Pregnancy RelatedNCT06734910
HealthyPregnancy - Digital Support for Pregnant Women with a BMI At 25 or Above (BMI≥25)
A study testing HealthyPregnancy in people with Pregnancy Related and Weight Gain, run by Center for Clinical Research and Prevention at 2 sites in Denmark.
Trial summary
The study aims to examine the effectiveness of a digital care guide offering support and information on diet, physical exercise and mental well-being on pregnancy weight gain among pregnant women with a BMI at 25 or above in a stepped-wedge cluster randomised study. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pregnancy Related, Weight Gain
- What is being tested?
- HealthyPregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesDenmark
- Study dates
- 9 Sep 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI 25 or above at first prenatal visit
- Age 18 years or older
- Singleton pregnancy
- Appropriate Danish or English language skills
- Written informed consent
Who cannot join
- Age under 18 years
- Multiple pregnancy
- Gestational age above 16+0 at inclusion
- Alcohol or drug abuse
- Being diagnosed with eating disorder, schizophrenia, psychosis, or similar
- Diagnosis of malformations or chromosomal disorder in the fetus
- Conditions that lead to recommendations against physical activity during pregnancy e.g., cerclage.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Nordsjaellands Hospital
Hillerød
Professor, 004548296249, ellen.christine.leth.loekkegaard@regionh.dk
- Recruiting
Slagelse Hospital
Slagelse
Assistant professor, 004538163097, lbrob@regionsjaelland.dk
About this study
Official title: Effectiveness of a Digital Support Intervention (HealthyPregnancy) for Pregnant Women with a BMI At 25 or Above (BMI≥25) in Addition to Standard Care: a Stepped-wedge Cluster Randomized Controlled Trial
The study aims to examine the effectiveness of a digital care guide offering support and information on diet, physical exercise and mental well-being on pregnancy weight gain among pregnant women with a BMI at 25 or above in a stepped-wedge cluster randomised study.
The investigators hypothesise that access to a digital care guide focusing on diet, exercise and mental support, will support a reduced weight gain in pregnancy and improve the mental wellbeing of the participants.
Read the detailed description
Being overweight is the most prevailing health issue among women of reproductive age, and in Denmark, the proportion of pregnant women with a body mass index at or above 25 (BMI≥25) is nearing 40%.
Women with overweight are at increased risk of complications in pregnancy and labor such as hypertensive disorders, gestational diabetes (GDM), and Cesarean section. Children of women with overweight more often have a high birthweight and are less likely to be breastfed, than children of women with a normal BMI. Both women and offspring, face an increased risk of overweight or obesity later in life. The risk of complications can increase if the pregnant woman gains excessive weight during pregnancy and conversely, reducing pregnancy weight gain can lower the risk of complications. However, more than half (60%) of pregnant women with overweight do not adhere to the pregnancy weight gain recommendations. In addition, only around one third of pregnant women with overweight meet the recommended daily levels of physical activity. This emphasizes a significant potential for prevention strategies focused on promoting healthy weight gain and physical activity during pregnancy.
It has previously been established, that interventions focusing on physical activity and nutritional counselling can help women with overweight reduce excessive pregnancy weight gain. However, traditional lifestyle interventions can be both cost-intensive and resource-demanding to implement. With digital technologies, lifestyle interventions have potential to less resource-intensive testing and implementation. New research indicates that a digital application with information on a healthy diet and physical activity may have potential to help women with overweight reduce pregnancy weight gain.
At Nordsjaellands Hospital and Slagelse Hospital respectively 37% and 49% of pregnant women are overweight with a BMI≥25. Pregnant women with overweight are offered standard care at Slagelse Hospital and at Nordsjaellands Hospital women with a BMI above 35 receive a minor supplement to standard care. However, both pregnant women and healthcare professionals request tailored and evidence-based care.
The aim of the HealthyPregnancy study is to evaluate the effect of a digital care guide offering support and information on diet, physical exercise, and mental well-being on gestational weight gain. The digital care guide will be tested in a stepped wedge cluster randomized controlled trial including 450 pregnant women with a BMI at 25 or above.
A secondary aim is to evaluate the effect of the digital care guide on pregnancy and diabetes outcomes among participating women diagnosed with gestational diabetes.
HealthyPregnancy is carried out in collaboration between Center for Clinical Research and Prevention, Nordsjaellands Hospital and Slagelse Hospital.
- Conditions
- Pregnancy Related, Weight Gain
- Being tested
- HealthyPregnancy
- Keywords
- Pregnancy, Gestational weight gain, Mental well-being, Digital interventions, Physical activity, Diet
- Medical subject headings
- Weight Gain, Gestational Weight Gain, Psychological Well-Being, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthyPregnancyBehavioural
A digital care guide comprising of:
- Information about diet, exercise and mental wellbeing in pregnancy. Presented in text, video and audio material featuring various healthcare professionals.
