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

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05529043
• Other study ID #: 2022-02956-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2023
• Source: Karolinska Institutet
• Contact: Christine Delisle Nyström, PhD
• Phone: +46764014500
• Email: christine.delisle.nystrom[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Overweight
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Department of Biosciences and Nutrition	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index	Body weight divided by height squared	At the end of the intervention which is 12-months after baseline
Secondary	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.
Secondary	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
Secondary	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
Secondary	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