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Healthy Living in Pregnancy (GeLiS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01958307
Recruitment Status : Unknown
Verified September 2017 by Technische Universität München.
Recruitment status was:  Active, not recruiting
First Posted : October 9, 2013
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief 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.


Condition or disease Intervention/treatment Phase
Lifestyle Weight Gain Pregnancy Behavioral: Lifestyle intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Healthy Living in Pregnancy
Study Start Date : September 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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



Primary Outcome Measures :
  1. Gestational weight gain [ Time Frame: 4 years ]
    Proportion of pregnant women showing excessive gestational weight gain according to Institute of Medicine (IOM) guidelines



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958307


Locations
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Germany
AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
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
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Hans Hauner, Prof. Else Kröner-Fresenius-Zentrum für Ernährungsmedizin

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01958307    
Other Study ID Numbers: GEL-1309--2500-S
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms