Clinical trial NCT02021786: A web-and Mobile Phone-based Intervention in 4-year-olds: a Population-based Randomized Controlled Trial
Official title: A Web- and Mobile Phone-based Intervention to Prevent Obesity in 4-year-olds (MINISTOP): a Population-based Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2013-12-27
Enrollment: 315
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body fat
timeFrame: At the end of the intervention and at a six month follow-up
Secondary outcomes:
measure: Diet and physical activity variables
timeFrame: At the end of the intervention and at a six month follow-up
Other outcomes:
measure: Composite scores
timeFrame: At the end of the intervention and at a six month follow-up
Locations:
city: Huddinge
country: Sweden
facility: Department of Biosciences and Nutrition, Karolinska Institute
Study officials:
affiliation: Karolinska Institutet
name: Marie Lof, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delisle C, Sandin S, Forsum E, Henriksson H, Trolle-Lagerros Y, Larsson C, Maddison R, Ortega FB, Ruiz JR, Silfvernagel K, Timpka T, Lof M. A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomized controlled trial. BMC Public Health. 2015 Feb 7;15:95. doi: 10.1186/s12889-015-1444-8.
citation: Delisle Nystrom C, Sandin S, Henriksson P, Henriksson H, Maddison R, Lof M. A 12-month follow-up of a mobile-based (mHealth) obesity prevention intervention in pre-school children: the MINISTOP randomized controlled trial. BMC Public Health. 2018 May 24;18(1):658. doi: 10.1186/s12889-018-5569-4.
citation: Cadenas-Sanchez C, Henriksson P, Henriksson H, Delisle Nystrom C, Pomeroy J, Ruiz JR, Ortega FB, Lof M. Parental body mass index and its association with body composition, physical fitness and lifestyle factors in their 4-year-old children: results from the MINISTOP trial. Eur J Clin Nutr. 2017 Oct;71(10):1200-1205. doi: 10.1038/ejcn.2017.62. Epub 2017 May 3.
citation: Nystrom CD, Sandin S, Henriksson P, Henriksson H, Trolle-Lagerros Y, Larsson C, Maddison R, Ortega FB, Pomeroy J, Ruiz JR, Silfvernagel K, Timpka T, Lof M. Mobile-based intervention intended to stop obesity in preschool-aged children: the MINISTOP randomized controlled trial. Am J Clin Nutr. 2017 Jun;105(6):1327-1335. doi: 10.3945/ajcn.116.150995. Epub 2017 Apr 26.