Educational Intervention in the First 18 Months of Life to Prevent/Manage Obesity of Children After Gestational Diabetes
Effect of an Educational Intervention for the Prevention and Management of Overweight and Obesity During the First 18 Months of Life Children and Mothers With Gestational Diabetes in Insured of the Instituto Mexicano Del Seguro Social.
1 other identifier
interventional
645
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedStudy Start
First participant enrolled
August 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2025
CompletedSeptember 28, 2023
September 1, 2023
5 years
July 17, 2020
September 26, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Prevention of overweight/obesity in offspring, determined by z-score in the indicator for weight for age
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.
18 months
Prevention of overweight/obesity mothers, determined by loss in body mass index (BMI)
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.
18 months
Secondary Outcomes (6)
Changes in blood concentration of glucose: GDM
18 months
Changes in blood concentration of glucose: intervention
18 months
Changes in blood concentration of glycosylated hemoglobin: GDM
18 months
Changes in blood concentration of glycosylated hemoglobin: intervention
18 months
Changes in blood concentration of lipids: GDM
18 months
- +1 more secondary outcomes
Study Arms (3)
Gestational diabetes intervention
EXPERIMENTALAll mothers with gestational diabetes will receive 18 months of educational intervention post-partum. They and their offspring will be evaluated at months 1,2,3,6,9,12,15,and 18.
No diabetes intervention
EXPERIMENTALMothers without gestational diabetes will receive 18 months of educational intervention post-partum. They and their offspring will be evaluated at months 1,2,3,6,9,12,15,and 18.
No diabetes no intervention
ACTIVE COMPARATORMothers without gestational diabetes will receive the conventional care for 18 months post-partum. They and their offspring will be evaluated at months 1,2,3,6,9,12,15,and 18.
Interventions
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 includes some early stimulation, monthly visits for height/weight measurement of the offspring.
Eligibility Criteria
You may qualify if:
- years old
- insured by IMSS
- with or without gestational diabetes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Instituto Mexicano del Seguro Sociallead
- Fundacion Rio Arrontecollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (1)
Hospital Gineco-Obstetrico #4
Mexico City, 06720, Mexico
Related Publications (1)
Soto Briseno AI, Gomez-Diaz RA, Saldana Espinoza RC, Lavielle P, Valdez Gonzalez AL, Wacher NH. Validation of the COVID-19 Fear Scale modified for application during the perinatal period. J Psychosom Obstet Gynaecol. 2022 Dec;43(4):447-452. doi: 10.1080/0167482X.2022.2050210. Epub 2022 Mar 16.
PMID: 35294335DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cesar R Gonzalez Bonilla, PhD
Secretary of Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 17, 2020
First Posted
July 30, 2020
Study Start
August 25, 2020
Primary Completion
August 25, 2025
Study Completion
August 25, 2025
Last Updated
September 28, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share
Research will be shared upon written request.