Back to resultsMINISTOP Plus Program for Pre-school Children With Overweight and Obesity
Primary Purpose
Obesity, Childhood
Status
Not yet recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
MINISTOP app
MINISTOP Plus Program
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Childhood
Eligibility Criteria
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
Sites / Locations
- Department of Biosciences and Nutrition
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
MINISTOP app
MINISTOP Plus Program
Arm Description
Receives the MINISTOP app for 12-months.
Receives the MINISTOP app for 12-months and receives Community Group Mini.
Outcomes
Primary Outcome Measures
Body mass index
Body weight divided by height squared
Secondary Outcome Measures
Intake of key dietary indicators as assessed by a questionnaire.
Intake of fruits, vegetables, sweet snacks, savoury snacks, and sweet drinks (grams/day)
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)
Screen time as assessed by a questionnaire
Number of minutes per day spent in front of a screen
Self-efficacy self-efficacy for promoting healthy dietary and physical activity behaviours in their children's
Questionnaire to parents
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05529043
Brief Title
MINISTOP Plus Program for Pre-school Children With Overweight and Obesity
Official Title
MINISTOP Plus Program for Pre-school Children With Overweight and Obesity: A Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MINISTOP app
Arm Type
Active Comparator
Arm Description
Receives the MINISTOP app for 12-months.
Arm Title
MINISTOP Plus Program
Arm Type
Experimental
Arm Description
Receives the MINISTOP app for 12-months and receives Community Group Mini.
Intervention Type
Behavioral
Intervention Name(s)
MINISTOP app
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MINISTOP Plus Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body mass index
Description
Body weight divided by height squared
Time Frame
At the end of the intervention which is 12-months after baseline
Secondary Outcome Measure Information:
Title
Intake of key dietary indicators as assessed by a questionnaire.
Description
Intake of fruits, vegetables, sweet snacks, savoury snacks, and sweet drinks (grams/day)
Time Frame
At the end of the intervention which is 12-months after baseline.
Title
Physical activity assessed using an accelerometer
Description
Time spent in different physical activity intensities, i.e., sedentary, light, moderate, vigourous, and moderate-to-vigorous physical activity (minutes/day)
Time Frame
At the end of the intervention which is 12-months after baseline
Title
Screen time as assessed by a questionnaire
Description
Number of minutes per day spent in front of a screen
Time Frame
At the end of the intervention which is 12-months after baseline
Title
Self-efficacy self-efficacy for promoting healthy dietary and physical activity behaviours in their children's
Description
Questionnaire to parents
Time Frame
At the end of the intervention which is 12-months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Delisle Nyström, PhD
Phone
+46764014500
Email
christine.delisle.nystrom@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Löf, PhD
Phone
+56852481095
Email
marie.lof@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Delisle Nyström, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biosciences and Nutrition
City
Huddinge
ZIP/Postal Code
141 83
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Delisle Nyström, PhD
Phone
+46764014500
Email
christine.delisle.nystrom@ki.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MINISTOP Plus Program for Pre-school Children With Overweight and Obesity
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