- Online exercise. Access to live online structured physical exercise twice a week and to an off line library of exercise videos.
- Chat function with possibility to chat safely with healthcare professionals.
- Push-notifications reminding the participants of upcoming antenatal appointments.
In addition an invitation to monthly café sessions focusing on e.g., mental health, parenting skills, breastfeeding and healthy lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard antenatal care. |
| HealthyPregnancy group | Active comparator | Digital care guide as supplement to standard antenatal care. Receives: Behavioral: HealthyPregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
Weight gain during pregnancy in kilograms
Measured: At inclusion and delivery
Secondary outcomes (32)
Postpartum weight retention
Self-reported weight in kilograms
Measured: Eight weeks after delivery and one year after delivery.
Mental well-being
Mental well-being is measured with the "World Health Organisation Five Well-being Index" (WHO-5). The lowest score of the scale is 0 and the highest total score is 100. Higher scores indicating better mental well-being.
Measured: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
Symptoms of depression
Symptoms of depression are measured with the "Edinburgh Postnatal Depression Scale" (EPDS) will be defined as cutoff score ≥ 13 and a cutoff score ≥ 10. The scale measures the intensity of common depressive symptoms on a 4-point Likert scale (0-3), where 0 indicates absence of depressive symptoms and 3 indicates the highest amount of depressive symptoms. The lowest score of the scale is 0 and the highest total score is 30.
Measured: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
Functional ability
Functional ability is measured with the "12-item General Health Questionnaire" (GHQ-12). The GHQ-12 consists of 12 items, with total scores ranging from 0 to 36, with higher scores indicating higher levels of psychological distress.
Measured: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
Digital health competence
Digital health competence is measured with the "eHealth Literacy Questionnaire" (eHLQ), using subscales 1. Using technology to process health information, 3. Ability to actively engage with digital services and 5. Motivated to engage in digital services.
Each subscale is scored individually and no overall eHLQ score is calculated. Subscales consists of 4 to 6 items on a 4-point Likert scale ranging from "strongly disagree" to "strongly agree", and higher scores indicate higher abilities
Measured: At inclusion, gestational week 35-37
Maternal sleep
Maternal sleep quality is measured with the "Pittsburgh Sleep Quality Index" (PSQI). The global score range from 0-21 with higher scores indicating worse sleep quality.
Measured: At inclusion, gestational week 35-37 and one year after delivery.
Exercise self-efficacy
Exercise self-efficacy is measured with the Danish version of the "Pregnancy Exercise Self-Efficacy Scale" (P-ESES-DK). The total score of the scale range from 10 to 50, with higher scores indicating higher self-efficacy.
Measured: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
Physical activity in pregnancy
Physical activity in pregnancy is subjectively measured with the Danish version of the "Pregnancy Physical Activity Questionnaire" (PPAQ-DK).
Measured: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
Pregnancy complications
Diagnosis with gestational diabetes, pregnancy induced hypertension or preeclampsia during pregnancy
Measured: 2 weeks post partum
Sick leave in pregnancy
Percentage of participants with sick leave, no matter cause. Sick leave will be measured in days
Measured: At inclusion, gestational week 35-37.
Antenatal contacts
Antenatal contacts measured as number of scheduled and unscheduled visits with obstetric doctors and midwifes
Measured: 2 weeks post partum
Pregnancy length
Gestational age at delivery.
Measured: 2 weeks post partum
Onset of labor
Onset of labor will be measured with spontaneous onset of labor or induced labor respectively (n/%).
Measured: 2 weeks post partum
Use of epidural analgesia
Use of epidural analgesia will be measured by yes or no (n/%).
Measured: 2 weeks post partum
Use of oxytocin for augmentation during labor
Use of oxytocin for augmentation during labor will be measured by yes or no (n/%).
Measured: 2 weeks post partum
Treatment with antibiotics during labor
Treatment with antibiotics during labor will be measured by yes or no (n/%).
Measured: 2 weeks post partum
Mode of delivery
Mode of delivery will be measured with spontaneous vaginal, instrumental vaginal or Caesarean section respectively (n/%).
Measured: 2 weeks post partum
Duration of labor
Duration of labor will be measured by hours of active labor.
Measured: 2 weeks post partum
Shoulder dystocia
Shoulder dystocia will be measured as yes or no (n/%).
Measured: 2 weeks post partum
Postpartum hemorrhage
Postpartum hemorrhage is measured as hemorrhage at or above 1000 ml yes or no (n/%).
Measured: 2 weeks post partum
Birth weight
Birth weight will be measured in kilograms (mean and SD).
Measured: 2 weeks post partum
Newborn's well-being at time of delivery (Apgar score)
Newborn's well-being at time of delivery will be measured by Apgar score (yes or no to an Apgar score ≤ 7 at 5 minutes postpartum) (n/%).
Measured: Delivery
Newborn's well-being at time of delivery (pH-value in cord blood)
Newborn's well-being at time of delivery will be measured by the pH-value in the cord blood at time of delivery.
Measured: Delivery
Admittance to neonatal intensive care unit in relation to delivery
Admittance to neonatal intensive care unit in relation to delivery is measured as yes or no (n/%).
Measured: 2 weeks post partum
Neonatal re-admittance
Neonatal re-admittance is measured as yes or no to hospital admittance within the first two weeks after initial discharge (mature infants only).
Measured: 2 weeks post partum
Hospitalization, length of stay
The duration of hospitalization will be measured in days.
Measured: 2 weeks post partum
Breastfeeding intention
Self-reported breastfeeding intention is measured with yes or no (n/%).
Measured: Gestational week 35-37, eight weeks after delivery and one year after delivery.
Intended duration of breastfeeding
Self-reported intended duration of breastfeeding intention is measured in months.
Measured: Gestational week 35-37, eight weeks after delivery and one year after delivery.
Breastfeeding duration
Self-reported duration of full and partial breastfeeding respectively is measured in months.
Measured: Gestational week 35-37, eight weeks after delivery and one year after delivery.
Postpartum oral glucose tolerance test
Postpartum oral glucose tolerance test is measured as yes or no (only women diagnosed with gestational diabetes).
Measured: One year postpartum
Self-reported blood glucose values
Self-reported blood glucose values during pregnancy are measured in mmol/l (only women diagnosed with gestational diabetes).
Measured: 2 weeks post partum
Treatment with insulin during pregnancy
Treatment with insulin during pregnancy are measured with yes or no (only women diagnosed with gestational diabetes).
Measured: 2 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start9 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Model description
- Randomization of two study sites in three steps: Step 1: Both study sites acting as control. Step 2: One study site acting as control, 1 study site acting as intervention. Step 3: Both study sites acting as intervention.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Clinical Research and Prevention
- Sponsor type
- Research network
- Collaborators
- Nordsjaellands Hospital, Slagelse Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734910
- Sponsor's protocol ID
- R232-A5142
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Digital Support Intervention (HealthyPregnancy) for Pregnant Women with a BMI At 25 or Above (BMI≥25) in Addition to Standard Care: a Stepped-wedge Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06734910
- Acronym / sponsor ID
- R232-A5142
- Conditions
- Pregnancy Related, Weight Gain
- Keywords
- Pregnancy, Gestational weight gain, Mental well-being, Digital interventions, Physical activity, Diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Center for Clinical Research and PreventionResearch network
- Collaborators
- Nordsjaellands Hospital, Slagelse Hospital
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Dec 2024 (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 study aims to examine the effectiveness of a digital care guide offering support and information on diet, physical exercise and mental well-being on pregnancy weight gain among pregnant women with a BMI at 25 or above in a stepped-wedge cluster randomised study.
The investigators hypothesise that access to a digital care guide focusing on diet, exercise and mental support, will support a reduced weight gain in pregnancy and improve the mental wellbeing of the participants.
Detailed description
Being overweight is the most prevailing health issue among women of reproductive age, and in Denmark, the proportion of pregnant women with a body mass index at or above 25 (BMI≥25) is nearing 40%.
Women with overweight are at increased risk of complications in pregnancy and labor such as hypertensive disorders, gestational diabetes (GDM), and Cesarean section. Children of women with overweight more often have a high birthweight and are less likely to be breastfed, than children of women with a normal BMI. Both women and offspring, face an increased risk of overweight or obesity later in life. The risk of complications can increase if the pregnant woman gains excessive weight during pregnancy and conversely, reducing pregnancy weight gain can lower the risk of complications. However, more than half (60%) of pregnant women with overweight do not adhere to the pregnancy weight gain recommendations. In addition, only around one third of pregnant women with overweight meet the recommended daily levels of physical activity. This emphasizes a significant potential for prevention strategies focused on promoting healthy weight gain and physical activity during pregnancy.
It has previously been established, that interventions focusing on physical activity and nutritional counselling can help women with overweight reduce excessive pregnancy weight gain. However, traditional lifestyle interventions can be both cost-intensive and resource-demanding to implement. With digital technologies, lifestyle interventions have potential to less resource-intensive testing and implementation. New research indicates that a digital application with information on a healthy diet and physical activity may have potential to help women with overweight reduce pregnancy weight gain.
At Nordsjaellands Hospital and Slagelse Hospital respectively 37% and 49% of pregnant women are overweight with a BMI≥25. Pregnant women with overweight are offered standard care at Slagelse Hospital and at Nordsjaellands Hospital women with a BMI above 35 receive a minor supplement to standard care. However, both pregnant women and healthcare professionals request tailored and evidence-based care.
