Physical activity following very low calorie diet (PA_VLCD)
Research type
Research Study
Full title
A behavioural intervention targeting physical activity: sustaining weight loss and type 2 diabetes remission following a very low calorie diet
IRAS ID
269947
Contact name
Kelly Bowden Davies
Contact email
Sponsor organisation
Manchester Metropolitan University
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Reversal of type 2 diabetes (T2D), termed ‘remission’ can be achieved by a very low calorie diet (VLCD). This is most successful in individuals who are able to maintain the significant weight loss that is achieved through the diet. However, weight regain, which occurs in a large proportion of patients, is associated with a relapse in remission. The purpose of this study is to investigate if an intervention to increase physical activity (PA) amongst T2D patients that have recently achieved remission (through VLCD) can sustain weight loss, and therefore remission. Patients who have recently (≤6 months) achieved diabetes remission through VLCD will be recruited and randomised to an intervention or control group. The intervention group will receive a theory-based behavioural intervention targeting an increase in PA, one session per month (a proven and feasible approach from our previous investigations). Health assessments will be taken at baseline, 3 and 6 months follow-up and include: anthropometrics (weight, body mass index [BMI], hip/waist circumferences), blood pressure, body composition (muscle mass and fat mass by stand on medical analyser), fasting bloods to determine diabetic control (e.g. glucose, insulin), fitness assessment (exercise test), as well as dietary assessment and quality of life questionnaires. PA (sedentary time, light activity etc.) will monitored for 7 days at each time point using a wrist or hip (to preference) worn device (ActiGraph). Based on the likelihood of observing a meaningful 3kg difference between-groups in weight at 6 months, 17 patients are required in each group. The intervention will be evaluated for how it was received and delivered from one-to-one interviews at the end of the study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0314
Date of REC Opinion
3 Dec 2019
REC opinion
Further Information Favourable Opinion