Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Sponsors
Brunel University London
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 85 years 2. Diagnosed with type 2 diabetes 3. Able to ambulate unassisted (with or without the use of a walking aid) 4. Self-report sitting for =7 h/day
Exclusion criteria
Exclusion criteria: 1. Using insulin medication 2. Unable to communicate in English 3. Pregnant 4. Cognitive or physical conditions interfering with the ability to stand and ambulate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcome measures calculated at the end of the study: 1. Participant eligibility will be calculated as: participants eligible/participants assessed for eligibility x 100 2. Recruitment rate will be calculated as: participants randomised / number of eligible participants screened x 100 3. Retention rate will be calculated as: participants completing the intervention/participants enrolled x 100) 4. Completion rates for the data collection measures will be calculated as: participants providing full outcome data/participants completing the study x 100 5. Acceptability of the intervention will be evaluated using self-report questionnaires that include closed and open-ended questions around engagement with the different intervention components. Self-report questionnaires will be completed by all participants to explore if the data collection measurements affected their behaviour. Semi-structured interviews will be completed with a subset of intervention participants to examine acceptability of the intervention. Semi-structured interviews will also assess the suitability of data collection procedures with a subset of control and intervention participants | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sitting, standing and stepping: this will be measured using the activPAL4 activity monitor worn on the thigh for 24 hours/day for eight consecutive days Measured at baseline, 3 months and 6 months: 2. Body composition, anthropometry and blood pressure: 2.1. Height will be measured using a stadiometer 2.2. Weight and body fat % will be measured using a bioelectrical impedance analysis device 2.3. Blood pressure will be measured on the right arm in a seated position using an automatic monitoring device 3. Biochemical measures: A finger prick sample technique will be used to collect fasting capillary blood samples to measure glycated haemoglobin, lipid profile and glucose concentrations 4. Psychological, sleep, musculoskeletal and wellbeing measures: 4.1. Perceived fatigue will be measured using the Chalder Fatigue Scale 4.2. Self-efficacy for reducing sitting will be assessed using an adapted Physical Exercise Self-Efficacy Scale 4.3. A perceived sense of control over one’s actions and outcomes will be assessed using the Generalised Self-Efficacy Scale and the Cohen Perceived Stress questionnaire will assess perceived stress 4.4. The Positive and Negative Affect Scale will measure positive and negative mood 4.5. The World Health Organization Five Well-Being Index will measure psychological wellbeing and quality of life will be measured using the WHOQOL-BREF questionnaire 4.6. The Pittsburgh Sleep Quality Index questionnaire will assess sleep quality and duration and musculoskeletal symptoms will be measured using the Standardised Nordic Questionnaire. 5. Physical function: this will be assessed using the Short Physical Performance Battery (which includes standing balance, walking speed and rising from a chair) and handgrip strength | — |
Countries
England, United Kingdom
Outcome results
None listed