The aim of the HealthyPregnancy study is to evaluate the effect of a digital care guide offering support and information on diet, physical exercise, and mental well-being on gestational weight gain. The digital care guide will be tested in a stepped wedge cluster randomized controlled trial including 450 pregnant women with a BMI at 25 or above.
A secondary aim is to evaluate the effect of the digital care guide on pregnancy and diabetes outcomes among participating women diagnosed with gestational diabetes.
HealthyPregnancy is carried out in collaboration between Center for Clinical Research and Prevention, Nordsjaellands Hospital and Slagelse Hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization of two study sites in three steps: Step 1: Both study sites acting as control. Step 2: One study site acting as control, 1 study site acting as intervention. Step 3: Both study sites acting as intervention.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard antenatal care. |
| HealthyPregnancy group | Active comparator | Behavioral: HealthyPregnancyDigital care guide as supplement to standard antenatal care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI 25 or above at first prenatal visit
- Age 18 years or older
- Singleton pregnancy
- Appropriate Danish or English language skills
- Written informed consent
Key exclusion criteria (7 listed)
- Age under 18 years
- Multiple pregnancy
- Gestational age above 16+0 at inclusion
- Alcohol or drug abuse
- Being diagnosed with eating disorder, schizophrenia, psychosis, or similar
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 |
|---|---|---|
| HealthyPregnancyA digital care guide comprising of: 1. Information about diet, exercise and mental wellbeing in pregnancy. Presented in text, video and audio material featuring various healthcare professionals. 2. Online exercise. Access to live online structured physical exercise twice a week and to an off line library of exercise videos. 3. Chat function with possibility to chat safely with healthcare professionals. 4. Push-notifications reminding the participants of upcoming antenatal appointments. In addition an invitation to monthly café sessions focusing on e.g., mental health, parenting skills, breastfeeding and healthy lifestyle. | Behavioural | HealthyPregnancy group |
Primary outcome
Gestational weight gain
Time frame: At inclusion and delivery
Weight gain during pregnancy in kilograms
32 secondary outcomes
Postpartum weight retention
Time frame: Eight weeks after delivery and one year after delivery.
Mental well-being
Time frame: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
Symptoms of depression
Time frame: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
Functional ability
Time frame: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
Digital health competence
Time frame: At inclusion, gestational week 35-37
Maternal sleep
Time frame: At inclusion, gestational week 35-37 and one year after delivery.
Exercise self-efficacy
Time frame: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
Physical activity in pregnancy
Time frame: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
Pregnancy complications
Time frame: 2 weeks post partum
Sick leave in pregnancy
Time frame: At inclusion, gestational week 35-37.
Antenatal contacts
Time frame: 2 weeks post partum
Pregnancy length
Time frame: 2 weeks post partum
Onset of labor
Time frame: 2 weeks post partum
Use of epidural analgesia
Time frame: 2 weeks post partum
Use of oxytocin for augmentation during labor
Time frame: 2 weeks post partum
Treatment with antibiotics during labor
Time frame: 2 weeks post partum
Mode of delivery
Time frame: 2 weeks post partum
Duration of labor
Time frame: 2 weeks post partum
Shoulder dystocia
Time frame: 2 weeks post partum
Postpartum hemorrhage
Time frame: 2 weeks post partum
Birth weight
Time frame: 2 weeks post partum
Newborn's well-being at time of delivery (Apgar score)
Time frame: Delivery
Newborn's well-being at time of delivery (pH-value in cord blood)
Time frame: Delivery
Admittance to neonatal intensive care unit in relation to delivery
Time frame: 2 weeks post partum
Neonatal re-admittance
Time frame: 2 weeks post partum
Hospitalization, length of stay
Time frame: 2 weeks post partum
Breastfeeding intention
Time frame: Gestational week 35-37, eight weeks after delivery and one year after delivery.
Intended duration of breastfeeding
Time frame: Gestational week 35-37, eight weeks after delivery and one year after delivery.
Breastfeeding duration
Time frame: Gestational week 35-37, eight weeks after delivery and one year after delivery.
Postpartum oral glucose tolerance test
Time frame: One year postpartum
Self-reported blood glucose values
Time frame: 2 weeks post partum
Treatment with insulin during pregnancy
Time frame: 2 weeks post partum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Undecided. Undecided: It is not yet known if there will be a plan to make IPD available.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthyPregnancy in people with Pregnancy Related and Weight Gain, run by Center for Clinical Research and Prevention at 2 sites 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 7 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: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lotte Broberg, Ph.d. (+45 38163097, lotte.broberg.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational weight gain (time frame: At inclusion and delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2024.