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A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds

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ClinicalTrials.gov Identifier: NCT04147039
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
FORTE
Information provided by (Responsible Party):
Marie Löf, docent, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE October 21, 2019
First Posted Date  ICMJE October 31, 2019
Last Update Posted Date November 5, 2019
Actual Study Start Date  ICMJE November 2, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
  • Intake of dietary key indicators as assessed by a questionnaire [ Time Frame: At the end of the intervention which is six months after baseline ]
    Intake of dietary indicators such as fruits and vegetables, candy, sugar-sweetened drinks (in portions or grams per day)
  • Physical activity as assessed by a questionnaire [ Time Frame: At the end of the intervention which is six months after baseline ]
    Time spent on moderate-to-vigorous physical activity, screen time (min/day)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04147039 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
  • Body mass index [ Time Frame: At the end of the intervention which is six months after baseline ]
    Body weight divided by squared height
  • Satisfaction and usage of the app as assessed by a questionnaire [ Time Frame: At the end of the intervention which is six months after baseline ]
    Percentage of users (parents and primary health care nurses) that were satisfied with app, used features in the app
  • Usage of the app as assessed using the objectively measured activity in the app [ Time Frame: At the end of the intervention which is six months after baseline ]
    Number of recordings and messages read in the app (per time unit such as per week)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds
Official Title  ICMJE A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds - a Randomised Controlled Trial in Primary Child Health Care.
Brief Summary Childhood obesity is still a major global health issue. The preschool age (2-5 years) has been identified as a critical period to intervene, Mobile technology (mHealth) has been successful for weight loss and behavior changes in adults. This proposed randomized controlled trial aims to assess the effectiveness of an 6-month intervention program, the Mobile-based intervention to stop obesity in preschoolers (MINISTOP) 2.0 mobile phone app integrated in primary child health care for parents of children aged 2.5 years. The MINISTOP 2.0 app is built on the previous MINISTOP 1.0 app. Three hundred children will be recruited at their routine visit at 2.5 years of age and after baseline measures randomized to the intervention or control group. In addition, the investigators will assess acceptability, feasibility and adoption of the app by parents and primary child health care nurses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Obesity, Childhood
Intervention  ICMJE Behavioral: MINISTOP 2.0
The MINISTOP 2.0 is a behavioural change program aiming to promote healthier diet and physical activity among 2.5-year-old children. The program consists of features such as information, monitoring and feedback (dietary key variables, physical activity, screen time) and it is built around 12 themes during the 6-month period.
Study Arms  ICMJE
  • Experimental: Intervention
    Receives the MINISTOP 2.0 mobile phone app for 6 months
    Intervention: Behavioral: MINISTOP 2.0
  • No Intervention: Control
    Receives standard care through primary child health care
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 29, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

-Children at the routine visit at 2.5-3 years of age at selected primary child health centers in Sweden

Exclusion criteria:

  • Children diagnosed with neurological or endocrine diseases
  • Children who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family
  • Children from families who will not be able to understand the content of the app (i.e. do not speak Swedish, English, Somali or Arabic)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Months to 38 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04147039
Other Study ID Numbers  ICMJE 2019-02747
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marie Löf, docent, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE FORTE
Investigators  ICMJE Not Provided
PRS Account Karolinska Institutet
Verification Date November 2019

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