NCT01958307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

8.3 years

First QC Date

October 4, 2013

Last Update Submit

December 11, 2023

Conditions

LifestyleWeight GainPregnancy

Outcome Measures

Primary Outcomes (1)

  • Gestational weight gain

    Proportion of pregnant women showing excessive gestational weight gain according to Institute of Medicine (IOM) guidelines

    4 years

Study Arms (2)

Intervention

EXPERIMENTAL

Lifestyle intervention

Behavioral: Lifestyle intervention

No intervention

NO INTERVENTION

Standard prenatal care, short information leaflet about healthy lifestyle in pregnancy

Interventions

Lifestyle interventionBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung

Bayreuth, 95447, Germany

Location

AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung

Fürstenfeldbruck, 82256, Germany

Location

AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung

Fürth, 90763, Germany

Location

AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung

Regensburg, 93057, Germany

Location

AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung

Würzburg, 97074, Germany

Location

Related Publications (7)

  • 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.

    PMID: 23865624BACKGROUND

  • 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.

    PMID: 37055730DERIVED

  • 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.

    PMID: 35313852DERIVED

  • 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.

    PMID: 32703266DERIVED

  • 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.

    PMID: 31711430DERIVED

  • 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.

    PMID: 30636636DERIVED

  • 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.

    PMID: 24678761DERIVED

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hans Hauner, Prof. Dr.

    Else Kröner-Fresenius-Zentrum für Ernährungsmedizin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2013

First Posted

October 9, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

December 15, 2023

Record last verified: 2023-12

Locations

DE(5)