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Lifestyle interventions among Gestational Diabetes Mothers of central Kerala

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/073158
Enrollment
1000
Registered
2024-08-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z863- Personal history of endocrine, nutritional and metabolic diseases

Interventions

Intervention1: 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,

Sponsors

Indian Council of Medical research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 motherâ??s homes before delivery. We wanted to ensure these women would be connected to health services after migration and receive postpartum follow-up.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
glycemic statusTimepoint: 6 weeks ,1st year,2nd year pand 3rd year

Secondary

MeasureTime frame
Prediabetes state and impaired glycemic status Physical activity, healthy dietary patternTimepoint: 0 (baseline) at the time of GDM diagnosis, 45th day, 6 months, 9 months, 12th month, 18th month, 24th month, 30th month

Countries

India

Contacts

Public ContactUMA V SANKAR

Aster Medcity

umasanthosh23@gmail.com9496293865

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 9, 2026