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Trial registered on ANZCTR


Registration number
ACTRN12617001233314
Ethics application status
Approved
Date submitted
25/07/2017
Date registered
23/08/2017
Date last updated
23/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Protocol for a randomized clinical trial investigating the clinical effectiveness and cost benefit of a lifestyle intervention targeting Type 2 Diabetes Mellitus.

Scientific title
An investigation into the clinical effectiveness and cost benefit of an intensive therapeutic lifestyle intervention for people with Type 2 Diabetes.
Secondary ID [1] 291803 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 303033 0
Condition category
Condition code
Metabolic and Endocrine 302493 302493 0 0
Diabetes
Public Health 302494 302494 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of participants enrolled in the intervention arm of the study participating in a lifestyle intervention known as the Complete Health Improvement Program (CHIP) for 12 weeks. Thereafter, participants will be contacted for the purpose of providing motivation and support on a monthly basis for an additional 9 months. This opportunity will be used to provide ongoing encouragement and support for lifestyle change, to answer questions, and to provide additional information as required or requested by the participants. Participants will also be invited to attend Club CHIP events, if and when available in their local area. Club CHIP is an optional support and continuing education group usually established and run by CHIP graduates. Club CHIP is not a requirement and therefore it is not available in all locations. There is one Club CHIP in operation which is geographically accessible to participants who may enroll in the study.

The CHIP intervention consists of 18 education sessions, each of 90 minutes duration. The 18 sessions are run over a 12 week period according to group availability The following pattern is mostly adopted. 3 sessions per week for the first 2 weeks, then 2 sessions a week for the next 2 weeks and then 1 session a week for another 8 weeks. Approximately half of each session is devoted to viewing pre-recorded visual material while interactive group discussions and activities, including food preparation and exercise demonstrations, make up the remaining time. An outline of the topics covered over the 18 sessions can be viewed below.
1 The rise of chronic disease
2 Lifestyle as medicine
3 The common denominator of chronic disease
4 The optimal lifestyle
5 Eat more, weigh less
6 Fibre, your new best friend
7 Disarming Diabetes
8 The heart of the matter – heart healthy
9 Controlling blood pressure and discovering protein
10 Bone health essentials
11 Cancer prevention
12 Understanding your results and taking action
13 Become what you believe. Your DNA is not your destiny
14 Practicing forgiveness
15 Re-engineering your environment
16 Stress relieving strategies
17 Fix how you feel
18 From surviving to thriving

Sessions 1 to 11 provides information on the aetiology, risk factors and pathological mechanism responsible for lifestyle related chronic disease. Emphasis is placed on the links between obesity, diabetes, hypertension, hyperlipidaemia and cardiovascular disease. Participants are provided with information relating to how lifestyle changes, particularly in diet and levels of physical activity, can positively alter the risk factors for as well as the course of chronic diseases. Specifically, the adoption of a plant-based, restricted sugar and salt diet is encouraged as well as daily physical activity involving a combination of aerobic and strengthening exercise most days of the week. Sessions 12 to 18 provide information related to other important lifestyle behaviors like substance use, rest, and sleep and stress management. Participants are provided with strategies that will assist them in assuming a position of control of their health, to overcome barriers, to manage and maintain behavior change and to cope with environmental pressures and stressors.
Each participant receives a CHIP kit containing a textbook, workbook, recipe book, water bottle and pedometer.
The intervention is run by voluntary facilitators who have been specifically trained to run the intervention. The intervention was designed, written and recorded by a team of health professionals and is under license from Sanitarium Health and Well Being. The intervention will be run in community halls on the central coast of NSW. The additional follow up will be conducted by the researcher who is a trained facilitator via telephone.
A record of participants attendance will be kept.
The workbook contains a page where participants may keep records of their own goals and adherence. These pages will not be assessed as part of the research. participants will complete the Active Q survey and questions relating to their eating pattern on commencement, at 12 weeks and again at 12 months as described in the outcomes section

Intervention code [1] 297912 0
Lifestyle
Intervention code [2] 298730 0
Treatment: Other
Comparator / control treatment
The control group will continue to receive their usual diabetes care and not receive any intervention or details about the CHIP intervention.
Control group
Active

Outcomes
Primary outcome [1] 301909 0
Change in glycaemic control. This will be measured through fasting blood sugar level, and Hb A1C measurements (serum assay) as well as changes in medication requirements, This is a composite primary outcome. medication change will be assessed from the patient survey

Timepoint [1] 301909 0
Prior to commencement and at 3 months and 12 months after commencement of the intervention.
Primary outcome [2] 301910 0
To determine the cost benefit of the intervention. This will be obtained through a cost analysis which will include the cost of the intervention and assessment tools e.g. SF-36 Quality of life questionnaire, as well as cost relating to medical appointments, interventions, hospitalizations as well as monitoring and treatment costs.
Timepoint [2] 301910 0
Cost of the programme will be obtained prior to commencement and at 3 months post commencement of the intervention. Pre commencement costs relate to venue hire and cost of kits (textbook, workbook, recipe book and pedometer) that will be distributed to participants. Cost of the programme at 3 months will include the cost of materials and food required for demonstrations and refreshment. Cost of materials, appointments and medical care will be obtained on a monthly basis (for 12 months) from the participants. Cost benefit will be determined over the full 12 month period
Secondary outcome [1] 334261 0
Change in body mass index (BMI). This will be measured using calibrated weight and height scales and the formula BMI =weight (in kilograms)/height x height (in metres)
Timepoint [1] 334261 0
Body weight and height, will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [2] 334262 0
Change in levels of total cholesterol. This will be measured through serum assay.
Timepoint [2] 334262 0
Blood tests will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [3] 335112 0
Change in blood pressure levels. Blood pressure will be measured by a trained health professional, using a calibrated sphygmomanometer and stethoscope.
Timepoint [3] 335112 0
Blood pressure levels will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [4] 335113 0
Change in levels of physical activity.
This will be assessed using the Revised Active-Q physical activity questionnaire obtained from Stephanie Bonn from Karlinska Instutet, Sweden. This questionnaire has been validated in its web based form. It has not been validated in its paper format, however the questions are identical.
Timepoint [4] 335113 0
The activity survey will be administered prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [5] 335114 0
Change in quality of life. This will be measured using the RAND 36 Health Survey.
Timepoint [5] 335114 0
The survey will be administered prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [6] 335115 0
Change in lifestyle measured over a 12 month period. This will be assessed using dietary questions designed specifically for this study and included in the demographic and medical history assessment form.
Timepoint [6] 335115 0
This assessment will be completed prior to commencement and at 3 months, and 12 months after commencement of the intervention.,
Secondary outcome [7] 337353 0
Change in waist to hip ratio. This will be measured using a calibrated tape measure according to the WHO STEPS protocol and using the formula waist circumference (cm)/hip circumference (cm)
Timepoint [7] 337353 0
Waist to hip ratio will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [8] 337354 0
Change in waist to height ratio. This will be measured using a calibrated height measure and tape measure according to the WHO STEPS protocol and using the formula waist circumference (cm) /height (cm)
Timepoint [8] 337354 0
Waist to height ratio will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [9] 337355 0
Change in LDL Cholesterol levels. This will be measured through serum assay.
Timepoint [9] 337355 0
Blood tests and medication use will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [10] 337360 0
Change in tryiglyceride levels. This will be measured through serum assay.
Timepoint [10] 337360 0
Blood tests and medication use will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [11] 337361 0
Change in HDL cholesterol levels. This will be measured through serum assay.
Timepoint [11] 337361 0
Blood tests and medication use will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [12] 338038 0
Change in levels of total cholesterol. This will be measured through a change in lipid modulating medication requirements. This information will be obtained from the patient survey.
Timepoint [12] 338038 0
Medication use will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [13] 338039 0
Change in blood pressure measurement. Data will be obtained regarding a change in requirements for antihypertensive medication.
Timepoint [13] 338039 0
Blood pressure medication use will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention. This information will be obtained from the patient survey.
Secondary outcome [14] 338040 0
Change in LDL Cholesterol levels. This will be measured through a change in lipid modulating medication requirements. This information will be obtained from the participant survey
Timepoint [14] 338040 0
Medication use will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [15] 338041 0
Change in HDL cholesterol levels. This will be measured through a change in lipid modulating medication requirements. The information will be obtained from the participant survey.
Timepoint [15] 338041 0
Medication use will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention.
Secondary outcome [16] 338042 0
Change in tryiglyceride levels. This will be measured through a change in lipid modulating medication requirements. The information will be obtained from the participant survey
Timepoint [16] 338042 0
Medication use will be obtained prior to commencement and at 3 months and 12 months after commencement of the intervention.

Eligibility
Key inclusion criteria
A current diagnosis of Type 2 Diabetes Mellitus
Over the age of 18 years
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons will be ineligible for the study if:
a. they are aged less than 18 years
b. the consulting medical practitioner considers that an alteration in nutrient or calorie consumption or that the participating in regular moderate exercise could result in an increased health risk. This may include but may not be limited to:
i. persons having a history of uncontrolled hypertension with consistent resting blood pressure readings greater than 180mmHg systolic and or greater than 110 mm Hg diastolic;
ii. persons having a BMI lower than 21 kg/m²; and making use of weight-loss medication;
iii. persons experiencing recurrent chest pain or unstable angina;
iv. pregnant or lactating females, or females planning to become pregnant in the next year;
v. persons having undergone angioplasty or having had a myocardial infarction or cardiac surgery within the previous 3 months;
c. they have any condition that precludes the potential participant from increasing their level of physical activity;
d.. they have any physical condition or language barrier that would preclude them from understanding or safely adopting the lifestyle changes recommended by the CHIP intervention.

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 concealment will be applied by list in groups of about 30 and 40 individuals. Once the list contains the names of about 30-40 individuals, the names with then be randomized by a person independent of the research team
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer aided sequence generation by a person independent of the research team.
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
Sample size
The study is sufficiently powered at 80% to detect a 3.5% reduction in fasting glucose, with significance determined to be < 0.05 (95% confidence interval). The sample size was calculated to be 75 in both the control and intervention, allowing for a 10% drop out rate of participants during the study.

Statistical Analysis
All data collected will be coded and entered into IBM® SPSS® version 22 for Windows® (SPSS Inc, 2013) prior to analysis.

Analysis for primary outcomes 1 and 2 and secondary outcomes.
Descriptive statistics will be used to analyse demographic data, anthropometric measurement data, blood results and activity levels on commencement of the program and also at the described re-evaluation intervals. Descriptive statistics will include frequencies, percentage distribution, means and medians as well as standard deviation from the mean. The Shapiro-Wilk test will be used to determine normal distribution in order to decide on whether to use parametric or non-parametric testing for correlations and variance analysis. A paired sample t-test (dependent t-test) will be used to compare pre intervention data with post intervention (12 weeks) and pre intervention data with post intervention (12 months) data. An independent t-test will be used to compare data between intervention and control groups. Pearson’s correlation will be used to explore relationships between continuous variables. The dietary inventory, health survey, and quality of life survey will be independently scored and the results between groups compared using linear regression. The level of significance is set at p<0.05

Analysis for primary outcome 3.
To determine the cost benefit of the intervention, a cost-benefit analysis will be undertaken. The cost benefit analysis will involve assessment of beneficial effects of the intervention. The analysis will include benefits and costs attributed to the project and indirect costs. Therefore, where B represents all the benefits and C represents all the costs, the project will be considered beneficial if B-C > 0. A cost benefit ratio will also be calculated. Costs included in the analysis will include opportunity costs. Costs from published literature and from government agencies will be used wherever possible, for example, the Medical Benefits Scheme and Pharmaceutical Benefits Scheme.

