Pregnancy RelatedNCT03854331
OBEAT - Beating Obesity
A study testing Resilience program in people with Pregnancy Related and Obesity, Childhood, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The primary objective of this trial is to study the feasibility of a resilience intervention to reduce stress and thus improve sleep, healthy diet and physical activity in normal weight pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Obesity, Childhood, Stress
- What is being tested?
- Resilience program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Jun 2019to 28 Oct 2020
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Expecting first child
- Speaks Danish
- Non-obese (BMI < 30)
- Singleton pregnancy
- Visited to basic level midwife care
Who cannot join
- Non-danish speakers
- Type 1 or 2 diabetes
- Visited to specialist midwife care for psychosocial reasons
- Expecting twins
- BMI > 30
- Multipara
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OBEAT - Beating Obesity: A Feasibility Trial
The primary objective of this trial is to study the feasibility of a resilience intervention to reduce stress and thus improve sleep, healthy diet and physical activity in normal weight pregnant women.
Initially, an exploratory study of stressors and worrying in pregnant women will be done by use of qualitative methods (focus group interviews) followed by a randomised controlled feasibility trial with a parallel qualitative process evaluation.
This project is expected to improve the understanding of the processes and feasibility of conducting a randomized intervention study to examine if improvements in chronic stress and poor sleep during pregnancy improves early weight gain and childhood risk of obesity.
Read the detailed description
Phase 1: Planning In Phase 1 (6 months), the project will be developed and planned, and approvals from the Danish Data Protection Agency and Ethical Committee of the Capital Region to conduct the study will be obtained.
Validated questionnaires to measure perceived stress, sleep patterns, physical activity- and dietary habits will be selected and pilot tested.
Phase 2: Recruitment and data collection In Phase 2 (12 months), participants will be recruited and randomized. Pregnant women living in Denmark are offered public, antenatal care delivered by hospital employed midwives. Healthy, non-obese, pregnant women assigned to antenatal care and birth at Hvidovre Hospital, are routinely invited to a first antenatal midwife session at gestational week 14-18. At these sessions, participants will be informed and recruited to the feasibility study. In 8 weeks approximately 240 pregnant women will be eligible, thus 120 women corresponding to 50% of all eligible pregnant women in one month will be recruited. In this feasibility study 50% of the women will be randomised to the intervention group and introduced to the resilience internet-based program/ smart phone app and 50% will be randomised to the control group and receive standard care. Computer-based randomization procedures will be used.
Phase 3: Feasibility study evaluation In Phase 3 (19 months), the knowledge obtained in Phase 2 will be evaluated.
An effect evaluation of the project will be conducted by analysing the collected clinical data, primarily related to changes and correlations in chronic stress in mother and infant (measured by hair cortisol), perceived stress, physical activity- and dietary habits, infant birth length and weight, and gestational age.
A process evaluation will also be conducted. The Committee of Health Education will collect data on how much and what parts of the resilience program has been used by the participating pregnant women. In addition, the participants will be asked to complete a short questionnaire on how frequent and how satisfied they have been with using the program. The researchers also want to use qualitative focus group interviews to investigate the participants' attitudes and acceptability of the proposed intervention.
The results of the effect- and process evaluations will be synthesized and will, depending on the results of the feasibility study, be implemented in a following planning of a large RCT.
Qualitative analytical methods The interview guide will be developed based on a literature search of existing literature in the field. To minimize the bias of my own influence I will consider my own experience and pre-understanding as a midwife.
The interviews will be recorded digitally and subsequently transcribed literally. The data will be analyzed using content analysis as described by Graneheim \& Lundman. The purpose of the content analysis is to organize and understand the meaning of the data collected in the focus group interviews and to draw conclusions from it.
Statistical analysis The clinical outcomes will be examined using paired t-tests as well as linear or logistic regression analyses. Analyses will be done crude and adjusted for potential confounders obtained from the completed questionnaires. Results of the analyses of the clinical outcomes are expected to be underpowered due to the feasibility design of this study but will however provide estimates indicating any direction or effect size of the resilience program on this target group.
