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

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

Tracking Information

• First Submitted Date: October 21, 2019
• First Posted Date: October 31, 2019
• Last Update Posted Date: November 5, 2019
• Actual Study Start Date: November 2, 2019
• Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT04147039 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds
• 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.
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Prevention
• Condition: Obesity, Childhood

Intervention

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

• 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

Recruitment Information

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

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 24 Months to 38 Months (Child)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT04147039
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Marie Löf, docent, Karolinska Institutet
• Study Sponsor: Karolinska Institutet
• Collaborators: FORTE
• Investigators: Not Provided
• PRS Account: Karolinska Institutet
• Verification Date: November 2019