Lifestyle Intervention IN Gestational Diabetes (LIVING)

NCT03305939 | Completed

• 1 other identifier: LIVING
• Study Type: interventional
• Target: 1,612
• Locations: 3 countries
• Sites: 20

Brief Summary

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).

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

Gestational Diabetes,Lifestyle,Type 2 DM

Outcome Measures

Primary Outcomes (1)

• Proportion of women with a change of glycaemic category, at or prior to final visit

  From Normal Glucose Tolerance to Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) or T2DM; or Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) to Type 2 Diabetes Mellitus (T2DM).

  3 years

Secondary Outcomes (6)

• Changes in fasting blood glucose as assessed by OGTT

  3 years

• Change in body weight as assessed by the standard study weighing scale

  3 years

• Change in waist circumference (in cm) as assessed by the standard study measuring tape

  3 years

• Change in systolic blood pressure (SBP) as assessed by Omron BP measuring machine

  3 years

• Change in physical activity level as assessed by Modified Global Physical Activity Questionnaire (MGPAQ)

  3 years

Study Arms (2)

Intervention

EXPERIMENTAL

Participants randomized in to the intervention group will receive group sessions, monthly phone calls, and telephonic prompts (text/voice recording).

Behavioral: Life style Intervention

Control

NO INTERVENTION

Control group participants will be referred to their usual doctor for ongoing management, with no attempt made to influence this. They will not get any part of the intervention but will receive the usual care (if any exists). Any abnormal OGTT results during the follow-up visits will be provided to the patient and their doctor. This is entirely consistent with current usual care.

Interventions

Life style Intervention BEHAVIORAL

The intervention will include 4 face-to-face group sessions in the first 6 months, followed by remote support strategies and intensification counseling sessions when needed. Ongoing support and contact shown to be important in supporting behavior change will consist of reminders, and motivational messages for small actionable behaviors, delivered using mobile text or voice messages. Program intensification will be offered to women who fail to meet their weight goals by the 6 month time point. All phases of the program focus on self- management across 3 themes 1. simple healthy eating and moderate physical activity messages; 2. behavioral skills such as problem solving/goal setting/self-monitoring; and 3. enhancing internal motivation, self-efficacy and self-management. The program is deliberately not prescriptive, and has a focus on sustainable behaviors and local context.

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Participants must be women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Travel time to hospital more than 2 hours (unless individual circumstances will not impede hospital attendance for study visits), lack of access to a mobile telephone, use of steroids during pregnancy (other than for lung maturation of the baby), confirmed case of Type 2 Diabetes, likelihood of moving residence in the next 3 years, refused consent .

Sponsors & Collaborators

• The George Institute: lead
• National Health and Medical Research Council, Australia: collaborator
• All India Institute of Medical Sciences: collaborator

Study Sites (20)

Marie Stopes Clinic

Dhaka, 1207, Bangladesh

Location

Azimpur Matenity Clinic

Dhaka, Bangladesh

Location

BIRDEM (Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders)

Dhaka, Bangladesh

Location

Mohammadpur Fertility Services & Training Centre

Dhaka, Bangladesh

Location

M S Ramaiah Medical College

Bengaluru, India

Location

PGIMER

Chandigarh, India

Location

Madras Diabetes Research Centre

Chennai, India

Location

Goa Medical College & Hospital

Goa, India

Location

Fernandez Hospital Foundation

Hyderabad, India

Location

King Edward Memorial (KEM) Hospital

Mumbai, India

Location

TNM College & BYL Nair Ch.Hospital

Mumbai, India

Location

Kalpavriksh Super Speciality Centre

New Delhi, India

Location

JIPMER (Jawaharlal Institute of Postgraduate Medical Education and Research)

Puducherry, India

Location

Maharaja Agrasen Hospital

Punjābi Bāgh, India

Location

Christian Medical College

Vellore, India

Location

Castle Street Hospital for Women

Colombo, Sri Lanka

Location

De Soyza Maternity Hospital

Colombo, Sri Lanka

Location

Colombo South Teaching Hospital

Kalubowila, Sri Lanka

Location

Negombo District General Hospital

Negombo, Sri Lanka

Location

Colombo North Teaching Hospital

Ragama, Sri Lanka

Location

Related Publications (5)

• Gupta Y, Kapoor D, Josyula LK, Praveen D, Naheed A, Desai AK, Pathmeswaran A, de Silva HA, Lombard CB, Shamsul Alam D, Prabhakaran D, Teede HJ, Billot L, Bhatla N, Joshi R, Zoungas S, Jan S, Patel A, Tandon N. 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. Diabet Med. 2019 Feb;36(2):243-251. doi: 10.1111/dme.13850. Epub 2018 Nov 29.

  PMID: 30368898 BACKGROUND

• Tewari A, Praveen D, Madhira P, Josyula LK, Joshi R, Kokku SB, Garg V, Rawal I, Chopra K, Chakma N, Ahmed S, Pathmeswaran A, Godamunne P, Lata AS, Sahay R, Patel T, Gupta Y, Tandon N, Naheed A, Patel A, Kapoor D. Feasibility of a Lifestyle Intervention Program for Prevention of Diabetes Among Women With Prior Gestational Diabetes Mellitus (LIVING Study) in South Asia: A Formative Research Study. Front Glob Womens Health. 2020 Nov 27;1:587607. doi: 10.3389/fgwh.2020.587607. eCollection 2020.

  PMID: 34816163 BACKGROUND

• Shanthosh J, Kapoor D, Josyula LK, Patel A, Gupta Y, Tandon N, Jan S, Teede HJ, Desai A, Joshi R, Praveen D. Lifestyle InterVention IN Gestational diabetes (LIVING) in India, Bangladesh and Sri Lanka: protocol for process evaluation of a randomised controlled trial. BMJ Open. 2020 Dec 13;10(12):e037774. doi: 10.1136/bmjopen-2020-037774.

  PMID: 33318108 BACKGROUND

• Gupta Y, Kapoor D, Lakshmi JK, Praveen D, Santos JA, Billot L, Naheed A, de Silva HA, Gupta I, Farzana N, John R, Ajanthan S, Bhatla N, Desai A, Pathmeswaran A, Prabhakaran D, Teede H, Zoungas S, Patel A, Tandon N; LIVING Collaborative Group. 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. Diabetes Res Clin Pract. 2023 Oct;204:110893. doi: 10.1016/j.diabres.2023.110893. Epub 2023 Aug 31.

  PMID: 37657646 DERIVED

• Tandon N, Gupta Y, Kapoor D, Lakshmi JK, Praveen D, Bhattacharya A, Billot L, Naheed A, de Silva A, Gupta I, Farzana N, John R, Ajanthan S, Divakar H, Bhatla N, Desai A, Pathmeswaran A, Prabhakaran D, Joshi R, Jan S, Teede H, Zoungas S, Patel A; LIVING Collaborative Group. Effects of a Lifestyle Intervention to Prevent Deterioration in Glycemic Status Among South Asian Women With Recent Gestational Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e220773. doi: 10.1001/jamanetworkopen.2022.0773.

  PMID: 35234881 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Anushka Patel, Ph.D

  The George Institute

  PRINCIPAL INVESTIGATOR

• Nikhil Tandon, Ph.D.

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: October 10, 2017
• Study Start: August 1, 2017
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: To be determined
• Access Criteria: To de determined

Locations

SR (5); BA (4); IN (11)