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Gestational DiabetesGUIDESNCT03937050

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

A study testing Intervention in people with Gestational Diabetes, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Gestational Diabetes
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16,500 participants
Where
2 sitesin 2 countries
Study dates
5 May 2021to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Pregnant women aged 18 or over attending for antenatal care at participating health facilities.
  • Pregnant women willing and able to give informed consent.

Who cannot join

  • Pregnant women <18 years
  • No informed consent

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

India1 site

  • Indian Institute of Public Health

    Hyderabad

Other trials in India

Uganda1 site

  • MRC/UVRI and LSHTM Uganda Research Unit

    Entebbe

Other trials in Uganda

About this study

Official title: 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.

Being tested
Intervention
Keywords
pregnancy, gestational diabetes, India, Uganda, cluster randomized trial
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    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.
Study groups in NCT03937050
Study groupRoleWhat they receive
InterventionExperimentalA 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.
Receives: Behavioral: Intervention
ControlNo interventionUsual care practices.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. GDM screening

    Proportion of women who were tested for GDM at or after 24 weeks of pregnancy. Self-reported via telephone contact.

    Measured: 32 weeks of pregnancy

  2. Mean fasting blood sugar (women with GDM)

    Mean fasting blood sugar in women diagnosed with GDM. Measured at clinic visit.

    Measured: 34 weeks of pregnancy

Secondary outcomes (1)

  1. 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.

    Measured: 28 days postpartum (measured 6 weeks after expected date of delivery (EDD))

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2019
  2. Study start5 May 2021
  3. Primary completion1 Jul 2023
  4. Study completion1 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03937050
Sponsor's protocol ID
108-KEP-179
Acronym
GUIDES
Status last verified
Feb 2025
First submitted
1 May 2019
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Oakley LL, Ravi D, Lieber J, Namara A, Ana Y, Coombe H, Sahu B, Mallinson PAC, Karthik M, Lobo E, Mukherjee D, Birk N, Hopkins L, Nadal IP, Seeley J, Oteng-Ntim E, Nyirenda M, Kinra S, Babu GR. Educational films for improving perinatal outcomes associated with gestational diabetes in Uganda and India: a cluster randomised trial. BMJ Glob Health. 2026 Apr 27;11(4):e022676. doi: 10.1136/bmjgh-2025-022676.

    PubMed 42044921

  • Birk N, Oakley LL, Mallinson PAC, R D, Babu GR, Nyirenda M, Kinra S. Statistical analysis plan and protocol updates for Gestational diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) trial. Trials. 2023 Aug 12;24(1):520. doi: 10.1186/s13063-023-07508-5.

    PubMed 37568171

  • Oakley LL, R D, Namara A, Sahu B, Nadal IP, Ana Y, Coombe H, Oteng-Ntim E, Seeley J, Nyirenda M, Babu G, Kinra S. Educational films for improving screening and self-management of gestational diabetes in India and Uganda (GUIDES): study protocol for a cluster-randomised controlled trial. Trials. 2021 Jul 28;22(1):501. doi: 10.1186/s13063-021-05435-x.

    PubMed 34321046

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Gestational Diabetes, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GDM screening (time frame: 32 weeks of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03937050, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.

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