NCT05039307Completed
Prevention of Type 2 Diabetes and Gestational Diabetes Among Women in Kisantu, Democratic Republic of Congo
Prevention of Type 2 Diabetes and Gestational Diabetes Among Women of Reproductive Age in Kisantu, Democratic Republic of Congo
Source: ClinicalTrials.gov · Last updated 16 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 288 (actual)
- First submitted
- 19 Aug 2021
- Start date
- 4 Oct 2021
- Primary completion date
- 20 Feb 2024
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Diseases
- Type 2 diabetes
- NCT number
- NCT05039307
What you commit to
- Study type: Interventional
- Participants enrolled: 288
- From 4 Oct 2021 to the primary completion date, 20 Feb 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pregnant women with active gestational diabetes
- Pre-existent severe chronic conditions (e.g. chronic liver or kidney disease, chronic obstructive pulmonary disease)
Age
- Adult males, and children and adolescents \<18 years old of both sexes
Other
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to 49 years · Sex: Female · Accepts healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KINKOKA Coordinator of this site? Confirm its status | Kisantu | Democratic Republic of the Congo | Unknown status |
| Kintanu Etat Coordinator of this site? Confirm its status | Kisantu | Democratic Republic of the Congo | Unknown status |
| KAVWAYA Coordinator of this site? Confirm its status | Kisantu | Democratic Republic of the Congo | Unknown status |
| MADIMBA Coordinator of this site? Confirm its status | Kisantu | Democratic Republic of the Congo | Unknown status |
| NGEBA Coordinator of this site? Confirm its status | Kisantu | Democratic Republic of the Congo | Unknown status |
| NKANDU 1 Coordinator of this site? Confirm its status | Kisantu | Democratic Republic of the Congo | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.