JMIR Publications

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 biofeedback 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 were identified by the general practitioner (GP) who conducted a search using HbA1c results recorded in the previous 12 months. Participants potentially eligible were then invited for a further screening. Those who had a current HbA1c level of 39–47 mmol/mol were invited to volunteer. The intervention integrated a smartphone application delivering an online e-DPP course with text messages incorporating motivational interviewing techniques and biofeedback delivered via a wearable device over a period of 12 months. The control group received the wearable technology and access to the e-DDP, but not the text messaging. As this was a feasibility study, the primary measures were estimating the potential sample size at different stages of the study, from the size of the target study population to the proportion of participants who completed follow-up data collection. We also measured the main outcomes as for a full-scale RCT, namely change in weight and physical activity (PA) at six- and 12-month follow-ups. We conducted a process evaluation, including focus groups with participants who: i) received the intervention, ii) were in the control group, and iii) dropped out of the intervention.

Results:

We enrolled 200 participants: 98 were randomized to the intervention group and 102 to the control group. 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 six 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 six 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). The three focus groups included 14 participants (n=8 males) aged 49-65 years. Four main themes emerged: awareness of diabetes risk, quality of technology, self-efficacy and behaviour change.

Conclusions:

We have demonstrated the feasibility of conducting a RCT of an e-DPP. We found that the e-DPP intervention was not effective in improving participants’ weight or PA levels. The process evaluation identified several barriers to implementing the intervention. Clinical Trial: ClinicalTrials.gov NCT02919397.