<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04493177</url>
  </required_header>
  <id_info>
    <org_study_id>R2018-785-079</org_study_id>
    <nct_id>NCT04493177</nct_id>
  </id_info>
  <brief_title>Educational Intervention in the First 18 Months of Life to Prevent/Manage Obesity of Children After Gestational Diabetes</brief_title>
  <official_title>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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Mexicano del Seguro Social</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundacion Rio Arronte</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Mexicano del Seguro Social</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In order to evaluate the effect of an educational intervention on mothers with gestational&#xD;
      diabetes and their offspring in the first 18 months of life, The intervention will be applied&#xD;
      to mothers with gestational diabetes, and a group of mothers without diabetes, against a&#xD;
      control group with the normal post-partum treatment. Effects on overweight and obesity will&#xD;
      be evaluated in both mothers and offspring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Effect of an education intervention for the prevention and management of overweight and&#xD;
      obesity during the first 18 months of life of offspring and mother with gestational diabetes&#xD;
      among insured of the Instituto Mexicano del Seguro Social.&#xD;
&#xD;
      ABSTRACT BACKGROUND: According to ENSANUT 2012, 9.7% of children &lt;5 years already are&#xD;
      overweight or obese. Recently, an increase was reported in the frequency of overweight and&#xD;
      obesity worldwide, beginning at earlier ages, especially in Mexico. The predisposition to&#xD;
      chronic diseases in adults may be programmed in the womb (&quot;fetal programming&quot;). Also, women&#xD;
      that suffer diabetes during pregnancy have a very high risk (6.4 times more) of developing&#xD;
      diabetes in a middle range. The challenge for health personnel dedicated to the care of&#xD;
      mother-child pairs is to achieve glycemic control from conception and to identify all the&#xD;
      maternal-fetal secondary complications. To carry out compliance with adherence to medical&#xD;
      management and/or healthy eating habits would allow us to reduce future overweight, obesity&#xD;
      and the incidence of type 2 diabetes in mother-child pairs. Approaching the mother-child pair&#xD;
      is a great opportunity to study the intervention, which would allow us not only have a new,&#xD;
      useful awareness in the evaluation of educational strategies, but also to apply good&#xD;
      practices of healthy habits for the prevention of obesity and to avoid progression to&#xD;
      diabetes. For the aforementioned reasons, the objective is: to implement and evaluate the&#xD;
      effect of an education intervention for the prevention and management of overweight and&#xD;
      obesity during the first 18 months of life of child and in mothers with and without&#xD;
      gestational diabetes in insured members of the Instituto Mexicano del Seguro Social.&#xD;
&#xD;
      MATERIAL AND METHODS. Pregnant women will be invited to participate, who receive their&#xD;
      prenatal and/or birth care in the Unidad Médica de Alta Especialidad (UMAE) Gineco-Obstretric&#xD;
      Hospital No. 4 (HGO #4) and UMAE HGO #3 of Centro Médico &quot;La Raza&quot; of IMSS. After acceptance&#xD;
      and signing an informed consent to participate in the study, 645 mother-child pairs will be&#xD;
      included, with and without gestational diabetes mellitus (GDM), which will be diagnosed&#xD;
      according to the criteria of the American Diabetes Association; all mothers with be between&#xD;
      18 and 40 years old. There will be 3 groups of binomials: 1) with GDM, 2) without GDM who&#xD;
      will received the education intervention, and 3) without GDM who will receive the&#xD;
      conventional care IMSS offers to mothers and nursing infants, during the first 18 months&#xD;
      post-partum.&#xD;
&#xD;
      At the time of canalization before delivery or cesarean, a blood sample (15 mL) will be taken&#xD;
      from the mother for measurement of glucose, glucosylated hemoglobin (A1c) and lipid profile.&#xD;
      After birth, blood (15 mL) will be extracted directly from the umbilical cord for measurement&#xD;
      of the child's glucose and lipid profile. Once the pediatric doctor has carried out&#xD;
      reanimation of the newborn, previously-standardized health staff will take anthropometric&#xD;
      measurements. During the 18 months of follow-up from birth, the mother-child pair will be&#xD;
      given appointments at 0, 1, 2, 3, 6, 9, 12, 15 and 18 months, in which health care personnel&#xD;
      involved in the study (nutritionist, social worker, pediatrician and family doctor) will&#xD;
      perform activities to promote health and prevent disease, directed towards the mother-child&#xD;
      pair and planned within the education intervention strategy based on the First 1000 Days&#xD;
      program, or the conventional care that mothers and nursing infants receive in IMSS, according&#xD;
      to the study group. Weekly, the mothers will be sent, by digital media and social networks,&#xD;
      educational material to promote healthy diet and physical activity; for the child material&#xD;
      will include the promotion of exclusive breastfeeding until 6 months, at which time promotion&#xD;
      will be of adequate complementary foods, in addition to early stimulation activities;&#xD;
      educational material will be handed out: posters and brochures will serve to reinforce and&#xD;
      remind of the information given during appointments. Also, characteristics of the diet&#xD;
      consumed by mother and child will be recorded monthly, along with the physical activity&#xD;
      performed by the mother.&#xD;
&#xD;
      The education intervention has as objective the acquiring of knowledge, motivation, creation&#xD;
      of an awareness of disease, adoption of healthy diet and physical activity; its components&#xD;
      will be individual sessions, group sessions, electronic messages, etc.&#xD;
&#xD;
      SAMPLE SIZE: The sample size necessary, with a 95% confidence interval and a power of 80%, is&#xD;
      645 mother-child pairs, among which 215 mother-child pairs will be included with mothers who&#xD;
      presented gestational diabetes and will receive the education intervention, and 430 pairs&#xD;
      without gestational diabetes (215 pairs with the education intervention and 215 with&#xD;
      conventional care).&#xD;
&#xD;
      STATISTICAL ANALYSIS: Anthropometric and biochemical data will be described using mean and&#xD;
      standard deviation for continuous variables, or percentages for nominal or ordinal variables.&#xD;
      The difference between variables of offspring of mothers with and without GDM, as well as the&#xD;
      difference between groups with and without education intervention, will be analyzed with&#xD;
      Mann-Whitney U test, Student t test, or chi square, as appropriate. Multivariate analysis&#xD;
      will be performed, using lineal regression in models of repeated measures, to evaluate the&#xD;
