The More and Less Study: a randomized controlled trial testing different approaches to treat obesity in preschoolers.

BACKGROUND: While obesity has been shown to be difficult to treat in school aged children and in adolescence, promising results have been detected for children who started treatment in early childhood. Yet knowledge on the effectiveness of structured early childhood obesity treatment programs is limited, preventing the widespread implementation of such programs. The main objective of this study is to evaluate the effectiveness of early treatment of childhood obesity with respect to treatment focus (parenting practices or lifestyle), length and intensity. The study will also examine the influence of gender, age, parental weight status, parenting practices, child behavior as well as parents' socioeconomic status and child and parental psychosocial health on children's weight status.

METHODS/DESIGN: This is a parallel open label randomized controlled trial assessing two different behavioral treatment approaches offered in three conditions to families with children aged 4-6 years in Stockholm County, Sweden. Children (n = 180) identified as obese will be referred from primary child health care, school health care, and from outpatient pediatric clinics, and randomized to: 1) a standard treatment with focus on lifestyle, provided within the current healthcare system (n = 90); 2) a 10-session, 1.5 h/week group treatment with focus on parenting (n = 45); or 3) the same group treatment as 2) with additional follow-up sessions (n = 45). The primary study outcome is change in children's body mass index standard deviation score (BMI SDS) one year post-baseline. Secondary outcomes include changes in children's waist circumference, metabolic health, lifestyle patterns (Food Frequency Questionnaire), obesity-related child behaviors (Child Eating Behavior Questionnaire and Lifestyle Behavior Checklist, Problem Scale), parents' general and feeding parenting practices (Communicating with Children and Child Feeding Questionnaire) and lifestyle-specific self-efficacy (Lifestyle Behavior Checklist, Confidence Scale), family functioning (Family Assessment Device), child and parental psychosocial health (Child Behavior Checklist and Beck's Depression Inventory II).

DISCUSSION: This study will facilitate a close examination of key components of treatment for obesity during early childhood and mechanisms of change. Results from this study will lead to better healthcare options for obesity treatment during early childhood and ultimately to the prevention of obesity later in life.

TRIAL REGISTRATION: ClinicalTrials.gov NCT01792531 Registered February 14, 2013.