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

NCT ID: NCT06798597

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-07-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Health4Life app

Receives the Health4Life app for 16 months

Group Type EXPERIMENTAL

Health4Life app

Intervention Type BEHAVIORAL

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.

Usual care

Receives standard care through child healthcare

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

0 Months

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Forte

INDUSTRY

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Christine Delisle Nyström

Assistant Professor, Docent

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine Delsile Nyström, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet

Huddinge, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Christine Delisle Nyström, PhD

Role: CONTACT

+46 764014500

Facility Contacts

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Christine Delisle Nyström, PhD

Role: primary

+46764014500

Other Identifiers

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2024-07372-01

Identifier Type: -

Identifier Source: org_study_id

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