Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Screening for Glucose Intolerance and Development of a Lifestyle Education Programme for Prevention of Type 2 Diabetes in a Population With Learning Disabilities
People with learning (intellectual) disabilities have more health problems than the rest of
the populationÍž 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.
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.
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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