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

NCT04147039 | Completed

• 1 other identifier: 2019-02747
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (2)

• Intake of dietary key indicators as assessed by a questionnaire

  Intake of dietary indicators such as fruits and vegetables, sweet and savory treats, sugar-sweetened drinks (in portions or grams per day)

  At the end of the intervention which is six months after baseline

• Physical activity as assessed by a questionnaire

  Time spent on moderate-to-vigorous physical activity, screen time (min/day)

  At the end of the intervention which is six months after baseline

Secondary Outcomes (4)

• Body mass index

  At the end of the intervention which is six months after baseline

• Satisfaction and usage of the app as assessed by a questionnaire and interviews

  At the end of the intervention which is six months after baseline

• Usage of the app as assessed using the objectively measured activity in the app

  At the end of the intervention which is six months after baseline

• Parental self-efficacy to promote healthy diet and physical activity behaviors in their child as assessed by a questionnaire

  At the end of the intervention which is six months after baseline

Study Arms (2)

Intervention

EXPERIMENTAL

Receives the MINISTOP 2.0 mobile phone app for 6 months

Behavioral: MINISTOP 2.0

Control

NO INTERVENTION

Receives standard care through primary child health care

Interventions

MINISTOP 2.0 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.

Intervention

Eligibility Criteria

• Age: 24 Months - 38 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Forte: collaborator

Study Sites (2)

Department of Biosciences and Nutrition, Karolinska Institute

Huddinge, 14183, Sweden

Location

Linköping University

Linköping, Sweden

Location

Related Publications (2)

• 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.

  PMID: 36810069 DERIVED

• 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.

  PMID: 33228572 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 31, 2019
• Study Start: November 2, 2019
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)