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

• ClinicalTrials.gov Identifier: NCT02021786
• Recruitment Status: Completed
• First Posted: December 27, 2013
• Last Update Posted: March 3, 2017
• Sponsor: Karolinska Institutet
• Collaborator: The Swedish Research Council
• Information provided by (Responsible Party): Marie Löf, docent, Karolinska Institutet

Study Description

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

Condition or disease	Intervention/treatment	Phase
Obesity	Behavioral: Mobile phone based intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 315 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Web- and Mobile Phone-based Intervention to Prevent Obesity in 4-year-olds (MINISTOP): a Population-based Randomized Controlled Trial
• Study Start Date: January 2014
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mobile phone based intervention; The intervention in the present study is a web- and mobile phone based intervention aiming to develop healthy lifestyle behaviors regarding physical activity and dietary habits in 4-year-olds. The intervention will be delivered to the parents and it is available to the parents during six months.	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.
No Intervention: Control; The control group receive a pamphlet on healthy eating and physical activity in pre-school children based on the existing guidelines. The information is similar to what parents receive from the Swedish child healthcare system

Outcome Measures

Primary Outcome Measures :

1. Body fat [ Time Frame: At the end of the intervention and at a six month follow-up ]
   Fat mass index, FMI

Secondary Outcome Measures :

1. Diet and physical activity variables [ Time Frame: At the end of the intervention and at a six month follow-up ]
   Fruit, vegetables, candy, sweetened beverages, sedentary time and physical activity

Other Outcome Measures:

1. Composite scores [ Time Frame: At the end of the intervention and at a six month follow-up ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 5 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Sweden

Department of Biosciences and Nutrition, Karolinska Institute

Huddinge, Sweden, 14183

Sponsors and Collaborators

Karolinska Institutet

The Swedish Research Council

Investigators

• Principal Investigator: Marie Lof, PhD; Karolinska Institutet

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Marie Löf, docent, Associate professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT02021786
• Other Study ID Numbers: VF-2012-09062883
• First Posted: December 27, 2013
• Last Update Posted: March 3, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight