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 : September 12, 2018
|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|
|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 :||July 31, 2020|
|Estimated Study Completion Date :||July 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
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.
- 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 ]
- 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 MGPAQ (Modified Global Physical Activity Questionnaire) [ Time Frame: 3 years ]Mean change in Physical activity level during the study period among the respondents.
- 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.
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
|Contact: Aliya Naheed, Dr||01709651476 ext firstname.lastname@example.org|
|Contact: Sabrina Ahmed, Dr||01674750046 ext email@example.com|
|Dhaka, Bangladesh, 1212|
|Contact: Aliya Naheed, Dr 01709651476 ext 2521 firstname.lastname@example.org|
|Contact: Sabrina Ahmed, Dr 01674750046 ext 2540 email@example.com|
|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|