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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937050
Recruitment Status : Not yet recruiting
First Posted : May 3, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
MRC/UVRI Uganda Research Unit on Aids
Indian Institute of Public Health, India
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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.


Condition or disease Intervention/treatment Phase
Gestational Diabetes Behavioral: Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Gestational Diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


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 and neonatal care, and lifestyle counselling. These films will be screened 6-monthly at routine professional development meetings.
  2. Awareness-raising among pregnant women and family members regarding GDM and the importance of healthy lifestyles during pregnancy. The films will be culturally tailored and will be screened in waiting areas of antenatal clinics.
  3. Structured diabetes self-management education 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 weekly group sessions and optimised for viewing on mobile devices.

No Intervention: Control
Usual care practices.



Primary Outcome Measures :
  1. GDM diagnosis [ Time Frame: 32 weeks of pregnancy ]
    Proportion of women with a diagnosis of GDM. Self-reported via telephone contact.

  2. 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.


Secondary Outcome Measures :
  1. Adverse perinatal outcomes (composite measure) [ Time Frame: 6 weeks post-partum ]
    Proportion of women with adverse perinatal outcomes related to GDM (composite of Caesarean section delivery, perinatal mortality, and infant hospitalization within 6 weeks of delivery). Self-reported via telephone contact post delivery.

  2. HbA1c (women with GDM) [ Time Frame: 34 weeks. ]
    Average blood sugar level in women diagnosed with GDM. Measured at clinic visit.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937050


Contacts
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Contact: Laura Oakley 00 44 207 9272901 laura.oakley@lshtm.ac.uk

Locations
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India
Indian Institute of Public Health
Hyderabad, India
Contact: Giridhara R Babu       giridhar@iiphh.org   
Uganda
MRC/UVRI and LSHTM Uganda Research Unit
Entebbe, Uganda
Contact: Moffat Nyirenda       Moffat.Nyirenda@mrcuganda.org   
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
MRC/UVRI Uganda Research Unit on Aids
Indian Institute of Public Health, India
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Sanjay Kinra London School of Hygiene and Tropical Medicine
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03937050    
Other Study ID Numbers: 108-KEP-179
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by London School of Hygiene and Tropical Medicine:
pregnancy
gestational diabetes
India
Uganda
cluster randomized trial
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications