NCT06798597

Health4Life a Digital Intervention to Promote Healthy Lifestyle Behaviours From the Start of Life

Health4Life: A Digital Intervention to Promote Healthy Lifestyle Behaviours From the Start of Life: Protocol for a Hybrid Effectiveness-implementation Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 504 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 0 Months – 2 Months
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BEHAVIORAL	Health4Life app	Health4Life is a program based on the anticipatory guidance approach aiming to support parents create healthy lifestyle behaviours starting in early infancy. The intervention consists of ten themes over a 16 month period and incorporates interactive features such as quizzes.

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-03-17
• Completion: 2027-07-31
• First posted: 2025-01-29
• Last updated: 2025-08-27

Locations

1 site across 1 country: Sweden