Clinical trial NCT04147039: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Forte
First posted: 2019-10-31
Enrollment: 552
Sex: ALL
Minimum age (years): 24
Maximum age (years): 38
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Intake of dietary key indicators as assessed by a questionnaire
timeFrame: At the end of the intervention which is six months after baseline
measure: Physical activity as assessed by a questionnaire
timeFrame: At the end of the intervention which is six months after baseline
Secondary outcomes:
measure: Body mass index
timeFrame: At the end of the intervention which is six months after baseline
measure: Satisfaction and usage of the app as assessed by a questionnaire and interviews
timeFrame: At the end of the intervention which is six months after baseline
measure: Usage of the app as assessed using the objectively measured activity in the app
timeFrame: At the end of the intervention which is six months after baseline
measure: Parental self-efficacy to promote healthy diet and physical activity behaviors in their child as assessed by a questionnaire
timeFrame: At the end of the intervention which is six months after baseline
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Department of Biosciences and Nutrition, Karolinska Institute
city: Linköping
country: Sweden
facility: Linköping University
Study officials:
References:
citation: 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.