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Clinical Trials in Mexico / NCT04493177
Active, not recruiting Not applicable

Educational Intervention in the First 18 Months of Life to Prevent/Manage Obesity of Children After Gestational Diabetes

NCT04493177 · tracked via the Priya Life Science Mexico tracker
Sponsor
Instituto Mexicano del Seguro Social
Phase
Not applicable
Started
2020-08-25
Last updated
2026-10-02

Condition(s) studied

Gestational DiabetesOverweight and Obesity

Investigational drug(s) / intervention(s)

Educational interventionConventional treatment Guia de Practica Clinica IMSS-029-08

Educational intervention: Monthly 45-minute sessions will be held, including dietary, and physical activity modification, early stimulation, exclusive breastfeeding for 6 months and the proper introduction of foods, and other support for the mother. The sessions will be supported by personalized contact by WhatsApp and programmed telephone calls, in addition to conventional treatment.

Conventional treatment Guia de Practica Clinica IMSS-029-08: Conventional treatment includes some early stimulation, monthly visits for height/weight measurement of the offspring.

Study summary

In order to evaluate the effect of an educational intervention on mothers with gestational diabetes and their offspring in the first 18 months of life, The intervention will be applied to mothers with gestational diabetes, and a group of mothers without diabetes, against a control group with the normal post-partum treatment. Effects on overweight and obesity will be evaluated in both mothers and offspring.

Eligibility

Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 18-40 years old * insured by IMSS * with or without gestational diabetes Exclusion Criteria: * History of type 1 or 2 diabetes, MODY or secondary diabetes * CKD, hepatic or cardiac disease, pregnancy hypertension, corioamniotis orpremature membrane rupture, pulmonary maturity 24 hours before birth, severe complications

Primary outcome measure(s)

  • Prevention of overweight/obesity in offspring, determined by z-score in the indicator for weight for age — 18 months
    Offspring will be expected to have a difference of at least 0,3 standard deviations in z-score of the indicator for weight for age, as measured by weight on a standard weight scale over the course of the study, and compared with WHO growth charts.
  • Prevention of overweight/obesity mothers, determined by loss in body mass index (BMI) — 18 months
    Mothers will be expected to have a loss of at least 1.8kg/m2 of body mass index (BMI, weight/height squared), as measured by weight, as measured by a standard weight scale, divided by height in meters squared over the course of the study.

Trial sites (1)

FacilityCityRegionStatus
Hospital Gineco-Obstetrico #4 Mexico City Mexico

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04493177 on ClinicalTrials.gov ↗ ← All trials in Mexico