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The PREDG study: testing whether an educational intervention can prevent excess weight gain during pregnancy

The PREDG study: a randomised controlled trial testing whether an educational intervention can prevent gestational weight gain in obese women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61793947
Enrollment
190
Registered
2018-12-10
Start date
2019-01-02
Completion date
Unknown
Last updated
2023-08-02

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

Conditions

Gestational weight gain in obese women Pregnancy and Childbirth Excessive weight gain in pregnancy

Interventions

The randomisation will be automatically generated by a informatic program that assigns an random number to consecutive patients. The intervention arm will have an educational session about an adequate

Sponsors

Fundación Investigación Biomédica Hospital Universitario La Paz (FIBHULP)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. BMI = 30 kg/m2 prior to becoming pregnant

Exclusion criteria

Exclusion criteria: 1. Treatment with an effect on body weight (fluoxetina, orlistat, metformina, GLP-1 agonists, pioglitazone) 2. Illness with organic deterioration (HIV disease, kidney or hepatic advanced insufficiency, cancer) 3. Invalidating mental disease 4. Participants of other study 5. Other criteria considered by the investigator

Design outcomes

Primary

MeasureTime frame
Gestational weight gain will be measured using weight (kg) in each monthly visit minus weight before pregnancy.

Secondary

MeasureTime frame
1. Pregnancy complications: 1.1. Gestational hypertension as arterial pressure >= 140 and/or 90 mmHg confirmed twice 1.2. Gestational diabetes as defined by NDDG criteria 1.3. Preterm birth as birth before 37 weeks of pregnancy 1.4. Cesarean section as rate of cesarean section 1.5. Macrosomia as neonatal birthweight >= 4 kg 1.6. Small as neonatal birthweight < 10th percentile for gestational age and sex 2. Postpartum weight retention as weight 6 months postpartum minus prepregnancy weight (kg).

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026