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

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Karolinska Institute

Status

Enrolling

Conditions

Healthy

Treatments

Behavioral: Health4Life app

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06798597
2024-07372-01

Details and patient eligibility

About

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.

Enrollment

504 estimated patients

Sex

All

Ages

Under 2 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

504 participants in 2 patient groups

Health4Life app
Experimental group
Description:
Receives the Health4Life app for 16 months
Treatment:
Behavioral: Health4Life app
Usual care
No Intervention group
Description:
Receives standard care through child healthcare

Trial contacts and locations

1

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Central trial contact

Christine Delisle Nyström, PhD

Data sourced from clinicaltrials.gov

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