Flexible time-restricted eating combined with exercise in a free-living setting for middle-aged women with overweight/obesity: a randomized controlled trial.

Obesity poses a significant public health challenge among middle-aged women, driven by physiological changes associated with aging and menopause. This parallel-group, assessor-blinded, four-arm randomized controlled trial investigated the effects of 12-week 8-hour flexible time-restricted eating (flexTRE) and aerobic exercise (EX), alone or in combination (flexTRE+EX), on body composition and metabolic health in a free-living setting. Participant enrolment began on September 1st 2023 and data collection was completed on July 1st 2024. Conducted at a single research site in Hong Kong, the trial enrolled women aged 40-60 years with overweight/obesity. Participants were randomized in a 1:1:1:1 ratio to a flexTRE, EX, flexTRE+EX, or control (CON) group (n = 26 per group), with all 104 participants included in the final intention-to-treat analysis. Outcomes were assessed at baseline, and week 12. The primary outcome was fat mass. The flexTRE+EX group achieved the greatest fat mass reduction compared to the CON group (adjusted mean difference [99% Confidence Interval] -2.85 kg [-4.01 to -1.69]), and additional benefit over the flexTRE group alone (-1.56 kg [-2.74 to -0.38]), and the EX group alone (-2.01 kg [-3.21 to -0.81]). Secondary outcomes were reported in the main text. No serious adverse events were reported, and adherence was high (83%-87%) across intervention groups. These findings suggest that the combined approach effectively reduces fat mass and enhances related metabolic parameters, providing a feasible and effective strategy in middle-aged women facing overweight/obesity. Trial registration: ChiCTR2300074846.