Overweight and Obesity in Preschoolers (MLEurope)

Karolinska Institute

Status: Active, not recruiting

Conditions: Overweight; Obesity

Treatments: Behavioral: mHealth component; Behavioral: Parent group; Behavioral: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT03800823

774548-WP8

Details and patient eligibility

About

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).

Full 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 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 2 to 6 year old children with overweight or obesity according to international cut-offs.
• Children who have no other underlying medical condition(s).
• Parent(s) who have the ability to communicate in Swedish (for the Swedish part), Romanian (for the Romanian part), and Spanish (for the Spanish part).

Exclusion criteria

• Parent(s) not owning a smartphone compatible with the MINISTOP app.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Parent group & mHealth component

Experimental group

Description:

The intervention in the present study is a 10 week parent training group session (More and Less Program) followed by a 6-month mobile phone based intervention. Both components aim to develop healthy lifestyle behaviours regarding dietary habits and physical activity in 2-6 year olds. The intervention is delivered towards the parents.

Treatment:

Behavioral: Parent group

Behavioral: mHealth component

Standard care

Active Comparator group

Description:

Standard care for overweight and obesity

Treatment:

Behavioral: Standard care