Gestational Diabetes MellitusMySweetHeartNCT02890693
Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring
A study testing interdisciplinary lifestyle and psychosocial intervention in people with Gestational Diabetes Mellitus, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
MySweetHeart Trial is a randomized controlled trial to test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardio-metabolic and mental health of women with GDM and their offspring. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- interdisciplinary lifestyle and psychosocial intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2016to 25 Oct 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women and their partners aged 18 yrs or older, with GDM at 24-32 weeks of gestation, and understanding French or English.
Who cannot join
- Women on strict bed-rest, with pre-existing diabetes or known severe mental disorder.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Lausanne
Lausanne, Canton of Vaud, 1011
About this study
Official title: Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus (GDM) and Their Offspring: MySweetHeart Trial
MySweetHeart Trial is a randomized controlled trial to test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardio-metabolic and mental health of women with GDM and their offspring.
Primary objective of MySweetHeart Trial:
Read more
To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention in women with GDM to improve 1) their metabolic health (decrease in maternal weight between study inclusion after GDM diagnosis and at 1 yr postpartum) and 2) their mental health (decrease in maternal symptoms of depression during the same time period).
Secondary objective of MySweetHeart Trial:
To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve other cardio-metabolic and mental health markers in women with GDM and their offspring.
MySweetHeart trial is linked to MySweetHeart Cohort, an observational cohort study that assesses the effect of GDM on offspring cardiovascular health early in life. The principal investigators of the cohort are Nicole Sekarski and Arnaud Chiolero (University Hospital Lausanne, Switzerland). Their primary objective is to assess the effect of GDM on the surrogate markers of cardiovascular disease (CVD) at birth (left ventricular mass index and subclinical atherosclerosis) and the secondary objective is to assess the effect of GDM on the cardiovascular structure and function during the fetal period and neonatal adverse cardiovascular risk factors.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- interdisciplinary lifestyle and psychosocial intervention
- Keywords
- gestational diabetes mellitus, randomized controlled trial, lifestyle intervention, cardiovascular, metabolic, mental health, depression, physical activity, dietary intervention
- Medical subject headings
- Diabetes, Gestational, Psychological Well-Being, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interdisciplinary lifestyle and psychosocial interventionBehavioural
Also called lifestyle intervention, physical activity, dietary intervention, psychosocial intervention
The multidimensional interdisciplinary lifestyle and psychosocial intervention will be offered on top of usual care. It will consist of individual sessions (face-to-face or telephone contact) with different members of the interdisciplinary team (dietician, physiotherapist, clinical psychologist or coach) and two group sessions. It will take place during pregnancy and during the first year postpartum.
| Study group | Role | What they receive |
|---|---|---|
| interdisciplinary lifestyle/psychosocial | Experimental | The multidimensional interdisciplinary lifestyle and psychosocial intervention will be offered on top of usual care. It will consist of individual sessions (face-to-face or telephone contact) with different members of the interdisciplinary team (dietician, physiotherapist, clinical psychologist or coach) and two group sessions. Receives: Behavioral: interdisciplinary lifestyle and psychosocial intervention |
| treatment as usual | No intervention | Usual clinical follow-up and treatment is based on the current American Diabetes Association, the Endocrine Society guidelines, and the NICE guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal weight measured on calibrated scale
decrease in maternal weight between study inclusion after GDM diagnosis and 1 year postpartum
Measured: study inclusion after GDM diagnosis and 1 year postpartum
Self-reported symptoms of depression (mother) measured by Edinburgh Postnatal Depression Scale
decrease in maternal symptoms of depression between study inclusion after GDM diagnosis and 1 year postpartum
Measured: study inclusion after GDM diagnosis and 1 year postpartum
Secondary outcomes (25)
Body composition (mother and infant) measured by bioelectrical impedance analysis
Measured: study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant)
