Obesity, ChildNCT05667753
Large Scale Implementation of MINISTOP 3.0
A study testing MINISTOP 3.0 in people with Obesity, Child, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
MINISTOP is an evidence-based app for parents of preschool aged children with the overall aim to promote healthy lifestyle behaviors and prevent the development of overweight and obesity. MINISTOP has been previously been evaluated in two previous trials (MINISTOP 1.0 and 2.0) with promising results. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Child
- What is being tested?
- MINISTOP 3.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 13 Mar 2023to 31 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Child healthcare nurse at participating child healthcare centers
- No exclusion criteria.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Large-scale Implementation of a mHealth Obesity Prevention Program Within Swedish Primary Child Healthcare: MINISTOP 3.0 Study Protocol
MINISTOP is an evidence-based app for parents of preschool aged children with the overall aim to promote healthy lifestyle behaviors and prevent the development of overweight and obesity. MINISTOP has been previously been evaluated in two previous trials (MINISTOP 1.0 and 2.0) with promising results. Therefore, the overall aim of this trial is to evaluate the large scale implementation of MINISTOP within Swedish primary child healthcare. The specific aims are to:
(i) To compare two different implementation strategies for MINISTOP 3.0 (i.e., Basic vs.
Read more
Enhanced) on: a) acceptability, appropriateness, feasibility as well as organizational readiness to implement MINISTOP 3.0 within primary child healthcare (primary outcomes) and b) reach, costs, adoption, and sustainability of MINISTOP 3.0 within primary child healthcare (secondary outcomes).
(ii) To compare two different implementation strategies of MINISTOP 3.0 within primary child healthcare on children's key dietary indicators, physical activity, and screen time (secondary outcomes).
(iii) To compare the cost-effectiveness of two different implementation strategies for MINISTOP 3.0.
- Conditions
- Obesity, Child
- Being tested
- MINISTOP 3.0
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINISTOP 3.0Behavioural
MINISTOP 3.0 is a behavioral changed program with the overall aim to promote healthier lifestyle behaviors (i.e., diet, physical activity, and sedentary behavior) among 2.5/3-year old children. The MINISTOP 3.0 program consists of features such as information, monitoring, and feedback (dietary variables, physical activity, and screen time) and is built around 13 themes over a 6-month period.
| Study group | Role | What they receive |
|---|---|---|
| Basic | Active comparator | The MINISTOP app will be offered to all parents of children at the 2.5/3-year routine visit at primary child healthcare. The child healthcare centers randomly allocated to the basic group will receive the basic implementation strategy package. Receives: Behavioral: MINISTOP 3.0 |
| Enhanced | Experimental | The MINISTOP app will be offered to all parents of children at the 2.5/3-year routine visit at primary child healthcare. The child healthcare centers randomly allocated to the enhanced group will receive the enhanced implementation strategy package. Receives: Behavioral: MINISTOP 3.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acceptability of MINISTOP 3.0
Acceptability of MINISTOP 3.0 by child healthcare nurses (assessed by the questionnaire by Weiner et al.). It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree.
Measured: Baseline, 3 &12 months after implementation
Change in appropriateness of MINISTOP 3.0
Appropriateness of MINISTOP 3.0 by child healthcare nurses (assessed by the questionnaire by Weiner et al.). It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree.
Measured: Baseline, 3 & 12 months after implementation
Change in feasibility of MINISTOP 3.0
Feasibility of MINISTOP 3.0 by child healthcare nurses (assessed by the questionnaire by Weiner et al.). It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree.
Measured: Baseline, 3 &12 months after implementation
Change in organizational readiness for implementing MINISTOP 3.0
Organizational readiness as perceived by child healthcare nurses, which will be measured using the E-READY questionnaire. This questionnaire consists of 32 questions rated on a 4-point likert scale.
Measured: Baseline 3 and 12 months after implementation
Secondary outcomes (7)
Adoption of MINISTOP 3.0
Assessment based on a questionnaire from 1 to 5 with 5 indicating a better score
Measured: 3, 8, and 12 months after implementation
Costs of the implementation of MINISTOP 3.0
Collected through administrative data from participating child healthcare centers regarding implementing and maintaining the MINISTOP platform, as well as the nurses time with the MINISTOP program (Swedish Krona, SEK).
Measured: Baseline and 2, 4, 6, 8, 10, and 12 months after implementation.
Sustainability
Semi-structured interviews with primary child healthcare nurses
Measured: 12 months after implementation
Parental usage of MINISTOP 3.0 using objectively measured activity in the app
Number of recordings and messages read in the app (per time unity such as per week)
Measured: 6 months after the families start using the MINISTOP app
Children's intake of key dietary indicators as assess by a questionnaire.
Intake of fruits, vegetables, sweet and savoury snacks, as well as sweetened beverages (grams/day)
Measured: Baseline and 6 months after receiving MINISTOP 3.0
Children's physical activity as assessed by a questionnaire
Time spent in moderate-to-vigorous physical activity (minutes/day)
Measured: Baseline and 6 months after receiving MINISTOP 3.0
Children's screen time as assessed by a questionnaire
Time spent watching screens (minutes/day)
Measured: Baseline and 6 months after receiving MINISTOP 3.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start13 Mar 2023
- Primary completion5 Mar 2026
- Study completion31 Dec 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 Obesity, ChildStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial utilizing a hybrid type III implementation-effectiveness design.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Delisle Nyström, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667753
- Sponsor's protocol ID
- 2022-01710-01
- Status last verified
- Aug 2026
- First submitted
- 19 Dec 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomas K, Lof M, Lundgren M, Fagerstrom M, Hesketh KD, Brown V, Habel H, Delisle Nystrom C. MINISTOP 3.0: Implementation of a mHealth obesity prevention program within Swedish child healthcare - study protocol for a cluster randomized controlled trial. BMC Public Health. 2024 Sep 27;24(1):2594. doi: 10.1186/s12889-024-20137-0.
