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Obesity, ChildhoodNCT04147039

A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds

A study testing MINISTOP 2.0 in people with Obesity, Childhood, run by Karolinska Institutet at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Childhood obesity is still a major global health issue. The preschool age (2-5 years) has been identified as a critical period to intervene, Mobile technology (mHealth) has been successful for weight loss and behavior changes in adults. Read more about this study

Who is it for?
Ages 24 to 38 monthsHealthy volunteers can take part
Conditions the study is for
Obesity, Childhood
What is being tested?
MINISTOP 2.0
Could I receive a placebo?
No, everyone receives an active treatment
How many people
552 participants
Where
2 sitesSweden
Study dates
2 Nov 2019to 8 Apr 2022
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 24 to 38 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • -Children at the routine visit at 2.5-3 years of age at selected primary child health centers in Sweden

Who cannot join

  • Children diagnosed with neurological or endocrine diseases
  • 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 content of the app (i.e. do not speak Swedish, English, Somali or Arabic)

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • Department of Biosciences and Nutrition, Karolinska Institute

    Huddinge, 14183

  • Linköping University

    Linköping

Other trials in Sweden

About this study

Official title: A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds - a Randomised Controlled Trial in Primary Child Health Care.

Childhood obesity is still a major global health issue. The preschool age (2-5 years) has been identified as a critical period to intervene, Mobile technology (mHealth) has been successful for weight loss and behavior changes in adults. This proposed randomized controlled trial aims to assess the effectiveness of an 6-month intervention program, the Mobile-based intervention to stop obesity in preschoolers (MINISTOP) 2.0 mobile phone app integrated in primary child health care for parents of children aged 2.5 years. The MINISTOP 2.0 app is built on the previous MINISTOP 1.0 app. Five hundred children will be recruited at their routine visit at 2.5 years of age and after baseline measures randomized to the intervention or control group. In addition, the investigators will assess acceptability, feasibility and appropriateness of the app by parents and primary child health care nurses.

Being tested
MINISTOP 2.0
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 2.0Behavioural

    The MINISTOP 2.0 is a behavioural change program aiming to promote healthier diet and physical activity among 2.5-year-old children. The program consists of features such as information, monitoring and feedback (dietary key variables, physical activity, screen time) and it is built around 13 themes during the 6-month period.

Study groups in NCT04147039
Study groupRoleWhat they receive
InterventionExperimentalReceives the MINISTOP 2.0 mobile phone app for 6 months
Receives: Behavioral: MINISTOP 2.0
ControlNo interventionReceives standard care through primary child health care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intake of dietary key indicators as assessed by a questionnaire

    Intake of dietary indicators such as fruits and vegetables, sweet and savory treats, sugar-sweetened drinks (in portions or grams per day)

    Measured: At the end of the intervention which is six months after baseline

  2. Physical activity as assessed by a questionnaire

    Time spent on moderate-to-vigorous physical activity, screen time (min/day)

    Measured: At the end of the intervention which is six months after baseline

Secondary outcomes (4)

  1. Body mass index

    Body weight divided by squared height

    Measured: At the end of the intervention which is six months after baseline

  2. Satisfaction and usage of the app as assessed by a questionnaire and interviews

    Percentage of users (parents and primary health care nurses) that were satisfied with app, used features in the app

    Measured: At the end of the intervention which is six months after baseline

  3. Usage of the app as assessed using the objectively measured activity in the app

    Number of recordings and messages read in the app (per time unit such as per week)

    Measured: At the end of the intervention which is six months after baseline

  4. Parental self-efficacy to promote healthy diet and physical activity behaviors in their child as assessed by a questionnaire

    Derived scores from selected questions from a questionnaire (Parental Self-Efficacy for Promoting Healthy Physical Activity and Dietary Behaviors in Children Scale (PSEPAD) Questionnaire). The minimum value is 0 and the maximum value 10.

    Measured: At the end of the intervention which is six months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2019
  2. Study start2 Nov 2019
  3. Primary completion8 Apr 2022
  4. Study completion8 Apr 2022

Resources

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
Single blind
Who is masked
Investigator
Enrolment
552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04147039
Sponsor's protocol ID
2019-02747
Other IDs
2019
Status last verified
Jul 2022
First submitted
21 Oct 2019
Last updated
6 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alexandrou C, Henriksson H, Henstrom M, Henriksson P, Delisle Nystrom C, Bendtsen M, Lof M. Effectiveness of a Smartphone App (MINISTOP 2.0) integrated in primary child health care to promote healthy diet and physical activity behaviors and prevent obesity in preschool-aged children: randomized controlled trial. Int J Behav Nutr Phys Act. 2023 Feb 21;20(1):22. doi: 10.1186/s12966-023-01405-5.

    PubMed 36810069

  • Henriksson H, Alexandrou C, Henriksson P, Henstrom M, Bendtsen M, Thomas K, Mussener U, Nilsen P, Lof M. MINISTOP 2.0: a smartphone app integrated in primary child health care to promote healthy diet and physical activity behaviours and prevent obesity in preschool-aged children: protocol for a hybrid design effectiveness-implementation study. BMC Public Health. 2020 Nov 23;20(1):1756. doi: 10.1186/s12889-020-09808-w.

    PubMed 33228572

Questions about this trial

What is this clinical trial studying?

A study testing MINISTOP 2.0 in people with Obesity, Childhood, run by Karolinska Institutet at 2 sites 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: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Intake of dietary key indicators as assessed by a questionnaire (time frame: At the end of the intervention which is six months after baseline). The study lists 2 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 NCT04147039, which also lists 2 linked publications.

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 6 Jul 2022.

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