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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Behavioral: MINISTOP 2.0


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 38 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Receives the MINISTOP 2.0 mobile phone app for 6 months | Behavioral: MINISTOP 2.0<br>* 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.<br>|
| No Intervention: Control<br>Receives standard care through primary child health care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | At the end of the intervention which is six months after baseline | 
| Physical activity as assessed by a questionnaire | Time spent on moderate-to-vigorous physical activity, screen time (min/day) | At the end of the intervention which is six months after baseline | 

Secondary Outcome Measures

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