PubMed 39333981
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large-scale Implementation of a mHealth Obesity Prevention Program Within Swedish Primary Child Healthcare: MINISTOP 3.0 Study Protocol
- ClinicalTrials.gov ID
- NCT05667753
- Acronym / sponsor ID
- 2022-01710-01
- Conditions
- Obesity, Child
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Dec 2022 (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.
MINISTOP is an evidence-based app for parents of preschool aged children with the overall aim to promote healthy lifestyle behaviors and prevent the development of overweight and obesity. MINISTOP has been previously been evaluated in two previous trials (MINISTOP 1.0 and 2.0) with promising results. Therefore, the overall aim of this trial is to evaluate the large scale implementation of MINISTOP within Swedish primary child healthcare. The specific aims are to:
(i) To compare two different implementation strategies for MINISTOP 3.0 (i.e., Basic vs.
Enhanced) on: a) acceptability, appropriateness, feasibility as well as organizational readiness to implement MINISTOP 3.0 within primary child healthcare (primary outcomes) and b) reach, costs, adoption, and sustainability of MINISTOP 3.0 within primary child healthcare (secondary outcomes).
(ii) To compare two different implementation strategies of MINISTOP 3.0 within primary child healthcare on children's key dietary indicators, physical activity, and screen time (secondary outcomes).
(iii) To compare the cost-effectiveness of two different implementation strategies for MINISTOP 3.0.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial utilizing a hybrid type III implementation-effectiveness design.
| Arm | Type | Receives |
|---|---|---|
| Basic | Active comparator | Behavioral: MINISTOP 3.0The MINISTOP app will be offered to all parents of children at the 2.5/3-year routine visit at primary child healthcare. The child healthcare centers randomly allocated to the basic group will receive the basic implementation strategy package. |
| Enhanced | Experimental | Behavioral: MINISTOP 3.0The MINISTOP app will be offered to all parents of children at the 2.5/3-year routine visit at primary child healthcare. The child healthcare centers randomly allocated to the enhanced group will receive the enhanced implementation strategy package. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Child healthcare nurse at participating child healthcare centers
- No exclusion criteria.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MINISTOP 3.0MINISTOP 3.0 is a behavioral changed program with the overall aim to promote healthier lifestyle behaviors (i.e., diet, physical activity, and sedentary behavior) among 2.5/3-year old children. The MINISTOP 3.0 program consists of features such as information, monitoring, and feedback (dietary variables, physical activity, and screen time) and is built around 13 themes over a 6-month period. | Behavioural | Basic, Enhanced |
Primary outcome
Change in acceptability of MINISTOP 3.0
Time frame: Baseline, 3 &12 months after implementation
Acceptability of MINISTOP 3.0 by child healthcare nurses (assessed by the questionnaire by Weiner et al.). It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree.
Change in appropriateness of MINISTOP 3.0
Time frame: Baseline, 3 & 12 months after implementation
Appropriateness of MINISTOP 3.0 by child healthcare nurses (assessed by the questionnaire by Weiner et al.). It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree.
Change in feasibility of MINISTOP 3.0
Time frame: Baseline, 3 &12 months after implementation
Feasibility of MINISTOP 3.0 by child healthcare nurses (assessed by the questionnaire by Weiner et al.). It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree.
Change in organizational readiness for implementing MINISTOP 3.0
Time frame: Baseline 3 and 12 months after implementation
Organizational readiness as perceived by child healthcare nurses, which will be measured using the E-READY questionnaire. This questionnaire consists of 32 questions rated on a 4-point likert scale.
7 secondary outcomes
Adoption of MINISTOP 3.0
Time frame: 3, 8, and 12 months after implementation
Costs of the implementation of MINISTOP 3.0
Time frame: Baseline and 2, 4, 6, 8, 10, and 12 months after implementation.
Sustainability
Time frame: 12 months after implementation
Parental usage of MINISTOP 3.0 using objectively measured activity in the app
Time frame: 6 months after the families start using the MINISTOP app
Children's intake of key dietary indicators as assess by a questionnaire.
Time frame: Baseline and 6 months after receiving MINISTOP 3.0
Children's physical activity as assessed by a questionnaire
Time frame: Baseline and 6 months after receiving MINISTOP 3.0
Children's screen time as assessed by a questionnaire
Time frame: Baseline and 6 months after receiving MINISTOP 3.0
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 12 Aug 2026.
- Derived from this study: PubMed 39333981Thomas K, Lof M, Lundgren M, Fagerstrom M, Hesketh KD, Brown V, Habel H, Delisle Nystrom C. MINISTOP 3.0: Implementation of a mHealth obesity prevention program within Swedish child healthcare - study protocol for a cluster randomized controlled trial. BMC Public Health. 2024 Sep 27;24(1):2594. doi: 10.1186/s12889-024-20137-0.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINISTOP 3.0 in people with Obesity, Child, 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 2 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in acceptability of MINISTOP 3.0 (time frame: Baseline, 3 &12 months after implementation). 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 NCT05667753, 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 12 Aug 2026.