NCT03305939: LIVING

Lifestyle Intervention IN Gestational Diabetes (LIVING)

Completed NA Last updated 23 March 2021

What this trial tests

NA trial testing Life style Intervention in Gestational Diabetes Mellitus in Pregnancy in 1,612 participants. Completed in 31 January 2021.

Timeline

1 August 2017

Primary endpoint
31 January 2021

31 January 2021

Quick facts

Lead sponsor	The George Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,612
Start date	1 August 2017
Primary completion	31 January 2021
Estimated completion	31 January 2021
Sites	20 locations across Sri Lanka, Bangladesh, India

Drugs / interventions tested

• Life style Intervention

Conditions studied

• Gestational Diabetes Mellitus in Pregnancy — all drugs for Gestational Diabetes Mellitus in Pregnancy →

Sponsor

The George Institute

Who can join

Adults 18 to 50, female only, with Gestational Diabetes Mellitus in Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Investigators have taken the learning from various programs to develop a new lifestyle program (LIVING) that has a high probability of being feasible, acceptable and cost-effective in the South Asian context for women with prior Gestational Diabetes Mellitus (GDM). Investigators will optimize this intervention using an iterative, systems-based and user-centered approach. The intervention will be delivered by auxiliary nurse midwives or their equivalent in each participating hospital, representing a strategy of within-system task-shifting to augment scalability and sustainability. Investigators will then evaluate this in a Randomised Controlled Trial (RCT) to determine whether it will reduce the incidence of Type 2 Diabetes Mellitus (T2DM), in a manner that is affordable, acceptable and scalable. This project focuses on generating new knowledge around implementation of a preventive strategy embedded within existing health systems, using mixed-methods evaluation to inform on cost-effectiveness, acceptability and scalability. It represents a case study into "Integrated Innovation TM" incorporating a science component (a program based on behavior change theory that supports a multi-level approach to prevention by combining individually targeted strategies with social support), a social component (an innovative workforce strategy) and a sustainability component (a systems perspective for integration with existing health system infrastructure).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of a Lifestyle Intervention to Prevent Deterioration in Glycemic Status Among South Asian Women With Recent Gestational Diabetes: A Randomized Clinical Trial.
   Tandon N, Gupta Y, Kapoor D, Lakshmi JK, et al · · 2022 · cited 60× · PMID 35234881 · DOI 10.1001/jamanetworkopen.2022.0773
2. A lifestyle intervention programme for the prevention of Type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus [LIVING study]: protocol for a randomized trial.
   Gupta Y, Kapoor D, Josyula LK, Praveen D, et al · · 2019 · cited 14× · PMID 30368898 · DOI 10.1111/dme.13850
3. 57^th EASD Annual Meeting of the European Association for the Study of Diabetes.
   · 2021 · cited 11× · PMID 34468792 · DOI 10.1007/s00125-021-05519-y
4. Lifestyle intervention to prevent type 2 diabetes after a pregnancy complicated by gestational diabetes mellitus: a systematic review and meta-analysis update.
   Bracco PA, Reichelt AJ, Alves LF, Vidor PR, et al · · 2025 · cited 9× · PMID 39980013 · DOI 10.1186/s13098-025-01606-x
5. Antenatal oral glucose tolerance test abnormalities in the prediction of future risk of postpartum diabetes in women with gestational diabetes: Results from the LIVING study.
   Gupta Y, Kapoor D, Lakshmi JK, Praveen D, et al · · 2024 · cited 7× · PMID 38708437 · DOI 10.1111/1753-0407.13559
6. The incidence and risk factors of postpartum diabetes in women from Bangladesh, India and Sri Lanka (South Asia) with prior gestational diabetes mellitus: Results from the LIVING study.
   Gupta Y, Kapoor D, Lakshmi JK, Praveen D, et al · · 2023 · cited 7× · PMID 37657646 · DOI 10.1016/j.diabres.2023.110893
7. Lifestyle InterVention IN Gestational diabetes (LIVING) in India, Bangladesh and Sri Lanka: protocol for process evaluation of a randomised controlled trial.
   Shanthosh J, Kapoor D, Josyula LK, Patel A, et al · · 2020 · cited 2× · PMID 33318108 · DOI 10.1136/bmjopen-2020-037774
8. The Effects of a Lifestyle Intervention to Prevent Deterioration in Glycaemic Status Among South Asian Women with Recent Gestational Diabetes Mellitus: A Randomised Control Trial
   Tandon N, Gupta Y, Kapoor D, Lakshmi JK, et al · · 2021 · cited 1× · DOI 10.2139/ssrn.3905922