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

Efecto Del Ejercicio De Fuerza-resistencia En La Disminución De La Diabetes Gestacional En Gestantes Con Sobrepeso U Obesidad

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05840497
Enrollment
200
Registered
2023-05-03
Start date
2023-03-01
Completion date
2025-09-30
Last updated
2024-11-22

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

Conditions

Diabetes, Gestational

Keywords

Exercise, Weight gain, Pregnant, Obese, Overweight

Brief summary

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.

Detailed 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.

Interventions

OTHERResistance exercise

The intervention group will train 3 times per week (30 minutes with 15 min warm-up). The resistance exercise is described as the voluntary contraction of the skeletal muscle of a particular muscle group against some type of resistance, using light weights, elastic bands or the weight of the body itself. Patients will be offered online sessions, they will receive a document with recommendations and a link to the videos with instructions. .

Sponsors

Fundacion Miguel Servet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Gestational diabetes24-28 gestational weeksGestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance with onset or first recognition during pregnancy: * O'Sullivan Test: if this is pathological; * SOG with 100 gr of glucose (GDM is diagnosed when 2 or more altered values: basal glycemia \>105 mg / dl, at 1 hour \>190 mg / dl, at 2h glycemia \>165 mg / dl, at 3h glycemia \>145 gr/dl).

Secondary

MeasureTime frameDescription
Weight gain and excessive body weight gainFrom baseline visit to the third trimester visitDetermined by IOM (Institute of Medicine) guideline
Maternal and fetal pregnancy outcomesAt birthNewborn weight, preterm deliveries, Apgar score and pH of umbilical cord, duration of labour and delivery mode

Countries

Spain

Contacts

Primary ContactTeresa Santa Cruz Sarasqueta
te.santa.cruz@navarra.es689203204

Outcome results

None listed

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