An interventional study of HealthyPregnancy in Pregnancy Related and Weight Gain, sponsored by Center for Clinical Research and Prevention. Recruiting at 2 sites in Denmark. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Center for Clinical Research and Prevention · Not applicable, Interventional, and Prevention
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.
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.
317 studies on the registry are indexed under Weight Gain; 48 are open to participants now.
This study's planned enrollment of 450 is above the median of 83 across 251 interventional studies indexed under Weight Gain.
Browse Weight Gain studies →Center for Clinical Research and Prevention is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard antenatal care.
Digital care guide as supplement to standard antenatal care.
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 addition an invitation to monthly café sessions focusing on e.g., mental health, parenting skills, breastfeeding and healthy lifestyle.
Gestational weight gain
Weight gain during pregnancy in kilograms
Time frame: At inclusion and delivery
Postpartum weight retention
Self-reported weight in kilograms
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 2 weeks post partum
Sick leave in pregnancy
Percentage of participants with sick leave, no matter cause. Sick leave will be measured in days
Time frame: At inclusion, gestational week 35-37.
Antenatal contacts
Antenatal contacts measured as number of scheduled and unscheduled visits with obstetric doctors and midwifes
Time frame: 2 weeks post partum
Pregnancy length
Gestational age at delivery.
Time frame: 2 weeks post partum
Onset of labor
Onset of labor will be measured with spontaneous onset of labor or induced labor respectively (n/%).
Time frame: 2 weeks post partum
Use of epidural analgesia
Use of epidural analgesia will be measured by yes or no (n/%).
Time frame: 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/%).
Time frame: 2 weeks post partum
Treatment with antibiotics during labor
Treatment with antibiotics during labor will be measured by yes or no (n/%).
Time frame: 2 weeks post partum
Mode of delivery
Mode of delivery will be measured with spontaneous vaginal, instrumental vaginal or Caesarean section respectively (n/%).
Time frame: 2 weeks post partum
Duration of labor
Duration of labor will be measured by hours of active labor.
Time frame: 2 weeks post partum
Shoulder dystocia
Shoulder dystocia will be measured as yes or no (n/%).
Time frame: 2 weeks post partum
Postpartum hemorrhage
Postpartum hemorrhage is measured as hemorrhage at or above 1000 ml yes or no (n/%).
Time frame: 2 weeks post partum
Birth weight
Birth weight will be measured in kilograms (mean and SD).
Time frame: 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/%).
Time frame: 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.
Time frame: 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/%).
Time frame: 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).
Time frame: 2 weeks post partum
Hospitalization, length of stay
The duration of hospitalization will be measured in days.
Time frame: 2 weeks post partum
Breastfeeding intention
Self-reported breastfeeding intention is measured with yes or no (n/%).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 2 weeks post partum
Diet quality
Self-rated diet quality will be measured by percentage of participants in each of five categories of diet quality (very healthy, healthy, somewhat healthy, unhealthy, very unhealthy).
Time frame: Baseline, gestational week 35-37, eight weeks after delivery and one year after delivery.
Diet
Diet will be measured by self-reported frequency of 20 selected foods and drinks (more than once daily, 5-7 times a week, 3-4 times a week, 1-2 times a week, rarely/never). Exploratory outcome.
Time frame: Baseline, gestational week 35-37, eight weeks after delivery and one year after delivery.
Body composition
Body composition during pregnancy, determined as the ratio of fatty mass to lean mass, are measured with BodPod using a Air Displacement Plethysmography System (only a sub-sample of women recrutied at NOH).
Time frame: Gestational age 35-37
Use of the HealthyPregnancy digital application
Use of the HealthyPregnancy digital application is measured as the percentages of women within three categories of engagement (low engagement, medium engagement, high engagement). Engagement data is available from the platform Emento in which the HealthyPregnancy digital application is embedded.
Time frame: 2 weeks post partum
Prenatal caregiving expectations
Prenatal caregiving expectations are measured with the"Prenatal Caregiving Expectations Questionnaire - Revised version" (PCEQ-R). Percentages of women with helpless-dysregulated, anxious-hyperactivated, and avoidant-deactivated caregiving representations respectively.
Time frame: Gestational week 35-37
Plan to share: Undecided — Undecided: It is not yet known if there will be a plan to make IPD available.
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Jun 2026, 21 months after the start.
Of 95 non-industry interventional studies with no phase under Weight Gain, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 21 months is below that.
Counting every sponsor, half of 101 studies reached it within 27 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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