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.

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: MINISTOP 2.0

• Study Type: Interventional
• Enrollment (Actual): 552
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge, Sweden, 14183
    • Department of Biosciences and Nutrition, Karolinska Institute
  • Linköping, Sweden
    • Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 13 themes during the 6-month period.
No Intervention: Control; Receives standard care through primary child health care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Body weight divided by squared height	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	Percentage of users (parents and primary health care nurses) that were satisfied with app, used features in the app	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	Number of recordings and messages read in the app (per time unit such as per week)	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	Derived 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.	At the end of the intervention which is six months after baseline

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Forte

Publications and helpful links

General Publications

• Henriksson H, Alexandrou C, Henriksson P, Henström M, Bendtsen M, Thomas K, Müssener U, Nilsen P, Löf 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2019
• Primary Completion (Actual): April 8, 2022
• Study Completion (Actual): April 8, 2022

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 2019-02747

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No