- Conditions
- Pregnancy Related, Obesity, Childhood, Stress
- Being tested
- Resilience program
- Keywords
- Resilience, Cortisol, Feasibility, Healthy lifestyle, Sleep
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience programBehavioural
The resilience program consists of different modules that are based on research on mentalization, mindfulness, parent management training, improving self-control and self-efficacy, cognitive behaviour therapy, social learning theory and neuroscience. The MyResilience program is also informed by cognitive bias modification and self-control training research. These techniques have been found to be effective in improving engagement in health behaviours and reducing symptoms and negative behaviours in clinical groups
| Study group | Role | What they receive |
|---|---|---|
| Resilience program | Experimental | The resilience program consists of different modules that are based on research on mentalization, mindfulness, parent management training, improving self-control and self-efficacy, cognitive behaviour therapy, social learning theory and neuroscience. The MyResilience program is also informed by cognitive bias modification and self-control training research. These techniques have been found to be effective in improving engagement in health behaviours and reducing symptoms and negative behaviours in clinical groups Receives: Behavioral: Resilience program |
| Standard care | No intervention | Danish antenatal standard care is 3 visits at the general practitioner, 5 midwife controls and 2 ultrasound scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment-rates - feasibility
Number of participants out of eligible pregnant women approached
Measured: Two months after birth
Recruitment-time - feasibility
Number of days used to recruit the decided number of 120 participants
Measured: Two months after birth
Attrition-rates - feasibility
Number of participants leaving the study before the end
Measured: Two months after birth
Follow up-rates - feasibility
Number of participants in final clinical examination
Measured: Two months after birth
Compliance-rates - feasibility
Use of resilience program measured from web-statistics
Measured: Two months after birth
Self-reported compliance-rates - feasibility
Use of resilience program from patient-reported questionnaire
Measured: Two months after birth
Satisfaction-rates - feasibility
Measured from patient-reported questionnaire
Measured: Two months after birth
Secondary outcomes (17)
Change in maternal chronic stress
Assessed by level of cortisol (ng/ml) in 3 cm scalp hair
Measured: Gestational week 14-18, 28, 35, birth and two months after birth
Change in maternal perceived stress
Assessed by Cohen's Perceived Stress Scale (PSS). PSS measures the respondent's experience of stress over the past four weeks using ten questions to answer to what extent the respondent experiences his life as unpredictable, uncontrollable and stressful, and whether he or she feels nervous or stressed. The scale goes from 0 to 40. The higher the score, the higher the level of stress experienced.
Measured: Gestational week 14-18, 28, 35 and two months after birth
Change in maternal depression, anxiety and tension/stress.
Assessed by The Depression and Anxiety Stress Scale (DASS). DASS is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The scale goes from 0 to 42 for every emotional state. The higher the score, the higher the level of depression, anxiety or stress experienced. Range: Stress: Normal 0-10, Mild 11-18, Moderate 19-26, Severe 27-34, Extremely severe 35-42.
Anxiety: Normal 0-6, Mild 7-9, Moderate 10-14, Severe 15-19, Extremely severe 20-42.
Depression: Normal 0-9, Mild 10-12, Moderate 13-20, Severe 21-27, Extremely severe 28-42.
Measured: Gestational week 14-18, 28, 35 and two months after birth
Change in mentalization ability
Assessed by the Reflective Functioning Questionnaire, which comprises eight items and includes two subscales: Certainty (RFQc) and uncertainty (RFQu) about mental states. The 7 point Likert scale contains answers ranging from strongly disagree to strongly agree. Of the 6 items on each subscale, two are unique and four shared across the two scales. With the RFQc subscale, strong disagreement reflects hypermentalizing, and agreement to any degree (or a neutral response) reflects more genuine mentalizing (acknowledging the opaqueness of mental states). With the RFQu subscale, high agreement scores reflect a stance characterised by a lack of knowledge about mental states, or 'hypo-mentalizing', and lower scores represent an acknowledgement of the opaqueness of mental states, a characteristic of good mentalizing. Both scales are based on a mean of the 6 items (Cucchi et al. (2018), PeerJ, DOI 10.7717/peerj.5756).
Measured: Gestational week 14-18, 28, 35 and two months after birth
Changes in maternal Sense of Coherence (SOC)
Assessed by Antonovsky's 13-item SOC scale, which measures comprehensibility (5 items), manageability (4 items), and meaningfulness (4 items). Each item has seven graded (Likert-type) response scale, which is summed up and the total scores can range from 13 (low SOC) to the maximum of 91 (highest possible SOC).
