Skip to content

Remote physical exercise for women with gestational diabetes

Effects of remote Home-based Physical Training on Birth Weight in Neonates of women with Gestational Diabetes: clinical effectiveness trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7rm8p8f
Enrollment
Unknown
Registered
2025-09-05
Start date
2023-09-18
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Diabetes, Gestational

Interventions

This is a two-arm, single-blind, randomized controlled trial. Randomization will be generated in blocks of 4 participants on the Randomly website, and the researcher in charge will not take part in th
G11.427.410.698.277

Sponsors

Maternidade Escola Januário Cicco - Universidade Federal do Rio Grande do Norte
Lead Sponsor
Empresa Brasileira de Serviços Hospitalares
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 45; women; diagnosis of gestational diabetes mellitus (GDM) according to World Health Organization (WHO) criteria; 1st trimester ultrasound performed (11th to 13th weeks); gestational age between 14 and 26 weeks; maximum of 3 visits to High Risk Prenatal Care; medical clearance to exercise; access to smartphone; interest in participating in any of the interventions

Exclusion criteria

Exclusion criteria: Insulin therapy (at recruitment); chronic arterial hypertension (at recruitment); pre-eclampsia; multiple pregnancies; history of intrauterine fetal death and/or multiple miscarriages (> 2); alcoholism (> 2 doses of alcohol per week); smoking; orthopedic limitations; neurological, language, hearing and/or visual limitations that may hinder participation in the study

Design outcomes

Primary

MeasureTime frame
Evaluate in the newborn the classification of birth weight as large-for-gestational-age (above the 90th percentile), determined by means of verified weight, gestational age at delivery and sex

Secondary

MeasureTime frame
We expect to see a reduction in the percentage of glycated hemoglobin in the blood measured by laboratory tests carried out one week before and after the intervention;We expect to see lower blood glucose levels in the members of the exercise group, as measured by laboratory tests carried out one week before and after the intervention;We expected to see lower values of excessive weight gain in the members of the exercise group, measured one week before and after the intervention;Evaluate movement behavior (physical activity and sedentary behavior), determined using an accelerometer at the beginning and end of the intervention;It is expected that there will be a lower rate of preterm birth among the children of members of the exercise group; Evaluate the cesarean delivery rate;Assess the incidence of neonatal hypoglycemia, determined by a glucose value < 40 mg/dL (2.2 mmol per liter) measured up to 4 hours after birth and before feeding;To assess the incidence of admission to the neonatal intensive care unit for any indication;To assess the weight of the infant 1 month after birth, according to the participant's self-report, taking into account the type of feeding of the child

Countries

Brazil

Contacts

Public ContactSavio Camargo

Maternidade Escola Januário Cicco - Universidade Federal do Rio Grande do Norte

saviocamargo@gmail.com+55(84)991387588

Outcome results

None listed

Source: REBEC (via WHO ICTRP)