Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000295943
Ethics application status
Not yet submitted
Date submitted
17/03/2011
Date registered
21/03/2011
Date last updated
21/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Lifestyle Intervention for early diabetes: A randomised controlled trial
Scientific title
Effect on patients with newly diagnosed diabetes of a lifestyle intervention + standard care or standard care alone on HbA1c levels.
Secondary ID [1] 259806 0
Nil
Universal Trial Number (UTN)
U1111-1120-0845
Trial acronym
LIFEDIAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 261385 0
Cardiovascular disease risk 261387 0
health service utilisation 261388 0
Psychological distress 261389 0
Condition category
Condition code
Metabolic and Endocrine 265542 265542 0 0
Diabetes
Cardiovascular 265543 265543 0 0
Other cardiovascular diseases
Public Health 265544 265544 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard care (i.e, standard diabetes management by a healthcare provider) plus a 1-week intensive residential lifestyle program with booster sessions held over 14 weeks. The multimodal lifestyle intervention will be held at The Gawler Foundation. This intervention will be delivered by a team of multidisciplinary health professionals and will consist of daily group sessions educating participants about diabetes pathophysiology, risks, stress management, and lifestyle factors (diet and exercise) and behaviour likely to better control T2DM. The minimum dietary change advocated to participants will be in line with recommendations of the American Diabetes Association. During the residential program a plant-based high-fibre wholefood diet will be available to participants and healthy eating behaviour will be encouraged. This will encompass the use of mindfulness when eating, awareness of hunger and satiety signals, and enjoyment of food through paced food consumption. Participants in the lifestyle group will also receive counselling and group interaction designed to improve their compliance with lifestyle change. The intervention will draw upon the ESSENCE framework for health. This is a model of wellbeing suitable for the layperson and is taught to medical graduates of Monash University. It is based on the tenet that there are seven factors that are essential to well being: Education, Stress management, Spirituality, Exercise, Nutrition, Connectedness, and Environment.

The duration of standard care will be variable for each patient. It will be determined by their usual general practitioner or endocrinologist as would normally occur in the context of usual care.
Intervention code [1] 264236 0
Lifestyle
Comparator / control treatment
Standard care only (i.e, standard diabetes management by a healthcare provider)
Control group
Active

Outcomes
Primary outcome [1] 262348 0
For all patients the primary outcome will be glycaemic control operationalised as HbA1c level.
Timepoint [1] 262348 0
Baseline (study entry) and 12 months post-intervention
Primary outcome [2] 262349 0
The percentage of patients achieving normal glycaemic control as assessed using fasting BSL (using WHO definition) and HbA1c (defined as a haemoglobin A1c <8%).
Timepoint [2] 262349 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [1] 273594 0
Cholesterol (Fasting LDL//HDL, total cholesterol)
Timepoint [1] 273594 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [2] 273595 0
Lipids: Fasting Serum triglyceride levels
Timepoint [2] 273595 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [3] 273596 0
Plasma Vitamin D (25-hydroxyvitamin D)
Timepoint [3] 273596 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [4] 273597 0
body mass index : Calculated from Height, weight
Timepoint [4] 273597 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [5] 273598 0
waist girth measured in centimetres by tape measure at the level of the naval while in the standing position.
Timepoint [5] 273598 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [6] 273599 0
blood pressure measured using a digital sphygmomanometer. The average of three measurements will be used.
Timepoint [6] 273599 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [7] 273600 0
pulse measured using a digital pulse oximeter.
Timepoint [7] 273600 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [8] 273601 0
Number of co-morbidities measured by patient self-report using a researcher devised survey
Timepoint [8] 273601 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [9] 273602 0
Diabetes symptoms (Type 2 diabetes Symptom Checklist)
Timepoint [9] 273602 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [10] 273603 0
Psychological Distress (Kessler Psychological Distress Scale (k-10))
Timepoint [10] 273603 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [11] 273604 0
Lifestyle indicators:
Diet, Exercise, Smoking, Alcohol intake,
Meditation, (via researcher designed survey)
Timepoint [11] 273604 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [12] 273605 0
Number and dose of hypoglycaemic drugs being taken for glycaemic control.
Timepoint [12] 273605 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [13] 273606 0
Number type and dose of other medications measured by patient self report and verified by medical records data.
Timepoint [13] 273606 0
Baseline (study entry) and 12 months post-intervention
Secondary outcome [14] 273607 0
Health service utilisation measured by (1) self report (and valdated by medical records data) for the number of general practitioner visits and (2) self-report for the number of unplanned hospital attendances.
Timepoint [14] 273607 0
Baseline (study entry) and 12 months post-intervention

Eligibility
Key inclusion criteria
Aged 18 years or more
With newly identified (within 24 months at the time of intervention) T2DM
Able to attend a 1-week residential program in and 4 X 3 hour booster sessions held over the subsequent 14 week period.
Willing to undertake significant lifestyle change
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unable to provide informed consent
Patients who are unable to communicate adequately in English
Patients who are cognitively impaired or in an altered conscious state
Patients that are receiving palliative care
Patients who have commenced sulfonylreas as an adjunct to metformin to treat their diabetes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A computer generated randomisation sequence will be created by a researcher independent to the study. After assessing study eligibility and obtaining participant consent the site investigator will call the research office (or officer if after hours) who holds the allocation schedule to determine the group to which the patient is randomly allocated. The study will be unblinded upon allocation and the patient will be allocated to one of two groups: lifestyle intervention (LI) + standard care group or a control group who will receive standard therapy (ST) alone.

