Trial results for a study investigating various components of digital interventions for Obesity were posted on ClinicalTrials.gov on 2025-07-20. The study enrolled 759 participants and reported mean weight losses ranging from 3.19 kg to 3.73 kg across different intervention arms.
Background
Obesity is a complex condition with significant public health implications. While mobile obesity interventions have shown promise in reaching diverse populations, their effectiveness in terms of weight loss has generally not matched that of in-person interventions. Newer digital approaches, such as Just-in-Time Adaptive Interventions (JITAI), aim to provide personalized feedback in real-time to enhance engagement and outcomes. This study sought to identify the most effective components of a comprehensive weight loss JITAI to achieve weight losses comparable to or exceeding existing remotely delivered interventions.
Trial design
This completed study, designated as Phase NA, enrolled 759 participants with Obesity. The trial aimed to identify the optimal components of a comprehensive weight loss Just-in-Time Adaptive Intervention (JITAI) that could lead to significant weight loss. The study explored various intervention components, including different approaches to dietary self-monitoring, activity goal setting, and message delivery strategies.
Key results
The trial reported mean weight changes across various intervention components:
- For "Weight (kg)" in the "Standard Diet Monitoring" group, the mean change was -3.61 kg.
- The "Simplified Diet Monitoring" group showed a mean change of -3.31 kg.
- Participants in the "Weekly Adaptive Activity Goals" group experienced a mean change of -3.32 kg.
- The "Daily Adaptive Activity Goals" group had a mean change of -3.60 kg.
- In the "Fixed Message Decision Points" group, the mean change was -3.66 kg.
- The "Adaptive Message Decision Points" group showed a mean change of -3.26 kg.
- For "Standard Message Decision Rules," the mean change was -3.65 kg.
- The "Adaptive Message Decision Rules" group had a mean change of -3.26 kg.
- Participants with "No Message Choice" experienced a mean change of -3.19 kg.
- The "Message Choice" group showed a mean change of -3.73 kg.
- Another measurement for "Standard Diet Monitoring" indicated a mean change of -2.54 kg.
- Another measurement for "Simplified Diet Monitoring" indicated a mean change of -2.30 kg.
Key analyses using Mixed Models Analysis compared the effects of different intervention components on weight change:
- For dietary self-monitoring over 6 months, the mean difference (net) between standard and simplified monitoring was 0.3 (95% CI: -0.61 to 1.2), with a p-value of 0.52.
- For adaptive activity goals over 6 months, the mean difference (net) between weekly and daily goals was -0.28 (95% CI: -1.19 to 0.63), with a p-value of 0.54.
- For message decision points over 6 months, the mean difference (net) was 0.4 (95% CI: -0.5 to 1.31), with a p-value of 0.39.
- For message decision rules over 6 months, the mean difference (net) between standard and adaptive rules was 0.39 (95% CI: -0.52 to 1.3), with a p-value of 0.7.
- For participant choice over 6 months, the mean difference (net) between no choice and message choice was -0.55 (95% CI: -1.45 to 0.36), with a p-value of 0.47.
- For dietary self-monitoring over 3 months, the mean difference (net) between standard and simplified monitoring was 0.24 (95% CI: -0.36 to 0.84), with a p-value of 0.43.
What this means
The results indicate that while all tested digital intervention components led to mean weight losses in participants with obesity, the specific variations in dietary self-monitoring, activity goal frequency, message decision points, message decision rules, and participant message choice did not demonstrate statistically significant differences in weight change over 3 or 6 months. The p-values for all analyzed factors were above 0.05, suggesting that the tested adaptive strategies were not superior to their respective comparators in this trial. This suggests that the core elements of the digital intervention may be effective, but the specific adaptive modifications explored in this study did not yield differential outcomes.
Source
The information for this condition update was sourced from ClinicalTrials.gov, a public registry of clinical studies. The trial results for NCT04922216, titled "Adaptive Goals and Interventions for Lifestyle Enhancement," were posted on 2025-07-20 on clinicaltrials.gov.