Background <p>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<sup>®</sup>) 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.</p> Methods <p>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)).</p> Results <p>Intervention participants reported higher retention than controls at 6 months (79.7% vs. 67.1%; OR = 2.06; 95% CI = 1.15–3.68; <i>P</i>=.01) and 12 months (78.3% vs. 53.1%; OR = 3.14; 95% CI = 1.11–8.88; <i>P</i>=.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 (<i>P</i>&lt;.001) and engagement (intervention <i>P</i>&lt;.001; control <i>P</i>=.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; <i>P</i>=.97, <i>P</i>=.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; <i>P</i>=.05).</p> Conclusions <p>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.</p> Trial registration <p>This clinical trial (ClinicalTrials.gov Identifier: NCT06656273) was retrospectively registered on October 18, 2024.</p>

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An iterative mindset approach as an adjunct to the national diabetes prevention program: a randomized trial assessing retention, engagement and weight loss

  • Joshua W. Leichter,
  • Michael J. Cannon,
  • Yvonne Mensa-Wilmot,
  • Zena W. Belay,
  • Anyssa S. Garza,
  • Abby M. Schmalz,
  • Keenan I. Walch,
  • Kyra Bobinet

摘要

Background

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.

Methods

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)).

Results

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).

Conclusions

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.

Trial registration

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