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

NCT02021786 | Completed DMC

• 1 other identifier: VF-2012-09062883
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Body fat

  Fat mass index, FMI

  At the end of the intervention and at a six month follow-up

Secondary Outcomes (1)

• Diet and physical activity variables

  At the end of the intervention and at a six month follow-up

Other Outcomes (1)

• Composite scores

  At the end of the intervention and at a six month follow-up

Study Arms (2)

Mobile phone based intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Mobile phone based intervention BEHAVIORAL

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.

Mobile phone based intervention

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Swedish Research Council: collaborator

Study Sites (1)

Department of Biosciences and Nutrition, Karolinska Institute

Huddinge, 14183, Sweden

Location

Related Publications (4)

• 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.

  PMID: 25886009 RESULT

• 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.

  PMID: 29793467 DERIVED

• 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.

  PMID: 28466851 DERIVED

• 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.

  PMID: 28446496 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Lof, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: January 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)