HealthyPregnancy - Digital Support for Pregnant Women with a BMI At 25 or Above (BMI≥25)
NCT ID: NCT06734910
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
450 participants
INTERVENTIONAL
2024-09-09
2027-06-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
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.
PREVENTION
NONE
Study Groups
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Control group
Standard antenatal care.
No interventions assigned to this group
HealthyPregnancy group
Digital care guide as supplement to standard antenatal care.
HealthyPregnancy
A 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.
Interventions
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HealthyPregnancy
A 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.
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
* Singleton pregnancy
* Appropriate Danish or English language skills
* Written informed consent
Exclusion Criteria
* 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.
18 Years
60 Years
FEMALE
No
Sponsors
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Nordsjaellands Hospital
OTHER
Slagelse Hospital
OTHER
Center for Clinical Research and Prevention
NETWORK
Responsible Party
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Locations
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Nordsjaellands Hospital
Hillerød, , Denmark
Slagelse Hospital
Slagelse, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Professor
Role: primary
Assistant professor
Role: primary
Other Identifiers
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R232-A5142
Identifier Type: -
Identifier Source: org_study_id