None listed
Conditions
Brief summary
A preliminary trial to assess the effectiveness of lifestyle and dietary intervention for the management of T2DM using electronic reminders, a fitness tracker wristband collecting exercise data and a web-based questionnaire to encourage participation. The question to be answered is whether the provision of quality dietary and exercise information known to be of benefit in T2DM control is better adopted by diabetics using simple electronic reminders and easy access to that information. There will be no control group, and this is an "n-of-one" trial in which each participant acts as their own control the beginning of the study. The degree of the participation will be matched to the outcome measures (HbA1c) to determine effectiveness of the entire approach. There is potential for follow-up of willing participants at 12 months. The hypothesis investigated for this clinical trial proposes to demonstrate that blood HbA1c levels can be successfully and significantly reduced through a healthy eating / exercise programme that is implemented at baseline to 25 weeks participation. Blood levels of HbA1c is an objective and accurate marker of metabolic syndrome status and T2DM progression. A 13.5 % (from at least e.g., 55.5 mmol/mol to 48 mmol/mol) reduction in blood HbA1C level will be associated with significant improved health outcomes from baseline. This benefit may translate into a significant reduction in health care costs associated with T2DM. The electronic intervention serves as a motivating tool and guide that supports patient programme compliance, resulting in fewer doctor and other allied health affiliated practitioner visits and most importantly decreased T2DM disease progression.
Interventions
The intervention in this clinical trial relates to electronic/ internet aids (mobile phone text messaging, emails, website usage and the constant wearing of a fitness tracker wristband) that will prompt patients diagnosed with T2DM to provide timely information of their lifestyle changes as part of the clinical study assessment requisite for this trial. The duration of this study is 26 weeks. Text messages and emails will be sent to participants daily. Participants are asked to use the website a
The intervention in this clinical trial relates to electronic/ internet aids (mobile phone text messaging, emails, website usage and the constant wearing of a fitness tracker wristband) that will prompt patients diagnosed with T2DM to provide timely information of their lifestyle changes as part of the clinical study assessment requisite for this trial. The duration of this study is 26 weeks. Text messages and emails will be sent to participants daily. Participants are asked to use the website at least once per day to log their food. Lifestyle changes from prospective participants in this clinical trial will be captured throughout the study, through a food log submitted though the website portal and exercise data collected through a fitness tracker wristband worn by participants constantly throughout the study. Participants will utilise the website daily to log food. The electronic intervention can be used by clinicians to tailor personalised health goals for patients diagnosed with T2DM. The electronic intervention is aimed at motivating, promoting and guiding the participant to execute a modest exercise and activity regime and dietary plan to reduce blood HbA1c levels. The Personalised e Health website contains diabetic friendly recipes, physical activity research and exercise tips, motivational quotes and facts on T2DM. Participants will be financially reimbursed (at beginning and end of trial) for their time to attend the screening visit and information visit at the clinic. The second payment at the end of the trail acts as an incentive to follow and complete the full trial. Participants also get to keep the fitness tracker wristband after the completion of the trial. If participants abandon the trial, the wristband will be taken back and financial travel reimbursement will discontinue. Stool samples will also be required on two occasions (baseline and 26 weeks), which will be collected by the participant in their own home and used to assess faecal microbial profiles. Participants will be provided with a specialised kit to collect the stool samples, which will be couriered to Bioscreen in Melbourne, at no cost for the participant.
Sponsors
Personalised e-Health Clinic
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1) Participants between 18 years and 75 years old 2) Ownership and ability to operate a smart phone and personal computer 3) Willingness to wear a fitness tracker wristband day and night (24 hours) throughout the entire study 4) Non-insulin-dependent type T2DM of more than 1 year’s duration 5) HbA1c no greater than 9.0% (75 mmol/mol) measured at the time of recruitment to the study 6) No chronic disease apart from (minor) complications of T2DM 7) Cognitive ability to give informed consent to participate
Exclusion criteria
1) History of alcohol or substance abuse including use of illicit drugs 2) Female participants who are lactating or pregnant 3) Presence of significant diagnosed disease unrelated to T2DM 4) Presence of diagnosed psychiatric disease which would impair participation or where participation could adversely the subject 5) Any other clinically relevant condition or abnormality, which, in the judgment of the clinical investigator, would make the subject unsuitable for the trial (e.g., dietary allergies, psychiatric symptoms, visual impairment etc.)
Outcome results
None listed