LifestyleGeliSNCT01958307
Healthy Living in Pregnancy
A study testing Lifestyle intervention in people with Lifestyle and Weight Gain, run by Technical University of Munich at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lifestyle, Weight Gain, Pregnancy
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,286 participants
- Where
- 5 sitesGermany
- Study dates
- Sep 2013to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
Bayreuth, 95447
AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
Fürstenfeldbruck, 82256
AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
Fürth, 90763
AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
Regensburg, 93057
AELF, Fachzentrum L 3.10 Ernährung/Gemeinschaftsverpflegung
Würzburg, 97074
About this study
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.
- Conditions
- Lifestyle, Weight Gain, Pregnancy
- Being tested
- Lifestyle intervention
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lifestyle intervention Receives: Behavioral: Lifestyle intervention |
| No intervention | No intervention | Standard prenatal care, short information leaflet about healthy lifestyle in pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
Proportion of pregnant women showing excessive gestational weight gain according to Institute of Medicine (IOM) guidelines
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2021
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for LifestyleStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Hauner, Prof. Dr., Principal investigator, Else Kröner-Fresenius-Zentrum für Ernährungsmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958307
- Sponsor's protocol ID
- GEL-1309--2500-S
- Acronym
- GeliS
- Status last verified
- Dec 2023
- First submitted
- 4 Oct 2013
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23865624Geyer 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.
PubMed 37055730Raab 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.
PubMed 35313852Johar 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.
PubMed 32703266Hoffmann 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.
PubMed 31711430Kunath 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.
PubMed 30636636Rauh 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.
PubMed 24678761
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Living in Pregnancy
- ClinicalTrials.gov ID
- NCT01958307
- Acronym / sponsor ID
- GeliS / GEL-1309--2500-S
- Conditions
- Lifestyle, Weight Gain, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,286 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Lifestyle interventionLifestyle intervention |
| No intervention | No intervention | –Standard prenatal care, short information leaflet about healthy lifestyle in pregnancy |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionThe 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. | Behavioural | Intervention |
Primary outcome
Gestational weight gain
Time frame: 4 years
Proportion of pregnant women showing excessive gestational weight gain according to Institute of Medicine (IOM) guidelines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Background: PubMed 23865624Rauh 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.
- Derived from this study: PubMed 37055730Geyer 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.
- Derived from this study: PubMed 35313852Raab 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.
- Derived from this study: PubMed 32703266Johar 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.
- Derived from this study: PubMed 31711430Hoffmann 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.
- Derived from this study: PubMed 30636636Kunath 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.
- Derived from this study: PubMed 24678761Rauh 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.
Related trials for Lifestyle
Not yet recruitingPhase 2
Fuling Yunhua Granules and Dihuang Baoyuan Granules in Adults With Type 2 Diabetes and Poor Glycemic Control Despite Lifestyle Intervention
Diabetes Mellitus, Type 2
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
Not yet recruiting
Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial
Lifestyle Adherence
Recruiting
Effects of Baduanjin Exercise on Improving Health in Sedentary Young and Middle-Aged Adults
Sedentary Lifestyle, Behavioral Intervention
Active, not recruiting
Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Hauner, Prof. Dr. principal investigator
Else Kröner-Fresenius-Zentrum für Ernährungsmedizin
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Lifestyle and Weight Gain, run by Technical University of Munich at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational weight gain (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01958307, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.