Clinical trial NCT03800823: Overweight and Obesity in Preschoolers
Official title: A Randomized Controlled Trial for Overweight and Obesity in Preschoolers - The More and Less Study Europe
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Overweight
Keywords: Children
Obesity
Treatment
Family
mHealth
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: University of Medicine and Pharmacy "Victor Babes" Timisoara
name: El Centro de Investigación Biomédica en Red, CIBER
First posted: 2019-01-11
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in body mass index (BMI) z-score.
timeFrame: Baseline, 10 weeks, 9 months, 15 months, 21 months
Secondary outcomes:
measure: Waist circumference
timeFrame: Baseline, 10 weeks, 9 months, 15 months, 21 months
measure: Eating behaviour
timeFrame: Baseline, 9 months, 15 months, 21 months
measure: Parenting behaviour
timeFrame: Baseline, 9 months, 15 months, 21 months
measure: Physical activity and sedentary behaviour
timeFrame: Baseline, 9 months
measure: Food intake
timeFrame: Baseline, 9 months
measure: Epigenetic and metabolic markers
timeFrame: Baseline, 9 months
measure: Feasibility, attrition, and acceptability of the intervention as assessed using semi-structured interviews with parents and health care professionals
timeFrame: Baseline, 4 months
Other outcomes:
Locations:
city: Timişoara
country: Romania
facility: University of Medicine and Pharmacy "Victor Babes"
city: Palma De Mallorca
country: Spain
facility: University of the Balearic Islands & CIBEROBN
city: Huddinge
country: Sweden
facility: Karolinska Instituet
Study officials:
affiliation: Karolinska Institutet
name: Paulina Nowicka
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.