      association between 1) child weight-for-age (in Z score), and 2) mother's BMI, and the&#xD;
      education intervention or having presented GDM or no, according to the independent variable,&#xD;
      or the exposure that is being analyzed (effect of GDM or effect of the intervention),&#xD;
      controlling for possible confounding variables. Values of p&lt;0.05 will be considered&#xD;
      statistically significant.&#xD;
&#xD;
      EXPECTED RESULTS: The education intervention was standardized in Boston, Mass, and will be&#xD;
      implemented with the adaptation necessary for our population, in order to evaluate if it is&#xD;
      better than the conventional treatment, for transference to the Family Medicine Units and&#xD;
      second-level hospitals that have Gineco-obstetric services in the IMSS.&#xD;
&#xD;
      Included will be surveys on the opinion of doctors and participants to measure the&#xD;
      acceptability of the intervention.&#xD;
&#xD;
      Expected results are: differences associated with the intervention in: a) body mass index and&#xD;
      weight-for-age, respectively, in the mother-child pair; b) speed of growth and growth&#xD;
      percentile score; as well as c) implementation of an education strategy that can be used as&#xD;
      part of the care the mother-child pair receives.&#xD;
&#xD;
      DELIVERABLE PRODUCTS: Situational analysis of the mother-child pair, from the clinical point&#xD;
      of view, laboratory studies, databases, plan for implementation of this strategy in IMSS. In&#xD;
      addition, there will be databases that can be used for other analyses. DNA banks are&#xD;
      contemplated, from serum and plasma, for scientific questions derived from this study.&#xD;
&#xD;
      SOCIAL IMPACT: This study will offer a model that can be implemented in all hospitals of IMSS&#xD;
      that attend to births and/or cesareans. This will contribute to the timely prevention of&#xD;
      obesity in insured families of IMSS, with an eye towards making it extend both at the&#xD;
      national level for IMSS and for other health institutions. It is hoped that the education&#xD;
      strategy will be a tool that allows a reduction in the frequency of overweight, obesity, and&#xD;
      diabetes mellitus in our country.&#xD;
&#xD;
      DURATION OF THE STUDY: 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Anticipated">August 25, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 25, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevention of overweight/obesity in offspring, determined by z-score in the indicator for weight for age</measure>
    <time_frame>18 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevention of overweight/obesity mothers, determined by loss in body mass index (BMI)</measure>
    <time_frame>18 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in blood concentration of glucose: GDM</measure>
    <time_frame>18 months</time_frame>
    <description>Compare blood measurements of glucose of the mother over the 18 months of mothers with vs without gestational diabetes (GDM).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood concentration of glucose: intervention</measure>
    <time_frame>18 months</time_frame>
    <description>Compare blood measurements of glucose of the mother over the 18 months of mothers with vs without educational intervention.&#xD;
.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood concentration of glycosylated hemoglobin: GDM</measure>
    <time_frame>18 months</time_frame>
    <description>Compare blood measurements of glycosylated hemoglobin (HbA1c) of the mother over the 18 months of mothers with vs without gestational diabetes.&#xD;
.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood concentration of glycosylated hemoglobin: intervention</measure>
    <time_frame>18 months</time_frame>
    <description>Compare blood measurements of glycosylated hemoglobin (HbA1c) of the mother over the 18 months of mothers with vs without educational intervention.&#xD;
.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood concentration of lipids: GDM</measure>
    <time_frame>18 months</time_frame>
    <description>Compare blood measurements of lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) of the mother over the 18 months of mothers with vs without gestational diabetes.&#xD;
.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood concentration of lipids: intervention</measure>
    <time_frame>18 months</time_frame>
    <description>Compare blood measurements of lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) of the mother over the 18 months of mothers with vs without educational intervention.&#xD;
.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">645</enrollment>
  <condition>Gestational Diabetes</condition>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Gestational diabetes intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No diabetes intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mothers 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No diabetes no intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mothers 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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>Gestational diabetes intervention</arm_group_label>
    <arm_group_label>No diabetes intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional treatment Guia de Practica Clinica IMSS-029-08</intervention_name>
    <description>Conventional treatment includes some early stimulation, monthly visits for height/weight measurement of the offspring.</description>
    <arm_group_label>Gestational diabetes intervention</arm_group_label>
    <arm_group_label>No diabetes intervention</arm_group_label>
    <arm_group_label>No diabetes no intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-40 years old&#xD;
&#xD;
          -  insured by IMSS&#xD;
&#xD;
          -  with or without gestational diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of type 1 or 2 diabetes, MODY or secondary diabetes&#xD;
&#xD;
          -  CKD, hepatic or cardiac disease, pregnancy hypertension, corioamniotis orpremature&#xD;
             membrane rupture, pulmonary maturity 24 hours before birth, severe complications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cesar R Gonzalez Bonilla, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Secretary of Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Gineco-Obstetrico #4</name>
      <address>
        <city>Mexico City</city>
        <zip>06720</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>June 14, 2021</last_update_submitted>
  <last_update_submitted_qc>June 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Mexicano del Seguro Social</investigator_affiliation>
    <investigator_full_name>Rita A. Gomez Diaz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Research will be shared upon written request.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493177
org study id: R2018-785-079
nct id: NCT04493177
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Effect of an education intervention for the prevention and management of overweight and
      obesity during the first 18 months of life of offspring and mother with gestational diabetes
      among insured of the Instituto Mexicano del Seguro Social.

