| CTRI Number |
CTRI/2024/08/073158 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Lifestyle interventions among Gestational Diabetes Mothers of central Kerala |
|
Scientific Title of Study
|
Effectiveness of a community-based peer lead P-MED intervention in Gestational Diabetes Mellitus (GDM) mothers of Southern state of India: A cluster randomized controlled pragmatic trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UMA V SANKAR |
| Designation |
Research Administrator |
| Affiliation |
Aster Medcity |
| Address |
Second floor, Annexure building,Aster Center For Clinical Research, Aster Medcity,
Cheranallor
P O, South Chittoor,
Kerala
Ernakulam
KERALA
682027
India |
| Phone |
9496293865 |
| Fax |
9496293865 |
| Email |
umasanthosh23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
UMA V SANKAR |
| Designation |
Research Administrator |
| Affiliation |
Aster Medcity |
| Address |
Aster Medcity,
Cheranallor
P O, South Chittoor,
Kerala
Ernakulam
KERALA
682027
India |
| Phone |
9496293865 |
| Fax |
9496293865 |
| Email |
umasanthosh23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
UMA V SANKAR |
| Designation |
Research Administrator |
| Affiliation |
Aster Medcity |
| Address |
Aster Medcity,
Cheranallor
P O, South Chittoor,
Kerala
Ernakulam
KERALA
682027
India |
| Phone |
9496293865 |
| Fax |
9496293865 |
| Email |
umasanthosh23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research(Extramural research grant),Department of Health Research, Ministry of Health and Family Welfare, Government of India,Ansari Nagar, New Delhi-110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical research |
| Address |
Indian Council of Medical Research, Newdelhi |
| Type of Sponsor |
Government funding agency |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr UMA V SANKAR |
Aster Medcity |
Second floor, Annexure building, Aster Centre for Clinical Research, Aster Medcity, Cheranallor, P O south Chittoor, Ernakulam, Kerala
Ernakulam
KERALA |
9496293865
umasanthosh23@gmail.com |
| Dr Uma V Sankar |
Primary Health Centres of Rural Ernakulam |
X7CJ+H6R, District Medical Office of Health, Park Avenue Road, Marine drive, Ernakulam,682011
Ernakulam
KERALA |
9496293865
umasanthosh23@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| institutional ethics committee,Aster Medcity,Kochi |
Approved |
| Institutional ethics committee,Aster Medcity,Kochi |
Approved |
| NOC from District medical officer, Ernakulam |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z863||Personal history of endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Community-based peer lead healthy lifestyle based
(P-MED) intervention |
Intervention Arm:
The intervention will involve a peer leader, peer educator, and peer mentor. The peer leader, chosen from the GDM (Gestational Diabetes Mellitus) mother’s family, will be supported by the peer educator who gives tailored advice, and the peer mentor, a middle-level service provider at the subcentre.
1. Sensitization Phase:
Objective: Assess the GDM mother’s capabilities, opportunities, and motivations after GDM diagnosis. Identify a suitable peer leader.
Activities: Conduct an initial session with the peer leader to educate the GDM mother on future diabetes risk and modification strategies. The ASHA worker will facilitate the intervention, and the MLSP will deliver it.
Focus Areas: a. Healthy dietary options b. Breastfeeding techniques c. Stress-relieving measures
Duration: 3 months, from diagnosis to delivery.
2. Activation Phase:
Objective: Record antenatal, family diabetes, and intranatal history at the 45th day post-birth. Introduce intervention sessions to the peer leader and GDM mother.
Activities: The GDM mother and peer leader will create and implement a diet plan. The peer educator (ASHA worker) and peer mentor (MLSP) will offer individualized advice based on COM-B model modules during visits to the subcentre or home. Address any doubts and barriers to adopting a healthy lifestyle.
Duration: 45 days post-birth to 1 year.
3. Intense Phase:
Objective: Reinforce behavior changes and adherence to P-MED strategies.
Activities: Conduct two home visits to encourage adherence. Provide refresher training for the peer leader and online refresher classes for both the peer leader and peer mentor.
Duration: 1 year to 2 years post-birth.
4. Plateau Phase:
Objective: Sustain behavior changes and integrate healthy practices into daily life.
Activities: Monthly recognition of the best performer at the subcentre. Maintain ongoing interaction with the peer team and participants to support and sustain healthy lifestyle practices.
Duration: 2 years to 2.5 years post-birth.
|
| Comparator Agent |
Control arm (Standard of Care Arm) |
The control arm will receive standard care through the Integrated Child Development Services (ICDS) and the existing Reproductive Child Health (RCH) Program. This care is provided by ICDS supervisors, Junior Public Health Nurses (JPHNs), and ASHA workers. JPHNs are responsible for antenatal and postnatal care through the RCH program in Kerala, which includes 4 antenatal visits and 3 postnatal visits per mother. GDM-specific components are not included in this standard care. Clinical consultations and basic investigations are provided either free of charge at the sub-centre or at a convenient healthcare setting. In addition to the standard care, GDM mothers will receive a booklet on healthy lifestyle practices when mothers visit the Anganwadi to receive Amritham powder as part of their antenatal and postnatal care. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Participants will be ≥18 years old (adults), between 28 and 36 weeks gestation, and ready to participate in the follow-up of 48 months postnatally.
The last trimester of pregnancy was chosen to recruit participants as the contextual study revealed women migrated to their mother’s homes before delivery.
We wanted to ensure these women would be connected to health services after migration and receive postpartum follow-up. |
|
| ExclusionCriteria |
| Details |
We will exclude the pregnant women if they have pre-existing diabetes mellitus, multiple pregnancies, use of medication that influences glucose metabolism (e.g., steroids, β-adrenergic agonists, and antipsychotic drugs), physical disability, or severe psychiatric disorders. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| glycemic status |
6 weeks ,1st year,2nd year pand 3rd year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prediabetes state and impaired glycemic status
Physical activity, healthy dietary pattern |
0 (baseline) at the time of GDM diagnosis, 45th day, 6 months,
9 months, 12th month, 18th month, 24th month, 30th month |
|
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Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "1725"
Final Enrollment numbers achieved (India)="1725" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
29/02/2028 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1)Why are women with gestational diabetes in Kerala at higher risk for T2DM? A
qualitative study on sociocultural factors- Women and children nursing -https://doi.org/10.1016/j.wcn.2026.02.003
2)Exploring Healthy Lifestyle Interventions among women with Gestational Diabetes Mellitus (GDM) in the Indian Subcontinent - Journal of Diabetes and Endocrine Clinics |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
- I) Rationale: Postpartum conversion of GDM to diabetes rate was 70% within ten years in India. Current GDM management aims to reduce the incidence of short-term adverse maternal and neonatal outcomes and not delay long-term adverse health consequences. Increased maternal weight gain and unhealthy lifestyle practices accelerate the GDM conversion to diabetes quickly. Lifestyle interventions among GDM women yielded a reduction of 24% in the incidence of T2D. No interventional studies to prevent or delay the incidence of T2D have been reported in the GDM population of southern states of India.
ii) Novelty: Peer (from the family) based healthy lifestyle intervention rooted in psychosocial well-being, regular blood glucose monitoring, personalized nutrition plans, and physical activity schedule based on mobile technology among the GDM mothers and volunteered by ASHA workers is a unique approach in India. iii) Objectives: Effectiveness of community-based peer-led P-MED intervention among the GDM mothers of rural areas in southern India. iv) Method: Community-based cluster randomized controlled pragmatic trial. a) Intervention arm b) control arm. The main components of the intervention arm are psychosocial well-being, medication, regular blood glucose monitoring, Exercise, and healthy dietary options (P-MED). Development of intervention based on the COM-B (Capability, Opportunity, and Motivation -Behaviour) change model. We plan to enroll 20 PHCs (clusters) in each arm and 50 participants per PHC and in total 1000 GDM mothers/ arm. v) Expected outcome: The primary outcome is to reduce the incidence of postpartum conversion of GDM into diabetes and pre-diabetes among GDM mothers. vi) Intervention Status: Intervention tools, including the P-MED website (www.diabetesfreemothers.com) were developed. Intervention materials such as the GDM mother diary, ASHA modules and control booklet were prepared. Face-to-face intervention was successfully delivered to 375 GDM mothers.
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