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

NCT06798597 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2025-08-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Christine Delsile Nyström, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-03-17
Completion
2027-07-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798597 on ClinicalTrials.gov