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

NCT05529043 | Withdrawn

• 1 other identifier: 2022-02956-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

• Body mass index

  Body weight divided by height squared

  At the end of the intervention which is 12-months after baseline

Secondary Outcomes (4)

• Intake of key dietary indicators as assessed by a questionnaire.

  At the end of the intervention which is 12-months after baseline.

• Physical activity assessed using an accelerometer

  At the end of the intervention which is 12-months after baseline

• Screen time as assessed by a questionnaire

  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

  At the end of the intervention which is 12-months after baseline

Study Arms (2)

MINISTOP app

ACTIVE COMPARATOR

Receives the MINISTOP app for 12-months.

Behavioral: MINISTOP app

MINISTOP Plus Program

EXPERIMENTAL

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

Behavioral: MINISTOP Plus Program

Interventions

MINISTOP app 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 app

MINISTOP Plus Program 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.

MINISTOP Plus Program

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 5 year old children with overweight and obesity residing in the municipality of Kungsbacka.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Biosciences and Nutrition

Huddinge, 141 83, Sweden

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christine Delisle Nyström, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)