A web-and Mobile Phone-based Intervention in 4-year-olds: a Population-based Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT02021786
• Lead Sponsor: Karolinska Institutet

Brief Summary

This study aims to evaluate the effects of a mobile phone-based dietary and physical activity intervention on body fatness, dietary intake and physical activity of preschoolers

Detailed Description

Childhood overweight and obesity is an increasing health problem globally, and can be established as early as 2-5 years of age. Mobile phone based (mHealth) interventions have been successful for weight management in adults; however, their potential in young children is yet to be established. Therefore, the ultimate goal of MINISTOP (Mobile-based INtervention Intended to STop Obesity in Preschoolers) trial is to help parents of four year old children to achieve a healthy weight and body fat via a smartphone app (MINISTOP). More specifically this trial aims to reduce body fat (primary outcome), increase the intake of fruits, vegetables as well as decrease the intake of candy, and sweetened beverages, and increase the amount of time spent in moderate-to-vigorous physical activity and decrease sedentary behaviors (secondary outcomes) in healthy preschool aged Swedish children. If the MINISTOP app is effective, it has the potential to be incorporated into the child health care to aid in counteracting overweight and obesity.

Study Timeline

• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Study Start: 2014-01
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

• parents having a four year old child and living in Östergötland; having the ability to have their child measured at baseline at 4.5 years ± 2 months of age
• at least one parent had to able to speak and read Swedish sufficiently well (i.e. be able to provide informed consent and understand the intervention content)

Exclusion Criteria

• A child with a neurological or endocrine disease effecting weight
• A child with a parent suffering from a serious physical or psychological disease making the study too demanding for the family.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body fat	At the end of the intervention and at a six month follow-up	Fat mass index, FMI

Secondary Outcome Measures

Name	Time	Method
Diet and physical activity variables	At the end of the intervention and at a six month follow-up	Fruit, vegetables, candy, sweetened beverages, sedentary time and physical activity

Trial Locations

Locations (1)

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