Clinical trial NCT06798597: Health4Life a Digital Intervention to Promote Healthy Lifestyle Behaviours From the Start of Life
Official title: Health4Life: A Digital Intervention to Promote Healthy Lifestyle Behaviours From the Start of Life: Protocol for a Hybrid Effectiveness-implementation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Lifestyle behaviours
Childhood
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Forte
First posted: 2025-01-29
Enrollment: 504
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Intake of key dietary indicators
timeFrame: Post-intervention (i.e., 16 months after baseline)
measure: Screen time
timeFrame: Baseline, mid-intervention (i.e., 8 months after baseline), and post-intervention (i.e., 16 months after baseline)
measure: Total physical activity
timeFrame: Post-intervention (i.e., 16 months after baseline)
measure: Sleep
timeFrame: Post-intervention (i.e., 16 months after baseline)
Secondary outcomes:
measure: BMI
timeFrame: Post-intervention (i.e., 16 months after baseline)
measure: Parental self-efficacy to promote healthy diet and physical activity behaviours in their child
timeFrame: Baseline, mid-intervention (i.e., 8 months after baseline), and post-intervention (i.e., 16 months after baseline)
measure: Satisfaction of the app (Questionnaire)
timeFrame: Post-intervention (i.e., 16 months after baseline)
measure: Satisfaction of the app (Interviews)
timeFrame: Post-intervention (i.e., 16 months after baseline)
measure: Usage of the app (Questionnaire)
timeFrame: Post-intervention (i.e., 16 months after baseline)
measure: Usage of the app (Interviews)
timeFrame: Post-intervention (i.e., 16 months after baseline)
measure: Accetability of the app
timeFrame: Post-intervention (i.e., 16 months after baseline)
measure: Approritateness of the app
timeFrame: Post-intervention (i.e., 16 months after baseline)
measure: Feasibility of the app
timeFrame: Post-intervention (i.e., 16 months after baseline)
measure: Usage of app by parents (measured objectively through the app)
timeFrame: Post-intervention (i.e., 16 months after baseline)
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Christine Delsile Nyström, PhD
role: PRINCIPAL_INVESTIGATOR
References: