Clinical trial NCT05039307: Prevention of Type 2 Diabetes and Gestational Diabetes Among Women in Kisantu, Democratic Republic of Congo
Official title: Prevention of Type 2 Diabetes and Gestational Diabetes Among Women of Reproductive Age in Kisantu, Democratic Republic of Congo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Gestational Diabetes
Keywords: Prevention
Type 2 diabetes
Gestational diabetes
Women of reproductive age
Healthy lifestyle
Democratic Republic of the Congo
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Memisa, Belgium
First posted: 2021-09-09
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster randomized controlled trial (cRCT) with a hierarchical design will be conducted whereby 2 groups of 3 healthcare centers (in total 6 healthcare centers) will be randomized to an intervention group or comparison group.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in the adherence to a healthy lifestyle score at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in the adherence to a healthy lifestyle score at 12 months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change from baseline in the minimum diet diversity of women (MDD-W) questionnaire at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in the minimum diet diversity of women (MDD-W) questionnaire at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in the International Physical Activity Questionnaire at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in the International Physical Activity Questionnaire at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in weight at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in weight at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in Body mass index (BMI) at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in Body mass index (BMI) at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in waist circumference at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in waist circumference at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in glycemia at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in glycemia at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in systolic and diastolic blood pressure at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in systolic and diastolic blood pressure at 12 months
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Kisantu
country: Congo, The Democratic Republic of the
facility: KAVWAYA
state: Kongo Central
city: Kisantu
country: Congo, The Democratic Republic of the
facility: KINKOKA
state: Kongo Central
city: Kisantu
country: Congo, The Democratic Republic of the
facility: MADIMBA
state: Kongo Central
city: Kisantu
country: Congo, The Democratic Republic of the
facility: NGEBA
state: Kongo Central
city: Kisantu
country: Congo, The Democratic Republic of the
facility: NKANDU 1
state: Kongo Central
city: Kisantu
country: Congo, The Democratic Republic of the
facility: Kintanu Etat
state: Kongo Cnetral
Study officials:
affiliation: Memisa
name: Jean C. Kalobu, MD; MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Tropical Medicine
name: José L. Peñalvo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Tropical Medicine
name: Diana M. Sagastume, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sagastume D, Sibongwere DK, Kidima O, Kembo DM, N'keto JM, Dimbelolo JC, Nkakirande DB, Kabundi JCK, Penalvo JL. Improving lifestyle behaviours among women in Kisantu, the Democratic Republic of the Congo: A protocol of a cluster randomised controlled trial. PLoS One. 2022 Sep 9;17(9):e0274517. doi: 10.1371/journal.pone.0274517. eCollection 2022.