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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

288

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline

Completed

Started Oct 2021

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

August 19, 2021

Completed

21 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed

25 days until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed

Last Updated

October 16, 2024

Status Verified

January 1, 2024

Enrollment Period

2.4 years

First QC Date

August 19, 2021

Last Update Submit

October 14, 2024

Conditions

Diabetes Mellitus, Type 2 Gestational Diabetes

Keywords

PreventionType 2 diabetesGestational diabetesWomen of reproductive ageHealthy lifestyleDemocratic Republic of the Congo

Outcome Measures

Primary Outcomes (2)

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.
Baseline and 24 months
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.
Baseline and 12 months

Secondary Outcomes (14)

Change from baseline in the minimum diet diversity of women (MDD-W) questionnaire at 24 months
Baseline and 24 months
Change from baseline in the minimum diet diversity of women (MDD-W) questionnaire at 12 months
Baseline and 12 months
Change from baseline in the International Physical Activity Questionnaire at 24 months
Baseline and 24 months
Change from baseline in the International Physical Activity Questionnaire at 12 months
Baseline and 12 months
Change from baseline in weight at 24 months
Baseline and 24 months
+9 more secondary outcomes

Study Arms (2)

Intervention group (Educational and motivational strategy)

EXPERIMENTAL

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.

Behavioral: Educational and motivational strategy

Comparison group (Basic educational strategy)

NO INTERVENTION

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

Interventions

Educational and motivational strategyBEHAVIORAL

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.

Intervention group (Educational and motivational strategy)

Eligibility Criteria

Age18 Years - 49 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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)

You may not qualify if:

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.

Contact the study team to confirm eligibility.