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.

The conceptual framework for a combined food literacy and physical activity intervention to optimize metabolic health among women of reproductive age in urban Uganda.

BACKGROUND: Metabolic health of urban Ugandans, mostly women, has increasingly become sub-optimal. As women are strategic for family behavioral change and do not meet WHO recommendations regarding dietary and physical activity (PA), there is an urgent need for science-based interventions to tackle unhealthy dietary and PA behaviors. OBJECTIVE: To develop a food literacy and PA promotion intervention to optimise metabolic health among women of reproductive age in urban Uganda. METHODOLOGY: Steps 1- 6 of the Intervention Mapping protocol were used to design the intervention. RESULTS: Notable determinants from Step 1 were health/beauty paradox, nonfactual nutrition information, socio-cultural misconceptions around moderate PA, fruits, and vegetables. Others included gaps in food/PA knowledge, skills, and self-efficacy. We hypothesised that changing the overall existing behaviours in one intervention may meet strong resistance. Thus, we decided to go for gradual stepwise changes. Hence in step 2, three behavioural intervention objectives were formulated; (1) women evaluate the accuracy of nutrition and PA information., (2) engage in moderate intensity PA for at least 150 min a week, and (3) consume at least one portion of vegetables and one portion of fruit every day. Based on the food literacy model, intervention objectives were formulated into performance objectives and matrices of change objectives. In step 3 a combination of eleven behavioural change techniques were selected and translated into practical strategies to effect changes in determinants. In step 4, intervention components and materials were developed. The intervention consists of five interactive group sessions, 150 min each. Infographics on benefits/recommendations, vegetable recipes, and practical tips to eat more fruits, vegetables, and to engage more in PA are included. Personalised goals and action plans tailored to personal metabolic health and lifestyle needs, and environmental opportunities form the basis of the intervention. A randomized controlled trial is being conducted to evaluate the intervention ( https://clinicaltrials.gov/ct2/show/NCT04635332 ). CONCLUSIONS: The intervention is novel, based on a holistic food literacy model. The intervention is built on determinants specific to urban Uganda, evidence based behavioural change theoretical models and techniques, detailing the hypothesised behavioural change mechanism. If effective, an evidence-based intervention will become available for reference in urban Uganda.