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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

Tracking Information
First Submitted Date  ICMJE December 20, 2013
First Posted Date  ICMJE December 27, 2013
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
Body fat [ Time Frame: At the end of the intervention and at a six month follow-up ]
Fat mass index, FMI
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
Body fatness (percentage of body weight) [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: March 1, 2017)
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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A web-and Mobile Phone-based Intervention in 4-year-olds: a Population-based Randomized Controlled Trial
Official Title  ICMJE A Web- and Mobile Phone-based Intervention to Prevent Obesity in 4-year-olds (MINISTOP): a Population-based Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Mobile phone based intervention
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2016)
315
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2013)
300
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02021786
Other Study ID Numbers  ICMJE VF-2012-09062883
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marie Löf, docent, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE The Swedish Research Council
Investigators  ICMJE
Principal Investigator: Marie Lof, PhD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP