Protocol for a randomized clinical trial investigating the clinical effectiveness and cost benefit of a lifestyle intervention targeting Type 2 Diabetes Mellitus.
- Conditions
- Type 2 Diabetes MellitusMetabolic and Endocrine - DiabetesPublic Health - Health promotion/education
- Registration Number
- ACTRN12617001233314
- Lead Sponsor
- Avondale College of Higher Education
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
A current diagnosis of Type 2 Diabetes Mellitus
Over the age of 18 years
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method