Healthy Living in Pregnancy (GeliS)

Technical University of Munich

Status

Completed

Conditions

Lifestyle

Weight Gain

Pregnancy

Treatments

Behavioral: Lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01958307

GEL-1309--2500-S

Details and patient eligibility

About

Multicenter and multidisciplinary public health project in 10 regions of Bavaria, a federal state of Germany, targeting maternal and fetal health. The objective of this trial is to evaluate the efficacy of a lifestyle intervention program focusing on diet, physical activity and weight monitoring during pregnancy. The intervention comprises 4 individual counseling sessions addressing healthy living. Primary outcome: gestational weight gain. Secondary outcomes are pregnancy and obstetric complications like gestational diabetes and rate of caesarean sections as well as offspring health.

The lifestyle intervention program is adapted to the German health care system to allow an immediate implementation after successful evaluation.

Enrollment

2,286 patients

Sex

Female

Ages

18 to 43 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Gestational age ≤ 12th week of gestation
Age: 18 years to 43 years
Prepregnancy BMI ≥ 18.5 kg/m2 and ≤ 40.0 kg/m2
Sufficient German language skills
Written informed consent

Exclusion criteria

Multiple pregnancy
Any condition preventing physical activity such as placenta praevia, persistent bleeding, cervical incompetence
Prepregnancy diabetes or early diagnosed gestational diabetes
Uncontrolled chronic diseases (e.g. thyroid dysfunction)
Psychiatric or psychosomatic diseases
Any condition that may interfere with the study protocol