| CTRI Number |
CTRI/2020/02/023605 [Registered on: 26/02/2020] Trial Registered Prospectively |
| Last Modified On: |
14/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Educational/behavioral ] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Improving Screening and Self-management of Gestational Diabetes Mellitus through video films in Uganda and India |
|
Scientific Title of Study
|
Gestational Diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) |
| Trial Acronym |
GUIDES |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT03937050 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Giridhara R Babu |
| Designation |
Professor, Head-Lifecourse Epidemiology, & Intermediate Fellow, Wellcome Trust DBT India Alliance |
| Affiliation |
Public Health Foundation of India, Indian Institute of Public Health, Bangalore |
| Address |
Public Health Foundation of India, Indian Institute of Public Health, Bangalore, Magadi Rd 1st cross, Next to leprosy hospital, SIHFW premises, Bengaluru, Karnataka
Magadi Rd 1st cross, Next to leprosy hospital, SIHFW premises, Bengaluru, Karnataka 560023
Bangalore
KARNATAKA
560023
India |
| Phone |
919845036197 |
| Fax |
|
| Email |
epigiridhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Giridhara R Babu |
| Designation |
Professor, Head-Lifecourse Epidemiology, & Intermediate Fellow, Wellcome Trust DBT India Alliance |
| Affiliation |
Public Health Foundation of India, Indian Institute of Public Health, Bangalore |
| Address |
Public Health Foundation of India, Indian Institute of Public Health, Bangalore, Magadi Rd 1st cross, Next to leprosy hospital, SIHFW premises, Bengaluru, Karnataka
Magadi Rd 1st cross, Next to leprosy hospital, SIHFW premises, Bengaluru, Karnataka 560023
Bangalore
KARNATAKA
560023
India |
| Phone |
919845036197 |
| Fax |
|
| Email |
epigiridhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Giridhara R Babu |
| Designation |
Professor, Head-Lifecourse Epidemiology, & Intermediate Fellow, Wellcome Trust DBT India Alliance |
| Affiliation |
Public Health Foundation of India, Indian Institute of Public Health, Bangalore |
| Address |
Public Health Foundation of India, Indian Institute of Public Health, Bangalore, Magadi Rd 1st cross, Next to leprosy hospital, SIHFW premises, Bengaluru, Karnataka
Magadi Rd 1st cross, Next to leprosy hospital, SIHFW premises, Bengaluru, Karnataka 560023
Bangalore
KARNATAKA
560023
India |
| Phone |
919845036197 |
| Fax |
|
| Email |
epigiridhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Bio Technology, Ministry of Science and Technology, Government of India.
Medical Research Council, UK
|
|
|
Primary Sponsor
|
| Name |
London School of Hygiene and Tropical Medicine |
| Address |
Keppel St, Bloomsbury, London WC1E 7HT, UK |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Public Health Foundation of India Indian Institute of Public HealthBangalore |
Public Health Foundation of India, Magadi Rd 1st cross, Next to leprosy hospital, SIHFW premises, Bengaluru, Karnataka 560023 |
|
|
Countries of Recruitment
|
India
Uganda |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Giridhara R Babu |
Indian Institute of Public Health, Bangalore |
Magadi Road 1st cross, Next to leprosy hospital, SIHFW premises, Bengaluru, Karnataka 560023
Bangalore
KARNATAKA |
9845036197
epigiridhar@gmail.com |
| Professor Moffat Nyirenda |
MRC/UVRI and LSHTM Uganda Research Unit |
Entebbe, Uganda
|
4402079272904
Moffat.Nyirenda@mrcuganda.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indian Institute of Public Health-Bengaluru Campus, Public Health Foundation of India |
Approved |
| Uganda National Council for Science and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O244||Gestational diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational/behavioural interventions |
Intervention arm includes
1. Professional development of doctors and nurses to improve their knowledge and skills in screening and management of GDM through professional development films for every six monthly for the duration of 30 minutes in the hospital.
2. Awareness-raising among pregnant women and their family members regarding GDM and the importance of GDM screening and healthy lifestyles during pregnancy through educational films during Antenatal Care (ANC) Out Patient Department (OPD) Days for the duration of ten minutes in waiting areas of antenatal clinics.
3. Structured diabetes self-management education programme for women with GDM and their partners through the educational films as weekly sessions for the duration of one hour in the hospital. |
| Comparator Agent |
usual care practices |
Usual health care practices as advised by the health care professionals which will undergo routinely. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women aged over 18 years attending ANC in the participating Health Facilities
2. Pregnant women with gestational age of <32 weeks
3. Pregnant women willing to give informed consent
4 Pregnant women available for follow-up for study duration
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women <18 years
2. Unwilling to provide written informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. GDM diagnosis : Proportion of women with a diagnosis of GDM. Self-reported via telephone contact.
2. Mean fasting blood sugar (women with GDM) : Mean fasting blood sugar in women diagnosed with GDM. Measured at clinic visit.
|
32 week of pregnancy
34 week of pregnancy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Adverse perinatal outcomes (composite measure): 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): Average blood sugar level in women diagnosed with GDM. Measured at clinic visit.
|
6 weeks post-partum
34 weeks of pregnancy |
|
|
Target Sample Size
|
Total Sample Size="20000"
Sample Size from India="10000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
• Study protocol: Oakley LL, 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 Dec;22(1):1-
• Findings from qualitative research in India: Sahu B, Babu GR, Gurav KS, Karthik M, Ravi D, Lobo E, John DA, Oakley L, Oteng-Ntim E, Nadal IP, Kinra S. Health care professionals’ perspectives on screening and management of gestational diabetes mellitus in public hospitals of South India–a qualitative study. BMC health services research. 2021 Dec;21(1):1 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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 LMICs. The research will be carried out in India (Bengaluru) and Uganda (Mpigi, Wakiso and Masaka). 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. Then the effectiveness of the intervention will be evaluated in independent cluster randomized trials, involving ~10,000 pregnant women across 32 maternity units in Uganda and 30 maternity units in India. 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. Our 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. We will evaluate this 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 of GDM. 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. |