HealthyHealth4LifeNCT06798597
Health4Life a Digital Intervention to Promote Healthy Lifestyle Behaviours From the Start of Life
A study testing Health4Life app in people with Healthy, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Health4Life app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 0-2 month old infants at routine visits at selected child healthcare centers in Sweden.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Huddinge, 141 83
Christine Delisle Nyström, PhD, +46764014500, christine.delisle.nystrom@ki.se
About this study
Official title: Health4Life: A Digital Intervention to Promote Healthy Lifestyle Behaviours From the Start of Life: Protocol for a Hybrid Effectiveness-implementation Study
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:
- evaluate the effectiveness of the 16-month Health4Life intervention on:
- Children's' dietary intake, screen time, physical activity, and sleep
- Children's body mass index (BMI) z-scores
- Parental self-efficacy
- Evaluate the cost-effectiveness of the Health4Life app.
- Evaluate and explore the implementation of the Health4Life app within primary child healthcare with regards to its:
- acceptability, appropriateness, and feasibility according to child healthcare nurses.
- satisfaction and usage by parents.
- Conditions
- Healthy
- Being tested
- Health4Life app
- Keywords
- Lifestyle behaviours, Childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health4Life appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Health4Life app | Experimental | Receives the Health4Life app for 16 months Receives: Behavioral: Health4Life app |
| Usual care | No intervention | Receives standard care through child healthcare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Post-intervention (i.e., 16 months after baseline)
Screen time
Time spent watching screens (min/day)
Measured: 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.
Measured: Post-intervention (i.e., 16 months after baseline)
Sleep
Total amount of time spent sleeping (min/day) measured with accelerometers.
Measured: Post-intervention (i.e., 16 months after baseline)
Secondary outcomes (10)
BMI
weight (kg) / height (m)^2
Measured: Post-intervention (i.e., 16 months after baseline)
Parental self-efficacy to promote healthy diet and physical activity behaviours in their child
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
Measured: Baseline, mid-intervention (i.e., 8 months after baseline), and post-intervention (i.e., 16 months after baseline)
Satisfaction of the app (Questionnaire)
Questionnaire to all parents in the intervention group
Measured: Post-intervention (i.e., 16 months after baseline)
Satisfaction of the app (Interviews)
Semi-structured interviews with parents
Measured: Post-intervention (i.e., 16 months after baseline)
Usage of the app (Questionnaire)
Questionnaire to all parents in the intervention group
Measured: Post-intervention (i.e., 16 months after baseline)
Usage of the app (Interviews)
Semi-structured interviews with parents
Measured: Post-intervention (i.e., 16 months after baseline)
Accetability of the app
Semi-structured interviews with child healthcare nurses
Measured: Post-intervention (i.e., 16 months after baseline)
Approritateness of the app
Semi-structured interviews with child healthcare nurses
Measured: Post-intervention (i.e., 16 months after baseline)
Feasibility of the app
Semi-structured interviews with child healthcare nurses
Measured: Post-intervention (i.e., 16 months after baseline)
Usage of app by parents (measured objectively through the app)
Number of times they went in the app, number of read messages, and number of quizzes completed.
Measured: Post-intervention (i.e., 16 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Apr 2025
- Primary completion17 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Forte
- Responsible party
- Principal investigator, Christine Delisle Nyström, Karolinska Institutet
- Investigators
- Christine Delsile Nyström, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798597
- Sponsor's protocol ID
- 2024-07372-01
- Acronym
- Health4Life
- Status last verified
- Aug 2025
- First submitted
- 20 Jan 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alexandrou C, Golsater M, Lof M, Hesketh KD, Brown V, Strid A, Gransten J, Habel H, Delisle Nystrom C. Health4Life: a digital intervention to promote healthy diet and movement behaviours from the start of life: protocol for a hybrid effectiveness-implementation study. BMC Public Health. 2026 Aug 3;26(1):3122. doi: 10.1186/s12889-026-28866-0.
PubMed 42958181
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health4Life: A Digital Intervention to Promote Healthy Lifestyle Behaviours From the Start of Life: Protocol for a Hybrid Effectiveness-implementation Study
- ClinicalTrials.gov ID
- NCT06798597
- Acronym / sponsor ID
- Health4Life / 2024-07372-01
- Conditions
- Healthy
- Keywords
- Lifestyle behaviours, Childhood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Forte
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 17 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- evaluate the effectiveness of the 16-month Health4Life intervention on:
- Children's' dietary intake, screen time, physical activity, and sleep
- Children's body mass index (BMI) z-scores
- Parental self-efficacy
- Evaluate the cost-effectiveness of the Health4Life app.
- Evaluate and explore the implementation of the Health4Life app within primary child healthcare with regards to its:
- acceptability, appropriateness, and feasibility according to child healthcare nurses.
- satisfaction and usage by parents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health4Life app | Experimental | Behavioral: Health4Life appReceives the Health4Life app for 16 months |
| Usual care | No intervention | –Receives standard care through child healthcare |
Who may qualify
- Ages
- 0 to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 0-2 month old infants at routine visits at selected child healthcare centers in Sweden.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health4Life appHealth4Life 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. | Behavioural | Health4Life app |
Primary outcome
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)
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)
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.
Sleep
Time frame: Post-intervention (i.e., 16 months after baseline)
Total amount of time spent sleeping (min/day) measured with accelerometers.
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Derived from this study: PubMed 42958181Alexandrou C, Golsater M, Lof M, Hesketh KD, Brown V, Strid A, Gransten J, Habel H, Delisle Nystrom C. Health4Life: a digital intervention to promote healthy diet and movement behaviours from the start of life: protocol for a hybrid effectiveness-implementation study. BMC Public Health. 2026 Aug 3;26(1):3122. doi: 10.1186/s12889-026-28866-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Delsile Nyström, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health4Life app in people with Healthy, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Delisle Nyström, PhD (+46 764014500, christine.delisle.nystrom@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intake of key dietary indicators (time frame: Post-intervention (i.e., 16 months after baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06798597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.