Measured: Gestational week 14-18, 28, 35 and two months after birth
Changes in maternal resilience
Assessed by the Connor-Davidson Resilience Scale (CD-risc). The scale comprises of 25 items, each rated on a 5-point scale (0-4). The total score ranges from 0-100, with higher scores reflecting greater resilience.
Measured: Gestational week 14-18, 28, 35 and two months after birth
Differences in parental stress
Assessed by The Parental Stress Scale (PSS). PSS is made up of 18 items rated on a Likert- type 5-point scale that describes the parent-child relationship and how each parent feels about it. A higher score indicates a higher level of parental stress.
Measured: Two months after birth
Changes in fear of childbirth
Fear of childbirth is assessed asking the question 'Are you anxious about the course of the upcoming delivery?' in a participant-reported questionnaire. Possible responses are: 'Not at all', 'A little' or 'A lot'. Only the last response is considered to represent fear of childbirth.
Measured: Gestational week 14-18, 28, 35
Changes in fetal health anxiety
Fetal health anxiety is assessed asking the question 'Are you anxious about the health of the expected child?' in a participant-reported questionnaire. Possible responses are: 'Not at all', 'A little' or 'A lot'. Only the last response is considered to represent fetal health anxiety.
Measured: Gestational week 14-18, 28, 35
Sleep patterns - mother
Self-reported sleep duration and sleep quality measured from participant-reported questionnaire
Measured: Gestational week 14-18, 28, 35 and two months after birth
Changes in participant's physical activity - transportation
Self-reported means of transportation (biking, public transportation, car, walking) in hours pr. week
Measured: Gestational week 14-18, 28, 35 and two months after birth
Changes in participant's physical activity - exercise
Self-reported exercise (i.e. dancing, yoga or badminton) in hours pr. week
Measured: Gestational week 14-18, 28, 35 and two months after birth
Changes in diet - mother
Measured with a Food Frequency Questionnaire (FFQ) developed for the Danish National Birth cohort is used for dietary assessment. Most questions focus on the dietary habits during the 4 weeks prior to completion of the questionnaire, but a number of questions address changes in dietary habits during pregnancy. The FFQ includes questions on intake of 360 food and beverage items in the previous 4 weeks and is validated with a 7-day weighted food record. The 360 food items recorded in the FFQ are aggregated into 36 food groups and, together with the daily intake (in grams) for each food group, eaten by a given individual, are used to identify dietary patterns.
Measured: Gestational week 14-18, 28, 35 and two months after birth
Weight - mother
Maternal weight (kg) measured at midwife sessions
Measured: Gestational week 14-18, 28, 35 and two months after birth
Weight - child
Weight (kg), obtained from birth records and clinical examination
Measured: Birth and two months after birth
Length - child
Length (cm) obtained from birth records and clinical examination
Measured: Birth and two months after birth
Head circumference - child
Head circumference (cm) obtained from birth records and clinical examination
Measured: Birth and two months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start18 Jun 2019
- Primary completion25 Jun 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation, Oak Foundation, Hvidovre University Hospital
- Responsible party
- Principal investigator, Berit Lilienthal Heitmann, Bispebjerg Hospital
- Investigators
- Berit Heitmann, Professor, Principal investigator, Research Unit for Dietary Studies at The Parker Institute Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854331
- Sponsor's protocol ID
- TRYG-125690
- Status last verified
- Jan 2022
- First submitted
- 4 Feb 2019
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ladekarl M, Specht IO, Adegboye ARA, Brodsgaard A, Nohr EA, Olsen NJ, Heitmann BL. The feasibility of a web-based resilience-building program to prevent stress among danish pregnant nulliparous women: A randomised controlled feasibility trial. PLOS Ment Health. 2025 Sep 8;2(9):e0000294. doi: 10.1371/journal.pmen.0000294. eCollection 2025.
PubMed 41661987Ladekarl M, Olsen NJ, Winckler K, Brodsgaard A, Nohr EA, Heitmann BL, Specht IO. Early Postpartum Stress, Anxiety, Depression, and Resilience Development among Danish First-Time Mothers before and during First-Wave COVID-19 Pandemic. Int J Environ Res Public Health. 2021 Nov 9;18(22):11734. doi: 10.3390/ijerph182211734.
PubMed 34831493
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBEAT - Beating Obesity: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03854331
- Acronym / sponsor ID
- TRYG-125690
- Conditions
- Pregnancy Related, Obesity, Childhood, Stress
- Keywords
- Resilience, Cortisol, Feasibility, Healthy lifestyle, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- TRYG Foundation, Oak Foundation, Hvidovre University Hospital
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 26 Feb 2019 (actual)
- 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.
The primary objective of this trial is to study the feasibility of a resilience intervention to reduce stress and thus improve sleep, healthy diet and physical activity in normal weight pregnant women.
Initially, an exploratory study of stressors and worrying in pregnant women will be done by use of qualitative methods (focus group interviews) followed by a randomised controlled feasibility trial with a parallel qualitative process evaluation.
This project is expected to improve the understanding of the processes and feasibility of conducting a randomized intervention study to examine if improvements in chronic stress and poor sleep during pregnancy improves early weight gain and childhood risk of obesity.
Detailed description
Phase 1: Planning In Phase 1 (6 months), the project will be developed and planned, and approvals from the Danish Data Protection Agency and Ethical Committee of the Capital Region to conduct the study will be obtained.
Validated questionnaires to measure perceived stress, sleep patterns, physical activity- and dietary habits will be selected and pilot tested.
Phase 2: Recruitment and data collection In Phase 2 (12 months), participants will be recruited and randomized. Pregnant women living in Denmark are offered public, antenatal care delivered by hospital employed midwives. Healthy, non-obese, pregnant women assigned to antenatal care and birth at Hvidovre Hospital, are routinely invited to a first antenatal midwife session at gestational week 14-18. At these sessions, participants will be informed and recruited to the feasibility study. In 8 weeks approximately 240 pregnant women will be eligible, thus 120 women corresponding to 50% of all eligible pregnant women in one month will be recruited. In this feasibility study 50% of the women will be randomised to the intervention group and introduced to the resilience internet-based program/ smart phone app and 50% will be randomised to the control group and receive standard care. Computer-based randomization procedures will be used.
Phase 3: Feasibility study evaluation In Phase 3 (19 months), the knowledge obtained in Phase 2 will be evaluated.
An effect evaluation of the project will be conducted by analysing the collected clinical data, primarily related to changes and correlations in chronic stress in mother and infant (measured by hair cortisol), perceived stress, physical activity- and dietary habits, infant birth length and weight, and gestational age.
A process evaluation will also be conducted. The Committee of Health Education will collect data on how much and what parts of the resilience program has been used by the participating pregnant women. In addition, the participants will be asked to complete a short questionnaire on how frequent and how satisfied they have been with using the program. The researchers also want to use qualitative focus group interviews to investigate the participants' attitudes and acceptability of the proposed intervention.
The results of the effect- and process evaluations will be synthesized and will, depending on the results of the feasibility study, be implemented in a following planning of a large RCT.
Qualitative analytical methods The interview guide will be developed based on a literature search of existing literature in the field. To minimize the bias of my own influence I will consider my own experience and pre-understanding as a midwife.
The interviews will be recorded digitally and subsequently transcribed literally. The data will be analyzed using content analysis as described by Graneheim \& Lundman. The purpose of the content analysis is to organize and understand the meaning of the data collected in the focus group interviews and to draw conclusions from it.
