Obesity, ChildhoodNCT05529043
MINISTOP Plus Program for Pre-school Children With Overweight and Obesity
A study testing MINISTOP app and MINISTOP Plus Program in people with Obesity, Childhood, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The Mobile-based intervention intended to stop obesity in preschoolers (MINISTOP) program has been developed to be a comprehensive digital support program for all children irrespective of weight status. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- MINISTOP app and MINISTOP Plus Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2 to 5 year old children with overweight and obesity residing in the municipality of Kungsbacka.
Who cannot join
- If a child has a disease or disorder that affects body size or feeding.
- Children who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family.
- Children from families who will not be able to understand the app content, i.e., those who do not speak Swedish, English, Arabic, or Somali
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MINISTOP Plus Program for Pre-school Children With Overweight and Obesity: A Pilot Randomized Controlled Trial
The Mobile-based intervention intended to stop obesity in preschoolers (MINISTOP) program has been developed to be a comprehensive digital support program for all children irrespective of weight status. However, a one size fits all approach may not be sufficient as some families may require extra support through in-person activities to achieve the required lifestyle behaviour change in order to attain and maintain a healthy weight. Therefore, the aims of this pilot randomized controlled trial are to evaluate the efficacy and feasibility of the MINISTOP Plus Program in pre-school children with overweight and obesity on: (i) children's BMI z-scores; (ii) intake of fruit and vegetables, sweet and savoury snacks, and sweet drinks; (iii) time spent in different physical activity intensities; (iv) screen time; and (v) parental self-efficacy.
- Conditions
- Obesity, Childhood
- Being tested
- MINISTOP app, MINISTOP Plus Program
- 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 appBehavioural
The MINISTOP app is a behavioural change program aiming to promote healthier diet and physical activity behaviours in pre-school children. The program consists of features such as information, monitoring and feedback (dietary variables, physical activity, and screen time) and it is built around 13 themes. The participants will have access to the app for 12-months.
MINISTOP Plus ProgramBehavioural
Consists of the MINISTOP app and the Community Group Mini. The Community Group Mini consists of group activities to promote physical activity for both children and parents. The Community Group Mini will meet once per week in different playgrounds and nature reserves and will be organized by a trained group leader.
| Study group | Role | What they receive |
|---|---|---|
| MINISTOP app | Active comparator | Receives the MINISTOP app for 12-months. Receives: Behavioral: MINISTOP app |
| MINISTOP Plus Program | Experimental | Receives the MINISTOP app for 12-months and receives Community Group Mini. Receives: Behavioral: MINISTOP Plus Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Body weight divided by height squared
Measured: At the end of the intervention which is 12-months after baseline
Secondary outcomes (4)
Intake of key dietary indicators as assessed by a questionnaire.
Intake of fruits, vegetables, sweet snacks, savoury snacks, and sweet drinks (grams/day)
Measured: At the end of the intervention which is 12-months after baseline.
Physical activity assessed using an accelerometer
Time spent in different physical activity intensities, i.e., sedentary, light, moderate, vigourous, and moderate-to-vigorous physical activity (minutes/day)
Measured: At the end of the intervention which is 12-months after baseline
Screen time as assessed by a questionnaire
Number of minutes per day spent in front of a screen
Measured: At the end of the intervention which is 12-months after baseline
Self-efficacy self-efficacy for promoting healthy dietary and physical activity behaviours in their children's
Questionnaire to parents
Measured: At the end of the intervention which is 12-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 posted6 Sep 2022
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Delisle Nyström, Karolinska Institutet
- Investigators
- Christine Delisle Nyström, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529043
- Sponsor's protocol ID
- 2022-02956-01
- Status last verified
- Jun 2024
- First submitted
- 1 Sep 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINISTOP Plus Program for Pre-school Children With Overweight and Obesity: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05529043
- Acronym / sponsor ID
- 2022-02956-01
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Sep 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.
The Mobile-based intervention intended to stop obesity in preschoolers (MINISTOP) program has been developed to be a comprehensive digital support program for all children irrespective of weight status. However, a one size fits all approach may not be sufficient as some families may require extra support through in-person activities to achieve the required lifestyle behaviour change in order to attain and maintain a healthy weight. Therefore, the aims of this pilot randomized controlled trial are to evaluate the efficacy and feasibility of the MINISTOP Plus Program in pre-school children with overweight and obesity on: (i) children's BMI z-scores; (ii) intake of fruit and vegetables, sweet and savoury snacks, and sweet drinks; (iii) time spent in different physical activity intensities; (iv) screen time; and (v) parental self-efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINISTOP app | Active comparator | Behavioral: MINISTOP appReceives the MINISTOP app for 12-months. |
| MINISTOP Plus Program | Experimental | Behavioral: MINISTOP Plus ProgramReceives the MINISTOP app for 12-months and receives Community Group Mini. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 2 to 5 year old children with overweight and obesity residing in the municipality of Kungsbacka.
Key exclusion criteria (3 listed)
- If a child has a disease or disorder that affects body size or feeding.
- Children who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family.
- Children from families who will not be able to understand the app content, i.e., those who do not speak Swedish, English, Arabic, or Somali
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 appThe MINISTOP app is a behavioural change program aiming to promote healthier diet and physical activity behaviours in pre-school children. The program consists of features such as information, monitoring and feedback (dietary variables, physical activity, and screen time) and it is built around 13 themes. The participants will have access to the app for 12-months. | Behavioural | MINISTOP app |
| MINISTOP Plus ProgramConsists of the MINISTOP app and the Community Group Mini. The Community Group Mini consists of group activities to promote physical activity for both children and parents. The Community Group Mini will meet once per week in different playgrounds and nature reserves and will be organized by a trained group leader. | Behavioural | MINISTOP Plus Program |
Primary outcome
Body mass index
Time frame: At the end of the intervention which is 12-months after baseline
Body weight divided by height squared
4 secondary outcomes
Intake of key dietary indicators as assessed by a questionnaire.
Time frame: At the end of the intervention which is 12-months after baseline.
Physical activity assessed using an accelerometer
Time frame: At the end of the intervention which is 12-months after baseline
Screen time as assessed by a questionnaire
Time frame: At the end of the intervention which is 12-months after baseline
Self-efficacy self-efficacy for promoting healthy dietary and physical activity behaviours in their children's
Time frame: At the end of the intervention which is 12-months after baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- 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.
Christine Delisle 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 MINISTOP app and MINISTOP Plus Program in people with Obesity, Childhood, 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: withdrawn, as of the sponsor's last update on 28 Jun 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Body mass index (time frame: At the end of the intervention which is 12-months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2024.