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

NCT ID: NCT04147039

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

552 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-02

Study Completion Date

2022-04-08

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention

Receives the MINISTOP 2.0 mobile phone app for 6 months

Group Type EXPERIMENTAL

MINISTOP 2.0

Intervention Type BEHAVIORAL

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.

Control

Receives standard care through primary child health care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 13 themes during the 6-month period.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

24 Months

Maximum Eligible Age

38 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Forte

INDUSTRY

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Marie Löf, docent

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Biosciences and Nutrition, Karolinska Institute

Huddinge, , Sweden

Site Status

Linköping University

Linköping, , Sweden

Site Status

Countries

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Sweden

References

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Alexandrou C, Henriksson H, Henstrom M, Henriksson P, Delisle Nystrom C, Bendtsen M, Lof M. Effectiveness of a Smartphone App (MINISTOP 2.0) integrated in primary child health care to promote healthy diet and physical activity behaviors and prevent obesity in preschool-aged children: randomized controlled trial. Int J Behav Nutr Phys Act. 2023 Feb 21;20(1):22. doi: 10.1186/s12966-023-01405-5.

Reference Type DERIVED
PMID: 36810069 (View on PubMed)

Henriksson H, Alexandrou C, Henriksson P, Henstrom M, Bendtsen M, Thomas K, Mussener U, Nilsen P, Lof M. MINISTOP 2.0: a smartphone app integrated in primary child health care to promote healthy diet and physical activity behaviours and prevent obesity in preschool-aged children: protocol for a hybrid design effectiveness-implementation study. BMC Public Health. 2020 Nov 23;20(1):1756. doi: 10.1186/s12889-020-09808-w.

Reference Type DERIVED
PMID: 33228572 (View on PubMed)

Other Identifiers

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2019-02747

Identifier Type: -

Identifier Source: org_study_id

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