Gestational Diabetes in Uganda and India Improving Screening and Self-management (GUIDES)

London School of Hygiene and Tropical Medicine

Status: Completed

Conditions: Gestational Diabetes

Treatments: Behavioral: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03937050

108-KEP-179

Details and patient eligibility

About

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.

Enrollment: 16,500 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16,500 participants in 2 patient groups

Intervention

Experimental group

Description:

A package of three interconnected educational/behavioural film-based interventions will developed for delivery at the cluster (clinic) level. The aim of the three components will be as follows: a) improving knowledge of GDM guidelines and skills among health providers involved in GDM management, b) raising awareness of GDM and the importance of screening among pregnant women and their family members, and c) improving confidence and skills in self-management of GDM among women diagnosed.

Treatment:

Behavioral: Intervention

Control

No Intervention group

Description:

Usual care practices.