Allocation will be concealed from the researcher determining eligibility; upon determining eligibility of a patient, the recruiting researcher will contact the holder of the allocation schedule (held at a centre administration site), at which time the allocation will be revealed to the recruiting researcher and participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation sequence will be created by a researcher independent to the study. After assessing study eligibility and obtaining participant consent the site investigator will call the research office (or officer if after hours) to determine the group to which the patient is randomly allocated. The study will be unblinded upon allocation and the patient will be allocated to one of two groups: lifestyle intervention (LI) + standard care group or a control group who will receive standard therapy (ST) alone.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264687 0
Charities/Societies/Foundations
Name [1] 264687 0
The Walter Pisciotta Foundation
Country [1] 264687 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University Human Research Ethics Committee (MUHREC)
Building 3e Room 111
Research Office
Monash University VIC 3800
Country
Australia
Secondary sponsor category [1] 263819 0
Hospital
Name [1] 263819 0
St. Vincent's Hospital Melbourne
Address [1] 263819 0
Emergency Practice Innovation Centre
PO Box 2900
Fitzroy VIC 3065
Country [1] 263819 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266680 0
Ethics committee address [1] 266680 0
Ethics committee country [1] 266680 0
Date submitted for ethics approval [1] 266680 0
23/12/2010
Approval date [1] 266680 0
Ethics approval number [1] 266680 0
CF10/3563-2010 001887

Summary
Brief summary
By 2010 T2DM is expected to affect in excess of 1.1 million Australians. This is clearly an epidemic that threatens to overwhelm the resources of our health system. Evidence-based strategies that engage patients to make lifestyle choices that result in better glucose control are urgently needed. Better glucose control has the potential to significantly decrease complications and health care costs, and halt or reverse disease progression. The proposed research offers an opportunity to manage chronic illness through sustained lifestyle change facilitated by delivery in a residential setting. The research aims to determine the feasibility and efficacy of a residential lifestyle intervention plus standard care compared to standard care alone in patients with newly established type 2 diabetes in (1) stabilising average blood glucose (as assessed using HbA1c); and (2) achieving normal glucose control assessed by fasting blood sugar level. A randomised controlled trial will be conducted for adult patients with newly diagnosed diabetes. Patients will be allocated to receive either standard care only (i.e, standard diabetes management by a healthcare provider) or standard care plus a 1-week intensive residential lifestyle program with booster sessions held over 14 weeks. The multimodal lifestyle intervention will be held at The Gawler Foundation. This intervention will be delivered by a team of multidisciplinary health professionals and will consist of daily group sessions educating participants about diabetes pathophysiology, risks, stress management, and lifestyle factors (diet and exercise) and behaviour likely to better control T2DM. The minimum dietary change advocated to participants will be in line with recommendations of the American Diabetes Association. During the residential program a plant-based high-fibre wholefood diet will be available to participants and healthy eating behaviour will be encouraged. This will encompass the use of mindfulness when eating, awareness of hunger and satiety signals, and enjoyment of food through paced food consumption. Participants in the lifestyle group will also receive counselling and group interaction designed to improve their compliance with lifestyle change. The intervention will draw upon the ESSENCE framework for health. This is a model of wellbeing suitable for the layperson and is taught to medical graduates of Monash University. It is based on the tenet that there are seven factors that are essential to well being: Education, Stress management, Spirituality, Exercise, Nutrition, Connectedness, and Environment. Patients will be followed up at 12 months. Outcome measures will include glycaemic control as measured using glycated haemoglobin A1c (HbA1c; primary outcome) and fasting capillary blood sugar. Secondary outcome measure will include lipid status (low density and high density lipoprotein, triglyceride levels), Vitamin D, bodyweight, body mass index, waist girth, waist-to-hip ratio, blood pressure, pulse, number of co-morbidities, diabetes symptoms and diabetes specific health-related quality of life, and compliance with lifestyle change. An economic analysis will be undertaken at the conclusion of the study to determine the cost-benefit of the program. Among other endpoints this will consider costs associated with medication use and health service utilisation.This research will add to the literature regarding strategies for controlling the diabetes epidemic by assessing whether intensive lifestyle interventions prevent the progression to diabetes in patients with pre-diabetes, or improved glycemic control in patients with diabetes. This may ultimately revolutionise treatment approaches to pre-diabetes and diabetes and decrease the costs borne by individuals and the health system. This research investigates an inexpensive approach with the capacity for widespread adoption that is likely to be highly cost-effective and sustainable.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32354 0
Address 32354 0
Country 32354 0
Phone 32354 0
Fax 32354 0
Email 32354 0
Contact person for public queries
Name 15601 0
Prof George Jelinek
Address 15601 0
Emergency Practice Innovation Centre
PO Box 2900
Fitzroy VIC 3065
Country 15601 0
Australia
Phone 15601 0
+61 3 92882734
Fax 15601 0
Email 15601 0
[email protected]
Contact person for scientific queries
Name 6529 0
Prof George Jelinek
Address 6529 0
Emergency Practice Innovation Centre
PO Box 2900
Fitzroy VIC 3065
Country 6529 0
Australia
Phone 6529 0
+61 3 92882734
Fax 6529 0
Email 6529 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.