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

NCT05529043 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-06-28

No results posted yet for this study

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.

Conditions

  • Obesity, Childhood

Interventions

BEHAVIORAL

MINISTOP 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.

BEHAVIORAL

MINISTOP 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 & Collaborators

Principal Investigators

  • Christine Delisle Nyström, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-31
Completion
2026-09-30

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05529043 on ClinicalTrials.gov