NCT06798597 Health4Life a Digital Intervention to Promote Healthy Lifestyle Behaviours From the Start of Life
| NCT ID | NCT06798597 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 504 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-03-17 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 504 participants in total. It began in 2025-04-01 with a primary completion date of 2027-03-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The overall aim of this project is to evaluate the effectiveness and implementation of a digital intervention to support parents to create healthy lifestyle behaviours from the start of their infant's life, in order to prevent overweight and obesity. Using a randomized controlled trial with a hybrid type I implementation-effectiveness design we will: 1. evaluate the effectiveness of the 16-month Health4Life intervention on: 1. Children's' dietary intake, screen time, physical activity, and sleep 2. Children's body mass index (BMI) z-scores 3. Parental self-efficacy 2. Evaluate the cost-effectiveness of the Health4Life app. 3. Evaluate and explore the implementation of the Health4Life app within primary child healthcare with regards to its: 1. acceptability, appropriateness, and feasibility according to child healthcare nurses. 2. satisfaction and usage by parents.
Eligibility Criteria
Inclusion Criteria: * 0-2 month old infants at routine visits at selected child healthcare centers in Sweden. Exclusion Criteria: * Infants diagnosed with a neurological or endocrine disorder. * Infants who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family. * Infants from families who will not be able understand the content of the app.
Contact & Investigator
Christine Delsile Nyström, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT06798597 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 2 Months, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06798597 currently recruiting?
Yes, NCT06798597 is actively recruiting participants. Contact the research team at christine.delisle.nystrom@ki.se for enrollment information.
Where is the NCT06798597 trial being conducted?
This trial is being conducted at Huddinge, Sweden.
Who is sponsoring the NCT06798597 clinical trial?
NCT06798597 is sponsored by Karolinska Institutet. The principal investigator is Christine Delsile Nyström, PhD at Karolinska Institutet. The trial plans to enroll 504 participants.