A Web- and Mobile Phone-based Intervention to Prevent Obesity in 4-year-olds (MINISTOP): a Population-based Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 315
- Locations
- 1
- Primary Endpoint
- Body fat
Study Overview
Brief Summary
This study aims to evaluate the effects of a mobile phone-based dietary and physical activity intervention on body fatness, dietary intake and physical activity of preschoolers
Detailed Description
Childhood overweight and obesity is an increasing health problem globally, and can be established as early as 2-5 years of age. Mobile phone based (mHealth) interventions have been successful for weight management in adults; however, their potential in young children is yet to be established. Therefore, the ultimate goal of MINISTOP (Mobile-based INtervention Intended to STop Obesity in Preschoolers) trial is to help parents of four year old children to achieve a healthy weight and body fat via a smartphone app (MINISTOP). More specifically this trial aims to reduce body fat (primary outcome), increase the intake of fruits, vegetables as well as decrease the intake of candy, and sweetened beverages, and increase the amount of time spent in moderate-to-vigorous physical activity and decrease sedentary behaviors (secondary outcomes) in healthy preschool aged Swedish children. If the MINISTOP app is effective, it has the potential to be incorporated into the child health care to aid in counteracting overweight and obesity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •parents having a four year old child and living in Östergötland; having the ability to have their child measured at baseline at 4.5 years ± 2 months of age
- •at least one parent had to able to speak and read Swedish sufficiently well (i.e. be able to provide informed consent and understand the intervention content)
Exclusion Criteria
- •A child with a neurological or endocrine disease effecting weight
- •A child with a parent suffering from a serious physical or psychological disease making the study too demanding for the family.
Arms & Interventions
Mobile phone based intervention
The intervention in the present study is a web- and mobile phone based intervention aiming to develop healthy lifestyle behaviors regarding physical activity and dietary habits in 4-year-olds. The intervention will be delivered to the parents and it is available to the parents during six months.
Intervention: Mobile phone based intervention (Behavioral)
Control
The control group receive a pamphlet on healthy eating and physical activity in pre-school children based on the existing guidelines. The information is similar to what parents receive from the Swedish child healthcare system
Outcomes
Primary Outcomes
Body fat
Time Frame: At the end of the intervention and at a six month follow-up
Fat mass index, FMI
Secondary Outcomes
- Diet and physical activity variables(At the end of the intervention and at a six month follow-up)
Investigators
Marie Löf, docent
Associate professor
Karolinska Institutet