Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Lifestyle intervention |
|
| No intervention | No Intervention | Standard prenatal care, short information leaflet about healthy lifestyle in pregnancy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational weight gain | Proportion of pregnant women showing excessive gestational weight gain according to Institute of Medicine (IOM) guidelines | 4 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hans Hauner, Prof. Dr. | Else Kröner-Fresenius-Zentrum für Ernährungsmedizin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung | Bayreuth | 95447 | Germany | |||
| AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23865624 | Background | 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. | |
| 37055730 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fürstenfeldbruck |
| 82256 |
| Germany |
| AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung | Fürth | 90763 | Germany |
| AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung | Regensburg | 93057 | Germany |
| AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung | Würzburg | 97074 | Germany |
| 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. |
| 35313852 | Derived | 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. |
| 32703266 | Derived | 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. |
| 31711430 | Derived | 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. |
| 30636636 | Derived | 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. |
| 24678761 | Derived | 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. |