A novel smartphone app to change risk behaviors of women after gestational diabetes: A randomized controlled trial
Open accessAbstract
Aims: Women after gestational diabetes mellitus (GDM) are a risk group for cardiometabolic diseases but are hard to reach by conventional lifestyle programs. Therefore, we tested whether a novel, smartphone-delivered intervention,TRIANGLE, is accepted by women after GDM and alters cardiometabolic risk behaviors and outcomes.TRIANGLE targets gradual habit change of mind and emotion, physical activity, nutrition, and sleep. Methods: We conducted a 6-month multicenter, randomized-controlled trial of TRIANGLE versus standard care with 66 women 3–18 months after GDM in Germany. The primary outcome was the proportion of women achieving ≥3 out of 5 Diabetes Prevention Program goals, i.e. physical activity ≥150 min/week (moderate to high intensity), fiber intake ≥15 g/1,000 kcal, fat intake <30% of total energy intake, saturated fat intake <10% of total energy intake, and weight reduction ≥5% if BMI ≥23 kg/m 2 or weight maintenance if BMI <23 kg/m 2. Intervention participants also rated the TRIANGLE app in the Mobile Application Rating Scale (uMARS). Results: In the predefined, modified intention-to-treat analysis including 64 women, 6 out of 27 women in the intervention group [22%(10–40)] and 3 out of 27 women in the control group [11%(3–27)] reached the primary outcome (p = 0.47). In the predefined per-protocol intervention subgroup, the proportion was 4 out of 14 women [29%(11–55); p = 0.20 vs. control].TRIANGLE app users were active on 42% of days and rated the app’s quality and perceived impact with 4.3±0.8 out of 5 uMARS points. Conclusions: This first trial did not show the efficacy of the TRIANGLE intervention. However, the app was well accepted and considered helpful by most users. Therefore, this trial supports further development and testing of TRIANGLE and other app interventions for women after GDM. Additionally, it identifies necessary adaptations in trial design to better accommodate non-intensive lifestyle interventions for this target group. Trial registration: Trial registration at drks.de (DRKS00012996).
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TM effects on consumer experience were varied: 5 (71.4%) studies reported positive effects, 1 (14.2%) no discernible effect, and 1 (14.2%) mixed effects.
“The effects of TM on consumer experience were varied, with 5 (71.4%) studies [39,44,48,53,54] reporting positive effects, 1 (14.2%) study [5] with no discernible effect, and 1 (14.2%) study [55] with mixed effects.”
From Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review (2025) · cites this paper as [44]
The Results section on process measures reports high user ratings of the app (4.3 out of 5), and the Discussion says users accepted it and deemed it effective. The paper’s lack of a significant intervention effect concerns its primary clinical outcome, not a lack of discernible positive consumer experience. (LLM, conf=0.82)
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Experimental — accuracy not yet measuredOf 3 DCP studies on consumer experience, Cha et al and Potzel et al reported better experience outcomes for patients in the DHI groups, while Block et al showed no effect.
“Of the 3 (23.1%) studies reporting the effectiveness of DCP on consumer experience, Cha et al [48] and Potzel et al [44] reported better experience outcomes for patients in the DHI groups, while Block et al [5] showed no effect.”
From Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review (2025) · cites this paper as [44]
The Results (Per-protocol group; page unavailable) report higher well-being and lower perceived stress than in controls among regular app users, but these differences were not statistically significant. The Results (Process measures of the intervention; page unavailable) also report favorable app ratings from users, without a control-group comparison. Thus the paper supports favorable experience findings, but not a clear improvement across the intervention group. (LLM, conf=0.83)
Experimental — accuracy not yet measuredOf 5 TM studies on T2DM development, 1 by Sakane et al indicated TM is effective, and the other 4 did not show significant differences compared to the control group.
“Of the 5 (20%) studies reporting the effects of TM on T2DM development, only 1 (20%) study by Sakane et al [39] indicated that TM is effective. The other 4 (80%) studies [35,40,44,50] did not show any significant differences compared to the control group.”
From Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review (2025) · cites this paper as [44]
Two DCP studies reported prevention effectiveness, and both had a neutral effect.
“In addition, 2 (15.4%) studies [40,44] reported prevention effectiveness of DCP, and both had a neutral effect.”
From Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review (2025) · cites this paper as [44]
Of 12 DCP studies assessing dysglycemia, 9 (75%) reported positive population health outcomes and 3 (25%) showed neutral effects.
“Of the 12 studies (92.3%) assessing the effects of dysglycemia, 9 (75%) reported positive population health outcomes, such as significant HbA1c reduction compared to the control group in Kim et al [45] using virtual reality (VR) technology and Everett et al [46] using AI interventions (P<.05). Furthermore, 3 (25%) studies [40,44,47] showed the effect was neutral.”
From Digital Health Interventions to Prevent Type 2 Diabetes Mellitus: Systematic Review (2025) · cites this paper as [44]
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- Authors
- Potzel, A. L., Gar, C., Banning, F., Sacco, V., Fritsche, A., Fritsche, L., Müssig, K., Dauben, L., Seissler, J., & Lechner, A.
- Affiliations
- Helmholtz Munich (DE)
- Deutsches Diabetes-Zentrum e.V. (DE)
- Corresponding author
- Lechner, Andreas
- ORCID
- Venue
- PLOS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2022-04-27
- Volume
- 17
- Issue
- 4
- Pages
- e0267258
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC9045614
- OpenAlex
- W4226059963
- Cited by
- 20
- References
- 41
- Citations by year
- 2026: 4 · 2025: 5 · 2024: 4 · 2023: 6 · 2022: 1
- FWCI
- 4.59
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Open access LMU (Ludwid Maxmilian's Universitat Munchen) (submittedVersion, cc-by)
- PuSH - Publication Server of Helmholtz Zentrum München (submittedVersion)
- Funders
- else kröner-fresenius-stiftung (2014_A186)
- German Center for Diabetes Research (82DZD01902)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- gestational diabetes mellitus, smartphone-based intervention, triangles, cardiometabolic risk, lifestyle intervention, physical activity, dietary fiber intake, saturated fat intake, weight loss, habit change, app acceptance, mobile health
- MeSH terms
- Cardiovascular Diseases, Female, Humans, Life Style, Male, Pregnancy, Risk-Taking, Diabetes, Gestational, Mobile Applications
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