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Clinical Trials in Sweden / NCT06798597
Recruiting Not applicable

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

NCT06798597 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska Institutet
Phase
Not applicable
Started
2025-04-01
Last updated
2025-08-27

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

Health4Life app

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.

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.

Eligibility

Sex
ALL
Min age
0 Months
Max age
2 Months
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Intake of key dietary indicators — Post-intervention (i.e., 16 months after baseline)
    Intake of dietary indicators such as fruit, vegetables, sweet snacks, savoury snacks, and sugar sweetened beverages (portions or grams per day)
  • Screen time — Baseline, mid-intervention (i.e., 8 months after baseline), and post-intervention (i.e., 16 months after baseline)
    Time spent watching screens (min/day)
  • Total physical activity — Post-intervention (i.e., 16 months after baseline)
    Total number of minutes spent in physical activity (min/day) assessed with accelerometers.
  • Sleep — Post-intervention (i.e., 16 months after baseline)
    Total amount of time spent sleeping (min/day) measured with accelerometers.

Trial sites (1)

FacilityCityRegionStatus
Karolinska Institutet Huddinge Sweden Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06798597 on ClinicalTrials.gov ↗ ← All trials in Sweden