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

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.

Conditions

• Diabetes Mellitus, Type 2
• Gestational Diabetes

Interventions

BEHAVIORAL

Educational and motivational strategy

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.

Sponsors & Collaborators

• Memisa, Belgium

  collaborator UNKNOWN

• Institute of Tropical Medicine, Belgium

  lead OTHER

Principal Investigators

• Jean C. Kalobu, MD; MPH · Memisa

• José L. Peñalvo, PhD · Institute of Tropical Medicine

• Diana M. Sagastume, MSc · Institute of Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-04

Primary Completion

2024-02-20

Completion

2024-02-20

Countries

• Democratic Republic of the Congo

Study Locations