Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2286 participants
INTERVENTIONAL
2013-09-30
2022-12-31
Brief Summary
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The lifestyle intervention program is adapted to the German health care system to allow an immediate implementation after successful evaluation.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention
Lifestyle intervention
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
Standard prenatal care, short information leaflet about healthy lifestyle in pregnancy
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
43 Years
FEMALE
Yes
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Hans Hauner, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin
Locations
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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, , Germany
Countries
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References
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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.
Geyer K, Raab R, Hoffmann J, Hauner H. Development and validation of a screening questionnaire for early identification of pregnant women at risk for excessive gestational weight gain. BMC Pregnancy Childbirth. 2023 Apr 13;23(1):249. doi: 10.1186/s12884-023-05569-7.
Raab R, Hoffmann J, Spies M, Geyer K, Meyer D, Gunther J, Hauner H. Are pre- and early pregnancy lifestyle factors associated with the risk of preterm birth? A secondary cohort analysis of the cluster-randomised GeliS trial. BMC Pregnancy Childbirth. 2022 Mar 21;22(1):230. doi: 10.1186/s12884-022-04513-5.
Johar H, Hoffmann J, Gunther J, Atasoy S, Stecher L, Spies M, Hauner H, Ladwig KH. Evaluation of antenatal risk factors for postpartum depression: a secondary cohort analysis of the cluster-randomised GeliS trial. BMC Med. 2020 Jul 24;18(1):227. doi: 10.1186/s12916-020-01679-7.
Hoffmann J, Gunther J, Geyer K, Stecher L, Rauh K, Kunath J, Meyer D, Sitzberger C, Spies M, Rosenfeld E, Kick L, Oberhoffer R, Hauner H. Effects of a lifestyle intervention in routine care on prenatal physical activity - findings from the cluster-randomised GeliS trial. BMC Pregnancy Childbirth. 2019 Nov 11;19(1):414. doi: 10.1186/s12884-019-2553-7.
Kunath J, Gunther J, Rauh K, Hoffmann J, Stecher L, Rosenfeld E, Kick L, Ulm K, Hauner H. Effects of a lifestyle intervention during pregnancy to prevent excessive gestational weight gain in routine care - the cluster-randomised GeliS trial. BMC Med. 2019 Jan 14;17(1):5. doi: 10.1186/s12916-018-1235-z.
Rauh K, Kunath J, Rosenfeld E, Kick L, Ulm K, Hauner H. Healthy living in pregnancy: a cluster-randomized controlled trial to prevent excessive gestational weight gain - rationale and design of the GeliS study. BMC Pregnancy Childbirth. 2014 Mar 28;14:119. doi: 10.1186/1471-2393-14-119.
Other Identifiers
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GEL-1309--2500-S
Identifier Type: -
Identifier Source: org_study_id