      ABSTRACT BACKGROUND: According to ENSANUT 2012, 9.7% of children <5 years already are
      overweight or obese. Recently, an increase was reported in the frequency of overweight and
      obesity worldwide, beginning at earlier ages, especially in Mexico. The predisposition to
      chronic diseases in adults may be programmed in the womb ("fetal programming"). Also, women
      that suffer diabetes during pregnancy have a very high risk (6.4 times more) of developing
      diabetes in a middle range. The challenge for health personnel dedicated to the care of
      mother-child pairs is to achieve glycemic control from conception and to identify all the
      maternal-fetal secondary complications. To carry out compliance with adherence to medical
      management and/or healthy eating habits would allow us to reduce future overweight, obesity
      and the incidence of type 2 diabetes in mother-child pairs. Approaching the mother-child pair
      is a great opportunity to study the intervention, which would allow us not only have a new,
      useful awareness in the evaluation of educational strategies, but also to apply good
      practices of healthy habits for the prevention of obesity and to avoid progression to
      diabetes. For the aforementioned reasons, the objective is: to implement and evaluate the
      effect of an education intervention for the prevention and management of overweight and
      obesity during the first 18 months of life of child and in mothers with and without
      gestational diabetes in insured members of the Instituto Mexicano del Seguro Social.

