0
Glycemic control (HbA1c ) measured by blood analysis.
Timepoint [2] 240578 0
Baseline, 6 months & 12 months
Primary outcome [3] 240581 0
Muscle strength which is assessed by measurement of 3 repeat maximum (3RM) strength test on the upper and lower body using the chest press and leg press equipment respectively.
Timepoint [3] 240581 0
Baseline, 6 months & 12 months
Secondary outcome [1] 257718 0
Body composition by measuring weight and height (to determine body mass index) and waist circumference.
Timepoint [1] 257718 0
0, 2, 4, 6 and 12 months
Secondary outcome [2] 257719 0
Functional fitness - assessed by a validated battery of 6 functional/physical test items, developed specifically for older adults measuring upper and lower body strength, aerobic endurance, upper and lower body flexibility, and agility. Specifically:
1. Chair Stand (lower body strength) - number of full stands from a seated position that can be completed in 30 seconds with arms folded across chest.
2. Arm Curl (upper body strength) - number of bicep curls that can be completed in 30 seconds holding a dumbbell of specified weight.
3. Two-Minute Step (aerobic endurance) - number of full steps completed in 2 minutes, raising each knee to a point midway between the kneecap and the front hip bone.
4. Chair Sit-and-Reach (lower body flexibility) - number of cm(+/-) between extended fingers and tip of toes, from a sitting position at the front of a chair with leg extended and hands reaching towards toes.
5. Back Scratch (shoulder flexibility) - number of cm (+/-) between the extended middle fingers, with one hand reaching over shoulder and one up the middle of the back.
6. Eight-Foot Up-and-Go (agility/dynamic balance) - number of seconds required to get up from a seated position, walk 2.44m, turn, and return to seated position.
Balance is assessed using the four-test balance scale which is a reliable and valid quantitative measure of static balance, encompassing four timed static balance tasks of increasing difficulty (diminishing base of support). The four stances (feet together, semi-tandem, tandem and one-leg) are completed without assistive devices and are scored as either (i) did not attempt, (ii) incomplete, or (iii) complete.
Timepoint [2] 257719 0
0, 2, 4, 6 and 12 months
Secondary outcome [3] 257720 0
Quality of life using the SF-36 Quality of Life Questionnaire.
Timepoint [3] 257720 0
0, 6 and 12 months
Secondary outcome [4] 257721 0
Behavioural change measured by validated questions designed to address changes in behaviour relating to strength training and other physical activity.
Timepoint [4] 257721 0
0, 6 and 12 months

Eligibility
Key inclusion criteria
Aged between 40-75
Have type 2 diabetes (> 3 months) or body mass index (BMI)>25- kg/m2
Have not performed strength training in the past 3 months (defined as lifting weights in a structured way including 6-8 exercises involving upper and lower body per session for 1 or more sessions per week within the last 3 months)
Have no plans to travel for 4 or more consecutive weeks within the next year
Have approval to participate in strength training from their General Practitioner (completion of a Doctors Approval form indicating any complete or relative contraindications to strength training),
Be willing to become a paying member of one of the 14 research gyms
Freely give written informed consent
Minimum age
40 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they do not freely give written informed consent, if they do not have approval from their General Practitioner, or if they do not join and pay membership at one of the research gyms

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)
All of those referred to the program or those who saw local media and inquired, were assessed for eligibility (aged 40-75 years, type 2 diabetes or a BMI greater than or equal to 25, and who performed no strength training) during an initial phone call to the centre where Deakin staff administered the screening questionnaire. Those who fulfilled the key entry requirements of the study were sent out an initial letter including the Plain Language Statement and a doctors medical clearance form to take to their GP for approval to participate. Upon returning the signed approval to participate form from the General Practitioner (GP), participants were allocated a strength training group at their local venue based on availability. Alloccation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In order to minimise contamination and facilitate logistical arrangements, randomisation to intervention and comparison groups was performed at the Health and Fitness Facility level. Gyms were randomised using random numbers generated in Microsoft Excel using the command =RAND(). The moment the organisation consent was received from the gym owner/manager, the gym was allocated the next random number determining group.
Masking / blinding
Open (masking not 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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267379 0
Government body
Name [1] 267379 0
National Health and Medical Research Council (NHMRC)
Address [1] 267379 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 267379 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC)
Address
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 266440 0
None
Name [1] 266440 0
Address [1] 266440 0
Country [1] 266440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243907 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 243907 0
Ethics committee country [1] 243907 0
Australia
Date submitted for ethics approval [1] 243907 0
Approval date [1] 243907 0
22/03/2007
Ethics approval number [1] 243907 0
Ethics committee name [2] 243908 0
International Diabetes Institute (now Baker IDI Heart & Diabetes Institute)
Ethics committee address [2] 243908 0
Ethics committee country [2] 243908 0
Australia
Date submitted for ethics approval [2] 243908 0
Approval date [2] 243908 0
27/03/2007
Ethics approval number [2] 243908 0

Summary
Brief summary
For people with type 2 diabetes (T2DM) it is essential that blood glucose levels are managed well to reduce the risk of developing complications. Physical activity is essential for maintaining glucose levels because it helps make the muscles use glucose more effectively. In particular, being active through strength training not only improves blood glucose levels, but can be very effective for maintaining good physical functioning. This study builds on our earlier research which demonstrated significantly improved blood glucose levels from a strength training program for older adults with T2DM. The strength training program is to be administered nationally in a research to practice trial (Lift for Life); however, the original research found that those who did not complete the program as it was intended (ie, poor adherence) did not show significant improvements in blood glucose levels. Furthermore, maintenance of strength training exercises after completion of the program was poor and resulted in return of blood glucose levels back to pre-starting levels. In people without diabetes, we have collected pilot data that shows that the use of behavioural strategies based on behavioural theories whereby each person’s motivations and barriers are taken into consideration is more effective than the traditional one-treatment-fits-all approach. This study will evaluate the effectiveness of using behavioural strategies for improving adherence and maintenance to the Lift for Life strength training program (Enhanced L4L) for older adults with T2DM compared with the Standard L4L program. It will also follow-up participants 6 months later to determine the extent to which the changes in behaviour can be maintained. The study will provide information that will assist in the design, delivery and uptake of programs to improve treatment strategies in older adults with T2DM through the maintenance of healthier behaviours and lifestyles.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30052 0
Address 30052 0
Country 30052 0
Phone 30052 0
Fax 30052 0
Email 30052 0
Contact person for public queries
Name 13299 0
Carol Robinson
Address 13299 0
Baker IDI Heart & Diabetes Institute
Level 4, 99 Commercial Road, Melbourne
Victoria 3004
Country 13299 0
Australia
Phone 13299 0
(613) 8532 1860
Fax 13299 0
(613) 8532 1100
Email 13299 0
carol.robinson@bakeridi.edu.au
Contact person for scientific queries
Name 4227 0
David Dunstan
Address 4227 0
Baker IDI Heart & Diabetes Institute
Level 4, 99 Commercial Road, Melbourne
Victoria 3004
Country 4227 0
Australia
Phone 4227 0
(613) 8532 1873
Fax 4227 0
(613) 8532 1100
Email 4227 0
david.dunstan@bakeridi.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary