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 10, 2017
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.
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)
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 or disease||Intervention/treatment|
|Gestational Diabetes Mellitus in Pregnancy||Behavioral: Life style Intervention|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305939
|Contact: Aliya Naheed, Dr||01709651476 ext email@example.com|
|Contact: Sabrina Ahmed, Dr||01674750046 ext firstname.lastname@example.org|
|Dhaka, Bangladesh, 1212|
|Contact: Aliya Naheed, Dr 01709651476 ext 2521 email@example.com|
|Contact: Sabrina Ahmed, Dr 01674750046 ext 2540 firstname.lastname@example.org|
|Maternal Child Health Training institute (MCHTI),Azimpur||Recruiting|
|Contact: Ishrat Jahan, Dr 01713009029 ext 1205 email@example.com|
|Principal Investigator:||Aliya Naheed, Dr||International Centre for Diarrhoeal Disease Research, Bangladesh|