What will I have to do in the trial as a participant?
Participating in the ASPIRE-DNA trial will require you to partake in a twelve-week intervention period plus a follow-up visit at fourteen weeks after the completion of the intervention period. Participation throughout this twenty-six week period (intervention period plus follow-up) will involve attending a series of visits and completing questionnaires.
Timings of Visits
These visits and questionnaires will occur at specific times in the trial spaced out at 0, 6, 12 and 26 weeks from the start of the intervention. Every effort will be made to provide you with options to choose your appointments within these timeframes. Please note that all appointments will be conducted between 8am-8pm Monday-Thursday and 8am-6pm Friday at the Imperial College Research Facility (ICRF) at Hammersmith Hospital, for more details on the ICRF, including transport options click here. It is very important that you will be able to commit to attending all 6 visits (consisting of the four clinical visits mentioned above, one screening visit and one dietitian visit) during these hours at the ICRF. As this is a randomised control trial, you will be randomly allocated into one of the following three groups. The group you are assigned to will determine which specific visits you will be required to attend.
Below are the three trial groups;
- Control group: Participants will receive standard dietary guidelines according to NICE guidelines for people at high risk of diabetes with regular interaction with a dietitian.
- Intervention group: Participants will receive personalised DNA-based dietary guidelines with regular interaction with a dietitian.
- Exploratory group: Participants will receive personalised DNA-based dietary guidelines with an initial consultation with a dietitian and a smartphone app to guide food shopping thereafter.
In each group the intervention will be assessed over 12 weeks with a final follow-up at 26 weeks.
There will be two types of visits throughout the trial; (i) Clinical visits and (ii) Dietitian visits.
(i) Clinical visits
Over the 26-week period you will be required to attend four clinical visits at the ICRF. At the clinical visits;
- You will be asked to abstain from eating, smoking and consuming caffeine from 12 hours before the visits
- A venous blood sample will be taken, requiring approximately 2 teaspoons of blood (15mL)
- Your blood pressure, weight, height, and body composition will be measured
- You will perform an oral glucose tolerance test (OGTT). This involves consuming a sugary beverage and two blood tests will be performed, requiring you to remain at the centre for 2 hours
- Two saliva samples will be taken by asking you to spit 2ml of saliva into the tubes provided
- If female, and of child-bearing age, you may be asked to complete a pregnancy test
- The visit will take up to 2.5 hours
Please note, clinical visits will be held between 8am-8pm Monday-Thursday and 8am-6pm Friday. It is important that you are aware of whether you can commit to these visiting hours before enrolling in the trial. Your data will not be eligible for the trial unless you complete all trial visits.
(ii) Dietitian visits
Over the 26-week period you will be required to attend one dietitian visit at the ICRF. Following this, depending on which of the trial groups you are allocated to, you will have four follow-up phone calls at various, pre-determined times throughout the trial. The follow-up phone calls do not require you to attend the ICRF. Regarding the Dietitian visits;
- The initial dietitian consult will take approximately one hour.
- Your diet history will be discussed
- You will be provided with your genetic results depending on the trial group you are allocated to
- The follow-up phone calls (which will take approximately 30 minutes) will discuss;
- Any issues with your intervention, respective of which trial group you are allocated to
- Further guidance and instruction on your dietary intervention
Throughout the trial you will be required to complete several questionnaires;
- A trial commencement questionnaire
- A trial completion questionnaire after 12 weeks and after 26 weeks of the trial.
- A Food Frequency Questionnaire (FFQ) at four pre-determined times throughout the trial
How long will the trial last?
The Intervention period for the trial will be twelve weeks. There there is a follow-up time period, fourteen weeks after the intervention period is completed. This means that the total time frame for the trial is twenty-six weeks (six months).