| CTRI Number |
CTRI/2022/04/042013 [Registered on: 21/04/2022] Trial Registered Prospectively |
| Last Modified On: |
12/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Predominant Millet based Diet on the Blood Sugar control compared to the Standard Diet among women with High Blood Sugars during Pregnancy in a Tertiary Care Hospital, Puducherry |
|
Scientific Title of Study
|
Effectiveness of Predominant Millet based Medical Nutrition Therapy on the Glycemic Control compared to the Standard Medical Nutrition Therapy among women with Gestational Diabetes Mellitus in a Tertiary Care Setting, Puducherry - An Explanatory Mixed Method Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahadevan D |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Preventive and Social Medicine (PSM)
3rd floor, JIPMER International School of Public Health (JISPH),
Dhanvantri Nagar, JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9500728836 |
| Fax |
|
| Email |
mahadevandoffjip46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VenkatachalamJ |
| Designation |
Additional Professor |
| Affiliation |
JIPMER |
| Address |
Department of Preventive and Social Medicine (PSM)
3rd floor JIPMER International School of Public Health (JISPH) Dhanvantri Nagar JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9244489850 |
| Fax |
|
| Email |
drvenkatpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahadevan D |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Preventive and Social Medicine (PSM)
3rd floor, JIPMER International School of Public Health (JISPH),
Dhanvantri Nagar, JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9500728836 |
| Fax |
|
| Email |
mahadevandoffjip46@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intra Mural research Funding (IMRF) JIPMER |
|
|
Primary Sponsor
|
| Name |
IMRF JIPMER |
| Address |
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mahadevan D |
JIPMER Tertiary Care Hospital OG OPD |
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006
Pondicherry
PONDICHERRY |
9500728836
mahadevandoffjip46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human studies) for Intervention studies JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O244||Gestational diabetes mellitus, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Predominant Millet based Medical Nutrition Therapy with physical activity |
• Diet and Physical Activity - • The recommended dietary calorie intake for the pregnant women will be measured based on pre-pregnancy BMI and activity level. Individualized counselling on the diet plan based on Low Glycemic Index foods (Wheat, millets) and Physical activity for maintaining blood glucose level during GDM will be advised to both pregnant women and their caretaker. A diet plan to be followed will be provided by the investigator.
• Take home ration of locally available millets, 30 packets of 200 gm pre-weighed locally available millet [Finger Millet flour (Ragi), Pearl Millet flour (Kambu), Kodo Millet (Varagu), Little Millet (Varagu)], to be taken at a fixed time daily for 30 days (1 month).
• Predominant millet recipes booklet and Diet diary will be given to the pregnant women involving their family member
• They will followed-up after 2 weeks and 1 month by the investigator |
| Comparator Agent |
Standard Medical Nutrition Therapy with physical activity |
• Diet and Physical activity – Mothers diagnosed with GDM in OG OPD in JIPMER by Clinician using OGTT following the IADPSG criteria, are advised MNT with Physical activity recommended for 30 minutes daily and referred to the dietitian who counsel them a diet plan according to their energy requirement.
• They will followed-up after 2 weeks and 1 month by the investigator.
|
| Intervention |
Strategies to ensure Adherence (Common to both groups) |
• WhatsApp reminder – Mothers from both groups will be will be reminded about maintaining diet diary and to follow the daily meal plan.
• Health education Booklets
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All mothers diagnosed with GDM between 24 – 28 weeks, attending OG OPD in JIPMER, Puducherry |
|
| ExclusionCriteria |
| Details |
1. History of previous recurrent miscarriages, stillbirth
2. Pregnancy following assisted reproductive technique and Twin gestation
3. Pre-existing medical conditions (Chronic hypertension, Chronic liver disease, chronic kidney disease)
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Glycemic goal
• Adherence to low GI diet
• Adherence to predominantly millet diet
• Physical Activity duration (minutes per week)
|
Base line, at 2 weeks and at 1 month (end line) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
In-depth Interview
i) Facilitator and Barriers to the adherence to predominant millet diet or Low GI diet
|
After delivery, at their convenient time during routine follow up |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="224"
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)
|
27/04/2022 |
| 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="2"
Months="6"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: "Effectiveness of Predominant Millet based Medical Nutrition Therapy on the Glycemic Control compared to the Standard Medical Nutrition Therapy among women with Gestational Diabetes Mellitus in a Tertiary Care Setting, Puducherry – An Explanatory Mixed Method Study"
Expected outcome and Applications: · We can assess the effectiveness of predominant millet-based medical nutrition therapy on the glycemic control in the management of GDM. · If found effective, more emphasis can be given on predominant millet diet in MNT, since its traditional, available and affordable and it can be included in the Public Distribution System (PDS) and Anganwadi centers. · Family support can be stressed in the GDM management. · This ultimately improves the maternal and neonatal outcome in the pregnancy and further incorporating the healthy lifestyle after the pregnancy, reduces the morbidity among GDM mothers and their offspring later in life. · It also helps in incorporating healthy diet practices among other household members. - It paves way for future studies in GDM involving millets
Primary Objective: To study the effectiveness of Predominant Millet based MNT compared to standard MNT among the mothers diagnosed with GDM between 24 – 28 weeks attending antenatal clinic at JIPMER, Puducherry - on achieving glycemic goal at 2 weeks and at 1 month of follow-up Hypothesis: What is the effect of predominant millet based medical nutrition therapy on the glycemic control among pregnant women with gestational diabetes mellitus? |