Clinical trial NCT06734910: HealthyPregnancy - Digital Support for Pregnant Women with a BMI At 25 or Above (BMI≥25)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Weight Gain
Keywords: Pregnancy
Gestational weight gain
Mental well-being
Digital interventions
Physical activity
Diet
Lead sponsor: Center for Clinical Research and Prevention
Sponsor class: NETWORK
Collaborators: name: Nordsjaellands Hospital
name: Slagelse Hospital
First posted: 2024-12-16
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* BMI 25 or above at first prenatal visit
* Age 18 years or older
* Singleton pregnancy
* Appropriate Danish or English language skills
* Written informed consent

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Gestational weight gain
timeFrame: At inclusion and delivery
Secondary outcomes:
measure: Postpartum weight retention
timeFrame: Eight weeks after delivery and one year after delivery.
measure: Mental well-being
timeFrame: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
measure: Symptoms of depression
timeFrame: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
measure: Functional ability
timeFrame: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
measure: Digital health competence
timeFrame: At inclusion, gestational week 35-37
measure: Maternal sleep
timeFrame: At inclusion, gestational week 35-37 and one year after delivery.
measure: Exercise self-efficacy
timeFrame: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
measure: Physical activity in pregnancy
timeFrame: At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.
measure: Pregnancy complications
timeFrame: 2 weeks post partum
measure: Sick leave in pregnancy
timeFrame: At inclusion, gestational week 35-37.
measure: Antenatal contacts
timeFrame: 2 weeks post partum
measure: Pregnancy length
timeFrame: 2 weeks post partum
measure: Onset of labor
timeFrame: 2 weeks post partum
measure: Use of epidural analgesia
timeFrame: 2 weeks post partum
measure: Use of oxytocin for augmentation during labor
timeFrame: 2 weeks post partum
measure: Treatment with antibiotics during labor
timeFrame: 2 weeks post partum
measure: Mode of delivery
timeFrame: 2 weeks post partum
measure: Duration of labor
timeFrame: 2 weeks post partum
measure: Shoulder dystocia
timeFrame: 2 weeks post partum
measure: Postpartum hemorrhage
timeFrame: 2 weeks post partum
measure: Birth weight
timeFrame: 2 weeks post partum
measure: Newborn's well-being at time of delivery (Apgar score)
timeFrame: Delivery
measure: Newborn's well-being at time of delivery (pH-value in cord blood)
timeFrame: Delivery
measure: Admittance to neonatal intensive care unit in relation to delivery
timeFrame: 2 weeks post partum
measure: Neonatal re-admittance
timeFrame: 2 weeks post partum
measure: Hospitalization, length of stay
timeFrame: 2 weeks post partum
measure: Breastfeeding intention
timeFrame: Gestational week 35-37, eight weeks after delivery and one year after delivery.
measure: Intended duration of breastfeeding
timeFrame: Gestational week 35-37, eight weeks after delivery and one year after delivery.
measure: Breastfeeding duration
timeFrame: Gestational week 35-37, eight weeks after delivery and one year after delivery.
measure: Postpartum oral glucose tolerance test
timeFrame: One year postpartum
measure: Self-reported blood glucose values
timeFrame: 2 weeks post partum
measure: Treatment with insulin during pregnancy
timeFrame: 2 weeks post partum
Other outcomes:
measure: Diet quality
timeFrame: Baseline, gestational week 35-37, eight weeks after delivery and one year after delivery.
measure: Diet
timeFrame: Baseline, gestational week 35-37, eight weeks after delivery and one year after delivery.
measure: Body composition
timeFrame: Gestational age 35-37
measure: Use of the HealthyPregnancy digital application
timeFrame: 2 weeks post partum
measure: Prenatal caregiving expectations
timeFrame: Gestational week 35-37
Locations:
city: Hillerød
country: Denmark
facility: Nordsjaellands Hospital
city: Slagelse
country: Denmark
facility: Slagelse Hospital
Study officials:
References: