Diabetes Screening & Prevention for People With Learning (Intellectual) Disabilities:STOP Diabetes Study
Condition: Diabetes Mellitus, Type 2; Prediabetic State; Intellectual Disability
MeSH terms: Intellectual Disability; Learning Disabilities; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
Study type: Observational

Summary: 
      People with learning (intellectual) disabilities have more health problems than the rest of
      the population; they are less likely to access help and have lifestyles that may increase
      their risk of getting diabetes (for example, poor diet and lack of physical activity). People
      with learning disabilities may also be prescribed drugs or have certain medical conditions
      (such as Down's syndrome) which can make their chances of getting diabetes greater.

      Diabetes is a long-term condition, which can cause damage to the eyes, heart, kidneys, nerves
      and feet. Impaired glucose regulation happens when sugar levels in the blood are higher than
      normal but are not high enough to be diagnosed with diabetes. People with impaired glucose
      regulation are more likely to develop diabetes, heart disease and stroke in the future. If
      people with impaired glucose regulation make changes to their lifestyle (diet and exercise)
      they can prevent or delay getting diabetes.

      The aim of this study is to screen people with learning disabilities for diabetes and
      impaired glucose regulation. The investigators also want to find out the best way to give
      people with learning disabilities some education around healthy lifestyles (for example,
      eating and exercise) to help with prevention of diabetes and cardiovascular disease.
      Therefore, the investigators also aim to develop a lifestyle education programme that is
      suitable for use in this population and test whether it is feasible and acceptable.
    

Detailed description: 
      Background -Adults with learning (intellectual) disabilities tend to have more health
      problems than the general population and are less likely to access help. Additionally,
      evidence suggests that due to a combination of lifestyle factors (e.g. poor diet, lack of
      physical activity), associated medical problems, and certain types of prescribed medication,
      people with learning disabilities may be at increased risk of developing type 2 diabetes and
      cardiovascular disease. Our overall aim is to undertake a programme of research that improves
      our knowledge and understanding of screening for impaired glucose regulation and type 2
      diabetes in a population with learning disabilities, and to develop a lifestyle education
      programme for prevention of type 2 diabetes that is suitable for use in this population.

      SCREENING PROGRAMME

      Aim - The main programme of work consists of a large diabetes screening programme. The
      primary aim of the screening study is to evaluate the feasibility and clinical and cost
      effectiveness of a screening programme for identifying undiagnosed type 2 diabetes and
      impaired glucose regulation that is suitable for use in a population with learning
      disabilities.

      Methods - A variety of approaches will be used to recruit people to the screening study:
      General practices will be approached first for participation in this study. If the practice
      does not agree, then the investigators will seek to approach eligible people on the
      Leicestershire Learning Disabilities Register. Learning disabilities consultants will also
      approach people face to face when attending for outpatient clinic appointments. Additionally,
      if individuals with learning disabilities (and/or their carer) contact the STOP Diabetes team
      to express an interest in the study, they will be given an invitation.

        -  Volunteers will be asked to attend an appointment(s) where consent will be obtained and
           biomedical and demographic data collected. The consent process and data collection will
           be staged and people may need to attend between one to three appointments to complete.

        -  People who are found to have type 2 diabetes or impaired glucose regulation will be
           asked to see their GP for care.

        -  At every stage, reasonable adjustments will be made to take into account people's
           communication needs and decision making capacity. This may include involving a carer or
           a

      DEVELOPMENT AND TESTING OF A STRUCTURED EDUCATION PROGRAMME

      The aims of additional work being carried out alongside the screening study are to: (1)
      develop a lifestyle education programme to meet the needs of a population with learning
      disabilities and impaired glucose regulation or high risk of diabetes; (2) assess the
      feasibility of collecting outcome measures for participants with learning disabilities before
      and 3-months after they attend the education programme.

      Methods - People approached to take part will be people who took part in the screening study
      and (1) gave their consent to be approached to take part in further phases of the research
      programme, and (2) were found to be at increased risk of developing diabetes according to
      their screening results.

      Qualitative Interviews to inform curriculum development:

        -  Interviews will be conducted with a sample of people with mild/moderate learning
           disabilities, their carers and healthcare professionals. Findings from the interviews
           will help inform development of an initial curriculum and education program.

      Delivery of initial curriculum and obtaining feedback:

        -  As part of the development work the education programme will be piloted with at least
           two groups of 6 - 8 people plus carers. Feedback will be collected from some of the
           people who attend the education sessions and any necessary changes made to the
           curriculum. These cycles of piloting, collecting feedback and modifying the programme
           will be repeated until the education programme developed is "fit for purpose".

      Delivery of programme with collection of before and after measures:

        -  Following initial development, testing and refinement of the curriculum, the education
           programme will be delivered with another sample of participants and the feasibility of
           collecting pre and post intervention outcome measures will be tested. The investigators
           anticipate delivering the programme to up to two groups of 6 - 8 people plus carers.
           Data will be collected at baseline and 3-months (12 weeks) following delivery of the
           final education session. Data and may include: physical activity and sedentary behaviour
           (as measured by accelerometer); body weight, BMI, waist circumference, blood pressure
           and dietary intake (fruit and vegetables). Uptake of the education programme
           (attendance) and retention at 3-months follow-up will also be explored. This phase will
           be subject to modification depending on the findings from prior iterations and any
           problems encountered.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults with a learning (intellectual) disability who are live in Leicester, Leicestershire
        or Rutland, UK;
      
Biospecimen description: 
      whole blood
    
Keywords: type 2 diabetes; impaired glucose regulation; intellectual disability; learning disability; screening; prevention; lifestyle education