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

A Web- and Mobile Phone-based Intervention to Prevent Obesity in 4-year-olds (MINISTOP): a Population-based Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02021786
Enrollment
315
Registered
2013-12-27
Start date
2014-01-31
Completion date
2015-10-31
Last updated
2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

Parents in the intervention group receive a six month mHealth program (the MINISTOP app) based on social cognitive theory with strategies to change unhealthy diet and physical activity behaviors. The program includes information, advice, and strategies to change unhealty behaviours and the possibility to register the child's intake of fruits, vegetables, candy, sweetened beverages, moderate-to-vigorous physical activity, and sedentary time. Feedback is then provided on reported variables. In addition, the parents are able to ask questions through the app to a dietician and a psychologist.

Sponsors

The Swedish Research Council
CollaboratorOTHER_GOV
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 5 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Body fatAt the end of the intervention and at a six month follow-upFat mass index, FMI

Secondary

MeasureTime frameDescription
Diet and physical activity variablesAt the end of the intervention and at a six month follow-upFruit, vegetables, candy, sweetened beverages, sedentary time and physical activity

Other

MeasureTime frameDescription
Composite scoresAt the end of the intervention and at a six month follow-upTwo scores based on the primary and secondary outcomes. The first one contains all seven outcomes (body composition, dietary variables, and physical activity variables), while the second one only includes the six secondary outcomes (dietary and physical activity variables).

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026