A Hybrid Lifestyle Program and Metabolic Health in Adults With Obesity: The PRAMEV Randomized Clinical Trial

Obesity disproportionately affects low- and middle-income countries, where access to structured, scalable treatment remains limited.

To evaluate whether a hybrid-format, intensive lifestyle modification program combined with usual medical care promotes a minimum weight loss of 5% in adults with obesity compared with usual medical care alone.

This open-label, parallel-group, superiority randomized clinical trial recruited adults with a body mass index of 30 or greater from a tertiary public hospital in São Paulo, Brazil, between January 1 and March 31, 2022, randomized 1:1 to PRAMEV (Advanced Program for Intensive Lifestyle Modification) or control. Data were analyzed from May to September 2025 using an intention-to-treat approach.

PRAMEV was a 20-week, hybrid lifestyle intervention that included group-based behavioral counseling, nutritional education, physical activity promotion, and continuous instructor support. The control group received usual medical care.

The primary outcome was the proportion of participants achieving a 5% or greater reduction in body weight assessed by bioelectrical impedance analysis at 20 weeks. Secondary outcomes included changes in weight, body mass index, waist circumference, metabolic parameters (lipid profile, glucose, and liver enzyme levels), dietary intake, and psychosocial variables.

A total of 200 participants (mean [SD] age, 47.9 [14.0] years; 172 [86.0%] women) were randomized to PRAMEV (n = 97) or control (n = 103). At 20 weeks, 143 participants (71.4%) completed follow-up, with higher dropout in the PRAMEV arm vs the control arm (39.2% [38 of 97] vs 21.4% [22 of 103]; P = .008). In the intention-to-treat analysis, groups did not differ in achieving 5% or greater weight loss (20.6% [20 of 97] vs 15.5% [16 of 103]; odds ratio, 1.34; 95% CI, 0.61-2.92; P = .46). Per-protocol analyses showed greater weight loss and improved anthropometric outcomes in the PRAMEV arm. The intervention improved the lipid profile, with reductions in liver enzyme and triglyceride levels and favorable changes in cholesterol fractions. No serious adverse events were reported.

In this randomized clinical trial of 200 adults with obesity receiving care in Brazil's public health care system, a hybrid-format lifestyle intervention did not improve the likelihood of achieving 5% or greater weight loss in the intention-to-treat analysis. However, secondary and per-protocol analyses suggested potential cardiometabolic benefits among adherent participants, warranting further investigation.

ReBEC Identifier: U1111-1273-8313.