Improving lifestyle behaviours among women in Kisantu, the Democratic Republic of the Congo: A protocol of a cluster randomised controlled trial.

INTRODUCTION: As the prevalence of obesity among women of reproductive age is increasing in sub-Saharan Africa, the burden of lifestyle-related conditions is expected to rise quickly. This study aims to develop and evaluate a multi-component health promotion programme for a healthy lifestyle to ultimately prevent the onset of type 2 diabetes and gestational diabetes among adult women in Kisantu, the Democratic Republic of the Congo. METHODS AND ANALYSIS: This study is a cluster randomised controlled trial whereby two groups of three healthcare centres each, matched by population size coverage and geographical area, will be randomised to an intervention or a comparison group. Adult women of reproductive age (18-49 years), non-pregnant or first-trimester pregnant, will be recruited from the healthcare centres. 144 women in the intervention centres will follow a 24-month multi-component health promotion programme based on educational and motivational strategies whereas the comparison centres (144 participants) will be limited to a basic educational strategy. The programme will be delivered by trained peer educators and entails individualised education sessions, education and physical activity group activities, and focus groups. Topics of an optimal diet, physical activity, weight management and awareness of type 2 and gestational diabetes will be covered. The primary outcome is the adherence to a healthy lifestyle measured by a validated closed-ended questionnaire and secondary outcomes include anthropometric measurements, clinical parameters, diet diversity and the level of physical activity. Participants from both groups will be assessed at baseline and every 6 months by trained health professionals from the recruiting healthcare centres. Data will be summarised by measures of central tendency for continuous outcomes, and frequency distribution and percentages for categorical data. The primary and secondary outcomes will be quantified using statistical mixed models. ETHICS: This research was approved by the Institutional Review Board of the Institute of Tropical Medicine Antwerp in Belgium (IRB/RR/AC/137) and the Ethical Committee of the University of Kinshasa in the Democratic Republic of the Congo (ESP/CE/130/2021). Any substantial change to the study protocol must be approved by all the bodies that have approved the initial protocol, before being implemented. Also, this journal will be informed regarding any protocol modification. Written informed consent will be required and obtained for all participants. No participant may be enrolled on the study until written informed consent has been obtained. TRIAL REGISTRATION NUMBER: NCT05039307.

A retrospective database study of the demographic features and glycemic control of patients with type 2 diabetes in Kinshasa, Democratic Republic of the Congo.

BACKGROUND: The Kin-Antwerp project aimed at improving the quality of care provided to patients with diabetes in Kinshasa, the Democratic Republic of the Congo in Central Africa, including the digitalisation of routine clinical data to improve patients' follow-up. We aim to analyse the data of a study population of Kin-Antwerp to characterise their demographic features, assess their achievement of glycemic target over time, and identify groups requiring prioritised attention. METHODS: We performed a secondary database analysis of routinely collected information from primary care patients with type 2 diabetes followed from 1991 to 2019. Data included demographics (age, sex), anthropometrics (weight, height), clinical parameters (blood pressure, plasma glucose), and anti-diabetic treatments. Achievement of glycemic target, defined as fasting plasma glucose < 126 mg/dL, over time was assessed using a multilevel mixed-effects logistic regression model. RESULTS: Our study population of patients with type 2 diabetes (N = 8976) comprised a higher proportion of women (67%) and patients between 40 and 65 years old (70.4%). At the first follow-up, most patients were on treatment with insulin (56.5%) and had glycemic levels under the target (79.9%). Women presented more often with obesity (27.4%) and high systolic blood pressure (41.8%) than men (8.6% and 37.0%, respectively). Patients had a median follow-up of 1.8 (interquartile range: 0.5-3.4) years. Overall, the odds of achieving glycemic target increased by 18.4% (odds ratio: 1.184, 95% CI: 1.130 to 1.239; p < 0.001) per year of follow-up. Stratified analyses suggested that the odds of achieving glycemic control over time increased among older patients (> 40 years), but not among younger patients (< 40 years). CONCLUSION: In our study population, an overall poor glycemic control was observed albeit with a modest improvement in the achievement of glycemic target throughout patients' follow-up. Younger patients may benefit from prioritised attention to achieve glycemic targets. Based on the information provided by the database, continue monitoring and improvement of the project Kin-Antwerp is recommended. Introducing further efforts to improve type 2 diabetes management should include robust glycemia-monitoring tools and haemoglobin A1c, as well as further outlining self-management strategies.