Mobile delivery of the Diabetes Prevention Program in people with prediabetes: randomized controlled trial.
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Abstract
Background: The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC’s diabetes prevention program (DPP). Objective: This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care. Methods: Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A1c (HbA1c) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA1c levels. Results: A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants’ weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA1c levels (mean difference 0.004%, SE 0.05; P=.94). Weight and BMI were lower in the intervention group by −2.64 kg (SE 0.71; P<.001) and −0.99 kg/m2 (SE 0.29; P=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their weight loss at 12 months. The control group lost −0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA1c level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA1c levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA1c levels. Conclusions: This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions. Trial Registration: ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342
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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 [16]
The Introduction (Previous Work; page unavailable) says long-term, fully mobile DPP interventions had not been tested in an RCT, supporting the claim that RCT evidence was limited. The paper does not date CDC recognition of digital DPPs to 2015 or establish that no digital DPP trial had directly compared its intervention with the criterion-standard DPP. Its Objective describes a comparison with usual care and paper-based DPP content, not an in-person DPP. (LLM, conf=0.85)
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 [16]
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“As the first long-term randomized intervention of its kind, the results of this study demonstrate that a novel fully mobile-based smartphone-delivered DPP with human coaching is an effective and powerful tool for attaining clinically and statistically significant weight loss up to 1 year, reducing T2DM risk as well as…”
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- Authors
- Toro-Ramos, T., Michaelides, A., Anton, M., Karim, Z., Kang-Oh, L., Argyrou, C., Loukaidou, E., Charitou, M. M., Sze, W., & Miller, J. D.
- Affiliations
- Noom (United States) (US)
- Stony Brook University (US)
- Corresponding author
- Michaelides, Andreas
- ORCID
- Venue
- JMIR mHealth and uHealth
- Publisher
- JMIR Publications Inc.
- Published
- 2020-07-08
- Volume
- 8
- Issue
- 7
- Pages
- e17842
- ISSN
- 2291-5222 (ISSN-L)
- PMC
- PMC7381044
- OpenAlex
- W3021895698
- Cited by
- 107
- References
- 45
- Citations by year
- 2026: 17 · 2025: 16 · 2024: 25 · 2023: 17 · 2022: 15 · 2021: 17
- FWCI
- 12.79
- 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)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- Diabetes Prevention Program, prediabetes, type 2 diabetes prevention, mobile health, weight loss, glycemic control, HbA1c, program engagement, behavior change, lifestyle modification, food logging, automated feedback, group messaging, weight maintenance, body mass index, digital health interventions, telehealth coaching
- MeSH terms
- Blood Glucose, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Male, Middle Aged, Motivation, Prediabetic State, United States, Telemedicine
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