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

NCT06734910 | Recruiting DMC

• 1 other identifier: R232-A5142
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pregnancy Related; Weight Gain

Keywords

Pregnancy; Gestational weight gain; Mental well-being; Digital interventions; Physical activity; Diet

Outcome Measures

Primary Outcomes (1)

• Gestational weight gain

  Weight gain during pregnancy in kilograms

  At inclusion and delivery

Secondary Outcomes (32)

• Postpartum weight retention

  Eight weeks after delivery and one year after delivery.

• Mental well-being

  At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.

• Symptoms of depression

  At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.

• Functional ability

  At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.

• Digital health competence

  At inclusion, gestational week 35-37

Other Outcomes (5)

• Diet quality

  Baseline, gestational week 35-37, eight weeks after delivery and one year after delivery.

• Diet

  Baseline, gestational week 35-37, eight weeks after delivery and one year after delivery.

• Body composition

  Gestational age 35-37

Study Arms (2)

Control group

NO INTERVENTION

Standard antenatal care.

HealthyPregnancy group

ACTIVE COMPARATOR

Digital care guide as supplement to standard antenatal care.

Behavioral: HealthyPregnancy

Interventions

HealthyPregnancy BEHAVIORAL

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.

HealthyPregnancy group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 25 or above at first prenatal visit
• Age 18 years or older
• Singleton pregnancy
• Appropriate Danish or English language skills
• Written informed consent

You may not qualify if:

• Age under 18 years
• Multiple pregnancy
• 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.

Sponsors & Collaborators

• Center for Clinical Research and Prevention: lead
• Nordsjaellands Hospital: collaborator
• Slagelse Hospital: collaborator

Study Sites (2)

Nordsjaellands Hospital

Hillerød, Denmark

RECRUITING

Slagelse Hospital

Slagelse, Denmark

RECRUITING

MeSH Terms

Conditions

Weight Gain; Gestational Weight Gain; Psychological Well-Being; Motor Activity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Central Study Contacts

Lotte Broberg, Ph.d.

CONTACT

+45 38163097; lotte.broberg.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 16, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

DK (2)