Clinical trial NCT01792531: The More & Less Study: A Trial Testing Different Treatment Approaches to Obesity in Preschoolers
Official title: The More & Less Study: A Randomized Controlled Trial Testing Different Treatment Approaches to Obesity in Preschoolers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: children
obesity
treatment
family
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Oregon Social Learning Center
First posted: 2013-02-15
Enrollment: 177
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity has been shown to be resistant to treatment in adults, adolescents, and in school age children, but not during early childhood. Yet knowledge on the effectiveness of early childhood treatment programs for obesity is still very limited, preventing the widespread implementation of such programs. The overarching purpose of this study is to evaluate the effectiveness of early treatment of childhood obesity. The investigators plan to perform a carefully-designed randomized controlled trial that will evaluate different treatment options offered to families with children with obesity, organized within the healthcare system and followed up for at least 1 year post-baseline. Participants will be children aged 4-6 years (N=180) with obesity and their parents. This study will facilitate a close examination of key treatment components and mechanisms of change. Results from this study will lead to better healthcare options for obesity treatment during childhood and ultimately to the prevention of obesity later in life from a public health perspective.

Detailed description: The proposed randomized controlled trial has four specific aims:

Specific Aim #1: PARENTING OR LIFESTYLE? To determine the effectiveness of two obesity treatment conditions: 1) parent training (n=90) and 2) treatment as usual focused on lifestyle changes (n=90). The two treatment conditions will be evaluated with respect to child weight status (BMI SDS; primary outcome), psychosocial and metabolic health, lifestyle choices, and family functioning (secondary outcomes).

Specific Aim #2: OPTIMAL LENGTH OF TREATMENT AND FOLLOW-UP? To understand the influence of treatment duration we will compare the effectiveness of the parent training program administered for 10 wks only and for 10 wks plus additional booster sessions at 8-week intervals for the following year. All groups will be followed up for at least one year post-baseline.

Specific Aim #3: TO START AT AGE 4,5 OR 6? To assess the influence of child age at the start of treatment on the treatment outcomes.

Specific Aim #4: MEDIATORS AND MODERATORS? To determine whether changes in targeted parenting skills (such as limit setting, monitoring and problem-solving) will mediate child obesity outcomes by examining all treatment groups. In addition, we will examine moderators of intervention effects (e.g. socioeconomic status (SES), parental weight status, and depression).

Eligibility criteria: Inclusion Criteria:

* age 4-6 years old
* obesity as defined by international cut-offs (Cole T. J. et al. BMJ, 2000).

Exclusion Criteria:

* weight affecting diseases

Primary outcomes:
measure: Change in Body Mass Index (BMI) SDS
timeFrame: 1 year
Secondary outcomes:
measure: Change in parenting practices, general and specific
timeFrame: 1 year
measure: Change in child's dietary intake and behaviour
timeFrame: 1 year
measure: Change in child's physical activity
timeFrame: 1 year
measure: Change in family functioning
timeFrame: 1 year
measure: Change in child's metabolic health
timeFrame: 1 year
measure: Change in parent's functioning
timeFrame: 1 year
measure: Waist circumference
timeFrame: Baseline, 3 months, 1 year
measure: Change in child's functioning
timeFrame: 1 year
measure: Change in socioeconomic status
timeFrame: 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institute
Study officials:
affiliation: Karolinska Institutet
name: Paulina Nowicka, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandvik P, Ek A, Eli K, Somaraki M, Bottai M, Nowicka P. Picky eating in an obesity intervention for preschool-aged children - what role does it play, and does the measurement instrument matter? Int J Behav Nutr Phys Act. 2019 Sep 3;16(1):76. doi: 10.1186/s12966-019-0845-y.
citation: Ek A, Lewis Chamberlain K, Sorjonen K, Hammar U, Etminan Malek M, Sandvik P, Somaraki M, Nyman J, Lindberg L, Nordin K, Ejderhamn J, Fisher PA, Chamberlain P, Marcus C, Nowicka P. A Parent Treatment Program for Preschoolers With Obesity: A Randomized Controlled Trial. Pediatrics. 2019 Aug;144(2):e20183457. doi: 10.1542/peds.2018-3457. Epub 2019 Jul 12.
citation: Ek A, Chamberlain KL, Ejderhamn J, Fisher PA, Marcus C, Chamberlain P, Nowicka P. The More and Less Study: a randomized controlled trial testing different approaches to treat obesity in preschoolers. BMC Public Health. 2015 Aug 1;15:735. doi: 10.1186/s12889-015-1912-1.