Overweight and Obesity in Preschoolers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obesity
- Overweight
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 2 years and 6 years
- Gender
- Both males and females
Description
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 ca...
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.
Tracking Information
- NCT #
- NCT03800823
- Collaborators
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- El Centro de Investigación Biomédica en Red, CIBER
- Investigators
- Principal Investigator: Paulina Nowicka Karolinska Institutet