Prevention of Type 2 Diabetes and Gestational Diabetes Among Women in Kisantu, Democratic Republic of Congo (KIS-Antwerp)

Institute of Tropical Medicine, Belgium

Status: Completed

Conditions: Gestational Diabetes; Diabetes Mellitus, Type 2

Treatments: Behavioral: Educational and motivational strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT05039307

1482/21

Details and patient eligibility

About

This study aims to develop and implement a long-term program focused on the prevention of type 2 diabetes Mellitus (T2DM) and gestational diabetes mellitus (GDM) in women of reproductive age through lifestyle modification. This is a cluster-randomized trial whereby 6 health centers across Kisantu, Democratic Republic of Congo (DRC) will be randomized to an intervention group (3 health centers) or a comparison group (3 health centers). The intervention group will be provided with a preventive program based on educational + motivational strategies when the comparison group will be limited to an educational strategy only. This study will last 24 months and is limited to women of reproductive age (18-49 years), pregnant and non-pregnant. Evaluation of this research will use mixed longitudinal analyses for healthy lifestyle adherence, anthropometric and clinical indicators, diet quality, and physical activity. Expected results of this study for women of reproductive age include the prevention of T2DM and GDM through the acquisition of healthy lifestyle behavior, reaching and maintaining an optimal weight, blood pressure and glycemia, and adhere to the weight gain recommendations during pregnancy. Other expected achievements encompass improvements in the usability of data capturing systems, expand knowledge among health care providers on effective strategies for T2DM and GDM prevention and improve the technique and precision of measurements concerning health visits among health care providers, among others.

Full description

Background: As the obesity epidemic continues to rise, it is expected that rates of T2DM and GDM will be also increasing among women in Sub-Saharan Africa (SSA). Women of reproductive age are a particularly vulnerable group, and there is a need for preventive programs addressing the incidence of obesity, T2DM, and GDM.

Objective: This study aims to develop, implement, and evaluate a long-term program (KIS-Antwerp) focused on the prevention of T2DM and GDM in women through a healthy lifestyle promotion.

Methods: The study will take place in 6 healthcare centers across Kisantu, DRC, and will be limited to women of reproductive age (18-49 years) irrespectively of pregnancy status. KIS-Antwerp will be implemented and evaluated using a matched cluster randomized controlled trial where the 6 healthcare will be randomized into an intervention group and a comparison group. The duration of the present study is 24 months. A total of 144 participants per arm is necessary to detect a 12% change in the primary outcome with a level of significance of 0.05, power >80%, and considering a 20% loss of follow-up. The intervention group will be provided with a preventive intervention program based on educational + motivational strategies including the following intervention program components: Individualized education, group education, physical activity sessions, setting goals, and usage of a pedometer. The comparison group will be limited to a basic educational strategy only (basic individual education). Participants will be followed up for 24 months and measurements will be assessed every 6-months period.

Statistical methods: Demographic characteristics will be reported as measures of central tendency for continuous outcomes and frequency distribution and percentages for binary/categorical data. Consequently, demographic data will be explored for differences at baseline by comparing and testing means. After the termination of the study, the primary and secondary outcomes will be evaluated for normality by the Kolmogorov-Simonov test and visual inspection of histograms. For the primary ordinal outcome, the impact of the intervention program between baseline and follow up of the 2 groups (intervention and comparison group) will be assessed by using linear mixed models for repeated measurements.

Safety: This study imposes a low risk for the participants as the intervention program compromises a lifestyle modification through education and motivational strategies and the measurements to be taken are non-invasive, with the exception of blood glucose assessment by blood sampling using a finger prick. For this measurement, guidelines with all the necessary steps and equipment will be followed.

Enrollment: 288 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Non-pregnant or (first trimester) pregnant women
• Women of reproductive age (18-49 years old)
• Without a previous diagnosis of type 1 diabetes or T2DM (confirmed by a random glucose test)

Exclusion criteria

• Pregnant women with active gestational diabetes
• Adult males, and children and adolescents <18 years old of both sexes
• Pre-existent severe chronic conditions (e.g. chronic liver or kidney disease, chronic obstructive pulmonary disease)
• Living outside of the surrounding catchment areas of the 6 healthcare centers.
• Women internationally displaced, without a permanent home or identified physical address.
• Women planning to move elsewhere in the following 2 years
• Women that do not provide a written Informed Consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 2 patient groups

Intervention group (Educational and motivational strategy)

Experimental group

Description:

The intervention group will be provided with a multi-component intervention entailing the following components distributed over the 24-months study: 4 individualized education sessions at the household, 4 group activities (2 group education sessions and 2 physical activity sessions) at the healthcare center, and 4 focus groups at the healthcare center as well. The motivational components of goal setting and the use of a pedometer will be incorporated in the individualized education sessions. Moreover, community activities will be incorporated in the second year of the study after exploring whether the activities are feasible and acceptable by the community. The topics covered by the intervention are healthy diet, physical activity, weight control strategies and knowledge and awareness of T2DM and GDM. Additionally, at baseline participants will be provided with a healthy lifestyle brochure with general recommendations.

Treatment:

Behavioral: Educational and motivational strategy

Comparison group (Basic educational strategy)

No Intervention group

Description:

The comparison group will be limited to receive the healthy lifestyle brochure with general recommendations at baseline only.