      MATERIAL AND METHODS. Pregnant women will be invited to participate, who receive their
      prenatal and/or birth care in the Unidad Médica de Alta Especialidad (UMAE) Gineco-Obstretric
      Hospital No. 4 (HGO #4) and UMAE HGO #3 of Centro Médico "La Raza" of IMSS. After acceptance
      and signing an informed consent to participate in the study, 645 mother-child pairs will be
      included, with and without gestational diabetes mellitus (GDM), which will be diagnosed
      according to the criteria of the American Diabetes Association; all mothers with be between
      18 and 40 years old. There will be 3 groups of binomials: 1) with GDM, 2) without GDM who
      will received the education intervention, and 3) without GDM who will receive the
      conventional care IMSS offers to mothers and nursing infants, during the first 18 months
      post-partum.

      At the time of canalization before delivery or cesarean, a blood sample (15 mL) will be taken
      from the mother for measurement of glucose, glucosylated hemoglobin (A1c) and lipid profile.
      After birth, blood (15 mL) will be extracted directly from the umbilical cord for measurement
      of the child's glucose and lipid profile. Once the pediatric doctor has carried out
      reanimation of the newborn, previously-standardized health staff will take anthropometric
      measurements. During the 18 months of follow-up from birth, the mother-child pair will be
      given appointments at 0, 1, 2, 3, 6, 9, 12, 15 and 18 months, in which health care personnel
      involved in the study (nutritionist, social worker, pediatrician and family doctor) will
      perform activities to promote health and prevent disease, directed towards the mother-child
      pair and planned within the education intervention strategy based on the First 1000 Days
      program, or the conventional care that mothers and nursing infants receive in IMSS, according
      to the study group. Weekly, the mothers will be sent, by digital media and social networks,
      educational material to promote healthy diet and physical activity; for the child material
      will include the promotion of exclusive breastfeeding until 6 months, at which time promotion
      will be of adequate complementary foods, in addition to early stimulation activities;
      educational material will be handed out: posters and brochures will serve to reinforce and
      remind of the information given during appointments. Also, characteristics of the diet
      consumed by mother and child will be recorded monthly, along with the physical activity
      performed by the mother.

      The education intervention has as objective the acquiring of knowledge, motivation, creation
      of an awareness of disease, adoption of healthy diet and physical activity; its components
      will be individual sessions, group sessions, electronic messages, etc.

      SAMPLE SIZE: The sample size necessary, with a 95% confidence interval and a power of 80%, is
      645 mother-child pairs, among which 215 mother-child pairs will be included with mothers who
      presented gestational diabetes and will receive the education intervention, and 430 pairs
      without gestational diabetes (215 pairs with the education intervention and 215 with
      conventional care).

      STATISTICAL ANALYSIS: Anthropometric and biochemical data will be described using mean and
      standard deviation for continuous variables, or percentages for nominal or ordinal variables.
      The difference between variables of offspring of mothers with and without GDM, as well as the
      difference between groups with and without education intervention, will be analyzed with
      Mann-Whitney U test, Student t test, or chi square, as appropriate. Multivariate analysis
      will be performed, using lineal regression in models of repeated measures, to evaluate the
      association between 1) child weight-for-age (in Z score), and 2) mother's BMI, and the
      education intervention or having presented GDM or no, according to the independent variable,
      or the exposure that is being analyzed (effect of GDM or effect of the intervention),
      controlling for possible confounding variables. Values of p<0.05 will be considered
      statistically significant.

