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Intervention to Promote Changes of Healthy Lifestyle (Physical Activity and Nutrition) During Gestation

Intervention en Changement Des Habitudes de Vie Par l'Activité Physique et un Support Nutritionnel Durant la Grossesse en Estrie

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01782105
Enrollment
16
Registered
2013-02-01
Start date
2011-12-31
Completion date
2013-10-31
Last updated
2013-12-11

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

Conditions

Excessive Weight Gain During Pregnancy, Gestational Diabetes

Keywords

weight gain, healthy lifestyle, gestational diabetes, adipokins, glycemic regulation

Brief summary

The purpose of this study are: * Assess the impact of an intervention to the adoption of healthy lifestyles among pregnant women at high risk of gestational diabetes mellitus on: * weight gain in pregnancy * the levels of maternal and fetal adipokines and * glycemic control maternal and fetal. * Determine whether the adoption of healthy lifestyles in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.

Interventions

Nutritionnal and physical activity counseling and physical activity session group

BEHAVIORALControl group

Evaluation of nutritional and physcial activity habits

Sponsors

Diabetes Québec
CollaboratorOTHER
Fonds de la Recherche en Santé du Québec
CollaboratorOTHER_GOV
Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* be aged ≥ 18 years, * have a pre-pregnancy BMI ≥ 25 kg/m2, * be at risk of developing a gestational diabetes mellitus (a history of gestational diabetes mellitus or glucose 1 hour post-50g \> 7.1 mmol/L.

Exclusion criteria

* Pre-pregnancy diabetes detected in the first trimester (A1c \> 6.5%, fasting glucose \> 7.0 mmol/L, random blood glucose\> 11.1 mmol/L, glucose \> 10.3 mmol/L 1 hour post-50g) * twin pregnancy * taking medications that can affect blood sugar or weight, * practice ≥ 150 minutes of physical activity per week * against formal-indication for physical activity.

Design outcomes

Primary

MeasureTime frame
Weight change during pregnancyWeeks 12, 24, 36 of gestation

Secondary

MeasureTime frameDescription
Levels of maternal and fetal adipokinesWeeks 12, 24 of gestation and at delivery (in cord blood)
Maternal and fetal glycemic controlWeeks 12, 24 of gestation and at deliveryResults of glucose tolerance test (50g and 75g)
Determine whether the adoption of healthy lifestyle in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.Weeks 12, 24 of gestation and at delivery (cord blood)
Optimize the intervention before measuring its impact on the prevention of gestational diabetes mellitus on a larger scale.throughout the studyDocumentation will be collected about appreciation of the participants and attendance.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026