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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021786
• Other study ID #: VF-2012-09062883
• Status: Completed
• Phase: N/A
• First received: December 20, 2013
• Last updated: March 1, 2017
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: March 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Mobile phone based intervention
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.

Locations

Country	Name	City	State
Sweden	Department of Biosciences and Nutrition, Karolinska Institute	Huddinge

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Delisle C, Sandin S, Forsum E, Henriksson H, Trolle-Lagerros Y, Larsson C, Maddison R, Ortega FB, Ruiz JR, Silfvernagel K, Timpka T, Löf M. A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite scores	Two 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).	At the end of the intervention and at a six month follow-up
Primary	Body fat	Fat mass index, FMI	At the end of the intervention and at a six month follow-up
Secondary	Diet and physical activity variables	Fruit, vegetables, candy, sweetened beverages, sedentary time and physical activity	At the end of the intervention and at a six month follow-up