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Lifestyle Intervention IN Gestational Diabetes (LIVING)

This study is currently recruiting participants.
Verified September 2017 by International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor:
ClinicalTrials.gov Identifier:
NCT03305939
First Posted: October 10, 2017
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
  Purpose

Burden: Diabetes mellitus is a major public health concern for both the developed and the developing countries. Globally 246 million people affected with diabetes, and will rise up to 300 million by 2025. In India, around 25% of the 25 million pregnancies are associated with gestational diabetes mellitus (GDM), and increasing rapidly over the time. Reported prevalence rates for GDM for Sri Lanka (13%) and Bangladesh (10%) have been described. However, in Bangladesh, estimate varies from 9.7% to 12.9% when different criteria were used.

Knowledge gap: There is knowledge gap on whether a resource- and culturally-appropriate lifestyle intervention program will be more effective and cost effective relative to usual care in delaying incidence of T2D among women in South Asia. Evidence of developed countries indicate that a low-intensity lifestyle intervention, integrated with antenatal care in health system, optimizes healthy diet and attenuates physical activity decline in early pregnancy.

Objective of the study: 1.To determine whether a resource- and culturally-appropriate lifestyle intervention program in Bangladesh , provided to women with prior gestational diabetes after delivery, will reduce the incidence of worsening of glycaemic status.

2. To explore whether the designated lifestyle intervention program is affordable, acceptable and scalable locally.

Methods:

Study design: An open-label parallel group pragmatic individual randomized controlled trial with blinded primary endpoint adjudication. The randomized controlled trial will be preceded by an intervention development and optimization phase.

Intervention: Low intensity lifestyle modification program Duration: 4 years (48 months) Study settings: In Bangladesh, the investigators will conduct the intervention trial in 4 maternity care hospitals in Dhaka city.

Sample size: A total of 1440 women with GDM from 24 hospitals (~60/hospital) will require for the RCT from 3 different countries. In Bangladesh, 360 participants from 4 selected maternity care hospitals (90 participants from each hospital, 45 cases and 45 controls) will be required.

Inclusion Criteria: Absence of T2DM at 6±3months post-partum OGTT.

Anticipated outcomes: Primary outcomes:

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; and/or impaired fasting glucose/impaired glucose tolerance to type 2 Diabetes Mellitus (DM)

Secondary outcomes:

Mean changes in Body weight, Mean changes in waist circumference, Mean changes in systolic blood pressure, mean changes in fasting blood glucose, increase physical activity level from low to moderate and increase fruits and vegetable consumption, incremental cost effectiveness ratio and feasibility of intervention.


Condition Intervention
Gestational Diabetes Mellitus in Pregnancy Behavioral: Life style Intervention

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Before and after changes of glycaemic status among the participants by OGTT, HBa1c [ Time Frame: 3 years ]
    What proportion of the respondents have develop type 2 DM, Or Impaired fasting glucose(IFG) or Impaired glucose tolerance (IFG) from normal glycaemic state after having 3 years of intervention among case and control group.


Secondary Outcome Measures:
  • 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

  • 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.

  • 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.

  • 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.

  • Before and after changes in physical activity level as assessed by GPEQ(Global Physical Activity Questionnaire) [ Time Frame: 3 years ]
    Increased Physical activity level during the study period among the respondents.

  • Change in cost effectiveness as assessed by economic evaluation [ Time Frame: 3 years ]
    change in incremental cost effectiveness ratio during the study period

  • Fidelity of intervention outcome during the study period as assessed by process evaluation [ Time Frame: 3 years ]
    Change of intervention adherence among the respondents during the study period


Estimated Enrollment: 360
Actual Study Start Date: August 1, 2017
Estimated Study Completion Date: December 31, 2020
Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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:

Confirmed case of Type 2 Diabetes. Travel time to hospital more than 2 hours. Lack of access to a mobile telephone. Use of steroids during pregnancy prior to diagnosis of GDM. Refused consent.

  Contacts and Locations
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   
Maternal Child Health Training institute (MCHTI),Azimpur Recruiting
Dhaka, Bangladesh
Contact: Ishrat Jahan, Dr    01713009029 ext 1205    mchtidhaka@gmail.com   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Aliya Naheed, Dr International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03305939     History of Changes
Other Study ID Numbers: PR- 17012
First Submitted: June 21, 2017
First Posted: October 10, 2017
Last Update Posted: October 10, 2017
Last Verified: September 2017
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 International Centre for Diarrhoeal Disease Research, Bangladesh:
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