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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

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.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Behavioral: MINISTOP 2.0 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : November 2, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Receives the MINISTOP 2.0 mobile phone app for 6 months
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.

No Intervention: Control
Receives standard care through primary child health care



Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. Body mass index [ Time Frame: At the end of the intervention which is six months after baseline ]
    Body weight divided by squared height

  2. 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

  3. 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)



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Ages Eligible for Study:   24 Months to 38 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT04147039


Locations
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Sweden
Department of Biosciences and Nutrition, Karolinska Institute Recruiting
Huddinge, Sweden, 14183
Contact: Marie Lof, PhD    +46-8-52481095    marie.lof@ki.se   
Principal Investigator: Marie Lof, PhD         
Linköping University Recruiting
Linköping, Sweden
Contact: Hanna Henriksson    073-0263858    hanna.henriksson@liu.se   
Sponsors and Collaborators
Karolinska Institutet
FORTE

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Responsible Party: Marie Löf, docent, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04147039     History of Changes
Other Study ID Numbers: 2019-02747
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms