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Weight gain is a recognized complication of modern antiretroviral therapy, especially with dolutegravir-based regimens associated with adverse metabolic outcomes. Lifestyle modification is first-line management. Randomized controlled trial evidence remains limited. Our study aimed to evaluate the efficacy of a six-month weight reduction intervention compared with standard treatment. A six-month, open-label, RCT was conducted in PLWH who had gained ≥ 5% of body weight since starting dolutegravir. Participants were randomized 1:1 to either a structured weight reduction program or standard care. The primary outcome was the percentage change in body weight from baseline to six months. Predictors of weight reduction were assessed using multivariable linear regression. Fifty-eight participants completed the study. At six months, the intervention group lost a mean of − 1.15 kg (–1.47%) compared with a gain of + 0.31 kg (+ 0.34%) in the standard care group, yielding a between-group difference of − 1.46 kg ( p = 0.039). In multivariable analysis, assignment to the intervention group was the only significant predictor of weight reduction (β = − 1.81; p = 0.049). A six-month structured lifestyle intervention resulted in modest but statistically significant weight reduction among PLWH with weight gain after DTG initiation. However, this weight reduction did not improve metabolic outcomes. Trial registration TCTR20240818003 (18 August 2024).
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Sitthilok et al. (2026) studied this question.
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