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

Not Applicable

Withdrawn

• Conditions: Obesity, Childhood
• Interventions: Behavioral: MINISTOP Plus Program; Behavioral: MINISTOP app

• Registration Number: NCT05529043
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-28
• Study Start: 2024-12-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MINISTOP Plus Program	MINISTOP Plus Program	Receives the MINISTOP app for 12-months and receives Community Group Mini.
MINISTOP app	MINISTOP app	Receives the MINISTOP app for 12-months.

Primary Outcome Measures

Name	Time	Method
Body mass index	At the end of the intervention which is 12-months after baseline	Body weight divided by height squared

Secondary Outcome Measures

Name	Time	Method
Physical activity assessed using an accelerometer	At the end of the intervention which is 12-months after baseline	Time spent in different physical activity intensities, i.e., sedentary, light, moderate, vigourous, and moderate-to-vigorous physical activity (minutes/day)
Self-efficacy self-efficacy for promoting healthy dietary and physical activity behaviours in their children's	At the end of the intervention which is 12-months after baseline	Questionnaire to parents
Screen time as assessed by a questionnaire	At the end of the intervention which is 12-months after baseline	Number of minutes per day spent in front of a screen
Intake of key dietary indicators as assessed by a questionnaire.	At the end of the intervention which is 12-months after baseline.	Intake of fruits, vegetables, sweet snacks, savoury snacks, and sweet drinks (grams/day)

Trial Locations

Locations (1)

Department of Biosciences and Nutrition; 🇸🇪 Huddinge, Sweden