NCT06798597

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. 1.evaluate the effectiveness of the 16-month Health4Life intervention on:
  2. 2.Children's' dietary intake, screen time, physical activity, and sleep
  3. 3.Children's body mass index (BMI) z-scores
  4. 4.Parental self-efficacy
  5. 5.Evaluate the cost-effectiveness of the Health4Life app.
  6. 6.Evaluate and explore the implementation of the Health4Life app within primary child healthcare with regards to its:
  7. 7.acceptability, appropriateness, and feasibility according to child healthcare nurses.
  8. 8.satisfaction and usage by parents.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
504

participants targeted

Target at P75+ for not_applicable healthy

Timeline
15mo left

Started Apr 2025

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Apr 2025Jul 2027

First Submitted

Initial submission to the registry

January 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

January 20, 2025

Last Update Submit

August 25, 2025

Conditions

Healthy

Keywords

Lifestyle behavioursChildhood

Outcome Measures

Primary Outcomes (4)

  • Intake of key dietary indicators

    Intake of dietary indicators such as fruit, vegetables, sweet snacks, savoury snacks, and sugar sweetened beverages (portions or grams per day)

    Post-intervention (i.e., 16 months after baseline)

  • Screen time

    Time spent watching screens (min/day)

    Baseline, mid-intervention (i.e., 8 months after baseline), and post-intervention (i.e., 16 months after baseline)

  • Total physical activity

    Total number of minutes spent in physical activity (min/day) assessed with accelerometers.

    Post-intervention (i.e., 16 months after baseline)

  • Sleep

    Total amount of time spent sleeping (min/day) measured with accelerometers.

    Post-intervention (i.e., 16 months after baseline)

Secondary Outcomes (10)

  • BMI

    Post-intervention (i.e., 16 months after baseline)

  • 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)

  • Satisfaction of the app (Questionnaire)

    Post-intervention (i.e., 16 months after baseline)

  • Satisfaction of the app (Interviews)

    Post-intervention (i.e., 16 months after baseline)

  • Usage of the app (Questionnaire)

    Post-intervention (i.e., 16 months after baseline)

  • +5 more secondary outcomes

Study Arms (2)

Health4Life app

EXPERIMENTAL

Receives the Health4Life app for 16 months

Behavioral: Health4Life app

Usual care

NO INTERVENTION

Receives standard care through child healthcare

Interventions

Health4Life appBEHAVIORAL

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.

Health4Life app

Eligibility Criteria

Age0 Months - 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • month old infants at routine visits at selected child healthcare centers in Sweden.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Huddinge, 141 83, Sweden

RECRUITING

Study Officials

  • Christine Delsile Nyström, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Delisle Nyström, PhD

CONTACT

+46 764014500christine.delisle.nystrom@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Docent

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 29, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

March 17, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)