| CTRI Number |
CTRI/2024/07/071107 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of High-Intensity Breastfeeding and Exercise on Blood Sugar Levels in Postpartum Mothers with Gestational Diabetes |
|
Scientific Title of Study
|
Effect Of High Intensity Breastfeeding Practices With Structured Exercise On Blood Glucose For Postpartum Mothers With Gestational Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharulatha N |
| Designation |
Post Graduate Student |
| Affiliation |
SRM College Of Physiotherapy, SRM Institute of Science and Technology |
| Address |
Room No-PT33 Department Of Physiotherapy SRM College Of Physiotherapy SRM Medical College Hospital and Research Center SRM Nagar Potheri KATTANKULATHUR KANCHEEPURAM
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8681978861 |
| Fax |
|
| Email |
sn2168@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
M Anbupriya |
| Designation |
Associate Professor |
| Affiliation |
SRM College Of Physiotherapy SRM Institute of Science and Technology |
| Address |
Room No:PT33 5th floor SRM College Of Physiotherapy SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalpattu Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9841549219 |
| Fax |
|
| Email |
anbuprim@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
M Anbupriya |
| Designation |
Associate Professor |
| Affiliation |
SRM College Of Physiotherapy SRM Institute of Science and Technology |
| Address |
Room No:PT33 5th floor SRM College Of Physiotherapy SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalpattu Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9841549219 |
| Fax |
|
| Email |
anbuprim@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalpattu Kancheepuram Tamil Nadu India 603203 |
|
|
Primary Sponsor
|
| Name |
Sharulatha N |
| Address |
Room No:PT33 5th floor SRM College of Physiotherapy SRM Medical College Hospital and Research Centre SRM Nagar Potheri Kattankulathur Chengalpattu Kancheepuram Tamil Nadu India 603203 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Anbupriya MPT |
SRM medical college hospital and research center |
SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalpattu 603203 Kancheepuram
Kancheepuram
TAMIL NADU |
9841549219
anbuprim@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM medical college hospital and research center institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O244||Gestational diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High intensity breastfeeding
structured exercise program |
A set of structures exercise program will be taught for 8 weeks with regular follow up a session will be for 15 minutes |
| Intervention |
High intensity breastfeeding
|
patient education on structured exercise program using visual representation and high intensity breastfeeding |
| Comparator Agent |
non high intensity breastfeeding
|
patient education on structured exercise program using visual representation and breast feeding |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed case of gestational diabetes mellites in postpartum
Age– above 18
Early postpartum 6 to 12 weeks
High intensity breast feeding mother included on self-reported breastfeeding stages
Both high intensity breastfeeding and non high intensity breastfeeding are included. |
|
| ExclusionCriteria |
| Details |
chronic diseases like heart disease, respiratory disease
Pelvic disease and infection
Subjects with neuromuscular disease- myasthenia gravis, inherited neuropathies and myopathies chronic autoimmune diseases
Non breastfeeding mothers
Participant not willing to participate |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood glucose level glucose tolerance test |
pre test
post test after the duration of 4th week
post test after the duration of 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Edinburgh postnatal depression scale
|
pretest
post test after the duration of 8 weeks |
| Pittsburg Sleep Quality Index questionnaire |
pretest
posttest after the duration of 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/08/2024 |
| 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="0"
Months="4"
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
|
Individuals will be selected for the study based on the inclusion and exclusion criteria The study will be clearly explained in patient words and an informed consent will be obtained The sociodemographic details such as name, age, occupation, education status, menstrual history, comorbidities, medical history, BMI, etc. will be collected. The Gestational diabetes postpartum mothers are selected by doing a pre test of glucose tolerance test (GTT) to check the sugar level and noted. Then, high intensity breast feeding assessment was done by interviewing using breastfeeding stages and the first 3 stages are considered as high intensity breastfeeding mothers. The mothers are differentiated by high intensity breast feeding and non high intensity breastfeeding both mothers are included and then separated. A structured exercise program for GDM postpartum mother was done, then 2 Intervention group and 1 control group According to randomized control trail, participant 1 will be in first group, 2 will be in second group and 3 will be in third group This procedure will be continued for all the 90 participants. |