Trial results for the Healthy Eating and Active Living Taught at Home (HEALTH) intervention for obesity were posted on ClinicalTrials.gov on 2025-11-12, showing participants in the intervention group had a mean weight change of -0.24 Kg.
Background
Obesity is a complex chronic disease characterized by excessive body fat, posing significant health risks including cardiovascular disease, diabetes, and certain cancers. Effective interventions are crucial for weight management and preventing related comorbidities. Lifestyle interventions focusing on diet and physical activity are foundational in obesity treatment, often delivered through various community and home-based programs. This study aimed to evaluate an evidence-based intervention in real-world settings to prevent weight gain and promote weight loss.
Trial design
This completed Phase 3 study enrolled 620 participants to evaluate an intervention for Obesity. The trial assessed the effectiveness of the Healthy Eating and Active Living Taught at Home (HEALTH) intervention, disseminated through Parents as Teachers, compared to a Usual Care group. While specific primary outcomes were not detailed in the provided results, key measurements included changes in weight and fidelity of intervention delivery.
Key results
The trial reported key measurements related to weight change and intervention fidelity:
- Change in Weight:
- Participants in the Healthy Eating & Active Living Taught at Home group showed a mean change of -0.24 Kg (Standard Deviation 9.75).
- Participants in the Usual Care group showed a mean change of 0.49 Kg (Standard Deviation 11.87).
- Fidelity of Delivery to the Intervention (measured in visit recordings for the Healthy Eating & Active Living Taught at Home group):
- 67 visit recordings.
- 12 visit recordings.
- 9 visit recordings.
What this means
The results indicate that the Healthy Eating and Active Living Taught at Home (HEALTH) intervention, when implemented in a real-world setting, was associated with a modest mean weight loss of 0.24 Kg among participants, in contrast to a mean weight gain of 0.49 Kg observed in the usual care group. This suggests a potential benefit of the HEALTH program in preventing weight gain and promoting slight weight loss within the context of home visiting organizations. The fidelity measurements provide insight into the implementation aspects of the program.
Source
The information for these trial results was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03758638, titled "Healthy Eating and Active Living Taught at Home (HEALTH) Dissemination & Implementation (D&I)", were posted on 2025-11-12 on clinicaltrials.gov.