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NCT Number: NCT04147039

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

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.

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

24 month–38 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biosciences and Nutrition, Karolinska Institute, Huddinge, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MINISTOP 2.0

Behavioral

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 outcomes

  1. 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)

  2. 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

  1. Body mass index

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

    Body weight divided by squared height

  2. Satisfaction and usage of the app as assessed by a questionnaire and interviews

    Time frame: 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

  3. Usage of the app as assessed using the objectively measured activity in the app

    Time frame: 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)

  4. Parental self-efficacy to promote healthy diet and physical activity behaviors in their child as assessed by a questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Forte

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2019
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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