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

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: MINISTOP app; Behavioral: MINISTOP Plus Program

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge, Sweden, 141 83
    • Department of Biosciences and Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MINISTOP app; Receives the MINISTOP app for 12-months.	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.
Experimental: MINISTOP Plus Program; Receives the MINISTOP app for 12-months and receives Community Group Mini.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Christine Delisle Nyström, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Pediatric Obesity; Overweight
• Other Study ID Numbers: 2022-02956-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No