Skinfolds (mother and infant) measured by calipers
Measured: study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant)
Total and regional fat mass measured by Dual-Energy X-Ray absorptiometry (mother)
Measured: 1 year postpartum
Self-reported food intake (mother) measured by Food Frequency Questionnaire
Measured: study inclusion after GDM diagnosis, 1 year postpartum
Self-reported eating behavior (mother) measured by French Intuitive Eating Scale
Measured: study inclusion after GDM diagnosis, 1 year postpartum
Self-reported breastfeeding (mother) measured by questionnaire
Measured: 6-8- weeks postpartum, 1 year postpartum
Self-reported feeding to soothe (mother) measured by Food to Soothe Questionnaire
Measured: 1 year postpartum
Self-reported recognition of hunger/satiety cues (mother) measured by Infant Feeding Style Questionnaire
Measured: 1 year postpartum
Physical activity (mother) measured by Accelerometer
Measured: study inclusion after GDM diagnosis, 1 year postpartum
Aerobic fitness (mother) measured by Chester Step Test
Measured: study inclusion after GDM diagnosis, 1 year postpartum
Grip strength (mother) measured by Jamar dynamometer
Measured: study inclusion after GDM diagnosis, 1 year postpartum
Self-reported anxiety (mother) measured by Hospital Anxiety and Depression Scale
Measured: study inclusion after GDM diagnosis, 1 year postpartum
Self-reported well-being (mother) measured by WHO Well-being Index
Measured: study inclusion after GDM diagnosis, 33-38 weeks GA, 6-8 weeks postpartum,1 year postpartum
Self-reported social support (mother) measured by Medical Outcomes Study Social Support Survey-short form
Measured: study inclusion after GDM diagnosis, 1 year postpartum
Weight (infant) measured on calibrated scale
Measured: 6-8 weeks postpartum, 1 year postpartum
Laboratory variables (mother): Lipid levels
Measured: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Cardiometabolic laboratory variables (mother), HDL cholesterol, LDL cholesterol, total cholesterol, triglycerides, HbA1C, insulin, glucose, indices of insulin resistance and insulin secretion, gamma-GT, B12 vitamin, ferritine, and miRNA
Fasting laboratory at inclusion and in addition 75 g oral glucose tolerance test at 6-8 weeks postpartum and 1 year postpartum
Measured: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Cord blood sample at the time of delivery for lipid levels
Measured: At delivery
Cord blood sample at the time of delivery for glucose control
Measured: At delivery
Cord blood sample at the time of delivery for insulin indices
Measured: At delivery
Cord blood sample at the time of delivery for Ferritin and Vitamin B12
Measured: At delivery
Cord blood sample at the time of delivery for miRNA
Measured: At delivery
Laboratory variables (mother): insulin, glucose, indices of insulin resistance and insulin secretion,
Fasting laboratory at inclusion and in addition 75 g oral glucose tolerance test at 6-8 weeks postpartum and 1 year postpartum
Measured: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Laboratory (mother): gamma-GT, B12 vitamin, ferritine
Measured: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Laboratory (mother): miRNA
Measured: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jardena Puder, University of Lausanne Hospitals
- Investigators
- Jardena Puder, MD, Principal investigator, University of Lausanne HospitalsAntje Horsch, DClinPsych, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890693
- Sponsor's protocol ID
- 2016-00745
- Other IDs
- 2016
- Acronym
- MySweetHeart
- Status last verified
- Oct 2022
- First submitted
- 5 Aug 2016
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Montandon L, Quansah DY, Lacroix A, Gonzalez-Rodriguez E, Horsch A, Arhab A, Puder JJ. Maternal Physical Activity, Fitness, and Body Composition in Women with Gestational Diabetes: A Prospective Study. Med Sci Sports Exerc. 2025 Aug 1;57(8):1646-1656. doi: 10.1249/MSS.0000000000003716. Epub 2025 Apr 4.
PubMed 40197687Quansah DY, Gilbert L, Arhab A, Gonzalez-Rodriguez E, Hans D, Gross J, Lanzi S, Stuijfzand B, Lacroix A, Horsch A, Puder JJ. Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial. BMJ Med. 2024 Feb 7;3(1):e000588. doi: 10.1136/bmjmed-2023-000588. eCollection 2024.
PubMed 38348309Gilbert L, Quansah DY, Arhab A, Schenk S, Gross J, Lanzi S, Stuijfzand B, Lacroix A, Horsch A, Puder JJ; MySweetheart Research group. Effect of the MySweetheart randomized controlled trial on birth, anthropometric and psychobehavioral outcomes in offspring of women with GDM. Front Endocrinol (Lausanne). 2023 Jun 7;14:1148426. doi: 10.3389/fendo.2023.1148426. eCollection 2023.
PubMed 37351105Horsch A, Gilbert L, Lanzi S, Gross J, Kayser B, Vial Y, Simeoni U, Hans D, Berney A, Scholz U, Barakat R, Puder JJ; MySweetHeart Research Group. Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for MySweetHeart Trial, a randomised controlled trial. BMJ Open. 2018 Feb 27;8(2):e020462. doi: 10.1136/bmjopen-2017-020462.
