Overweight and Obesity in Preschoolers

NCT03800823 | Active Not Recruiting

• 1 other identifier: 774548-WP8
• Study Type: interventional
• Target: 300
• Locations: 3 countries
• Sites: 3

Brief 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).

Conditions

Obesity; Overweight

Keywords

Children; Obesity; Treatment; Family; mHealth

Outcome Measures

Primary Outcomes (1)

• Change in body mass index (BMI) z-score.

  It is the most commonly used indicator of changes in weight status in pediatric obesity studies and enable comparison between other studies. The children's weight and height will be measured using standardized procedures and BMI z-scores will be derived from Swedish age and gender specific reference values.

  Baseline, 10 weeks, 9 months, 15 months, 21 months

Secondary Outcomes (7)

• Waist circumference

  Baseline, 10 weeks, 9 months, 15 months, 21 months

• Eating behaviour

  Baseline, 9 months, 15 months, 21 months

• Parenting behaviour

  Baseline, 9 months, 15 months, 21 months

• Physical activity and sedentary behaviour

  Baseline, 9 months

• Food intake

  Baseline, 9 months

Study Arms (2)

Parent group & mHealth component

EXPERIMENTAL

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.

Behavioral: Parent group; Behavioral: mHealth component

Standard care

ACTIVE COMPARATOR

Standard care for overweight and obesity

Behavioral: Standard care

Interventions

Parent group BEHAVIORAL

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.

Parent group & mHealth component

mHealth component BEHAVIORAL

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.

Parent group & mHealth component

Standard care BEHAVIORAL

Standard care for overweight and obesity.

Standard care

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• University of Medicine and Pharmacy "Victor Babes" Timisoara: collaborator
• El Centro de Investigación Biomédica en Red, CIBER: collaborator

Study Sites (3)

University of Medicine and Pharmacy "Victor Babes"

Timișoara, 30041, Romania

Location

University of the Balearic Islands & CIBEROBN

Palma de Mallorca, 07122, Spain

Location

Karolinska Instituet

Huddinge, 14157, Sweden

Location

Related Publications (4)

• Eli K, Neovius C, Nordin K, Brissman M, Ek A. Parents' experiences following conversations about their young child's weight in the primary health care setting: a study within the STOP project. BMC Public Health. 2022 Aug 12;22(1):1540. doi: 10.1186/s12889-022-13803-8.

  PMID: 35962359 DERIVED

• Serban CL, Putnoky S, Ek A, Eli K, Nowicka P, Chirita-Emandi A. Making Childhood Obesity a Priority: A Qualitative Study of Healthcare Professionals' Perspectives on Facilitating Communication and Improving Treatment. Front Public Health. 2021 Jul 15;9:652491. doi: 10.3389/fpubh.2021.652491. eCollection 2021.

  PMID: 34336760 DERIVED

• Sjunnestrand M, Nordin K, Eli K, Nowicka P, Ek A. Planting a seed - child health care nurses' perceptions of speaking to parents about overweight and obesity: a qualitative study within the STOP project. BMC Public Health. 2019 Nov 9;19(1):1494. doi: 10.1186/s12889-019-7852-4.

  PMID: 31706318 DERIVED

• Ek A, Delisle Nystrom C, Chirita-Emandi A, Tur JA, Nordin K, Bouzas C, Argelich E, Martinez JA, Frost G, Garcia-Perez I, Saez M, Paul C, Lof M, Nowicka P. A randomized controlled trial for overweight and obesity in preschoolers: the More and Less Europe study - an intervention within the STOP project. BMC Public Health. 2019 Jul 15;19(1):945. doi: 10.1186/s12889-019-7161-y.

  PMID: 31307412 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Paulina Nowicka

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 11, 2019
• Study Start: February 15, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

ES (1); SE (1); RO (1)