An iterative mindset approach as an adjunct to the national diabetes prevention program: a randomized trial assessing...

Retention and engagement continue to be a challenge for the National Diabetes Prevention Program lifestyle change program (LCP). This challenge is especially stark for persons living in medically-underserved, economically-disadvantaged communities. In the current work, we sought to investigate if a digital solution-an adjunct habit formation app (Fresh Tri^®) grounded in neuroscience theory around iteration (i.e., changing one's approach to a problem when encountering challenges)-could improve these metrics, as well as weight loss, in these populations.

We conducted a randomized study using a three-level, nested hierarchical structure, with 364 participants (212 intervention; 152 control) across 33 sites from February 1, 2021-October 13, 2022. We examined retention, engagement (number of sessions attended) and ≥ 5% body weight loss for participants in the intervention condition (standard LCP curriculum plus the Fresh Tri iterative mindset app) compared to the control condition (standard LCP curriculum) and also to a nationally representative group (National DPP LCP data from the United States Centers for Disease Control and Prevention (CDC)).

Intervention participants reported higher retention than controls at 6 months (79.7% vs. 67.1%; OR = 2.06; 95% CI = 1.15-3.68; P=.01) and 12 months (78.3% vs. 53.1%; OR = 3.14; 95% CI = 1.11-8.88; P=.03). Engagement at 6 and 12 months was not statistically different. Compared to the National DPP LCP participants overall, both the intervention and control arms had higher retention (P<.001) and engagement (intervention P<.001; control P=.02) at 6 months. We found no differences in ≥ 5% body weight loss between intervention and control groups at 6 months (26% vs. 27%; OR = 0.99; 95% CI = 0.57-1.73; P=.97, P=.90), but a statistically significant higher proportion of those in the intervention arm having ≥ 5% weight loss after 12 months (41.3% vs. 30.6%, OR = 1.72; 95% CI = 1.01-2.92; P=.05).

Overall, these results show promise for the applicability of a digital habit formation app, based on an iterative mindset, as an adjunct to the LCP for retention and weight loss.

This clinical trial (ClinicalTrials.gov Identifier: NCT06656273) was retrospectively registered on October 18, 2024.