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NCT Number: NCT06798597

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

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.

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Key information

Conditions

Healthy

Age range

0 month–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Huddinge, 141 83, Sweden

Location status: Recruiting

Location contact

Christine Delisle Nyström, PhD

CONTACT

[email protected]

+46764014500

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health4Life app

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.

Primary outcomes

  1. Intake of key dietary indicators

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

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

  2. Screen time

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

    Time spent watching screens (min/day)

  3. Total physical activity

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

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

  4. Sleep

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

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

Secondary outcomes

  1. BMI

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

    weight (kg) / height (m)^2

  2. 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)

    Parental self-efficacy for promoting healthy physical activity and dietary behaviours in children scale questionnaire. Minimum score = 0, Maximum score = 160, a better score indicates a better outcome

  3. Satisfaction of the app (Questionnaire)

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

    Questionnaire to all parents in the intervention group

  4. Satisfaction of the app (Interviews)

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

    Semi-structured interviews with parents

  5. Usage of the app (Questionnaire)

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

    Questionnaire to all parents in the intervention group

  6. Usage of the app (Interviews)

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

    Semi-structured interviews with parents

  7. Accetability of the app

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

    Semi-structured interviews with child healthcare nurses

  8. Approritateness of the app

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

    Semi-structured interviews with child healthcare nurses

  9. Feasibility of the app

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

    Semi-structured interviews with child healthcare nurses

  10. Usage of app by parents (measured objectively through the app)

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

    Number of times they went in the app, number of read messages, and number of quizzes completed.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Delisle Nyström, PhD

CONTACT

[email protected]

+46 764014500

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Forte

Registry information

Official study title

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

Acronym: Health4Life

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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