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

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

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.

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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

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



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).



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021786


Locations
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Sweden
Department of Biosciences and Nutrition, Karolinska Institute
Huddinge, Sweden, 14183
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Investigators
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Principal Investigator: Marie Lof, PhD Karolinska Institutet
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
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:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight