15-minute Individual Consultation to Improve Blood Glucose Control in Pre-diabetes
Condition: Pre-Diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      This research will assess the feasibility of conducting a randomised control trial to
      evaluate the effectiveness of a 15-minute one-to-one consultation to improve blood glucose
      control in pre-diabetes. The consultation will take the form of a 15-minute one-to-one
      consultation between a health-care practitioner and the patient in a primary care setting.
      Patients with a glycated haemoglobin (HbA1c) of between 42 and 47 mmol·mol-1 will be
      identified in general practise and will be eligible to participate. They will attend testing
      sessions at baseline (before the consultation), and at three months and six months post
      consultation. Body mass index (BMI), waist and hip girth, blood pressure and body composition
      will be recorded and blood analysed for HbA1c, cholesterol and dietary components. For a
      three-week period following each visit, urine will be collected, a 5-ml sample on nine
      occasions, and physical activity will be recorded in a sub group of participants. Urine will
      be analysed by flow infusion electrospray mass spectrometry (FIE-MS) to determine the
      metabolic content, providing an indication of the diet over the three-week sampling period.
      The research objectives are to assess the effectiveness of recruitment strategy and
      willingness of patients to engage in, and adhere to, the research process; to determine the
      impact of consultation on health outcome measures, including HbA1c, and to establish
      participant and practitioner perspectives of the consultation.
    

Detailed description: 
      Participants will be required to visit the Wellbeing Assessment Research Unit (WARU), Carywn
      James Building, Penglais Campus, Aberystwyth University, on 3 separate occasions, for
      baseline, 3 month and 6 month testing. During the baseline visit, the procedures and protocol
      of the study will be explained and informed consent will be received. Participant's height
      and body mass will be collected to calculate BMI and waist and hip girth recorded. Next,
      participants will be asked to sit quietly for 10 minutes in the laboratory before blood
      pressure is recorded from the upper non-dominant arm. Participants will remain seated prior
      to a 6 mL blood sample being obtained from the antecubital vein and collected into a
      heparinised vacutainer, with minimal stasis, using standard venepuncture methods performed by
      a trained member of the research team. Should patients HbA1c be outside the required values
      during the baseline visit, they will be informed and will take no further part in the
      research. WARU will inform the participant's general practicioner (GP) if their HbA1c is
      indicative of diabetes. Body composition will be analysed using bioelectrical impedance.

      Upon completion of this phase of data collection, participants will be provided with a series
      of validated questionnaires to complete (to be completed at every visit unless otherwise
      stated). These include; the International Physical Activity Questionnaire- Short Form, Food
      Frequency Questionnaire (baseline and 6 months), 36-Item Short Form Survey Instrument and
      components of the Personal Diabetes Questionnaire (baseline). Participants will complete the
      questionnaires unassisted although members of the research team will be available to answer
      any questions the participant may have relating to the questionnaires. Lastly, participants
      will receive instructions on the use of the urine collection kit for dietary monitoring and
      the ActiGraph for physical activity monitoring (if randomised). Participants will then be
      free to leave the laboratory. An additional acceptability questionnaire designed by the
      research team will be given to participants at the end of the 6 month visit and will include
      questions relating to the WARU visits, 15 minute consultation (if received), urine collection
      and ActiGraph use. Visits will last between approximately 120 minutes and 150 minutes
      depending on the time taken for participants to complete the relevant questionnaires.

      Following completion of the baseline visit, participants will be randomised into either the
      intervention group (INT) or the control group (CON). Randomisation will be achieved using a
      minimisation software package and will ensure that there will be only minor differences
      between groups in the variables used in the allocation process. Participants in INT will
      receive a focused 15 minute one to one consultation with a practice nurse at their registered
      general practice. The consultation derives from the original 30 minute protocol employed
      during a previous study conducted by the present research team which used 104 GP-registered
      patients. The first half of the 30 minute consultation in that study (led by general
      practice) collected baseline data (height, weight, waist circumference, blood pressure) and
      the second half provided patients with lifestyle advice on preventing diabetes. The
      consultation to be used in the proposed study does not require general practice to collect
      baseline data and therefore the consultation time has been reduced from 30 minute to 15
      minutes. The consultation will provide the participant with one to one information regarding
      the benefits of physical activity and healthy eating. Emphasis will placed on the importance
      of achieving at least 150 minutes of moderate physical activity each week as well as adhering
      to healthy dietary habits, based on the National Health Service (NHS) Eat Well Guide.
      Furthermore, participants will have the opportunity to discuss pre-diabetes with a trained
      practice nurse and ask any questions they may have. Participants placed in CON will not
      receive the consultation and will only attend visits to the WARU. Due to logistical and
      financial implications, a subgroup of participants will also be randomised for additional
      physical activity monitoring. 5 participants from INT and 5 from CON will receive an
      Actigraph (see below for further information on the Actigraph).

      Dietary Monitoring:

      Metabolic fingerprinting and metabolic profiling of human urine is able to provide a
      comprehensive and quantitative snapshot of dietary exposure for 12 - 24 hrs prior to urine
      collection. While a single sample snapshot is not representative of an individuals' habitual
      dietary exposure, a series of snapshots over a prolonged time period can give a robust
      overview of an individual's nutritional health. Previous work has demonstrated a community
      based urine collection protocol as a successful and non-disruptive method for monitoring
      habitual diet. Participants will be provided with a urine collection kit consisting of; of
      non-sterile urine collection straws, additive free evacuated vacutainer tubes and a urine
      collection container. Once urine has been collected, the sealed vacutainer tubes will be
      stored in an absorbent pouch within a sealed leak-proof bag and kept in the refrigerator. All
      urine storage equipment and instructions are fully compliant with standards for storage of
      Category B biological substances. Participants will receive instructions to fill the
      collection container with a mid-stream urine sample (in order to minimise the possibility of
      bacterial contamination from urethral contaminants). Any excess urine produced which is not
      collected in the container should be deposited within the lavatory. The tip of the transfer
      straw will be submerged into the urine and a vacutainer tube inserted into the transfer straw
      to draw the urine into the vacutainer. Any remaining urine in the container will be deposited
      within the lavatory. The collection container can be rinsed with tap water after each urine
      sample and reused for each sample collected. Vacutainer tubes will be labelled with anonymous
      information including participant number, sample number, weekday/weekend sample and week
      number. Samples will be stored in a refrigerator at 4 degrees (ºC) for a maximum of 10 days
      before the samples are returned to the lab either in person or by free post for freezing at
      -80 ºC to await analysis. Participants will record the collection details of their urine
      samples onto a sample collection sheet which notes the sample number and the date and time of
      collection. Participants will collect 3 samples a week for 3 weeks following each WARU visit.
      Participants must collect two urine samples within the week on non-consecutive days (e.g.
      Tuesday & Thursday) and collect a third sample on either day of the weekend
      (Saturday/Sunday). In total, participants will collect 27 urine samples during their
      participation in the study. Urine samples will be analysed using laboratory based Flow
      Infusion High Resolution Mass Spectrometry which is an established method for dietary
      analysis using urine samples.

      Physical Activity Monitoring:

      Physical activity and sedentary lifestyle will be determined using ActiGraph following
      baseline, 3 months and 6 month WARU visits. Participants will be provided with written and
      verbal instructions on how to operate the device. Participants will choose one week within
      the three week urine collection period to wear the ActiGraph. Participants can choose any day
      within the week to begin wearing the ActiGraph but must then wear it for the following 7 days
      unless unfeasible to do so (e.g. swimming, bathing or showering). In this instance,
      participants will record at what time and the amount of time they are not wearing the
      ActiGraph. Should participants forget to wear the device; the same procedure will be
      followed. Should participants miss a whole day; they must record for an extra day directly
      after the 7th day. An additional sheet will be provided for participants to record any time
      when the device is not worn. Participants do not need to wear the ActiGraph when sleeping
      although they must record the time they go to sleep and at what time they wake up.
      Participants must fit the ActiGraph in the morning as soon as it is feasible to do so.
      Participants can return the ActiGraph at the end of the 7 day recording period either in
      person or be post.
    

Intervention name(s): Consultation
Intervention type(s): Behavioral
Intervention description(s): 15 minute, one to one consultation with a trained practice nurse at a GP surgery. Participants will have the opportunity to discuss pre-diabetes, the risks of developing diabetes and the steps that can be taken to improve lifestyle behaviors and reduce the risk of diabetes development.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomised into either the intervention or the control group. Participants in INT will receive a 15 minute one to one consultation with a nurse at their general practice. The consultation will provide the participant with information regarding the benefits of physical activity and healthy eating. Emphasis will placed on the importance of achieving at least 150 minutes of moderate physical activity each week as well as adhering to healthy dietary habits, based on the NHS Eatwell Guide. Participants will have the opportunity to discuss pre-diabetes with a nurse and ask any questions they may have. Participants placed in CON will not receive the consultation and will only attend visits to the WARU. A subgroup of participants will also be randomised for additional physical activity monitoring.
Masking: None (Open Label)
Primary purpose: Prevention