HealthyPregnancy - Digital Support for Pregnant Women with a BMI At 25 or Above (BMI≥25)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorCenter for Clinical Research and Prevention
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI 25 or above at first prenatal visit
Age 18 years or older
Singleton pregnancy
Appropriate Danish or English language skills
Disqualifiers
Age under 18 years
Multiple pregnancy
Gestational age above 16+0 at inclusion
Alcohol or drug abuse
Trial design
Design model
Sequential
Treatments tested in this trial
HealthyPregnancy
BehavioralA 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.
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: HealthyPregnancy groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gestational weight gain
Weight gain during pregnancy in kilograms
Time frame
At inclusion and deliverySecondary outcomes
1
Postpartum weight retention
Self-reported weight in kilograms
Time frame
Eight weeks after delivery and one year after delivery.2
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.3
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.4
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.Other outcomes
1
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.2
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.3
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 35-374
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 partumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Center for Clinical Research and Prevention
Lead sponsor
Nordsjaellands Hospital
Collaborator
Slagelse Hospital
Collaborator
Source ClinicalTrials.gov