Trial results for a behavioral weight loss intervention in individuals with overweight and obesity were posted on ClinicalTrials.gov on 2025-07-30. The intervention demonstrated a mean net weight reduction of 3.2 kg at 18 months compared to a control group.
Background
Obesity is a significant public health concern, often co-occurring with serious mental illnesses. Effective weight management strategies are crucial for improving overall health outcomes in these populations. This study aimed to determine the effectiveness of a behavioral weight loss intervention, which included dietary counseling and exercise, in helping individuals with serious mental illnesses achieve weight loss.
Trial design
This completed study, designated as Phase NA, enrolled 291 participants diagnosed with Overweight and Obesity. The trial investigated a behavioral weight loss intervention that included dietary counseling and exercise, comparing its effects against a control group.
Key results
The trial reported several key measurements and analyses:
- Change in Weight Loss in Kilograms (kg):
- For the ACHIEVE Intervention group, the mean weight loss was -1.8 kg.
- For the Control group, the mean weight loss was -0.3 kg.
- In another measurement, the ACHIEVE Intervention group showed a mean weight loss of -3.4 kg.
- The Control group showed a mean weight loss of -0.2 kg.
- Change in Waist Circumference in Centimeters (cm):
- The ACHIEVE Intervention group experienced a mean change of -1.5 cm.
- The Control group experienced a mean change of 0.5 cm.
- Minutes Cycled During Cycle Ergometry Testing:
- For the ACHIEVE Intervention group, the mean was 6.95 minutes (Standard Deviation 2.64).
- For the Control group, the mean was 6.86 minutes (Standard Deviation 2.86).
- In another measurement, the ACHIEVE Intervention group mean was 7.12 minutes (Standard Deviation 2.86).
- The Control group mean was 6.91 minutes (Standard Deviation 2.82).
- In a third measurement, the ACHIEVE Intervention group mean was 7.19 minutes (Standard Deviation 3.03).
- The Control group mean was 6.79 minutes (Standard Deviation 2.60).
Key analyses comparing the intervention to control included:
- For 6-month intervention versus control, the Mean Difference (Net) was -1.5 kg (95.0% Confidence Interval: -2.6 to -0.4).
- For 18-month intervention versus control, the Mean Difference (Net) was -3.2 kg (95.0% Confidence Interval: -5.1 to -1.2).
- Regarding waist circumference for 6-month intervention versus control, the Mean Difference (Net) was -2.0 cm (95.0% Confidence Interval: -3.6 to -0.4).
- For 18-month intervention versus control, the Mean Difference (Net) was -1.9 cm (95.0% Confidence Interval: -4.1 to 0.3).
- For 6-month systolic blood pressure intervention versus control, the Mean Difference (Net) was -0.4 (95.0% Confidence Interval: -3.2 to 2.4).
- For 6-month diastolic blood pressure intervention versus control, the Mean Difference (Net) was 0.2 (95.0% Confidence Interval: -1.6 to 2.1).
What this means
The results indicate that the behavioral weight loss intervention was effective in promoting weight reduction in individuals with overweight and obesity, particularly those with serious mental illnesses. A sustained mean net weight loss of 3.2 kg at 18 months suggests a clinically meaningful impact. Additionally, the intervention led to a reduction in waist circumference, with a net mean difference of -2.0 cm at 6 months. While the intervention showed clear benefits for weight and waist circumference, the analyses for blood pressure at 6 months did not demonstrate a significant net difference between the groups, with confidence intervals crossing zero.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT00902694, titled "Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation", were posted on 2025-07-30 on clinicaltrials.gov.