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A Randomized Controlled Trial for Overweight and Obesity in Preschoolers - The More and Less Study Europe
Obesity interventions in early childhood are recommended as they have been proven to be more effective than interventions later in life. The overall aim of this study is to assess the effectiveness, feasibility, and acceptance of an overweight and obesity intervention in socially disadvantaged families. Participants will be families with children aged 2-6 years (n = 300) with overweight or obesity and will be recruited from three sites: Stockholm, Sweden (n = 100); Timisoara, Romania (n = 100); and Mallorca, Spain (n = 100).
The proposed randomized controlled trial has five specific aims: Specific Aim 1: To determine the effectiveness of a 10 week parent-only group support program focusing on evidence-based parenting practices followed by a mobile health (mHealth) component for 6-months (n = 150) compared to standard care (n = 150) for overweight and obesity in pre-school children (change in BMI z-scores after 9 months primary outcome). Specific Aim 2: To determine if the intervention can improve body composition (waist circumference), child eating behaviour, physical activity, and parental feeding practices in comparison to the control group. Specific Aim 3: To assess reversibility of the molecular signatures of obesity following the intervention through epigenetic markers in white blood cells (methylation) and analyzing the role of the gut hormones. Specific Aim 4: To assess and validate child food intake with metabolic markers in urine. Specific Aim 5: To evaluate the feasibility of recruitment (facilitators and barriers), attrition and acceptability, as well as patient and caregiver satisfaction to the intervention.
Age
2 - 6 years
Sex
ALL
Healthy Volunteers
Yes
University of Medicine and Pharmacy "Victor Babes"
Timișoara, Romania
University of the Balearic Islands & CIBEROBN
Palma de Mallorca, Spain
Karolinska Instituet
Huddinge, Sweden
Start Date
February 15, 2019
Primary Completion Date
December 31, 2022
Completion Date
December 31, 2025
Last Updated
October 9, 2024
300
ESTIMATED participants
Parent group
BEHAVIORAL
mHealth component
BEHAVIORAL
Standard care
BEHAVIORAL
Lead Sponsor
Karolinska Institutet
Collaborators
NCT01143454
NCT07472881
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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