Clinical trial NCT01958307: Healthy Living in Pregnancy
Official title: Healthy Living in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lifestyle
Weight Gain
Pregnancy
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 2286
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Gestational weight gain
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bayreuth
country: Germany
facility: AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
city: Fürstenfeldbruck
country: Germany
facility: AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
city: Fürth
country: Germany
facility: AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
city: Regensburg
country: Germany
facility: AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
city: Würzburg
country: Germany
facility: AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
Study officials:
affiliation: Else Kröner-Fresenius-Zentrum für Ernährungsmedizin
name: Hans Hauner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.