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Recruiting NCT06798597

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

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health4Life app.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 0 months — 2 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Behavioral 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.

Primary outcome measures

  • Intake of key dietary indicators [Time frame: Post-intervention (i.e., 16 months after baseline)]
  • Screen time [Time frame: Baseline, mid-intervention (i.e., 8 months after baseline), and post-intervention (i.e., 16 months after baseline)]
  • Total physical activity [Time frame: Post-intervention (i.e., 16 months after baseline)]
  • Sleep [Time frame: Post-intervention (i.e., 16 months after baseline)]
Secondary outcome measures (10)
  • BMI [Time frame: Post-intervention (i.e., 16 months after baseline)]
  • Parental self-efficacy to promote healthy diet and physical activity behaviours in their child [Time frame: Baseline, mid-intervention (i.e., 8 months after baseline), and post-intervention (i.e., 16 months after baseline)]
  • Satisfaction of the app (Questionnaire) [Time frame: Post-intervention (i.e., 16 months after baseline)]
  • Satisfaction of the app (Interviews) [Time frame: Post-intervention (i.e., 16 months after baseline)]
  • Usage of the app (Questionnaire) [Time frame: Post-intervention (i.e., 16 months after baseline)]
  • Usage of the app (Interviews) [Time frame: Post-intervention (i.e., 16 months after baseline)]
  • Accetability of the app [Time frame: Post-intervention (i.e., 16 months after baseline)]
  • Approritateness of the app [Time frame: Post-intervention (i.e., 16 months after baseline)]
  • Feasibility of the app [Time frame: Post-intervention (i.e., 16 months after baseline)]
  • Usage of app by parents (measured objectively through the app) [Time frame: Post-intervention (i.e., 16 months after baseline)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Sweden · 1 center
  • Karolinska Institutet — Huddinge

Identifiers

NCT: NCT06798597 · 2024-07372-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