Gestational Diabetes in Uganda and India Improving Screening and Self-management

Gestational Diabetes Clinical Trial

— GUIDES  

Official title:

Gestational Diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03937050
• Other study ID #: 108-KEP-179
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: November 2022
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial will evaluate a package of three interconnected educational/behavioural interventions aimed at: a) improving knowledge and skills of GDM guidelines and skills of health providers; b) raising awareness of importance of GDM screening among pregnant women and their families; and c) improving confidence and skills in self-management among those diagnosed with GDM. The interventions will be delivered through the medium of film as they are low-cost and scalable, and are particularly suitable for people who are not very literate, making them ideal for low- and middle-income countries (LMICs).

The research will be carried out in Uganda (Entebbe) and India (Bengaluru). A careful contextual analysis will precede the development of a culturally-tailored film-based intervention for each setting, which will be iteratively refined using qualitative research methods till it is fit for purpose. The effectiveness of the intervention will be evaluated in independent cluster randomised trials, involving ~10,000 pregnant women across 30 maternity units at each site. The films will be made available in the intervention arm facilities: for viewing by doctors and nurses at their meetings, for continual screening in waiting areas of antenatal clinics, and during group education sessions (and personal mobile use) for GDM patients. Where video/projection facilities are unavailable, small low-cost projectors will be made available. Control arms will follow usual care practices.

The principal research question is whether a low-cost educational/behavioural intervention delivered through a package of culturally-tailored films can provide scalable improvements in timely detection and management of GDM. This will be evaluated through assessing three endpoints: a) detection of GDM at 32 weeks of; b) glycaemic control (fasting glucose) in women with GDM at ~34 weeks of pregnancy; and c) adverse perinatal outcomes associated with GDM. Interviews will be conducted with women and health providers to help understand how and why the intervention may be (or may not be) successful. The ultimate aim of the project is to contribute to scientific evidence underpinning the use of films in cost-effectively scaling up behavioural interventions in low literacy settings.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16500
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnant women aged 18 or over attending for antenatal care at participating health facilities.

• Pregnant women willing and able to give informed consent.

Exclusion Criteria:

• Pregnant women <18 years

• No informed consent

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• Intervention
Three film-based components: Professional development of doctors and nurses to improve screening and management of GDM. Modules will cover knowledge and relevant clinical guidelines, skills for glucose monitoring and managing medication, specialist obstetric care, and lifestyle counselling. The films will be screened at professional development meetings. Awareness-raising among pregnant women and family members regarding GDM and the importance of healthy lifestyles during pregnancy. The film will be culturally tailored and will be screened in waiting areas of antenatal clinics/electronic versions of the films will be made available for viewing on mobile devices. Structured diabetes self-management programme for women with GDM to empower them with the necessary knowledge, skills, and confidence to manage GDM successfully. The programme will incorporate behavioural counselling and educational reinforcement. Films will be screened at group sessions/viewed on mobile devices.

Locations

Country	Name	City	State
India	Indian Institute of Public Health	Hyderabad
Uganda	MRC/UVRI and LSHTM Uganda Research Unit	Entebbe

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Guy's and St Thomas' NHS Foundation Trust, Indian Institute of Public Health, India, MRC/UVRI & LSHTM Uganda Research Unit

Countries where clinical trial is conducted

India,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GDM screening	Proportion of women who were tested for GDM at or after 24 weeks of pregnancy. Self-reported via telephone contact.	32 weeks of pregnancy
Primary	Mean fasting blood sugar (women with GDM)	Mean fasting blood sugar in women diagnosed with GDM. Measured at clinic visit.	34 weeks of pregnancy
Secondary	Adverse perinatal outcomes (composite measure)	Proportion of women with adverse perinatal outcomes related to GDM (composite of emergency caesarean section delivery, perinatal or neonatal mortality, and infant hospitalization within 28 days). Self-reported via telephone contact post delivery.	28 days postpartum (measured 6 weeks after expected date of delivery (EDD))