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MINISTOP Plus Program for Pre-school Children With Overweight and Obesity

MINISTOP Plus Program for Pre-school Children With Overweight and Obesity: A Pilot Randomized Controlled Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05529043
Enrollment
0
Registered
2022-09-06
Start date
2024-12-01
Completion date
2026-09-30
Last updated
2024-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

Brief 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. 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.

Interventions

BEHAVIORALMINISTOP app

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.

BEHAVIORALMINISTOP Plus Program

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.

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* 2 to 5 year old children with overweight and obesity residing in the municipality of Kungsbacka.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Body mass indexAt the end of the intervention which is 12-months after baselineBody weight divided by height squared

Secondary

MeasureTime frameDescription
Intake of key dietary indicators as assessed by a questionnaire.At the end of the intervention which is 12-months after baseline.Intake of fruits, vegetables, sweet snacks, savoury snacks, and sweet drinks (grams/day)
Physical activity assessed using an accelerometerAt the end of the intervention which is 12-months after baselineTime spent in different physical activity intensities, i.e., sedentary, light, moderate, vigourous, and moderate-to-vigorous physical activity (minutes/day)
Screen time as assessed by a questionnaireAt the end of the intervention which is 12-months after baselineNumber of minutes per day spent in front of a screen
Self-efficacy self-efficacy for promoting healthy dietary and physical activity behaviours in their children'sAt the end of the intervention which is 12-months after baselineQuestionnaire to parents

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026