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

Université de Sherbrooke

Status: Completed

Conditions: Gestational Diabetes; Excessive Weight Gain During Pregnancy

Treatments: Behavioral: Control group; Behavioral: Healthy lifestyle counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01782105

I-CHANGE

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Control group

Active Comparator group

Description:

In addition to the usual monitoring of pregnancy, this group will receive information about the recommended weight gain during pregnancy and an evaluation about of their nutritional and physical activity habits.

Treatment:

Behavioral: Control group

Intervention group

Experimental group

Description:

This group will receive a regular monitoring by health professionals (nutritionist and kinesiologist) who will ensure nutritional changes and physical activity necessary to secure the adoption of a healthy lifestyle and could participate to a physical activity group session once a week until week 36 of gestation. The intervention include: A nutritional counseling every 2 weeks by a nutritionist until week 36 of gestation; a physical activity group session once a week lead by a kinesiologist until week 36 of gestation; 2 sessions of physical activity counseling (weeks 12 and 24).

Treatment:

Behavioral: Healthy lifestyle counseling