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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 2 months
Healthy Volunteers: t
View:

• 0-2 month old infants at routine visits at selected child healthcare centers in Sweden.

Locations
Other Locations
Sweden
Karolinska Institutet
RECRUITING
Huddinge
Contact Information
Primary
Christine Delisle Nyström, PhD
christine.delisle.nystrom@ki.se
+46 764014500
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 504
Treatments
Experimental: Health4Life app
Receives the Health4Life app for 16 months
No_intervention: Usual care
Receives standard care through child healthcare
Related Therapeutic Areas
Sponsors
Collaborators: Forte
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov