Clinical trial Recruiting at 1 site Interventional Ages 0 Months to 2 Months

Digital intervention to promote healthy lifestyle behaviors in infants

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

Run by Karolinska Institutet · NCT06798597 · Data updated 2026-11-12

This study tests if the Health4Life app can help parents encourage healthier habits in their infants, like better eating, more activity, and less screen time.

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Quick facts

Study typeInterventional
Ages0 Months to 2 Months
SexAll
Enrollment504 (estimated)
SponsorKarolinska Institutet
Academic / other
Locations1 site (Huddinge)
StatusRecruiting
StartedApril 1, 2025
Main results expectedMarch 17, 2027
Study endsJuly 31, 2027
Registry record updatedAugust 27, 2025
Trial IDNCT06798597 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are parents of infants aged 0-2 months attending routine visits at selected child healthcare centers in Sweden.

Probably not a fit

Patients who may not benefit from this study include infants with neurological or endocrine disorders or those from families unable to understand the app's content.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project evaluates the effectiveness of the Health4Life app, a digital intervention designed to support parents in fostering healthy lifestyle behaviors in their infants from birth. The study employs a randomized controlled trial with a hybrid implementation-effectiveness design, focusing on children's dietary intake, screen time, physical activity, sleep, and body mass index (BMI) z-scores over a 16-month period. Additionally, it assesses parental self-efficacy and the cost-effectiveness of the app, while exploring its acceptability and feasibility within primary child healthcare settings in Sweden.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the risk of overweight and obesity in children by promoting healthy habits from an early age.

How similar studies have gone: Other studies have shown success with similar digital interventions aimed at promoting healthy behaviors in children, indicating potential for positive outcomes.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Karolinska Institutet
    Huddinge, Sweden
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.