A wearable technology delivering a web-based diabetes prevention program to people at high risk of type 2 diabetes: randomized controlled trial.
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Abstract
Background: Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. Objective: This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. Methods: We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. Results: We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) 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 physical activity 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 the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. Conclusions: This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. Trial Registration: ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397
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Despite CDC recognition of digital DPPs since 2015, limited RCT evidence has evaluated their effectiveness, with no trials comparing them directly to the criterion-standard DPP.
“Despite CDC recognition of digital DPPs since 2015, limited RCT evidence has evaluated their effectiveness, with no trials comparing them directly to the criterion-standard DPP.14-19,37”
From An AI-Powered Lifestyle Intervention vs Human Coaching in the Diabetes Prevention Program: A Randomized Clinical Trial (2025) · cites this paper as [18]
The Introduction > Background (page not provided) says evidence for web-based DPPs is limited and discusses RCTs alongside noncontrolled evidence. It does not say that the CDC has recognized digital DPPs since 2015 or that no trial has directly compared a digital DPP with the face-to-face standard. Methods > Intervention mentions a CDC curriculum, but not that recognition or date. (LLM, conf=0.86)
Experimental — accuracy not yet measuredPrior randomized trials of digital DPP adaptations did not include fully automated AI-based experimental groups or a human-led DPP control group.
“Although previous randomized trials have assessed digital adaptations of the DPP, none had experimental groups that were fully automated and AI-based and none used a human-led DPP control group.14-19”
From An AI-Powered Lifestyle Intervention vs Human Coaching in the Diabetes Prevention Program: A Randomized Clinical Trial (2025) · cites this paper as [18]
Of 5 PHT studies on T2DM prevention, 1 (20%) posted a positive effect and 4 (80%) reported a neutral effect.
“Of the 5 (13.5%) studies on PHT reporting its effects on preventing T2DM, 1 (20%) study [39] posted a positive effect, with 4 (80%) other studies [35,36,40,41] reporting a neutral effect on T2DM development.”
From Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review (2025) · cites this paper as [41]
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- Authors
- Staite, E., Bayley, A., Al-Ozairi, E., Stewart, K., Hopkins, D., Rundle, J., Basudev, N., Mohamedali, Z., & Ismail, K.
- Affiliations
- King's College London (GB)
- King's College Hospital NHS Foundation Trust (GB)
- St Thomas' Hospital (GB)
- Health Innovation Network South London (GB)
- Corresponding author
- Ismail, Khalida
- ORCID
- Venue
- JMIR mHealth and uHealth
- Publisher
- JMIR Publications Inc.
- Published
- 2020-07-15
- Volume
- 8
- Issue
- 7
- Pages
- e15448
- ISSN
- 2291-5222 (ISSN-L)
- PMC
- PMC7391669
- OpenAlex
- W3007413194
- Cited by
- 39
- References
- 29
- Citations by year
- 2026: 2 · 2025: 11 · 2024: 7 · 2023: 8 · 2022: 6 · 2021: 5
- FWCI
- 4.96
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JMIR mhealth and uhealth (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Research Portal (King's College London) (submittedVersion, other-oa)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Keywords
- type 2 diabetes prevention, prediabetes, wearable devices, motivational interviewing, safety management systems, mobile application, online intervention, digital lifestyle intervention, feasibility, sample size determination, weight change, physical activity, HbA1c, blood pressure, waist circumference, serum lipids, general practice recruitment, follow-up retention, cost-effectiveness, diabetes prevention
- MeSH terms
- Wearable Electronic Devices, Internet-Based Intervention, Diabetes Mellitus, Type 2, Feasibility Studies, Female, Humans, Male, Middle Aged, Risk Assessment
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