Information in English
The More & Less Study: A Trial Testing Different Treatment Approaches to Obesity in Preschoolers (M&L)
ClinicalTrials.gov Identifier: NCT01792531
Purpose and Aims
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. We 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 1 year post-baseline. Participants will be children aged 4-6 years (N=120) 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.
In total, 120 families with children aged 4-6 years with obesity will be referred by primary child healthcare to our research group at KI. The families will be randomized to one of two conditions: treatment as usual (standard treatment with focus on lifestyle) (n=60) or parent training (More and Less parent groups) (n=60). The parent training condition will be further randomized into two groups: one will receive the intervention for 12 weeks. (n=30) and one will receive the intervention plus booster sessions (n=30).
More and Less parent groups
The More & Less groups will focus on how to use positive parenting practices (e.g., reinforcement/encouragement, limit setting, monitoring, problem-solving, positive involvement, and emotion regulation) instead of ineffective practices (e.g., coercive behavior, negative reciprocity, escalation, and negative reinforcement). Using a parent-group approach to intervention administration, each of the twelve More & Less sessions (1.5h/wk) consist of introduction to effective parenting practices followed by a discussion and practice using role play and home practice assignments. The information and procedures will be tailored to focus on changes in the home environment, mostly related to child food habits and physical activity.
Standard treatment with focus on lifestyle
The standard treatment will be provided by local pediatricians in outpatient pediatric departments and will be based on lifestyle modifications, as recommended in the action plan for Stockholm County.
4 Specific Aims with the More and Less Study
Specific Aim #1: PARENTING OR LIFESTYLE? To determine the effectiveness of two obesity treatment conditions: 1) parent training (n=60) and 2) treatment as usual focused on lifestyle changes (n=60). 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). This design will allow us to assess whether a program, targeting only parents and focusing on parenting practices will result in better outcomes than treatment as usual emphasizing lifestyle changes.
Specific Aim #2: START AT AGE 4 OR 6? To explore how the child's age at baseline affect treatment outcome. By including children that are 4, 5 to 6 years, it will be possible to determine the effects of age on treatment outcomes.
Specific Aim #3: 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 12 weeks only and for 12 weeks plus additional booster sessions at 8-week intervals for the following year. All groups will be followed up annually for 1 year post-baseline. This design will allow us to evaluate if prolonged care is necessary to maintain intervention effects, or if a 12-week program is equally effective.
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).
This study will demonstrate the clinical effectiveness of different treatment approaches for childhood obesity, specifically: the optimal focus (parenting skills or lifestyle changes), other key determinants influencing treatment outcomes (e.g., SES, parental depression), most effective age to start treatment (4 or 6 years) and optimal treatment duration. In summary, this study will bolster the limited evidence base in this field and provide results highly relevant to the design of future early childhood obesity treatment programs.
The research team including international collaborations
Paulina Nowicka, PhD in pediatrics, registered dietician, family therapist, is the principal investigator (PI) and provides overall programmatic and administrative oversight for the project. She has extensive clinical and scientific experience in childhood obesity treatment. Dr Claude Marcus (Co-investigator), Professor in Pediatrics, assists Dr. Nowicka with the programmatic and administrative oversight of the project as the head of the obesity research team and the head of the Unit of Pediatrics at the Department of Clinical Science, Intervention and Technology (CLINTEC) at Karolinska Institute (KI). Dr. Jan Ejderhamn, MD, PhD (Co-Investigator), provides guidance for the optimal implementation of the treatment condition in the Stockholm County care system. He is in charge of 11 outpatient pediatric obesity clinics in Stockholm County. Dr. Patricia Chamberlain (Co-Investigator), PhD in educational psychology, provides expertise in adapting the parent training for obesity and in implementing the program within Stockholm County. As a senior research scientist at Oregon Social Learning Center, she has an extensive knowledge in implementation processes of parenting programs. Professor Philip Fisher (Consultant) assists in analyzing, interpreting and reporting the data on parenting skills. Dr. Fisher is a Professor in Clinical Psychology at University of Oregon and a senior research scientist at Oregon Social Learning Center with expertise in family-based interventions for preschoolers. Stanley Ulijaszek, PhD, Professor in Human Ecology and Director of the Unit of Biocultural Variation and Obesity at the Institute of Social and Cultural Anthropology at the University of Oxford, assists in analyzing, interpreting and reporting data on sociocultural aspects. Finally, Anna Ek, registered dietician, is a PhD student who has received partial doctoral funding for this project (with Paulina Nowicka as the main supervisor).