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NCT01958307 Clinical Trial

Healthy Living in Pregnancy

Pregnancy Clinical Trial

— GeliS  

Official title:
Healthy Living in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01958307
Other study ID # GEL-1309--2500-S
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date December 2022

Study information
Verified date December 2023
Source Technical University of Munich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 2286
Est. completion date December 2022
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 43 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Lifestyle intervention
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.

Locations
Country Name City State
Germany AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung Bayreuth
Germany AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung Fürstenfeldbruck
Germany AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung Fürth
Germany AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung Regensburg
Germany AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung Würzburg

Sponsors (1)
Lead Sponsor Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Rauh K, Gabriel E, Kerschbaum E, Schuster T, von Kries R, Amann-Gassner U, Hauner H. Safety and efficacy of a lifestyle intervention for pregnant women to prevent excessive maternal weight gain: a cluster-randomized controlled trial. BMC Pregnancy Childbirth. 2013 Jul 16;13:151. doi: 10.1186/1471-2393-13-151. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Gestational weight gain Proportion of pregnant women showing excessive gestational weight gain according to Institute of Medicine (IOM) guidelines 4 years
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