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

Not Applicable

Completed

• Conditions: Obesity, Childhood
• Interventions: Behavioral: MINISTOP 2.0

• Registration Number: NCT04147039
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-31
• Study Start: 2019-11-02
• Primary Completion: 2022-04-08
• Study Completion: 2022-04-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 552

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	MINISTOP 2.0	Receives the MINISTOP 2.0 mobile phone app for 6 months

Primary Outcome Measures

Name	Time	Method
Intake of dietary key indicators as assessed by a questionnaire	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	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 Outcome Measures

Name	Time	Method
Body mass index	At the end of the intervention which is six months after baseline	Body weight divided by squared height
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	Number of recordings and messages read in the app (per time unit such as per week)
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	Percentage of users (parents and primary health care nurses) that were satisfied with app, used features in the app
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	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.

Trial Locations

Locations (2)

Linköping University; 🇸🇪 Linköping, Sweden

Department of Biosciences and Nutrition, Karolinska Institute; 🇸🇪 Huddinge, Sweden