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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04147039
Enrollment
552
Registered
2019-10-31
Start date
2019-11-02
Completion date
2022-04-08
Last updated
2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

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. Five 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 appropriateness of the app by parents and primary child health care nurses.

Interventions

BEHAVIORALMINISTOP 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 13 themes during the 6-month period.

Sponsors

Forte
CollaboratorINDUSTRY
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
24 Months to 38 Months
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Intake of dietary key indicators as assessed by a questionnaireAt the end of the intervention which is six months after baselineIntake of dietary indicators such as fruits and vegetables, sweet and savory treats, sugar-sweetened drinks (in portions or grams per day)
Physical activity as assessed by a questionnaireAt the end of the intervention which is six months after baselineTime spent on moderate-to-vigorous physical activity, screen time (min/day)

Secondary

MeasureTime frameDescription
Body mass indexAt the end of the intervention which is six months after baselineBody weight divided by squared height
Satisfaction and usage of the app as assessed by a questionnaire and interviewsAt the end of the intervention which is six months after baselinePercentage 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 appAt the end of the intervention which is six months after baselineNumber of recordings and messages read in the app (per time unit such as per week)
Parental self-efficacy to promote healthy diet and physical activity behaviors in their child as assessed by a questionnaireAt the end of the intervention which is six months after baselineDerived scores from selected questions from a questionnaire (Parental Self-Efficacy for Promoting Healthy Physical Activity and Dietary Behaviors in Children Scale (PSEPAD) Questionnaire). The minimum value is 0 and the maximum value 10.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026