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

Not Applicable

Recruiting

• Conditions: Healthy

• Registration Number: NCT06798597
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-01-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Study Start: 2025-04-10
• Primary Completion: 2026-03-17
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 504

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Usage of the app (Interviews)	Post-intervention (i.e., 16 months after baseline)	Semi-structured interviews with parents
Accetability of the app	Post-intervention (i.e., 16 months after baseline)	Semi-structured interviews with child healthcare nurses
Approritateness of the app	Post-intervention (i.e., 16 months after baseline)	Semi-structured interviews with child healthcare nurses
Feasibility of the app	Post-intervention (i.e., 16 months after baseline)	Semi-structured interviews with child healthcare nurses
BMI	Post-intervention (i.e., 16 months after baseline)	weight (kg) / height (m)\^2
Parental self-efficacy to promote healthy diet and physical activity behaviours in their child	Baseline, mid-intervention (i.e., 8 months after baseline), and post-intervention (i.e., 16 months after baseline)	Parental self-efficacy for promoting healthy physical activity and dietary behaviours in children scale questionnaire. Minimum score = 0, Maximum score = 160, a better score indicates a better outcome
Satisfaction of the app (Questionnaire)	Post-intervention (i.e., 16 months after baseline)	Questionnaire to all parents in the intervention group
Satisfaction of the app (Interviews)	Post-intervention (i.e., 16 months after baseline)	Semi-structured interviews with parents
Usage of the app (Questionnaire)	Post-intervention (i.e., 16 months after baseline)	Questionnaire to all parents in the intervention group
Usage of app by parents (measured objectively through the app)	Post-intervention (i.e., 16 months after baseline)	Number of times they went in the app, number of read messages, and number of quizzes completed.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Huddinge, Sweden