Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000203358
Ethics application status
Approved
Date submitted
14/04/2008
Date registered
16/04/2008
Date last updated
25/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Living Well with Diabetes - Telephone Counselling for Maintenance of Physical Activity, Weight Loss and Glycaemic Control in Type 2 diabetes
Scientific title
A randomised controlled trial to evaluate a telephone counselling intervention for physical activity, weight loss and glycaemic control in adult patients with type 2 diabetes
Secondary ID [1] 283674 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LWWD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 3029 0
Condition category
Condition code
Metabolic and Endocrine 3182 3182 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Intervention Group: Participants receive a series of telephone calls over the 18-month intervention. Calls are delivered weekly and fortnightly for the first 6 months and monthly for the following 12 months. Calls will be tapered according to particpant needs. Participants receive a detailed workbook containing feedback on their baseline assessment, sections on physical activity, diet and weight loss, information on goal setting, problem-solving, self-monitoring and supports. Participants receive feedback following each assessment. Using the workbook during calls, participants work collaboratively with their telephone counsellor to set goals for physical activity, dietary change and weight loss. Barriers and supports are identified; confidence is assessed and problem solving is discussed as necessary. Participants are encouraged to work towards achieving overall physical activity targets of putting together at least 200 minutes a week of moderate-intensity physical activity, 3-4 sessions a week of strength training and to reduce their sedentary time; weight loss targets of a loss of 5-7% of initial body weight and diet targets of reducing energy intake by 2000kJ, total fat intake to less than 30% of energy intake and saturated fat to less than 7% of energy intake.
Intervention code [1] 2775 0
Lifestyle
Comparator / control treatment
The Control group: After each assessment, usual care participants are sent a thank you letter that includes brief feedback on their assessment. Included in this mailing are standard, off-the shelf brochures, that are suitable for persons with diabetes, on a range of health behaviours (including diet, physical activity, alcohol) and a project newsletter that updates them on how many people are participating in the study and gives general health tips.
Control group
Active

Outcomes
Primary outcome [1] 4070 0
Changes in Physical activity (exact measures to be confirmed)
Timepoint [1] 4070 0
Assessed at baseline, 6-months, 12-months, 18-months and 24-months
Primary outcome [2] 4071 0
Weight Loss
Timepoint [2] 4071 0
Assessed at baseline, 6-months, 12-months, 18-months and 24-months
Primary outcome [3] 4072 0
Glycaemic Control (HbA1c)
Timepoint [3] 4072 0
Assessed at baseline, 6-months, 18-months and 24-months.
Secondary outcome [1] 6849 0
Changes in dietary intake (exact changes to be confirmed)
Timepoint [1] 6849 0
Assessed at baseline, 6-months, 18-months and 24-months.
Secondary outcome [2] 6850 0
Changes in blood lipid level (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides)
Timepoint [2] 6850 0
Assessed at baseline, 6-months, 18-months and 24-months.
Secondary outcome [3] 6851 0
Changes in blood glucose level
Timepoint [3] 6851 0
Assessed at baseline, 6-months, 18-months and 24-months.
Secondary outcome [4] 6852 0
Changes in blood pressure
Timepoint [4] 6852 0
Assessed at baseline, 6-months, 18-months and 24-months.
Secondary outcome [5] 6853 0
Changes in liver function (Alanine Amino-Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Alkaline Phosphatase and Gamma-Glutamyl Transpeptidase)
Timepoint [5] 6853 0
Assessed at baseline, 6-months, 18-months and 24-months.
Secondary outcome [6] 6854 0
Changes in body composition (waist circumference and body fat, using bio-electrical impedance analysis)
Timepoint [6] 6854 0
Assessed at baseline, 6-months, 12-months, 18-months and 24-months
Secondary outcome [7] 6855 0
Changes in medication use (including diabetes, cholesterol and hypertension medications)
Timepoint [7] 6855 0
Assessed at baseline, 6-months, 18-months and 24-months.
Secondary outcome [8] 6856 0
Quality of Life, measured using the Short-Form (SF)-12 Health Survey
Timepoint [8] 6856 0
Assessed at baseline, 6-months, 18-months and 24-months.

Eligibility
Key inclusion criteria
Diagnosis of type 2 diabetes; English speaking; minimum age: 20 years, maximum age: 75 years; both males and females.
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not undergoing active treatment for cancer; not planning hip/knee replacement in next year; not using mobility aid; not with active heart disease; not with breathing problems; not undergoing dialysis; not taking warfarin; not pregnant.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
17/03/2009
Date of last participant enrolment
Anticipated
Actual
21/03/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
302
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 3297 0
Government body
Name [1] 3297 0
National Health and Medical Research Council
Country [1] 3297 0
Australia
Primary sponsor type
University
Name
School of Public Health, The University of Queensland
Address
Level 4
Public Health Building
Herston road
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 2951 0
None
Name [1] 2951 0
Address [1] 2951 0
Country [1] 2951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5282 0
The University of Queensland
Ethics committee address [1] 5282 0
Ethics committee country [1] 5282 0
Australia
Date submitted for ethics approval [1] 5282 0
01/02/2008
Approval date [1] 5282 0
26/02/2008
Ethics approval number [1] 5282 0
2008000188

Summary
Brief summary
This 5-year, randomised controlled trial is evaluating a telephone-delivered physical activity, weight loss and glycaemic control intervention targeting patients with type 2 diabetes, recruited from the primary care setting, and compared to usual care.
Trial website
Trial related presentations / publications
Papers:

Eakin EG, Reeves MM, Marshall AL, Dunstan DW, Graves N, Healy GN, Bleier J, Barnett AG, O’Moore-Sullivan T, Russell A, Wilkie K. Living Well with Diabetes: a randomized controlled trial of a telephone-delivered intervention for maintenance of weight loss, physical activity and glycaemic control in adults with type 2 diabetes. BMC Public Health, 2010:10:452.

Eakin EG, Reeves MM, Winkler E, Healy GN, Dunstan DW, Owen N, Marshall AM, Wilkie KC. Six-month outcomes from Living Well with Diabetes: A randomized trial of a telephone-delivered weight loss and physical activity intervention to improve glycemic control. Annals of Behavioral Medicine, 2013:46(2):193-203.

Winkler E, Waters L, Eakin E, Fjeldsoe B, Owen N, Reeves M. Is measurement error altered by participation in a physical activity intervention? Medicine & Science in Sports & Exercise, 2013:45(5):1004-1011.

Eakin EG, Winkler EA, Dunstan DW, Healy GN, Owen N, Marshall AM, Graves N, Reeves MM. Living Well with Diabetes: 24-month outcomes from a randomized trial of telephone-delivered weight loss and physical activity intervention to improve glycemic control. Diabetes Care, 2014: 37(8): 2177-85.

Goode AD, Winkler EAH, Reeves MM, Eakin EG. Relationship between intervention dose and outcomes in Living Well with Diabetes - a randomized trial of a telephone-delivered lifestyle-based weight loss intervention. American Journal of Health Promotion. Epub ahead of print, 5 November 2014.

Presentation:

Eakin E, Reeves M, Dunstan D, Healy G, Winkler E, Marshall A, Owen N. (31 October – 3 November 2012). Living Well with Diabetes: Six-month randomised trial outcomes of a telephone-delivered weight loss intervention. Paper presented at the 4th International Congress on Physical Activity and Public Health, Sydney, Australia.
Public notes

Contacts
Principal investigator
Name 28516 0
Prof Elizabeth Eakin
Address 28516 0
The University of Queensland, School of Public Health, Cancer Prevention Research Centre, Level 4 Public Health Building, Herston road, HERSTON, QLD, 4006
Country 28516 0
Australia
Phone 28516 0
+61 7 3365 5505
Fax 28516 0
+61 7 3365 5540
Email 28516 0
[email protected]
Contact person for public queries
Name 11673 0
Prof Elizabeth Eakin
Address 11673 0
The University of Queensland, School of Public Health, Cancer Prevention Research Centre, Level 4 Public Health Building, Herston road, HERSTON, QLD, 4006
Country 11673 0
Australia
Phone 11673 0
+61 7 3365 5505
Fax 11673 0
+61 7 33655540
Email 11673 0
[email protected]
Contact person for scientific queries
Name 2601 0
Prof Elizabeth Eakin
Address 2601 0
The University of Queensland, School of Public Health, Cancer Prevention Research Centre, Level 4 Public Health Building, Herston road, HERSTON, QLD, 4006
Country 2601 0
Australia
Phone 2601 0
+61 7 33464692
Fax 2601 0
+61 7 33655540
Email 2601 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
EmbaseAccelerometer-derived sedentary and physical activity time in overweight/obese adults with type 2 diabetes: Cross-sectional associations with cardiometabolic biomarkers.2015https://dx.doi.org/10.1371/journal.pone.0119140
EmbaseRelationship between intervention dose and outcomes in living well with diabetes--a randomized trial of a telephone-delivered lifestyle-based weight loss intervention.2015https://dx.doi.org/10.4278/ajhp.140206-QUAN-62
N.B. These documents automatically identified may not have been verified by the study sponsor.