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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06798597
Acronym
Health4Life
Enrollment
504
Registered
2025-01-29
Start date
2025-04-01
Completion date
2027-07-31
Last updated
2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Lifestyle behaviours, Childhood

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.

Interventions

BEHAVIORALHealth4Life 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

Forte
CollaboratorINDUSTRY
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Months to 2 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Screen timeBaseline, 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 activityPost-intervention (i.e., 16 months after baseline)Total number of minutes spent in physical activity (min/day) assessed with accelerometers.
SleepPost-intervention (i.e., 16 months after baseline)Total amount of time spent sleeping (min/day) measured with accelerometers.
Intake of key dietary indicatorsPost-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)

Secondary

MeasureTime frameDescription
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 the app (Interviews)Post-intervention (i.e., 16 months after baseline)Semi-structured interviews with parents
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.
Approritateness of the appPost-intervention (i.e., 16 months after baseline)Semi-structured interviews with child healthcare nurses
Feasibility of the appPost-intervention (i.e., 16 months after baseline)Semi-structured interviews with child healthcare nurses
Accetability of the appPost-intervention (i.e., 16 months after baseline)Semi-structured interviews with child healthcare nurses
BMIPost-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 childBaseline, 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

Countries

Sweden

Contacts

Primary ContactChristine Delisle Nyström, PhD
christine.delisle.nystrom@ki.se+46 764014500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026