Trial results for a study evaluating mobile integrated care for Childhood Obesity were posted on ClinicalTrials.gov on 2025-07-24, indicating that participants in the Healthy Lifestyle intervention group experienced a mean change of -0.55 in BMI percentile.
Background
Childhood obesity represents a substantial public health challenge, with long-term implications for health and well-being. Current approaches often involve discussions with primary care providers regarding healthy lifestyles. However, the effectiveness of these traditional methods can vary. The development of innovative healthcare delivery models, such as mobile integrated care programs, is crucial to provide more comprehensive and accessible support for children and families managing unhealthy weight, potentially improving outcomes beyond standard primary care interventions.
Trial design
This completed study, identified as Phase NA, enrolled 59 participants with Obesity. The trial aimed to evaluate a new method of providing healthcare to children with an unhealthy weight. Participants were randomly assigned to one of two groups for 6 months. One group received standard of care, involving discussions with their child's primary care provider about healthy lifestyles. The other group participated in a Healthy Lifestyle program, which included check-ins with lifestyle specialists and community health workers, a mobile app for support, and access to community programs and activities. The primary outcome measured was the change in child adiposity, specifically the change in BMI percentile.
Key results
The trial results focused on the change in child adiposity, measured as the change in BMI percentile, and visit adherence.
- For the "Healthy Lifestyle" group, the mean change in child adiposity was -0.55 (Standard Deviation: 7.18 change in BMI percentile).
- For the "Standard of Care" group, the mean change in child adiposity was 0.64 (Standard Deviation: 5.30 change in BMI percentile).
- Regarding visit adherence, 8 participants in the "Healthy Lifestyle" group and 8 participants in the "Standard of Care" group were counted.
Further analysis on differences in change in child adiposity based on child sociodemographic characteristics showed varied outcomes:
- One measurement for the "Healthy Lifestyle" group showed a mean change of -0.56 (Standard Deviation: 7.11 change in BMI percentile), compared to -0.09 (Standard Deviation: 6.83 change in BMI percentile) for the "Standard of Care" group.
- Another measurement for the "Healthy Lifestyle" group showed a mean change of 0.81 (Standard Deviation: 4.61 change in BMI percentile), compared to 1.67 (Standard Deviation: 4.38 change in BMI percentile) for the "Standard of Care" group.
- A third measurement for the "Healthy Lifestyle" group showed a mean change of -1.90 (Standard Deviation: 9.68 change in BMI percentile), compared to -0.04 (Standard Deviation: 4.43 change in BMI percentile) for the "Standard of Care" group.
- A fourth measurement for the "Healthy Lifestyle" group showed a mean change of -1.64 (Standard Deviation: 2.16 change in BMI percentile), compared to 0.04 (Standard Deviation: 6.24 change in BMI percentile) for the "Standard of Care" group.
What this means
The results suggest that a mobile integrated Healthy Lifestyle program may be more effective in reducing child adiposity compared to standard primary care discussions for childhood obesity. Participants in the Healthy Lifestyle group experienced a mean reduction in BMI percentile, while those in the standard of care group saw a mean increase. This indicates a potential benefit of the intervention's comprehensive approach, which includes specialist support, a mobile app, and community resources. The varied outcomes observed across different sociodemographic characteristics suggest that responses to interventions for childhood obesity may differ based on specific patient populations, highlighting the need for further investigation into tailored approaches.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05936385, titled "Mobile Integrated Care for Childhood Obesity", were posted on 2025-07-24 on clinicaltrials.gov.