MINISTOP Plus Program for Pre-school Children With Overweight and Obesity: A Pilot Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Karolinska Institutet
- Locations
- 1
- Primary Endpoint
- Body mass index
Overview
Brief Summary
The Mobile-based intervention intended to stop obesity in preschoolers (MINISTOP) program has been developed to be a comprehensive digital support program for all children irrespective of weight status. However, a one size fits all approach may not be sufficient as some families may require extra support through in-person activities to achieve the required lifestyle behaviour change in order to attain and maintain a healthy weight. Therefore, the aims of this pilot randomized controlled trial are to evaluate the efficacy and feasibility of the MINISTOP Plus Program in pre-school children with overweight and obesity on: (i) children's BMI z-scores; (ii) intake of fruit and vegetables, sweet and savoury snacks, and sweet drinks; (iii) time spent in different physical activity intensities; (iv) screen time; and (v) parental self-efficacy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 2 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •2 to 5 year old children with overweight and obesity residing in the municipality of Kungsbacka.
Exclusion Criteria
- •If a child has a disease or disorder that affects body size or feeding.
- •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 app content, i.e., those who do not speak Swedish, English, Arabic, or Somali
Outcomes
Primary Outcomes
Body mass index
Time Frame: At the end of the intervention which is 12-months after baseline
Body weight divided by height squared
Secondary Outcomes
- Physical activity assessed using an accelerometer(At the end of the intervention which is 12-months after baseline)
- Self-efficacy self-efficacy for promoting healthy dietary and physical activity behaviours in their children's(At the end of the intervention which is 12-months after baseline)
- Screen time as assessed by a questionnaire(At the end of the intervention which is 12-months after baseline)
- Intake of key dietary indicators as assessed by a questionnaire.(At the end of the intervention which is 12-months after baseline.)
Investigators
Christine Delisle Nyström
Principal investigator
Karolinska Institutet