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

Study Overview
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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.

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

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Behavioral: MINISTOP app
* Behavioral: MINISTOP Plus Program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MINISTOP app<br>Receives the MINISTOP app for 12-months. | Behavioral: MINISTOP app<br>* 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.<br>|
| Experimental: MINISTOP Plus Program<br>Receives the MINISTOP app for 12-months and receives Community Group Mini. | Behavioral: MINISTOP Plus Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | Body weight divided by height squared | At the end of the intervention which is 12-months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intake of key dietary indicators as assessed by a questionnaire. | Intake of fruits, vegetables, sweet snacks, savoury snacks, and sweet drinks (grams/day) | 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) | 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 | 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 | At the end of the intervention which is 12-months after baseline |