None listed
Conditions
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.
Interventions
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 informatio
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
Sponsors
Avondale College of Higher Education
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A current diagnosis of Type 2 Diabetes Mellitus Over the age of 18 years
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.
Outcome results
None listed