Recruitment
Recruitment status
Not yet recruiting
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)
NSW
Recruitment postcode(s) [1] 16118 0
2265 - Cooranbong
Recruitment postcode(s) [2] 16122 0
2259 - Kanwal
Recruitment postcode(s) [3] 16963 0
2250 - Gosford
Recruitment postcode(s) [4] 16964 0
2264 - Bonnells Bay
Recruitment postcode(s) [5] 16966 0
2263 - Toukley
Recruitment postcode(s) [6] 16967 0
2259 - Warnervale
Recruitment postcode(s) [7] 16968 0
2264 - Morisset

Funding & Sponsors
Funding source category [1] 296304 0
University
Name [1] 296304 0
Avondale College of Higher Education
Address [1] 296304 0
582 Freemans Drive, Cooranbong, NSW, 2265
Country [1] 296304 0
Australia
Primary sponsor type
University
Name
Avondale College of Higher Education
Address
582 Freemans Drive, Cooranbong, NSW, 2265
Country
Australia
Secondary sponsor category [1] 295613 0
None
Name [1] 295613 0
Address [1] 295613 0
Country [1] 295613 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297534 0
Avondale Human Research Ethics Committee
Ethics committee address [1] 297534 0
582 Freemans Drive, Cooranbong, NSW, 2265
Ethics committee country [1] 297534 0
Australia
Date submitted for ethics approval [1] 297534 0
23/01/2017
Approval date [1] 297534 0
09/03/2017
Ethics approval number [1] 297534 0
2017:02

Summary
Brief summary
It is well recognised that rates of T2DM are increasing at dramatic rates in Australia. A number of interrelated factors are associated with increased risk of developing the condition, however, much of the cause can be attributed to obesity as a result of high energy, high fat and high animal protein diets along with a lack of regular physical activity. Currently, there is no known medical cure for the condition. However, studies conducted on participants enrolled in a number of lifestyle modification programs suggest that the symptoms of T2DM are reversible where energy intake is reduced resulting in improved body weight and Body Mass Index. Previous studies conducted on individuals with abnormal blood glucose levels also indicate that the adoption of the Complete Health Improvement Program (CHIP) lifestyle intervention significantly reduced blood sugar levels in compliant individuals.
This study will investigate:
The effect of the CHIP intervention on obesity, blood sugar and medication levels of a group of participants with established T2DM.
It will also examine the cost benefit of such an intervention.
This will be done by evaluating the following:
The blood sugar, HBA1c, cholesterol and blood pressure readings in those participating in the CHIP intervention delivered over a period of 12 weeks with additional monthly follow up for another nine months compared to a control group receiving their usual diabetes care.
The levels of compliance over a 12-month period in those participating in the CHIP intervention delivered over a period of 12 weeks with an additional follow up for another nine months compared to a control group receiving their usual diabetes care.
The cost benefit (over a 12-month period) of implementing the CHIP intervention delivered over a period of 12 weeks with an additional follow up for another nine months compared to a control group receiving their usual diabetes care.
The outcomes of this study have the potential to inform decisions about patient treatment and potentially provide an incentive for the provision of funded lifestyle based preventive and restorative programs for patients diagnosed with T2DM.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74362 0
Mrs Linda Cloete
Address 74362 0
Avondale College of Higher Education
Clinical Education Building
185 Fox Valley Rd,
Wahroonga
NSW 2076

Country 74362 0
Australia
Phone 74362 0
+61 41 670 4849
Fax 74362 0
Email 74362 0
linda.cloete@avondale.edu.au
Contact person for public queries
Name 74363 0
Mrs Linda Cloete
Address 74363 0
Avondale College of Higher Education
Clinical Education Building
185 Fox Valley Rd,
Wahroonga
NSW 2076
Country 74363 0
Australia
Phone 74363 0
+61 2 9480 3643
Fax 74363 0
Email 74363 0
linda.cloete@avondale.edu.au
Contact person for scientific queries
Name 74364 0
Mrs Linda Cloete
Address 74364 0
Avondale College of Higher Education
Clinical Education Building
185 Fox Valley Rd,
Wahroonga
NSW 2076
Country 74364 0
Australia
Phone 74364 0
+61 416704849
Fax 74364 0
Email 74364 0
linda.cloete@avondale.edu.au

No data has been provided for results reporting
Summary results
Not applicable