Home » Trials » SLCTR/2017/001
A lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus
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SLCTR Registration Number
SLCTR/2017/001
Date of Registration
The date of last modification
May 07, 2021
Trial Status
Scientific Title of Trial
A lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus
Public Title of Trial
A lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus
Disease or Health Condition(s) Studied
Gestational Diabetes
Scientific Acronym
LIVING (Lifestyle InterVention IN Gestational Diabetes)
Public Acronym
LIVING (Lifestyle InterVention IN Gestational Diabetes)
Brief title
A lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus.
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P/163/10/2016 (ERC: Kelaniya)
What is the research question being addressed?
Will a resource- and culturally-appropriate lifestyle intervention program in South Asian countries, provided to women with gestational diabetes after delivery, reduce the incidence of worsening of glycaemic status, in a manner that is affordable, acceptable and scalable?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
The study will be conducted in 4 hospital sites • Colombo North Teaching Hospital, Ragama • Colombo South Teaching Hospital, Kalubowila • Negombo District General Hospital • De Soysa Hospital for Women
There will be two (2) study arms Consenting participants will be randomized through a central, computer-based randomisation service, and will be stratified by country, centre and use of insulin during pregnancy.
Intervention arm
Intervention will include up to 4 face-to-face group sessions reinforced by technology aided/mobile platform based messaging in the first six months. Face-to-face sessions will be delivered by a trained facilitator using the existing HeLP-her training program optimised for each country.
Eligible and consenting women will attend a local hospital in groups of 15-20 and will have baseline measures assessed prior to the commencement of the program. During session 1 they will receive a program specific user manual and over the following weeks work through the behavioural skills sessions with a health worker trained in the delivery of the program Following the face to face visits participants will receive reminders, motivational messages and small actionable behaviours delivered using mobile text messages and/ or video which we will adapt from a mobile phone/web application recently piloted in an Indian population (DPP-based Habits Program). Home visits and/or telephone calls will be utilised for participants who are unable to attend sessions to ensure all components are delivered.
All phases of the program focus on self-management through small feasible and sustainable changes by building knowledge and skills across 3 themes (1) simple healthy eating and moderate physical activity messages; 2) behavioural skills such as problem solving/goal setting/self-monitoring; and 3) enhancing internal motivation, self-efficacy and self-management.
Program intensification will be offered to women who gain weight by the 6 month time point; those who gain >2% of baseline weight (which accounts for transient weight fluctuations) will receive monthly phone coaching for the remaining 6 months, delivered by the trained facilitators.
The first encounter will take 3 -9 months after delivery when the women comes for an OGTT (oral glucose tolerance test)
The duration of the face-to-face sessions and number of text/video messages/home visits/telephone calls will be informed by the learnings from the formative phase.
Control arm Control group participants will be referred to their usual doctor for ongoing management, with no attempt made to influence this. Any abnormal OGTT results during follow up will be provided to the Patient and their doctor. This is entirely consistent with current usual care.
Inclusion criteria
Absence of type 2 diabetes mellitus (T2DM) as confirmed by findings of Impaired Glucose Tolerance, Impaired Fasting Glucose, Normal Glucose Tolerance at the at 6±3 months post-partum OGTT (Oral Glucose Tolerance Test)
Exclusion criteria
Primary outcome(s)
1.
Proportion of women with a change of glycaemic category, at or prior to final visit: |
[ At baseline and at the final visit. (The median follow up period of the study is 24 months and minimum follow up is 12 months.The end of study visit would be different for each participant depending on when they are randomized) ] |
Secondary outcome(s)
1.
Percentage reduction in Fasting plasma glucose |
[ At baseline and then 6 monthly until the end of the follow-up period. ] |
2.
Percentage reduction in : Area under the curve of OGTT |
[ At baseline and then 6 monthly until the end of the follow-up period. ] |
3.
Percentage reduction in Body weight |
[ At baseline and then 6 monthly until the end of the follow-up period. ] |
4.
Percentage reduction in Waist circumference |
[ At baseline and then 6 monthly until the end of the follow-up period. ] |
5.
Percentage reduction in Systolic blood pressure |
[ At baseline and then 6 monthly until the end of the follow-up period. ] |
6.
Improvement of Physical activity level using the GPAQ (global physical activity questionnaire |
[ At baseline and then 6 monthly until the end of the follow-up period. ] |
7.
Improvement of Diet using 24 hour diet recall |
[ At baseline and then 6 monthly until the end of the follow-up period. ] |
8.
Improvement of Quality of life using the EQ5D questionnaire |
[ At baseline and then 6 monthly until the end of the follow-up period. ] |
9.
Affordability: will be measured using a specific health economic model using health care costs and outcomes both within trial and on long term basis. |
[ At baseline and then 6 monthly until the end of the follow-up period. ] |
Target number/sample size
350 Subjects from Sri Lanka (175 in each arm)
Countries of recruitment
Bangladesh, India, Sri Lanka
Anticipated start date
2017-01-16
Anticipated end date
2020-12-01
Date of first enrollment
2017-06-13
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
National Medical Research Council (NHMRC) - Global alliance for chronic disease (GACD) collaboration on implementation research for prevention and control of type 2 diabetes
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2016-10-11
Approval number
P/163/10/2016
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
Telephone: | +94-11-2961267 |
Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof Asita de Silva
Director
Clinical Trials Unit, Department of Pharmacology, Faculty of Medicine, University of Kelaniya Thalagolla Road, Ragama, Sri Lanka
Tel: +94 112665266
asitades@gmail.com
Contact Person for Public Queries
Prof Arunasalam Pathmeswaran
Professor in Public Health, Faculty of Medicine, University of Kelaniya
Department of public health
Faculty of Medicine
University of Kelaniya
PO box 6
Ragama
+94 112953411
pathmes@kln.ac.lk
Primary study sponsor/organization
Dr. Anushka Patel
Chief Scientist
The George Institute for Global Health
PO Box M201
Missenden Road
NSW 2050
Australia
Tel: +6199934500
Fax: +6199934501
apatel@georgeinstitute.org
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Applicable
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results