Statistical analysis The clinical outcomes will be examined using paired t-tests as well as linear or logistic regression analyses. Analyses will be done crude and adjusted for potential confounders obtained from the completed questionnaires. Results of the analyses of the clinical outcomes are expected to be underpowered due to the feasibility design of this study but will however provide estimates indicating any direction or effect size of the resilience program on this target group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resilience program | Experimental | Behavioral: Resilience programThe resilience program consists of different modules that are based on research on mentalization, mindfulness, parent management training, improving self-control and self-efficacy, cognitive behaviour therapy, social learning theory and neuroscience. The MyResilience program is also informed by cognitive bias modification and self-control training research. These techniques have been found to be effective in improving engagement in health behaviours and reducing symptoms and negative behaviours in clinical groups |
| Standard care | No intervention | –Danish antenatal standard care is 3 visits at the general practitioner, 5 midwife controls and 2 ultrasound scans |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Expecting first child
- Speaks Danish
- Non-obese (BMI < 30)
- Singleton pregnancy
- Visited to basic level midwife care
Key exclusion criteria (6 listed)
- Non-danish speakers
- Type 1 or 2 diabetes
- Visited to specialist midwife care for psychosocial reasons
- Expecting twins
- BMI > 30
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 |
|---|---|---|
| Resilience programThe resilience program consists of different modules that are based on research on mentalization, mindfulness, parent management training, improving self-control and self-efficacy, cognitive behaviour therapy, social learning theory and neuroscience. The MyResilience program is also informed by cognitive bias modification and self-control training research. These techniques have been found to be effective in improving engagement in health behaviours and reducing symptoms and negative behaviours in clinical groups | Behavioural | Resilience program |
Primary outcome
Recruitment-rates - feasibility
Time frame: Two months after birth
Number of participants out of eligible pregnant women approached
Recruitment-time - feasibility
Time frame: Two months after birth
Number of days used to recruit the decided number of 120 participants
Attrition-rates - feasibility
Time frame: Two months after birth
Number of participants leaving the study before the end
Follow up-rates - feasibility
Time frame: Two months after birth
Number of participants in final clinical examination
Compliance-rates - feasibility
Time frame: Two months after birth
Use of resilience program measured from web-statistics
Self-reported compliance-rates - feasibility
Time frame: Two months after birth
Use of resilience program from patient-reported questionnaire
Satisfaction-rates - feasibility
Time frame: Two months after birth
Measured from patient-reported questionnaire
17 secondary outcomes
Change in maternal chronic stress
Time frame: Gestational week 14-18, 28, 35, birth and two months after birth
Change in maternal perceived stress
Time frame: Gestational week 14-18, 28, 35 and two months after birth
Change in maternal depression, anxiety and tension/stress.
Time frame: Gestational week 14-18, 28, 35 and two months after birth
Change in mentalization ability
Time frame: Gestational week 14-18, 28, 35 and two months after birth
Changes in maternal Sense of Coherence (SOC)
Time frame: Gestational week 14-18, 28, 35 and two months after birth
Changes in maternal resilience
Time frame: Gestational week 14-18, 28, 35 and two months after birth
Differences in parental stress
Time frame: Two months after birth
Changes in fear of childbirth
Time frame: Gestational week 14-18, 28, 35
Changes in fetal health anxiety
Time frame: Gestational week 14-18, 28, 35
Sleep patterns - mother
Time frame: Gestational week 14-18, 28, 35 and two months after birth
Changes in participant's physical activity - transportation
Time frame: Gestational week 14-18, 28, 35 and two months after birth
Changes in participant's physical activity - exercise
Time frame: Gestational week 14-18, 28, 35 and two months after birth
Changes in diet - mother
Time frame: Gestational week 14-18, 28, 35 and two months after birth
Weight - mother
Time frame: Gestational week 14-18, 28, 35 and two months after birth
Weight - child
Time frame: Birth and two months after birth
Length - child
Time frame: Birth and two months after birth
Head circumference - child
Time frame: Birth and two months after birth
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 21 Jan 2022.
- Derived from this study: PubMed 41661987Ladekarl M, Specht IO, Adegboye ARA, Brodsgaard A, Nohr EA, Olsen NJ, Heitmann BL. The feasibility of a web-based resilience-building program to prevent stress among danish pregnant nulliparous women: A randomised controlled feasibility trial. PLOS Ment Health. 2025 Sep 8;2(9):e0000294. doi: 10.1371/journal.pmen.0000294. eCollection 2025.
- Derived from this study: PubMed 34831493Ladekarl M, Olsen NJ, Winckler K, Brodsgaard A, Nohr EA, Heitmann BL, Specht IO. Early Postpartum Stress, Anxiety, Depression, and Resilience Development among Danish First-Time Mothers before and during First-Wave COVID-19 Pandemic. Int J Environ Res Public Health. 2021 Nov 9;18(22):11734. doi: 10.3390/ijerph182211734.
- 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.
Berit Heitmann, Professor principal investigator
Research Unit for Dietary Studies at The Parker Institute Bispebjerg and Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience program in people with Pregnancy Related and Obesity, Childhood, run by Bispebjerg Hospital at 1 site in Denmark.
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 21 Jan 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 Denmark. 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?
Recruitment-rates - feasibility (time frame: Two months after birth). The study lists 7 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 NCT03854331, which also lists 2 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 21 Jan 2022.