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A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds

Primary Purpose

Obesity, Childhood

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
MINISTOP 2.0
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood

Eligibility Criteria

24 Months - 38 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria:

-Children at the routine visit at 2.5-3 years of age at selected primary child health centers in Sweden

Exclusion criteria:

  • Children diagnosed with neurological or endocrine diseases
  • 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 content of the app (i.e. do not speak Swedish, English, Somali or Arabic)

Sites / Locations

  • Department of Biosciences and Nutrition, Karolinska Institute
  • Linköping University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Receives the MINISTOP 2.0 mobile phone app for 6 months

Receives standard care through primary child health care

Outcomes

Primary Outcome Measures

Intake of dietary key indicators as assessed by a questionnaire
Intake of dietary indicators such as fruits and vegetables, sweet and savory treats, sugar-sweetened drinks (in portions or grams per day)
Physical activity as assessed by a questionnaire
Time spent on moderate-to-vigorous physical activity, screen time (min/day)

Secondary Outcome Measures

Body mass index
Body weight divided by squared height
Satisfaction and usage of the app as assessed by a questionnaire and interviews
Percentage of users (parents and primary health care nurses) that were satisfied with app, used features in the app
Usage of the app as assessed using the objectively measured activity in the app
Number of recordings and messages read in the app (per time unit such as per week)
Parental self-efficacy to promote healthy diet and physical activity behaviors in their child as assessed by a questionnaire
Derived scores from selected questions from a questionnaire (Parental Self-Efficacy for Promoting Healthy Physical Activity and Dietary Behaviors in Children Scale (PSEPAD) Questionnaire). The minimum value is 0 and the maximum value 10.

Full Information

First Posted
October 21, 2019
Last Updated
July 1, 2022
Sponsor
Karolinska Institutet
Collaborators
Forte
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1. Study Identification

Unique Protocol Identification Number
NCT04147039
Brief Title
A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds
Official Title
A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds - a Randomised Controlled Trial in Primary Child Health Care.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2019 (Actual)
Primary Completion Date
April 8, 2022 (Actual)
Study Completion Date
April 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Forte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Childhood obesity is still a major global health issue. The preschool age (2-5 years) has been identified as a critical period to intervene, Mobile technology (mHealth) has been successful for weight loss and behavior changes in adults. This proposed randomized controlled trial aims to assess the effectiveness of an 6-month intervention program, the Mobile-based intervention to stop obesity in preschoolers (MINISTOP) 2.0 mobile phone app integrated in primary child health care for parents of children aged 2.5 years. The MINISTOP 2.0 app is built on the previous MINISTOP 1.0 app. Five hundred children will be recruited at their routine visit at 2.5 years of age and after baseline measures randomized to the intervention or control group. In addition, the investigators will assess acceptability, feasibility and appropriateness of the app by parents and primary child health care nurses.

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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
552 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Receives the MINISTOP 2.0 mobile phone app for 6 months
Arm Title
Control
Arm Type
No Intervention
Arm Description
Receives standard care through primary child health care
Intervention Type
Behavioral
Intervention Name(s)
MINISTOP 2.0
Intervention Description
The MINISTOP 2.0 is a behavioural change program aiming to promote healthier diet and physical activity among 2.5-year-old children. The program consists of features such as information, monitoring and feedback (dietary key variables, physical activity, screen time) and it is built around 13 themes during the 6-month period.
Primary Outcome Measure Information:
Title
Intake of dietary key indicators as assessed by a questionnaire
Description
Intake of dietary indicators such as fruits and vegetables, sweet and savory treats, sugar-sweetened drinks (in portions or grams per day)
Time Frame
At the end of the intervention which is six months after baseline
Title
Physical activity as assessed by a questionnaire
Description
Time spent on moderate-to-vigorous physical activity, screen time (min/day)
Time Frame
At the end of the intervention which is six months after baseline
Secondary Outcome Measure Information:
Title
Body mass index
Description
Body weight divided by squared height
Time Frame
At the end of the intervention which is six months after baseline
Title
Satisfaction and usage of the app as assessed by a questionnaire and interviews
Description
Percentage of users (parents and primary health care nurses) that were satisfied with app, used features in the app
Time Frame
At the end of the intervention which is six months after baseline
Title
Usage of the app as assessed using the objectively measured activity in the app
Description
Number of recordings and messages read in the app (per time unit such as per week)
Time Frame
At the end of the intervention which is six months after baseline
Title
Parental self-efficacy to promote healthy diet and physical activity behaviors in their child as assessed by a questionnaire
Description
Derived scores from selected questions from a questionnaire (Parental Self-Efficacy for Promoting Healthy Physical Activity and Dietary Behaviors in Children Scale (PSEPAD) Questionnaire). The minimum value is 0 and the maximum value 10.
Time Frame
At the end of the intervention which is six months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
38 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: -Children at the routine visit at 2.5-3 years of age at selected primary child health centers in Sweden Exclusion criteria: Children diagnosed with neurological or endocrine diseases 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 content of the app (i.e. do not speak Swedish, English, Somali or Arabic)
Facility Information:
Facility Name
Department of Biosciences and Nutrition, Karolinska Institute
City
Huddinge
ZIP/Postal Code
14183
Country
Sweden
Facility Name
Linköping University
City
Linköping
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33228572
Citation
Henriksson H, Alexandrou C, Henriksson P, Henstrom M, Bendtsen M, Thomas K, Mussener U, Nilsen P, Lof M. MINISTOP 2.0: a smartphone app integrated in primary child health care to promote healthy diet and physical activity behaviours and prevent obesity in preschool-aged children: protocol for a hybrid design effectiveness-implementation study. BMC Public Health. 2020 Nov 23;20(1):1756. doi: 10.1186/s12889-020-09808-w.
Results Reference
derived

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A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds

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