Trial results for a mobile, web-based diabetes prevention program (STEPS) for Hispanics in rural areas were posted on ClinicalTrials.gov on 2026-02-23, indicating no statistically significant difference in percentage weight loss (p=0.1) or Hemoglobin A1C levels (p=0.452 at 3 months, p=0.76 at 6 months) compared to usual care.
Background
Type 2 Diabetes is a chronic condition characterized by high blood sugar levels, often resulting from insulin resistance or insufficient insulin production. It is a major public health concern, particularly among certain demographic groups. Lifestyle interventions, including weight management and dietary changes, are foundational for preventing or delaying the onset of Type 2 Diabetes, especially in at-risk populations. For individuals living in rural communities, access to traditional in-person prevention programs can be limited. Mobile and web-based interventions offer a potential solution to overcome geographical barriers and provide accessible health education and support, aiming to reduce the risk of developing the condition.
Trial design
This completed randomized controlled trial enrolled 179 participants to test the effectiveness of a mobile, web-based diabetes prevention program, STEPS, for Hispanics living in rural communities. The study focused on individuals at risk for Type 2 Diabetes. Participants were randomly assigned to either receive the mobile STEPS intervention or usual care for a total of three months. The primary aim was to determine if the STEPS program could reduce the risk of Type 2 Diabetes compared to usual care. Researchers compared percentage weight loss and changes in Hemoglobin A1C levels between the two groups.
Key results
The trial results provided key measurements and analyses comparing the STEPS intervention group to the control group:
- Percent Weight Change at Intervention Completion: The STEPS Intervention group showed a mean change of -.14 percent (Standard Deviation: 4.1), while the Control group showed a mean change of 2.3 percent (Standard Deviation: 11.9).
- Percent Weight Change Three Months Post Intervention: The STEPS Intervention group had a mean change of -.50 percent (Standard Deviation: 4.8), compared to the Control group's mean change of -.12 percent (Standard Deviation: 5.7).
- Change in Hemoglobin A1C Levels (Initial Measurement): The STEPS Intervention group had a mean A1C of 5.7 percent (Standard Deviation: .82), and the Control group had a mean of 5.8 percent (Standard Deviation: .95).
- Change in Hemoglobin A1C Levels (Second Measurement): The STEPS Intervention group had a mean A1C of 5.6 percent (Standard Deviation: .64), and the Control group had a mean of 5. percent (Standard Deviation: .74).
- Change in Hemoglobin A1C Levels (Third Measurement): The STEPS Intervention group had a mean A1C of 5.7 percent (Standard Deviation: .82), and the Control group had a mean of 5.8 percent (Standard Deviation: .96).
- Change in Hemoglobin A1C Levels (Fourth Measurement): The STEPS Intervention group had a mean A1C of 5.5 percent (Standard Deviation: .80), and the Control group had a mean of 5.5 percent (Standard Deviation: .45).
Key analyses using Mixed Models Analysis showed the following p-values:
- For percent weight loss between STEPS and control participants from baseline to 3 months 1 week post: p=0.1.
- For A1C levels between STEPS and control participants from baseline to 3 months 1 week post: p=0.452.
- For A1C levels between STEPS and control participants from baseline to 6 months 1 week post: p=0.76.
What this means
The results of this trial suggest that the STEPS mobile, web-based diabetes prevention program did not achieve a statistically significant difference in percentage weight loss or Hemoglobin A1C levels when compared to usual care in rural Hispanic participants. While mobile health interventions hold promise for increasing access to care, this specific program, as evaluated in this trial, did not demonstrate a significant benefit in these key metabolic markers. The p-values for weight loss (0.1) and A1C (0.452 and 0.76) indicate that any observed differences between the groups could be due to chance rather than the intervention itself. These findings suggest that further research or modifications to the STEPS program may be needed to achieve a measurable impact on diabetes prevention outcomes in this population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05856149, titled "Mobile Diabetes Prevention for Hispanics Living in Rural Areas", were posted on 2026-02-23 on clinicaltrials.gov.