RecruitingNot ApplicableNCT06734910

HealthyPregnancy - Digital Support for Pregnant Women with a BMI At 25 or Above (BMI≥25)

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

Sponsor

Center for Clinical Research and Prevention

Enrollment

450 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

Weight Gain Pregnancy Related

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

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 Criteria7

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.

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Interventions

BEHAVIORALHealthyPregnancy

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.