Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Jul 19, 2019
Open Peer Review Period: Jul 22, 2019 - Sep 16, 2019
Date Accepted: Feb 29, 2020
Date Submitted to PubMed: May 27, 2020
(closed for review but you can still tweet)
A randomised controlled trial of a wearable technology delivering an e-diabetes prevention programme in people at high risk of type 2 diabetes: A feasibility study
ABSTRACT
Background:
Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of research findings from landmark studies is expensive and time-consuming for the patient and health systems. The availability of digital lifestyle interventions is increasing, but the evidence of their effectiveness in reducing the risk of type 2 diabetes is limited.
Objective:
This randomised controlled trial (RCT) aims to test the feasibility of an e-diabetes prevention programme (e-DPP) with step-dependent feedback messages and personalised messages versus a standard e-DPP in people with pre-diabetes.
Methods:
A two-arm, parallel, single-blind RCT for people at high risk of developing type 2 diabetes. Patients with a HbA1c level of 39-47 mmol/mol were recruited from 21 GP surgeries from three London Clinical Commissioning Groups (CGGs) (Lambeth, Southwark and Lewisham). The intervention integrated a smartphone application delivering an online e-DPP course with short messaging service (SMS) texts incorporating motivational interviewing techniques as well as step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and had access to the e-DDP, but not the SMS texts. As this was a feasibility study, the primary aim was to estimate the potential sample size at different stages of the study, including the size of the target study population to the proportion of participants who completed follow-up data collection. We also measured the main outcomes for a full-scale RCT, namely change in weight and physical activity (PA) at 6-month and 12-month follow-ups, and secondary outcomes, including change in HbA1c, BP, waist circumference, waist:hip ratio and lipid levels.
Results:
We enrolled 200 participants: 98 and 102 were randomized to the intervention group and the control group respectively. The follow-up rate was higher in the control group (87 [85.3%]) than the intervention group (69 [70.4%]) for the primary outcomes at 12 months. There was no treatment effect on weight at 6 months (mean difference=0.15, 95% CI=-0.93 to 1.23) or 12 months (mean difference=0.07 kg, 95% CI=-1.29 to 1.44), or for PA levels at 6 months (mean difference=-382.90 steps, 95% CI=-860.65 to 94.85) or 12 months (mean difference=92.64 steps, 95% CI=-380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at 6-month or 12-month follow-up.
Conclusions:
This study demonstrates that it is feasible to successfully recruit and retain patients in a RCT of an e-DPP. Clinical Trial: ClinicalTrials.gov NCT02919397.
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