Healthy Living in Pregnancy (GeliS)

December 11, 2023 updated by: Technical University of Munich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2286

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bayreuth, Germany, 95447
        • AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
      • Fürstenfeldbruck, Germany, 82256
        • AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
      • Fürth, Germany, 90763
        • AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
      • Regensburg, Germany, 93057
        • AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
      • Würzburg, Germany, 97074
        • AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Lifestyle 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.
No Intervention: No intervention
Standard prenatal care, short information leaflet about healthy lifestyle in pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational weight gain
Time Frame: 4 years
Proportion of pregnant women showing excessive gestational weight gain according to Institute of Medicine (IOM) guidelines
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Hans Hauner, Prof. Dr., Else Kröner-Fresenius-Zentrum für Ernährungsmedizin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

October 4, 2013

First Submitted That Met QC Criteria

October 4, 2013

First Posted (Estimated)

October 9, 2013

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEL-1309--2500-S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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