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Diabetes Mellitus, Type 2KIS-AntwerpNCT05039307

Prevention of Type 2 Diabetes and Gestational Diabetes Among Women in Kisantu, Democratic Republic of Congo

A study testing Educational and motivational strategy in people with Diabetes Mellitus, Type 2 and Gestational Diabetes, run by Institute of Tropical Medicine, Belgium at 6 sites in Democratic Republic of the Congo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
What is being tested?
Educational and motivational strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
6 sitesDemocratic Republic of the Congo
Study dates
4 Oct 2021to 20 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

6 sites in 1 country.

6 sites in 1 country

Democratic Republic of the Congo6 sites

  • KAVWAYA

    Kisantu, Bas-Congo Province

  • KINKOKA

    Kisantu, Bas-Congo Province

  • MADIMBA

    Kisantu, Bas-Congo Province

  • NGEBA

    Kisantu, Bas-Congo Province

  • NKANDU 1

    Kisantu, Bas-Congo Province

  • Kintanu Etat

    Kisantu, Kongo Cnetral

Other trials in Democratic Republic of the Congo

About this study

Official title: Prevention of Type 2 Diabetes and Gestational Diabetes Among Women of Reproductive Age in Kisantu, Democratic Republic of Congo

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.

Read the 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.

Being tested
Educational and motivational strategy
Keywords
Prevention, Type 2 diabetes, Gestational diabetes, Women of reproductive age, Healthy lifestyle, Democratic Republic of the Congo
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational and motivational strategyBehavioural

    The intervention will focus on the following topics A) Healthy diet: food pyramid, a healthy plate distribution, type of carbohydrates and fats, healthy cooking techniques and healthy oils. B) Physical activity: definition, types of physical activity, advantages and benefits, examples, active physical activity sessions. C) Weight control: strategies, benefits and healthy weight gain during pregnancy. D) Knowledge and awareness of T2DM and GDM: definition, prevention, management and complications. These topics will be delivered through individualized education, group sessions and focus groups. Participants will be provided with printed material at baseline and also during the individual education sessions at the household containing a brief summary of the topics covered. The motivational components of goal setting and the use of a pedometer will be incorporated explained during the individual education sessions. The intervention will be primarily delivered by trained peer educators.

Study groups in NCT05039307
Study groupRoleWhat they receive
Intervention group (Educational and motivational strategy)ExperimentalThe 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.
Receives: Behavioral: Educational and motivational strategy
Comparison group (Basic educational strategy)No interventionThe comparison group will be limited to receive the healthy lifestyle brochure with general recommendations at baseline only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the adherence to a healthy lifestyle score at 24 months

    The adherence to a healthy lifestyle will be measured by using a validated questionnaire for weight control in lifestyle-related diseases that compromise 14 questions, 12 regarding diet and 2 related to physical activity. Each question has 5 multiple choice answers (A, B, C, D, E). This questionnaire provides a final score ranging between 14-65 points. A lower score indicates poor adherence to a healthy lifestyle, while a high score indicates good adherence.

    Measured: Baseline and 24 months

  2. Change from baseline in the adherence to a healthy lifestyle score at 12 months

    The adherence to a healthy lifestyle will be measured by using a validated questionnaire for weight control in lifestyle-related diseases that compromise 14 questions, 12 regarding diet and 2 related to physical activity. Each question has 5 multiple choice answers (A, B, C, D, E). This questionnaire provides a final score ranging between 14-65 points. A lower score indicates poor adherence to a healthy lifestyle, while a high score indicates good adherence.

    Measured: Baseline and 12 months

Secondary outcomes (14)

  1. Change from baseline in the minimum diet diversity of women (MDD-W) questionnaire at 24 months

    The MDD-W dichotomous questionnaire developed by the Food and Agriculture Organization of the United Nations (FAO) will be used to measure women's diet diversity.

    Measured: Baseline and 24 months

  2. Change from baseline in the minimum diet diversity of women (MDD-W) questionnaire at 12 months

    The MDD-W dichotomous questionnaire developed by the Food and Agriculture Organization of the United Nations (FAO) will be used to measure women's diet diversity.

    Measured: Baseline and 12 months

  3. Change from baseline in the International Physical Activity Questionnaire at 24 months

    The International Physical activity Questionnaire (IPAQ) short Form will be used to assess the level of physical activity of the participants.

    Measured: Baseline and 24 months

  4. Change from baseline in the International Physical Activity Questionnaire at 12 months

    The International Physical activity Questionnaire (IPAQ) short Form will be used to assess the level of physical activity of the participants.

    Measured: Baseline and 12 months

  5. Change from baseline in weight at 24 months

    Weight will be measured in kg and by using a digital weight scale. The WHO STEPwise guideline will be followed for this measurement.

    Measured: Baseline and 24 months

  6. Change from baseline in weight at 12 months

    Weight will be measured in kg and by using a digital weight scale. The WHO STEPwise guideline will be followed for this measurement.

    Measured: Baseline and 12 months

  7. Change from baseline in Body mass index (BMI) at 24 months

    BMI will be calculated by using the formula BMI= weight in kg/height in meters squared.

    Measured: Baseline and 24 months

  8. Change from baseline in Body mass index (BMI) at 12 months

    BMI will be calculated by using the formula BMI= weight in kg/height in meters squared.

    Measured: Baseline and 12 months

  9. Change from baseline in waist circumference at 24 months

    Waist circumference will be measured in cm and y using a constant tension tape. The WHO STEPwise guideline will be followed for this measurement.

    Measured: Baseline and 24 months

  10. Change from baseline in waist circumference at 12 months

    Waist circumference will be measured in cm and y using a constant tension tape. The WHO STEPwise guideline will be followed for this measurement.

    Measured: Baseline and 12 months

  11. Change from baseline in glycemia at 24 months

    Glycemia will be measured in mg/dL by using by pricking the fingertip with a lancet and glucometer. The WHO STEPwise guideline will be followed for this measurement.

    Measured: Baseline and 24 months

  12. Change from baseline in glycemia at 12 months

    Glycemia will be measured in mg/dL by using by pricking the fingertip with a lancet and glucometer. The WHO STEPwise guideline will be followed for this measurement.

    Measured: Baseline and 12 months

  13. Change from baseline in systolic and diastolic blood pressure at 24 months

    Systolic and diastolic blood pressure will me measured in mm Hg and by using an OMRON. The WHO STEPwise guideline will be followed for this measurement.

    Measured: Baseline and 24 months

  14. Change from baseline in systolic and diastolic blood pressure at 12 months

    Systolic and diastolic blood pressure will me measured in mm Hg and by using an OMRON. The WHO STEPwise guideline will be followed for this measurement.

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2021
  2. Study start4 Oct 2021
  3. Primary completion20 Feb 2024
  4. Study completion20 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05039307
Sponsor's protocol ID
1482/21
Acronym
KIS-Antwerp
Status last verified
Jan 2024
First submitted
19 Aug 2021
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36084047

Questions about this trial

What is this clinical trial studying?

A study testing Educational and motivational strategy in people with Diabetes Mellitus, Type 2 and Gestational Diabetes, run by Institute of Tropical Medicine, Belgium at 6 sites in Democratic Republic of the Congo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the adherence to a healthy lifestyle score at 24 months (time frame: Baseline and 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05039307, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.

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