Healthy Living in Pregnancy

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.

Completed

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Key information

Conditions

Lifestyle Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms Weight Gain

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung, Bayreuth, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

The intervention program consists of four individual counseling modules focusing on diet, physical activity and weight monitoring (12th-16th, 16th-20th, 30th-34th week of gestation and 6th-8th week postpartum). The counseling sessions are given by carefully trained midwives or medical staff in combination with prenatal visits and follow a standardized curriculum. Women are provided with brochures including a list of adequate prenatal exercise programs and a pedometer. Furthermore, they receive a chart personalized according to their baseline BMI category to monitor weight development.

Primary outcomes

Gestational weight gain

Time frame: 4 years

Proportion of pregnant women showing excessive gestational weight gain according to Institute of Medicine (IOM) guidelines

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Acronym: GeliS

Important dates

Study start: 2013
Primary completion: 2021
Study completion: 2022
First posted: Oct 9, 2013
Registry last updated: Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed