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

Diana Sagastume, Deogratias Katsuva Sibongwere, Olivier Kidima, Diertho Mputu Kembo, José Mavuna N'keto, Jean-Claude Dimbelolo, Dorothée Bulemfu Nkakirande, Jean Clovis Kalobu Kabundi, José L Peñalvo, Diana Sagastume, Deogratias Katsuva Sibongwere, Olivier Kidima, Diertho Mputu Kembo, José Mavuna N'keto, Jean-Claude Dimbelolo, Dorothée Bulemfu Nkakirande, Jean Clovis Kalobu Kabundi, José L Peñalvo

Abstract

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.

Conflict of interest statement

All authors declare that they have no competing interests.

Figures

Fig 1. SPIRIT flow diagram of enrolment,…
Fig 1. SPIRIT flow diagram of enrolment, intervention and assessment.
Fig 2. Study design and randomization.
Fig 2. Study design and randomization.
Fig 3. Timeline of the multi-component health…
Fig 3. Timeline of the multi-component health promotion programme.

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