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CTRI Number  CTRI/2025/07/091973 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the level of adherence between three 10 minutes short post meal walks and standard 30 minutes walk after two weeks of intervention 
Scientific Title of Study   Comparison of level of adherence between three 10 minutes post-meal walks to standard 30 minutes walk in Gestational Diabetes Mellitus - A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Y Jane Jasmine 
Designation  Senior Resident 
Affiliation  JIPMER 
Address  Department of Obstetrics and Gynaecology Women and Children hospital JIPMER Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9787423967  
Fax    
Email  jasmine7jane@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Haritha Sagili 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Obstetrics and Gynaecology Women and Children hospital JIPMER Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9489390630  
Fax    
Email  harithasagili@gmail.com  
 
Details of Contact Person
Public Query  
Name  Haritha Sagili 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Obstetrics and Gynaecology Women and Children hospital JIPMER Pondicherry


PONDICHERRY
605006
India 
Phone  9489390630  
Fax    
Email  harithasagili@gmail.com  
 
Source of Monetary or Material Support  
JIPMER, Puducherry  
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Y Jane Jasmine  Jawaharlal Institute of Postgraduate Medical Education and Research  2nd floor, Department of Obstetrics and Gynaecology, Women and Children Hospital Pondicherry
Pondicherry
PONDICHERRY 		 9787423967

jasmine7jane@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Interventional Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Post meal walk  Three short 10 minutes post meal walks: post breakfast, lunch and dinner within 60 minutes of finishing the meal for 2 weeks of duration from enrollment 
Comparator Agent  Standard walk  Continuous 30 minutes walk performed any time during the day for 2 weeks of duration from enrollment  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Age: 18 years
2. Singleton pregnancy
3. Period of gestation: 24 to 30 weeks
4. Diagnosed as GDM with 75gm OGTT using IADPSG criteria 2010
5. Owning a smart phone 
 
ExclusionCriteria 
Details  1. Pregestational Diabetes
2. Placenta previa
3. Hypertension in pregnancy
4. Cardiovascular/ Respiratory disorders
5. Preterm labour 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the level of adherence between three 10 minutes short post meal walks and standard 30 minute walk in women diagnosed with GDM  2 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1. To identify factors associated with level of adherence
2. To assess glycemic control before and after the intervention
 		 2 weeks of intervention 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Gestational diabetes mellitus (GDM) is defined as Diabetes diagnosed in the second or third trimester of pregnancy that was not clearly Overt diabetes prior to gestation. GDM is associated with adverse maternal and perinatal outcomes and is the fastest growing Diabetes subtype in many parts of the world, reported to affect approximately 17% of the pregnancies. The preliminary management of GDM is Medical Nutrition Therapy with Exercise.  
American College of Obstetrics and Gynecology (ACOG) recommends moderate intensity aerobic exercise namely walking at least 30 minutes per day for 5 days a week or 150 minutes per week to optimize blood sugar levels.
The goal of our study is to compare the level of adherence of women with GDM to  three 10 minutes short post-meal walks with standard 30 minutes continuous walk. The women will be advised to carry a smart phone preloaded with Google fit pedometer app for measuring step count, time and no of days a week walked. After two weeks glycaemic control and the following parameters will be assessed and recorded from the smartphone.  
If the level of adherence to three short 10 minutes postprandial walks is better than the standard 30 minutes continuous walk then it can be advocated to GDM women in future to improve adherence. Further research can be aimed at whether this alternative prescription can impact physical activity over longer duration and improve the health outcomes of mother and baby. 
 
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