      EXPECTED RESULTS: The education intervention was standardized in Boston, Mass, and will be
      implemented with the adaptation necessary for our population, in order to evaluate if it is
      better than the conventional treatment, for transference to the Family Medicine Units and
      second-level hospitals that have Gineco-obstetric services in the IMSS.

      Included will be surveys on the opinion of doctors and participants to measure the
      acceptability of the intervention.

      Expected results are: differences associated with the intervention in: a) body mass index and
      weight-for-age, respectively, in the mother-child pair; b) speed of growth and growth
      percentile score; as well as c) implementation of an education strategy that can be used as
      part of the care the mother-child pair receives.

      DELIVERABLE PRODUCTS: Situational analysis of the mother-child pair, from the clinical point
      of view, laboratory studies, databases, plan for implementation of this strategy in IMSS. In
      addition, there will be databases that can be used for other analyses. DNA banks are
      contemplated, from serum and plasma, for scientific questions derived from this study.

      SOCIAL IMPACT: This study will offer a model that can be implemented in all hospitals of IMSS
      that attend to births and/or cesareans. This will contribute to the timely prevention of
      obesity in insured families of IMSS, with an eye towards making it extend both at the
      national level for IMSS and for other health institutions. It is hoped that the education
      strategy will be a tool that allows a reduction in the frequency of overweight, obesity, and
      diabetes mellitus in our country.

      DURATION OF THE STUDY: 2 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Care Provider)
measure: Prevention of overweight/obesity in offspring, determined by z-score in the indicator for weight for age
time frame: 18 months
description: 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.
measure: Prevention of overweight/obesity mothers, determined by loss in body mass index (BMI)
time frame: 18 months
description: 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.
measure: Changes in blood concentration of glucose: GDM
time frame: 18 months
description: Compare blood measurements of glucose of the mother over the 18 months of mothers with vs without gestational diabetes (GDM).
measure: Changes in blood concentration of glucose: intervention
time frame: 18 months
description: Compare blood measurements of glucose of the mother over the 18 months of mothers with vs without educational intervention.
.
measure: Changes in blood concentration of glycosylated hemoglobin: GDM
time frame: 18 months
description: Compare blood measurements of glycosylated hemoglobin (HbA1c) of the mother over the 18 months of mothers with vs without gestational diabetes.
.
measure: Changes in blood concentration of glycosylated hemoglobin: intervention
time frame: 18 months
description: Compare blood measurements of glycosylated hemoglobin (HbA1c) of the mother over the 18 months of mothers with vs without educational intervention.
.
measure: Changes in blood concentration of lipids: GDM
time frame: 18 months
description: Compare blood measurements of lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) of the mother over the 18 months of mothers with vs without gestational diabetes.
.
measure: Changes in blood concentration of lipids: intervention
time frame: 18 months
description: Compare blood measurements of lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) of the mother over the 18 months of mothers with vs without educational intervention.
.
arm group label: Gestational diabetes intervention
arm group type: Experimental
description: All 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.
arm group label: No diabetes intervention
arm group type: Experimental
description: Mothers 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.
arm group label: No diabetes no intervention
arm group type: Active Comparator
description: Mothers 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.
intervention type: Behavioral
intervention name: Educational intervention
description: 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.
arm group label: Gestational diabetes intervention
arm group label: No diabetes intervention
intervention type: Other
intervention name: Conventional treatment Guia de Practica Clinica IMSS-029-08
description: Conventional treatment includes some early stimulation, monthly visits for height/weight measurement of the offspring.
arm group label: Gestational diabetes intervention
arm group label: No diabetes intervention
arm group label: No diabetes no intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cesar R Gonzalez Bonilla, PhD
role: Study Chair
affiliation: Secretary of Health
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Mexicano del Seguro Social
investigator full name: Rita A. Gomez Diaz
investigator title: Principal Investigator
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
mesh term: Obesity
mesh term: Overweight
sharing ipd: No
ipd description: Research will be shared upon written request.