HealthyPregnancy - Digital Support for Pregnant Women with a BMI At 25 or Above (BMI≥25)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HealthyPregnancy.
- Who it may be relevant to
- Registry conditions: Pregnancy Related, Weight Gain. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Behavioral 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 addi
Primary outcome measures
- Gestational weight gain [Time frame: At inclusion and delivery]
Secondary outcome measures (12)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Denmark · 2 centers
- Nordsjaellands Hospital — Hillerød
- Slagelse Hospital — Slagelse
Identifiers
NCT: NCT06734910 · R232-A5142