PubMed 29487077Di Bernardo S, Mivelaz Y, Epure AM, Vial Y, Simeoni U, Bovet P, Estoppey Younes S, Chiolero A, Sekarski N; MySweetHeart Research Group. Assessing the consequences of gestational diabetes mellitus on offspring's cardiovascular health: MySweetHeart Cohort study protocol, Switzerland. BMJ Open. 2017 Nov 14;7(11):e016972. doi: 10.1136/bmjopen-2017-016972.
PubMed 29138200
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus (GDM) and Their Offspring: MySweetHeart Trial
- ClinicalTrials.gov ID
- NCT02890693
- Acronym / sponsor ID
- MySweetHeart / 2016-00745
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- gestational diabetes mellitus, randomized controlled trial, lifestyle intervention, cardiovascular, metabolic, mental health, depression, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 7 Sep 2016 (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.
MySweetHeart Trial is a randomized controlled trial to test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardio-metabolic and mental health of women with GDM and their offspring.
Primary objective of MySweetHeart Trial:
To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention in women with GDM to improve 1) their metabolic health (decrease in maternal weight between study inclusion after GDM diagnosis and at 1 yr postpartum) and 2) their mental health (decrease in maternal symptoms of depression during the same time period).
Secondary objective of MySweetHeart Trial:
To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve other cardio-metabolic and mental health markers in women with GDM and their offspring.
MySweetHeart trial is linked to MySweetHeart Cohort, an observational cohort study that assesses the effect of GDM on offspring cardiovascular health early in life. The principal investigators of the cohort are Nicole Sekarski and Arnaud Chiolero (University Hospital Lausanne, Switzerland). Their primary objective is to assess the effect of GDM on the surrogate markers of cardiovascular disease (CVD) at birth (left ventricular mass index and subclinical atherosclerosis) and the secondary objective is to assess the effect of GDM on the cardiovascular structure and function during the fetal period and neonatal adverse cardiovascular risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interdisciplinary lifestyle/psychosocial | Experimental | Behavioral: interdisciplinary lifestyle and psychosocial interventionThe multidimensional interdisciplinary lifestyle and psychosocial intervention will be offered on top of usual care. It will consist of individual sessions (face-to-face or telephone contact) with different members of the interdisciplinary team (dietician, physiotherapist, clinical psychologist or coach) and two group sessions. |
| treatment as usual | No intervention | –Usual clinical follow-up and treatment is based on the current American Diabetes Association, the Endocrine Society guidelines, and the NICE guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women and their partners aged 18 yrs or older, with GDM at 24-32 weeks of gestation, and understanding French or English.
Key exclusion criteria (1 listed)
- Women on strict bed-rest, with pre-existing diabetes or known severe mental disorder.
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 |
|---|---|---|
| interdisciplinary lifestyle and psychosocial interventionAlso: lifestyle intervention, physical activity, dietary intervention, psychosocial interventionThe multidimensional interdisciplinary lifestyle and psychosocial intervention will be offered on top of usual care. It will consist of individual sessions (face-to-face or telephone contact) with different members of the interdisciplinary team (dietician, physiotherapist, clinical psychologist or coach) and two group sessions. It will take place during pregnancy and during the first year postpartum. | Behavioural | interdisciplinary lifestyle/psychosocial |
Primary outcome
maternal weight measured on calibrated scale
Time frame: study inclusion after GDM diagnosis and 1 year postpartum
decrease in maternal weight between study inclusion after GDM diagnosis and 1 year postpartum
Self-reported symptoms of depression (mother) measured by Edinburgh Postnatal Depression Scale
Time frame: study inclusion after GDM diagnosis and 1 year postpartum
decrease in maternal symptoms of depression between study inclusion after GDM diagnosis and 1 year postpartum
25 secondary outcomes
Body composition (mother and infant) measured by bioelectrical impedance analysis
Time frame: study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant)
Skinfolds (mother and infant) measured by calipers
Time frame: study inclusion after GDM diagnosis (mother), 6-8 weeks postpartum (mother), 1 year postpartum (infant)
Total and regional fat mass measured by Dual-Energy X-Ray absorptiometry (mother)
Time frame: 1 year postpartum
Self-reported food intake (mother) measured by Food Frequency Questionnaire
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Self-reported eating behavior (mother) measured by French Intuitive Eating Scale
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Self-reported breastfeeding (mother) measured by questionnaire
