Background: Obesity is a risk factor for frailty and muscle weakness, so weight loss in obese older adults may prevent frailty and functional decline.
Objective: To assess the safety and efficacy of a multimodal weight-loss intervention in improving functional performance and reducing frailty risk in obese older adults.
Design: Randomized controlled trial with 2 parallel arms.
Setting and participants: Community-dwelling obese adults aged 65-75 years with body mass index (BMI) 30-39 kg/m2.
Intervention: 6-month multimodal intervention based on diet and a physical activity program.
Control group: Usual care. Main and secondary outcome measures: Frailty (Fried criteria) rate and functional performance at 6, 12, and 24 months of follow-up, respectively. Intermediate outcome measures: Weight loss, body composition changes, and metabolic and inflammatory biomarker changes.
Results: N=305. The study intervention increased gait speed at 12 and 24 months of follow-up, but had no significant effect on frailty prevention. It was effective in reducing weight, BMI, fat mass, interleukin 6, and insulin resistance and improving self-reported quality of life.
Conclusions: The study intervention was not demonstrated to be effective in preventing frailty in obese people aged 65-75 years at 24 months of follow-up. However, it allowed weight loss and a reduction in inflammatory and insulin resistance markers, which could have a long-term effect on frailty that requires further research.
Keywords: Randomized controlled trial; frailty; insulin resistance; multimodal intervention; obese.