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Lifestyle Intervention IN Gestational Diabetes (LIVING)

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ClinicalTrials.gov Identifier: NCT03305939
Recruitment Status : Recruiting
First Posted : October 10, 2017
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
All India Institute of Medical Sciences, New Delhi
Information provided by (Responsible Party):
The George Institute

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 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 RCT to determine whether it will reduce the incidence of 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).

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus in Pregnancy Behavioral: Life style Intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Lifestyle Intervention Program for the Prevention of Type 2 Diabetes Mellitus Among South Asian Women With Prior Gestational Diabetes Mellitus.
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Intervention group will be selected by randomization and we receive all the intervention contents according to the protocol ,such as group sessions, monthly phone calls ,text/ SMSs and also receive 6 monthly Follow ups.
Behavioral: Life style Intervention

Total 1 yr ,Month 1-3: Session 1 - Week 1: Group session Session 2-Week 3: Group session Session 3-Week 6: Group session+ Support strategies delivered remotely. Following this session, participants receive reminders of core messages, behaviours, and actions via SMS and phone calls.

Month 6- Session4: Week 26- Group session +Support strategies delivered remotely: Participants receive reminders of core messages, behaviours, and actions via SMS or voice messages and phone calls.

Month 7-12-2 Intensification Sessions (week 32 and week 44); Individual sessions: If participants are persistently overweight, or gain >2% of baseline weight.

Week 26 -48 onwards: Support strategies delivered remotely: Participants who lose desired weight continue to receive reminders of core messages, behaviours, and actions via SMS and voice messages.

Week 52 End of intervention evaluation: Individual visit: Participants provide feedback on different elements of the intervention.


No Intervention: Control
Control group participants will be selected by randomization and 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 exists). Any abnormal OGTT results during follow up will be provided to the patient and their doctor.This is entirely consistent with current usual care.



Primary Outcome Measures :
  1. 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 [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Before and after changes in fasting blood glucose as assessed by OGTT [ Time Frame: 3 years ]
    Mean Change in fasting blood glucose status during the study period among the respondents

  2. Before and after changes in body weight as assessed by weight machine [ Time Frame: 3 years ]
    Mean change in Body weight during the study period among the respondents.

  3. Before and after changes in Waist circumference (cm) as assessed by measuring tape [ Time Frame: 3 years ]
    Mean change in Waist circumference (cm) during the study period among the respondents.

  4. Before and after changes in Systolic blood pressure (SBP) as assessed by Omron BP measuring machine [ Time Frame: 3 years ]
    Changes in mean Systolic blood pressure (SBP) during the study period among the respondents.

  5. Before and after changes in physical activity level as assessed by MGPAQ (Modified Global Physical Activity Questionnaire) [ Time Frame: 3 years ]
    Mean change in Physical activity level during the study period among the respondents.

  6. Before and after changes in dietary habit as assessed by intake 24 ( 24 HRS RECALL ONLINE Questionnaire) [ Time Frame: 3 years ]
    Mean change in dietary practice during the study period among the respondents.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The inclusion criteria will be the absence of T2DM (i.e. confirmation of NGT, IFG or IGT) at 3 to 9 months post-partum OGTT.

Exclusion Criteria:

  • Exclusion criteria will be limited to:

Travel time to hospital more than 2 hours, lack of access to a mobile telephone, use of steroids during pregnancy, confirmed case of Type 2 Diabetes, likelihood of moving residence in the next 3 years, refused consent .


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305939


Contacts
Contact: Aliya Naheed, Dr 01709651476 ext 2521 anaheed@icddrb.org
Contact: Sabrina Ahmed, Dr 01674750046 ext 2540 sabrina.ahmed@icddrb.org

Locations
Bangladesh
Icddr,B Recruiting
Dhaka, Bangladesh, 1212
Contact: Aliya Naheed, Dr    01709651476 ext 2521    anaheed@icddrb.org   
Contact: Sabrina Ahmed, Dr    01674750046 ext 2540    sabrina.ahmed@icddrb.org   
Sponsors and Collaborators
The George Institute
National Health and Medical Research Council, Australia
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Aliya Naheed, Dr International Centre for Diarrhoeal Disease Research, Bangladesh
Principal Investigator: Anushka Patel, Ph.D. The George Institute
Principal Investigator: Nikhil Tandon, Ph.D. All India Institute of Medical Sciences, New Delhi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The George Institute
ClinicalTrials.gov Identifier: NCT03305939     History of Changes
Other Study ID Numbers: PR- 17012
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The George Institute:
Gestational diabetes,Lifestyle,Type 2 DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications