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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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MINISTOP app

Receives the MINISTOP app for 12-months.

Group Type ACTIVE_COMPARATOR

MINISTOP app

Intervention Type BEHAVIORAL

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 Program

Receives the MINISTOP app for 12-months and receives Community Group Mini.

Group Type EXPERIMENTAL

MINISTOP Plus Program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes