Effect of a complex lifestyle intervention to optimize metabolic health among females of reproductive age in urban Uganda, a randomized controlled trial.

Background: The metabolic health of urban Ugandans, mostly females, is increasingly becoming sub-optimal.

Objectives: We assessed the effect of a complex lifestyle intervention, based on a small change approach, on metabolic health among females of reproductive age in urban Uganda.

Methods: A cluster randomized controlled two-arm trial with a 1:1 allocation involving church communities in Kampala (Uganda) was undertaken. The intervention arm received infographics and face-to-face group sessions, whereas the comparison arm received infographics only. Eligible participants were aged 18 to 45 years with a waist circumference of ≥80 cm and without cardiometabolic diseases. The study included a 3-month intervention and a 3-month postintervention follow-up. The primary outcome was a reduction in waist circumference. Secondary outcomes included optimization of cardiometabolic health, physical activity, and fruit and vegetable intake. Intention to treat analyses were performed using linear mixed models. This trial was registered at clinicaltrials.gov as NCT04635332.

Results: The study was conducted between 21 November 2020 and 8 May 2021. Six church communities were randomly selected, 3 (n = 66) per study arm. At 3 months and postintervention follow-up, 118 and 100 participants were analyzed, respectively. At 3 months, waist circumference tended to be lower in the intervention arm (-1.48 cm (95% CI: -3.05, 0.10) P = 0.06). The intervention showed an effect on fasting blood glucose concentrations (-6.95 mg/dL (95% CI: -13.37, -0.53) P = 0.034). Participants in the intervention arm consumed more fruits (62.6 g (95% CI: 1.9, 123.3) P = 0.046) and vegetables (66.2 g (95% CI: 25.5, 106.8) P = 0.002), whereas physical activity increased with no notable differences across the study arms. At 6 months, we found an intervention effect on waist circumference (-1.87 cm (95% CI: -3.32, -0.44) P = 0.011), fasting blood glucose concentration (-6.48 mg/dL (95% CI: -12.76, -0.21) P = 0.043), fruit consumption (29.7 g (95% CI: 5.8, 53.7) P = 0.015), and physical activity (2675.1 MET-mins/wk (95% CI: 1045.7, 4304.4) P = 0.001).

Conclusions: The intervention improved and sustained physical activity and fruit and vegetable intake, but these changes were accompanied by minimal cardiometabolic health improvements. If maintained over time, the attained lifestyle improvements may result in substantial cardiometabolic health improvements.