Effect of Strength-resistance Exercise in the Reduction of Gestational Diabetes in Pregnant Women with Overweight or Obesity

Fundacion Miguel Servet

Status: Enrolling

Conditions: Diabetes, Gestational

Treatments: Other: Resistance exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05840497

PI_2022/126

Details and patient eligibility

About

The aim of this trial is to test the efficacy of regular resistance exercise in early pregnancy to prevent gestational diabetes mellitus in overweight/ obese pregnant women.

Full description

The growing rate of obesity is a major public health problem in the West, where 28% of pregnant women are overweight and 11% are obese. Worldwide, 50% of pregnant women are obese or overweight.

One of the problems directly related to obesity is gestational diabetes. In fact, its prevalence is increasing as the prevalence of obesity increases, as well as other complications of pregnancy. The prevalence of gestational diabetes in our environment is 6-12%.

Compared with pregnant women with BMI <25 kg/m2, pregnancies among women with obesity are at increased risk of several adverse outcomes, including early pregnancy loss, congenital anomalies, stillbirth, pregnancy-associated hypertension, preterm birth and postterm, gestational diabetes mellitus, multiple gestation, cesarean delivery, and birth of a macrosome.

The consequences of obesity in pregnant women can be decreased through physical activity. This hypothesis is due to several mechanisms: reduction of blood pressure, improvement of the lipid profile, reduction of oxidative stress and the proinflammatory state.

In recent years, scientific societies have published new recommendations on physical exercise in pregnant women with clear guidelines. Even this, less than 15% of patients do the recommended exercise. Usually the recommended exercise is aerobic and in the group of obese and overweight patients this type of exercise requires more effort and time, with the consequent worse adherence.

In non-pregnant patients, exercise has been shown to be related to a decrease in cardiovascular risk and DM2. However, in pregnant patients, a meta-review of systematic reviews has shown that although lifestyle interventions decrease weight gain, they do not have a clear benefit in terms of maternal-fetal outcomes.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI≥25 kg/m2
• Singleton pregnancies

Exclusion criteria

• Chronic hypertension
• Pre-pregnancy DM (type I or 2 diabetes mellitus)
• Cardiovascular disease
• History of preterm delivery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Resistance exercise

Experimental group

Treatment:

Other: Resistance exercise

Control Group

No Intervention group

Description:

Standard control and usual recommendations.