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Clinical Trials/NCT04147039
NCT04147039
Completed
Not Applicable

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.

Karolinska Institutet2 sites in 1 country552 target enrollmentNovember 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity, Childhood
Sponsor
Karolinska Institutet
Enrollment
552
Locations
2
Primary Endpoint
Intake of dietary key indicators as assessed by a questionnaire
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2, 2019
End Date
April 8, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marie Löf, docent

Professor

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Intake of dietary key indicators as assessed by a questionnaire

Time Frame: At the end of the intervention which is six months after baseline

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 Frame: At the end of the intervention which is six months after baseline

Time spent on moderate-to-vigorous physical activity, screen time (min/day)

Secondary Outcomes

  • Body mass index(At the end of the intervention which is six months after baseline)
  • Usage of the app as assessed using the objectively measured activity in the app(At the end of the intervention which is six months after baseline)
  • Satisfaction and usage of the app as assessed by a questionnaire and interviews(At the end of the intervention which is six months after baseline)
  • Parental self-efficacy to promote healthy diet and physical activity behaviors in their child as assessed by a questionnaire(At the end of the intervention which is six months after baseline)

Study Sites (2)

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