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ACTIVE NOT RECRUITING
NCT03800823
NA

Overweight and Obesity in Preschoolers

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

Summary

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).

Official title: A Randomized Controlled Trial for Overweight and Obesity in Preschoolers - The More and Less Study Europe

Key Details

Gender

All

Age Range

2 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2019-02-15

Completion Date

2025-12-31

Last Updated

2024-10-09

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Parent group

In group sessions parents will learn how to use positive parenting practices (e.g., encouragement and limit setting) instead of ineffective practices (e.g., coercive behaviour, negative reciprocity). Using a parent group approach, each of the 10 sessions consist of introduction to effective parenting practices followed by a discussion and practice using role play and home practice assignments.

BEHAVIORAL

mHealth component

After the group sessions, parents will receive a 6-month mHealth program (MINISTOP app) based on social cognitive theory with strategies to change unhealthy diet/physical activity behaviours. The program includes information, advice, and strategies to change unhealthy behaviours and the possibility to register the child's intake of fruit, vegetables, candy, sweetened beverages, and sedentary time.

BEHAVIORAL

Standard care

Standard care for overweight and obesity.

Locations (3)

University of Medicine and Pharmacy "Victor Babes"

Timișoara, Romania

University of the Balearic Islands & CIBEROBN

Palma de Mallorca, Spain

Karolinska Instituet

Huddinge, Sweden