None listed
Conditions
Brief summary
Proposal Aim To compare the effectiveness and cost-effectiveness of several different diabetes prevention programs including face to face groups, phone only interventions and those that use the internet to deliver lifestyle modification programs. Research design Screening, recruitment and referral Screening, recruitment and referral will be undertaken by the two Medicare Locals (IWSML and WSML). Eligible participants will be English-speaking 40-65 years, have completed an AUSDRISK >12, and have diabetes excluded, and medical clearance from a doctor. Target number of referrals (i.e. participants who are allocated to one of the four programs (see below). IWSML = 200 participants WSML = 200 participants Diabetes Prevention Programs Once eligible participants will be referred to a central point in each ML. The ‘Program Coordinator’ in each ML will contact the eligible participants explain the study, confirm interest and motivation, obtain consent and give them a choice to take up one of the four programs available in each of their ML areas. There will be a slight variation in each ML as follows: Inner West Sydney ML: Get Healthy Service [phone only] Prevent Diabetes Live Life Well [face-to-face and phone] Prevent Diabetes Live Life Well [internet and phone] 50 in each stream and 100 in PDLLW face to face group program Western Sydney ML: Get Healthy Service [phone only] SHAPE [face-to-face and phone] Prevent Diabetes Live Life Well [internet and phone] 50 in each stream and 100 in SHAPE program The programs will have to be offered in random order to each participant to avoid a possible bias here. Once the numbers for each arm have been reached then the participant will be told that they only have a choice of what is left. In this research design the PDLLW face-to-face program is the reference group that we will compare the three others to. It has been estimated that a sample size of 100 participants in each arm will be sufficient to detect between 1-1.5kgs weight difference at the 12-month evaluation between groups. The follow up period has been set as short-term evaluation 6-months from entry into the program and medium-term – 12 months from baseline. This allows completion of the intensive intervention 3-month phase and both short-term and medium term effects to be assessed. Evaluation outcomes It is proposed that once participants have been referred and agreed to be in one of the four arms but before they begin one they will be contacted by Computer Assisted Telephone Interviewers from the Boden to assess the main outcomes. Weight/Height Physical Activity Dietary assessment Waist circumference A welcome pack with a letter and tape measure will be sent to participants advising them to have their weight and waist circumference measures ready to report. In addition, sociodemographics and other relevant information will be collected by CATI. Primary outcomes: The primary goals assessed as follows: Weight (self-report) Physical Activity: Active Australia questions at baseline and 12-months collected as part of the CATI. Nutrition: Fat and Fibre index could be measured by CATI or a 3-day non-weighed food diary collected at baseline at the 12-month review. Secondary outcomes: Waist circumference (self-report) General health will be measured using the SF12. CATI to be repeated at 6 and 12 months after baseline.
Interventions
Participants partake in only one program. They are offered the choice of one of 3 programs in their area - Inner Western Sydney: Live Life Well face to face; Live Life Well webinar; Get Healthy Phone Service and Western Sydney: Shape face to face; Live Life Well webinar; Get Healthy Phone Service.
