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| Name | Class |
|---|---|
| Nordsjaellands Hospital | OTHER |
| Slagelse Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Standard antenatal care. | |
| HealthyPregnancy group | Active Comparator | Digital care guide as supplement to standard antenatal care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HealthyPregnancy | Behavioral | A digital care guide comprising of:
In addition an invitation to monthly café sessions focusing on e.g., mental health, parenting skills, breastfeeding and healthy lifestyle. |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational weight gain | Weight gain during pregnancy in kilograms | At inclusion and delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Postpartum weight retention | Self-reported weight in kilograms | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, gestational week 35-37, eight weeks after delivery and one year after delivery. |
| Diet |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lotte Broberg, Ph.d. | Contact | +45 38163097 | lotte.broberg.01@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nordsjaellands Hospital | Recruiting | Hillerød | Denmark |
Undecided: It is not yet known if there will be a plan to make IPD available.
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D000078064 | Gestational Weight Gain |
| D000092862 | Psychological Well-Being |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| 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. | 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. | 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 | 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. | 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. | 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). | 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 | 2 weeks post partum |
| Sick leave in pregnancy | Percentage of participants with sick leave, no matter cause. Sick leave will be measured in days | At inclusion, gestational week 35-37. |
| Antenatal contacts | Antenatal contacts measured as number of scheduled and unscheduled visits with obstetric doctors and midwifes | 2 weeks post partum |
| Pregnancy length | Gestational age at delivery. | 2 weeks post partum |
| Onset of labor | Onset of labor will be measured with spontaneous onset of labor or induced labor respectively (n/%). | 2 weeks post partum |
| Use of epidural analgesia | Use of epidural analgesia will be measured by yes or no (n/%). | 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/%). | 2 weeks post partum |
| Treatment with antibiotics during labor | Treatment with antibiotics during labor will be measured by yes or no (n/%). | 2 weeks post partum |
| Mode of delivery | Mode of delivery will be measured with spontaneous vaginal, instrumental vaginal or Caesarean section respectively (n/%). | 2 weeks post partum |
| Duration of labor | Duration of labor will be measured by hours of active labor. | 2 weeks post partum |
| Shoulder dystocia | Shoulder dystocia will be measured as yes or no (n/%). | 2 weeks post partum |
| Postpartum hemorrhage | Postpartum hemorrhage is measured as hemorrhage at or above 1000 ml yes or no (n/%). | 2 weeks post partum |
| Birth weight | Birth weight will be measured in kilograms (mean and SD). | 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/%). | 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. | 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/%). | 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). | 2 weeks post partum |
| Hospitalization, length of stay | The duration of hospitalization will be measured in days. | 2 weeks post partum |
| Breastfeeding intention | Self-reported breastfeeding intention is measured with yes or no (n/%). | 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. | 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. | 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). | 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). | 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). | 2 weeks post partum |
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. |
| 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). | 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. | 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. | Gestational week 35-37 |
| Slagelse Hospital | Recruiting | Slagelse | Denmark |
|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |