Digital intervention to promote healthy lifestyle behaviors in infants
Health4Life: A Digital Intervention to Promote Healthy Lifestyle Behaviours From the Start of Life: Protocol for a Hybrid Effectiveness-implementation Study
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 504 (estimated) |
| Ages | 0 Months to 2 Months |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Huddinge) |
| Trial ID | NCT06798597 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown success with similar digital interventions aimed at promoting healthy behaviors in children, indicating potential for positive outcomes.
Eligibility criteria
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 this trial is running
Huddinge
- Karolinska Institutet — Huddinge, Sweden (Recruiting)
Study contacts
- Principal investigator: Christine Delsile Nyström, PhD — Karolinska Institutet
- Study coordinator: Christine Delisle Nyström, PhD
- Email: christine.delisle.nystrom@ki.se
- Phone: +46 764014500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.