Clinical trial NCT03937050: Gestational Diabetes in Uganda and India Improving Screening and Self-management
Official title: Gestational Diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: pregnancy
gestational diabetes
India
Uganda
cluster randomized trial
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Indian Institute of Public Health, India
name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2019-05-03
Enrollment: 16500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: GDM screening
timeFrame: 32 weeks of pregnancy
measure: Mean fasting blood sugar (women with GDM)
timeFrame: 34 weeks of pregnancy
Secondary outcomes:
measure: Adverse perinatal outcomes (composite measure)
timeFrame: 28 days postpartum (measured 6 weeks after expected date of delivery (EDD))
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Indian Institute of Public Health
city: Entebbe
country: Uganda
facility: MRC/UVRI and LSHTM Uganda Research Unit
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Sanjay Kinra
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.