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 -

SLCTR Registration Number

SLCTR/2017/001


Date of Registration

06 Jan 2017

The date of last modification

Jun 29, 2017



Application Summary


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 of 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 Trail Number

None


Any other number(s) assigned to the trial and issuing authority

P/163/10/2016 (ERC: Kelaniya)


Trial Details


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


Assignment

Parallel


Purpose

Health services research


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

  1. Place of residence outside the catchment of the treating hospital
  2. Lack of access to a mobile telephone


Primary outcome(s)

Proportion of women with a change of glycaemic category, at or prior to final visit:
• Normal glucose tolerance to impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or T2DM
• IFG or IGT to T2DM


Primary outcome(s) - Time of assessment(s)

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

Percentage reductions in
1) Fasting plasma glucose
2) Area under the curve of OGTT
3) Body weight
4) Waist circumference
5) Systolic blood pressure


Improvement of the following using standardized questionnaires
6) Physical activity level using the GPAQ (global physical activity questionnaire)
7) Diet using 24 hour diet recall
8) Quality of life using the EQ5D questionnaire

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.


Secondary outcome(s) - Time of assessment(s)

Percentage reductions in
1) Fasting plasma glucose
2) Area under the curve of OGTT
3) Body weight
4) Waist circumference
5) Systolic blood pressure


Improvement of the following using standardized questionnaires
6) Physical activity level using the GPAQ (global physical activity questionnaire)
7) Diet using 24 hour diet recall
8) Quality of life using the EQ5D questionnaire

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.



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


Recruitment status

Recruiting


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Kelaniya on 11th October 2016 (Ref: P/163/10/2016)


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



Contact & Sponsor Information


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

Secondary study sponsor (If any)

None