1. The Get Healthy Information and Coaching Service is a free, confidential, individually tailored telephone service funded by the NSW Ministry of Health. It aims to reduce the risks of lifestyle rel
Participants partake in only one program. They are offered the choice of one of 3 programs in their area - Inner Western Sydney: Live Life Well face to face; Live Life Well webinar; Get Healthy Phone Service and Western Sydney: Shape face to face; Live Life Well webinar; Get Healthy Phone Service. 1. The Get Healthy Information and Coaching Service is a free, confidential, individually tailored telephone service funded by the NSW Ministry of Health. It aims to reduce the risks of lifestyle related chronic disease by providing evidence-based information and advice about: Healthy eating; Being physically active; Achieving and maintaining a healthy weight. A health professional conducts an initial telephone assessment followed by 13 telephone coaching calls over the next 6 months. The Initial Consultation has an approximate duration of 25 – 30 minutes or beyond. There is no urgency to stop at 30 minutes and the individual requirements of the communication dictate the length of the conversation. The follow up calls last on average 5 to 15 minutes but may be longer depending on the individual situation. These calls are to to offer support and motivation. 2. The Live Life Well Face to Face program includes an individual consultation with a trained lifestyle officer followed by 3, 2-hour group sessions within the Inner West Medicare Local area. Each session includes information regarding exercise, healthy eating, how to change behavior and maintain it. Participants receive individualised goals and plans regarding what to eat, what exercise to do and how to do it. Participants will receive ongoing support through qualified lifestyle officers via follow-up telephone calls conducted at 3, 6, 9 and 12 month intervals. The initial consultation is approximately 60 – 90 minutes. For each group (of approximately 8 – 10 participants), the 3 x 2 hour sessions are held over 3 consecutive weeks in one month. A schedule of times and dates is provided when participants choose a program. The LLW face to face program is scheduled for September and October and further scheduling is to be announced. The support telephone calls take between 10 and 20 minutes but may be more or less depending on the circumstances. 3. The Live Life Well webinars. The Live Life Well online program includes an individual consultation on a web platform followed by 3 x 2-hour group sessions conducted by a qualified exercise physiologist and/or diabetes educator. Each session includes information regarding exercise, healthy eating, how to change behavior and maintain it. Participants receive individualised goals and plans regarding what to eat, what exercise to do and how to do it. To participate in this option participants are required to have a stable internet connection, a phone or headphones, a recent version of Adobe Flash Player and a quiet place to listen. Follow-up support telephone/skype calls are conducted at 3, 6, 9 and 12 month intervals. The initial consultation is conducted on skype or telephone with an approximate duration of 60 – 90 minutes. For each group (of approximately 8 – 10 participants), the 3 x 2 hour web-sessions are held over 3 consecutive weeks in one month. A schedule of times and dates is provided when participants choose a program. The support skype/telephone calls take between 10 and 20 minutes but may be more or less depending on the circumstances. 4. SHAPE sessions for health and physical exercise program (SHAPE) is an 8-session, face-to-face, health and fitness program for people who are at risk of developing Type 2 diabetes or heart disease conducted through the Western Sydney Medicare Local area. Exercise physiologists and/or dietiticians will lead the sessions, which include: an initial assessment with an Allied Health Professional to assess current fitness levels, lifestyle choices and set personal goals; 8 Healthy lifestyle group sessions combining diet and nutritional education with group exercise activities; a final assessment with an Allied Health Professional to measure progress throughout the program; and a post-program plan to ensure ongoing progress and self-management. The Initial assessment is approximately 90 minutes including anthropometric data, submaximal aerobic power test, blood pressure, resting heart rate, exercise, self-efficacy and nutritional questionnaires. The duration and frequency of the group sessions are 1 x 1 hour session per week for 8 weeks over a period of 8 to 10 weeks. Follow-up support telephone calls are conducted at 3, 6, 9 and 12 month intervals.These calls take between 10 and 20 minutes but may be more or less depending on the circumstances. With regard to monitoring adherence, throughout the programs, each intervention arm records attendance and is required to submit this information to the BODEN. The Boden Institute at the University of Sydney will be externally evaluating and comparing outcomes via self-report weight, waist circumference and diagnosed diabetes, as well as physical activity, fat and fibre eating behavior and quality of life scores.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Screening, recruitment and referral will be undertaken by the two Medicare Locals (IWSML and WSML). Eligible participants will be English-speaking and 40-65 years old, have completed an AUSDRISK >12, and have diabetes excluded, and medical clearance from a doctor.
Exclusion criteria
The exclusion criteria are determined by the General Practitioner They are: type 1 or 2 diabetes pregnancy untreated severe aortic stenosis or other structural heart disease end stage congestive heart failure progressive or terminal cancer severe cognitive impairment or behavioural disturbance malignant arrhythmias unstable CAD
Outcome results
None listed