Topic: Diabetes, Primary Care
Conditions
Interventions
Living Well, Taking Control: The Living Well, Taking Control programme is an existing community-based diabetes prevention programme adherent with NICE guidance that is being provided by voluntary sect
Sponsors
University of Exeter (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: As per existing programme eligibility criteria we will recruit people who: 1. Are aged 18-74 years. 2. Are considered on the basis of recent blood glucose tests to be at high risk for type 2 diabetes according to the criteria in the recent NICE diabetes prevention guidance (fasting plasma glucose level 6.1- 6.9 mmol/L, or HBA1c 42-47 mmol/l recorded at any point within the last year). A check for progression to diabetes amongst trial participants will be made at baseline using point-of-testing HbA1c assessment equipment. 3. Are resident in Exeter and Tiverton (postcodes EX1-6; EX 16) or Birmingham (postcodes B1-21). 4. Have a BMI of at least 25 (23 for certain ethnic minority populations e.g. South Asians) and less than 45 kg/m2
Exclusion criteria
Exclusion criteria: 1. We will exclude people who have a terminal illness or do not have the mental capacity to give informed consent and understand study procedures with assistance from the researcher, an interpreter or other representative as necessary (e.g., due to dementia, severe learning disability) 2. Participants who have an HbA1c reading recorded at their baseline assessment indicating progression to Type 2 diabetes will also be excluded from the trial but will still be able to access the diabetes management component of the Living Well, Taking Control programme and will be referred accordingly There are no other exclusion criteria as the programme providers cater for people with low literacy, needing translation services or with mental health problems, learning or physical disabilities, and will support consenting and collecting data from these groups.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss (kg); Timepoint(s): Baseline, 6 months, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 7-day objectively measured physical activity (i.e., accelerometry); Timepoint(s): Baseline, 6 months, 12 months 2. Blood pressure; Timepoint(s): Baseline, 6 months, 12 months 3. Dietary change (fat and fibre); Timepoint(s): Baseline, 6 months, 12 months 4. HbA1c (indicating average blood sugar levels over 3 months); Timepoint(s): Baseline, 6 months, 12 months 5. Mental health and well-being; Timepoint(s): Baseline, 6 months, 12 months 6. Other anthropometric measures (e.g., waist circumference, % body fat, muscle mass); Timepoint(s): Baseline, 6 months, 12 months 7. Perceived importance of and confidence in achieving healthy levels of activity and a healthy diet; Timepoint(s): Baseline, 6 months, 12 months 8. Quality of life (EuroQoL EQ5D); Timepoint(s): Baseline, 6 months, 12 months 9. Self-reported physical activity (NZPAQ); Timepoint(s): Baseline, 6 months, 12 months | — |
Countries
United Kingdom
Outcome results
None listed