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

March 21, 2023 updated by: London School of Hygiene and Tropical Medicine

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Hyderabad, India
        • Indian Institute of Public Health
  • Uganda
      • Entebbe, Uganda
        • MRC/UVRI and LSHTM Uganda Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
Behavioral: Intervention

Three film-based components:

  1. 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.
  2. 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.
  3. 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.
No Intervention: Control
Usual care practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GDM screening
Time Frame: 32 weeks of pregnancy
Proportion of women who were tested for GDM at or after 24 weeks of pregnancy. Self-reported via telephone contact.
32 weeks of pregnancy
Mean fasting blood sugar (women with GDM)
Time Frame: 34 weeks of pregnancy
Mean fasting blood sugar in women diagnosed with GDM. Measured at clinic visit.
34 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse perinatal outcomes (composite measure)
Time Frame: 28 days postpartum (measured 6 weeks after expected date of delivery (EDD))
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))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Guy's and St Thomas' NHS Foundation Trust
Indian Institute of Public Health, India
MRC/UVRI & LSHTM Uganda Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

May 1, 2019

First Submitted That Met QC Criteria

May 1, 2019

First Posted (Actual)

May 3, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108-KEP-179

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Indian Council of Medical Research guidance stipulates that the main India dataset should be retained in India. Therefore, anonymised data from either country will not made freely available. A controlled access model will be followed: anonymised data will be shared on request, subject to approval from the steering group and Independent Access Advisor. Data sharing will be subject to ethical approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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