Lifestyle Intervention IN Gestational Diabetes (LIVING)

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

Interventions

BEHAVIORAL

Life style Intervention

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.

Sponsors & Collaborators

• National Health and Medical Research Council, Australia

  collaborator OTHER

• All India Institute of Medical Sciences

  collaborator OTHER

• The George Institute

  lead OTHER

Principal Investigators

• Anushka Patel, Ph.D · The George Institute

• Nikhil Tandon, Ph.D. · All India Institute of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-01

Primary Completion

2021-01-31

Completion

2021-01-31

Countries

• Bangladesh
• India
• Sri Lanka

Study Locations