PMID- 32459631 OWN - NLM STAT- MEDLINE DCOM- 20210405 LR - 20221207 IS - 2291-5222 (Electronic) IS - 2291-5222 (Linking) VI - 8 IP - 7 DP - 2020 Jul 8 TI - Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial. PG - e17842 LID - 10.2196/17842 [doi] LID - e17842 AB - 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 A(1c) (HbA(1c)) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA(1c) 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 HbA(1c) 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 HbA(1c) level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA(1c) levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA(1c) 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. CI - (c)Tatiana Toro-Ramos, Andreas Michaelides, Maria Anton, Zulekha Karim, Leah Kang-Oh, Charalambos Argyrou, Elisavet Loukaidou, Marina M Charitou, Wilson Sze, Joshua D Miller. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 08.07.2020. FAU - Toro-Ramos, Tatiana AU - Toro-Ramos T AUID- ORCID: 0000-0003-4153-3316 AD - Noom, Inc, New York, NY, United States. FAU - Michaelides, Andreas AU - Michaelides A AUID- ORCID: 0000-0003-4983-5001 AD - Noom, Inc, New York, NY, United States. FAU - Anton, Maria AU - Anton M AUID- ORCID: 0000-0002-7702-9499 AD - Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States. FAU - Karim, Zulekha AU - Karim Z AUID- ORCID: 0000-0002-2072-4466 AD - Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States. FAU - Kang-Oh, Leah AU - Kang-Oh L AUID- ORCID: 0000-0003-3676-1664 AD - Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States. FAU - Argyrou, Charalambos AU - Argyrou C AUID- ORCID: 0000-0003-4027-7349 AD - Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States. FAU - Loukaidou, Elisavet AU - Loukaidou E AUID- ORCID: 0000-0003-3716-4714 AD - Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States. FAU - Charitou, Marina M AU - Charitou MM AUID- ORCID: 0000-0002-3641-3523 AD - Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States. FAU - Sze, Wilson AU - Sze W AUID- ORCID: 0000-0002-4070-952X AD - Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States. FAU - Miller, Joshua D AU - Miller JD AUID- ORCID: 0000-0001-9512-461X AD - Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States. LA - eng SI - ClinicalTrials.gov/NCT03865342 PT - Journal Article PT - Randomized Controlled Trial DEP - 20200708 PL - Canada TA - JMIR Mhealth Uhealth JT - JMIR mHealth and uHealth JID - 101624439 RN - 0 (Blood Glucose) RN - 0 (Glycated Hemoglobin A) SB - IM MH - Blood Glucose MH - *Diabetes Mellitus, Type 2/prevention & control MH - Female MH - Glycated Hemoglobin/analysis MH - Humans MH - Male MH - Middle Aged MH - Motivation MH - *Prediabetic State/therapy MH - *Telemedicine MH - United States PMC - PMC7381044 OTO - NOTNLM OT - body weight OT - mHealth OT - mobile app OT - mobile phone OT - prediabetes OT - randomized controlled trial COIS- Conflicts of Interest: TT and AM are employed by Noom, Inc and receive salary and stock options. AM holds a patent pending (3492.004US1) with Noom, Inc. Noom Coach is a mHealth program owned by Noom, Inc. The authors have no additional conflicts of interest, and no competing financial interests exist for the other authors. EDAT- 2020/05/28 06:00 MHDA- 2021/04/07 06:00 PMCR- 2020/07/08 CRDT- 2020/05/28 06:00 PHST- 2020/01/17 00:00 [received] PHST- 2020/04/15 00:00 [accepted] PHST- 2020/04/03 00:00 [revised] PHST- 2020/05/28 06:00 [pubmed] PHST- 2021/04/07 06:00 [medline] PHST- 2020/05/28 06:00 [entrez] PHST- 2020/07/08 00:00 [pmc-release] AID - v8i7e17842 [pii] AID - 10.2196/17842 [doi] PST - epublish SO - JMIR Mhealth Uhealth. 2020 Jul 8;8(7):e17842. doi: 10.2196/17842.