Time frame: 6-8- weeks postpartum, 1 year postpartum
Self-reported feeding to soothe (mother) measured by Food to Soothe Questionnaire
Time frame: 1 year postpartum
Self-reported recognition of hunger/satiety cues (mother) measured by Infant Feeding Style Questionnaire
Time frame: 1 year postpartum
Physical activity (mother) measured by Accelerometer
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Aerobic fitness (mother) measured by Chester Step Test
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Grip strength (mother) measured by Jamar dynamometer
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Self-reported anxiety (mother) measured by Hospital Anxiety and Depression Scale
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Self-reported well-being (mother) measured by WHO Well-being Index
Time frame: study inclusion after GDM diagnosis, 33-38 weeks GA, 6-8 weeks postpartum,1 year postpartum
Self-reported social support (mother) measured by Medical Outcomes Study Social Support Survey-short form
Time frame: study inclusion after GDM diagnosis, 1 year postpartum
Weight (infant) measured on calibrated scale
Time frame: 6-8 weeks postpartum, 1 year postpartum
Laboratory variables (mother): Lipid levels
Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Cardiometabolic laboratory variables (mother), HDL cholesterol, LDL cholesterol, total cholesterol, triglycerides, HbA1C, insulin, glucose, indices of insulin resistance and insulin secretion, gamma-GT, B12 vitamin, ferritine, and miRNA
Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Cord blood sample at the time of delivery for lipid levels
Time frame: At delivery
Cord blood sample at the time of delivery for glucose control
Time frame: At delivery
Cord blood sample at the time of delivery for insulin indices
Time frame: At delivery
Cord blood sample at the time of delivery for Ferritin and Vitamin B12
Time frame: At delivery
Cord blood sample at the time of delivery for miRNA
Time frame: At delivery
Laboratory variables (mother): insulin, glucose, indices of insulin resistance and insulin secretion,
Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Laboratory (mother): gamma-GT, B12 vitamin, ferritine
Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
Laboratory (mother): miRNA
Time frame: study inclusion after GDM diagnosis, 6-8 weeks postpartum, 1 year postpartum
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 3 Nov 2022.
- Derived from this study: PubMed 40197687Montandon L, Quansah DY, Lacroix A, Gonzalez-Rodriguez E, Horsch A, Arhab A, Puder JJ. Maternal Physical Activity, Fitness, and Body Composition in Women with Gestational Diabetes: A Prospective Study. Med Sci Sports Exerc. 2025 Aug 1;57(8):1646-1656. doi: 10.1249/MSS.0000000000003716. Epub 2025 Apr 4.
- Derived from this study: PubMed 38348309Quansah DY, Gilbert L, Arhab A, Gonzalez-Rodriguez E, Hans D, Gross J, Lanzi S, Stuijfzand B, Lacroix A, Horsch A, Puder JJ. Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial. BMJ Med. 2024 Feb 7;3(1):e000588. doi: 10.1136/bmjmed-2023-000588. eCollection 2024.
- Derived from this study: PubMed 37351105Gilbert L, Quansah DY, Arhab A, Schenk S, Gross J, Lanzi S, Stuijfzand B, Lacroix A, Horsch A, Puder JJ; MySweetheart Research group. Effect of the MySweetheart randomized controlled trial on birth, anthropometric and psychobehavioral outcomes in offspring of women with GDM. Front Endocrinol (Lausanne). 2023 Jun 7;14:1148426. doi: 10.3389/fendo.2023.1148426. eCollection 2023.
- Derived from this study: PubMed 29487077Horsch A, Gilbert L, Lanzi S, Gross J, Kayser B, Vial Y, Simeoni U, Hans D, Berney A, Scholz U, Barakat R, Puder JJ; MySweetHeart Research Group. Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for MySweetHeart Trial, a randomised controlled trial. BMJ Open. 2018 Feb 27;8(2):e020462. doi: 10.1136/bmjopen-2017-020462.
- Derived from this study: PubMed 29138200Di Bernardo S, Mivelaz Y, Epure AM, Vial Y, Simeoni U, Bovet P, Estoppey Younes S, Chiolero A, Sekarski N; MySweetHeart Research Group. Assessing the consequences of gestational diabetes mellitus on offspring's cardiovascular health: MySweetHeart Cohort study protocol, Switzerland. BMJ Open. 2017 Nov 14;7(11):e016972. doi: 10.1136/bmjopen-2017-016972.
- Individual participant dataSharing planned: Undecided
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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.
Jardena Puder, MD principal investigator
University of Lausanne Hospitals
Antje Horsch, DClinPsych principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interdisciplinary lifestyle and psychosocial intervention in people with Gestational Diabetes Mellitus, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 1 inclusion and 1 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
maternal weight measured on calibrated scale (time frame: study inclusion after GDM diagnosis and 1 year postpartum). The study lists 2 primary outcomes in all. 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 NCT02890693, which also lists 5 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 3 Nov 2022.