Trial results for a pilot study investigating incentivized lifestyle modification in individuals with obesity were posted on ClinicalTrials.gov on 2025-11-24. The study enrolled 8 participants to develop infrastructure for a larger study.
Background
Obesity is a complex chronic condition often associated with other health issues like diabetes mellitus. Lifestyle modifications, including increased physical activity and dietary changes, are fundamental to managing obesity. However, adherence to these modifications can be challenging. This pilot study aimed to explore the feasibility of an incentivized approach to lifestyle modification and establish the necessary infrastructure for future, larger-scale research.
Trial design
This completed pilot and feasibility study, designated as Phase NA, enrolled a total of 8 participants. The study focused on individuals with Obesity and Diabetes Mellitus. The primary objective of this pilot study was to develop the infrastructure for a larger study. Participants were randomly assigned to either a control group or an intervention group, which are presented in the results as "Required Supervised Walking" and "Non-required Supervised Walking" groups, respectively.
Key results
The study collected several key measurements related to physical activity and body composition:
- Miles Walked:
- In the Required Supervised Walking group, the mean was 1.1 Miles (Standard Error 0.4).
- In the Non-required Supervised Walking group, the mean was 6.06 Miles (Standard Error 3.6).
- Weight Change:
- For the Required Supervised Walking group, the mean change was 2.6 Pounds (lbs) (Standard Deviation 3.0).
- For the Non-required Supervised Walking group, the mean change was 0.8 Pounds (lbs) (Standard Deviation 1.6).
- Body Fat Percentage Change:
- The Required Supervised Walking group showed a mean change of 1.3 (Standard Deviation 3.1) in percentage of body fat.
- The Non-required Supervised Walking group showed a mean change of 3.5 (Standard Deviation 6.9) in percentage of body fat.
- Fat Mass Change:
- In the Required Supervised Walking group, the mean change was 4.8 Pounds (lbs) (Standard Deviation 6.9).
- In the Non-required Supervised Walking group, the mean change was 0.15 Pounds (lbs) (Standard Deviation 0.8).
- Fat Free Mass Change:
- The Required Supervised Walking group had a mean change of -2.15 Pounds (lbs) (Standard Deviation 5.1).
- The Non-required Supervised Walking group had a mean change of 2.8 Pounds (lbs) (Standard Deviation 3.9).
- Waist Circumference Change:
- For the Required Supervised Walking group, the mean change was 0.8 Inches (Standard Deviation 2.0).
- For the Non-required Supervised Walking group, the mean change was 0.7 Inches (Standard Deviation 2.1).
Key analyses were performed using Mixed Models Analysis:
- One analysis reported a Mean Difference (Net) of 4.35 with a p-value of 0.32.
- Another analysis reported a p-value of 0.93.
- A further analysis reported a Mean Difference (Net) of 4.79 with a p-value of 0.16.
- Another analysis reported a Mean Difference (Net) of 11.36 with a p-value of 0.4.
- An analysis reported a Mean Difference (Net) of -8.03 with a p-value of 0.77.
- Finally, an analysis reported a Mean Difference (Net) of 2.98 with a p-value of 0.42.
What this means
This pilot and feasibility study, with its small enrollment of 8 participants, primarily aimed to establish infrastructure for future research rather than to demonstrate efficacy. The reported key measurements provide initial data on various parameters related to physical activity and body composition changes in the context of lifestyle modification. For instance, the "Non-required Supervised Walking" group walked a mean of 6.06 Miles, compared to 1.1 Miles in the "Required Supervised Walking" group. Changes in weight, body fat percentage, fat mass, fat-free mass, and waist circumference were also measured, showing varying mean changes across the groups. The p-values from the Mixed Models Analysis, ranging from 0.16 to 0.93, indicate that no statistically significant differences were observed between the groups for the analyzed outcomes in this small pilot study. These preliminary findings will inform the design and execution of a larger, more definitive study.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02945332, titled "Incentivizing Lifestyle Modification to Reduce Disease Burden", were posted on 2025-11-24 on clinicaltrials.gov.