Hybrid lifestyle program and metabolic health in adults with obesity
A 20-week hybrid program combining group behavioral counseling, nutritional education, and physical activity with usual medical care did not significantly increase the proportion of adults with obesity achieving 5% weight loss in intention-to-treat analysis, though secondary analyses suggested cardiometabolic benefits in those who adhered.
Researchers in São Paulo, Brazil randomly assigned 200 adults with obesity (mean age 47.9 years, 86% women) to either PRAMEV—a 20-week hybrid lifestyle intervention including group-based behavioral counseling, nutritional education, and physical activity promotion—or usual medical care alone. The primary goal was to determine if PRAMEV would help more participants achieve at least 5% weight loss.
At 20 weeks, intention-to-treat analysis found no significant difference between groups: 20.6% of the PRAMEV group and 15.5% of the control group reached 5% weight loss (odds ratio 1.34, 95% CI 0.61–2.92, P=0.46). However, dropout was substantially higher in the PRAMEV arm (39.2% vs 21.4%), which may have masked potential benefits. Among participants who completed the program (per-protocol analysis), the PRAMEV group showed greater weight loss and improvements in cardiometabolic markers, including reductions in triglycerides and liver enzymes, and favorable shifts in cholesterol fractions. No serious adverse events occurred. The findings suggest that while the intensive program did not meet its primary endpoint in the full analysis, adherent participants experienced metabolic improvements that warrant further investigation with strategies to reduce dropout.
The large dropout rate (39% in the intervention arm) is the critical caveat here—it suggests the intensive program may be difficult to sustain for some participants, which is why the intention-to-treat analysis (the most honest measure of a real-world program) showed no advantage. Per-protocol results, however, reveal the true potential: among those who stuck with PRAMEV, weight loss was greater and lipid improvements were substantial. Secondary findings also showed reductions in liver enzyme levels (ALT and AST), indicating improved hepatic metabolic function—a marker of better overall metabolic health that goes beyond simple weight loss. The triglyceride reduction is particularly noteworthy because elevated triglycerides are an independent cardiovascular risk factor. The mechanism likely involves both the caloric deficit from dietary counseling and improved insulin sensitivity from regular physical activity. This is a common pattern in lifestyle trials: the intervention works for adherers, but the challenge is keeping people engaged. The trial design was rigorous (pre-registered, publicly funded), and the population represents real-world public health settings, making the findings practically relevant—but also honest about the implementation gap.
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- A Hybrid Lifestyle Program and Metabolic Health in Adults With Obesity: The PRAMEV Randomized Clinical Trial. — JAMA network open (Read the original)